66 results on '"Ginevra Fiori"'
Search Results
2. Switching from originator adalimumab to biosimilar SB5 in a rheumatology cohort: persistence on treatment, predictors of drug interruption and safety analysis
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Cosimo Bruni, Stefano Gentileschi, Giovanni Pacini, Marco Bardelli, Lorenzo Tofani, Francesca Bartoli, Caterina Baldi, Laura Cometi, Ginevra Fiori, Francesca Nacci, Luca Cantarini, Serena Guiducci, Alberto Moggi-Pignone, Bruno Frediani, and Marco Matucci-Cerinic
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Diseases of the musculoskeletal system ,RC925-935 - Abstract
Aims: Medical and non-medical switching strategies have been adopted in Europe in the last few years. We aimed to investigate persistence on treatment with a SB5 Adalimumab (SB5) biosimilar after switching from Adalimumab (ADA) originator among patients with inflammatory rheumatic musculoskeletal diseases (iRMD), identifying possible predictors of drug interruption and describing adverse events. Method: iRMD patients previously switched to SB5 after at least 6 months of ADA were enrolled. Data on concomitant medications, disease flares, and persistence on SB5 up to the last available follow up were collected retrospectively. Kaplan–Meier and Cox regression models were used. Result: A total of 172 patients (106 females, ADA duration 5.8 ± 3.8 years) were enrolled, including 34 rheumatoid arthritis, 59 psoriatic arthritis, and 61 axial spondyloarthritis patients. In a 10 ± 3 months follow up, 65 (37.8%) patients presented with adverse events, with 46 (26.7%) showing a clinically defined disease flare (no disease activity and patient reported outcomes assessment were available); 24 patients interrupted SB5 permanently (among them, 11 back-switched to ADA and 8 were prescribed a different biological therapy). Probability of persistence on SB5 was 94.7% at 6 months and 85.1% at 12 months. Baseline corticosteroid [hazard ratio (HR) 3.209, 95% confidence interval (CI) 1.193–8.635, p = 0.021] and therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) (HR 2.876, 95% CI 1.229–6.727, p = 0.015), as well as the baseline corticosteroid dose (HR 1.200, 95%CI 1.026–1.403, p = 0.022) were predictors of drug interruption. Conclusion: Our data on persistence of treatment and adverse events are in line with previous reports. Further large cohort studies may confirm baseline corticosteroid and NSAIDs use as predictors of SB5 interruption, helping to identify patients at higher risk of failure after switching.
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- 2021
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3. Baricitinib in the treatment of rheumatoid arthritis: clinical and ultrasound evaluation of a real-life single-centre experience
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Giulia Tesei, Laura Cometi, Francesca Nacci, Riccardo Terenzi, Lorenzo Tofani, Marco Capassoni, Francesca Bartoli, Ginevra Fiori, Marco Matucci-Cerinic, and Cosimo Bruni
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Diseases of the musculoskeletal system ,RC925-935 - Abstract
Background: Ultrasound (US) is useful in monitoring RA patients, with the US7 score allowing grey-scale and power-Doppler (PD) semi-quantitative evaluation of synovitis and teno-synovitis. We evaluated real-life efficacy and safety of Baricitinib, an oral selective JAK1-2 inhibitor, in RA patients using clinical, clinimetric, and US assessments. Methods: Disease activity score in 28 joints calculated with C-reactive protein (DAS28-CRP), disease activity score in 28 joints calculated with erythrocyte sedimentation rate (DAS28-ESR), clinical disease activity index (CDAI), simplified disease activity index (SDAI), visual analogue scale (VAS)-pain, health assessment questionnaire (HAQ), COCHIN scale, adverse events (AE), concomitant medications, laboratory parameters, and US7 were performed/recorded at baseline, 1, 3, and 6 months in RA patients starting Baricitinib. Responder/non-responder status was determined according to the EULAR Response Criteria at 3 months. SDAI clinical remission or low disease activity (LDA) were calculated at 3 and 6 months. Results: In 43 enrolled patients, a significant improvement in disease activity and US7 components (except tendon PD) and a reduction of steroid dosage were observed. Responders at 3 months showed a significantly higher reduction of CDAI, SDAI, COCHIN scale, VAS-pain, and US7 synovialPD, compared with non-responders. At 3 and 6 months, remission/LDA was achieved by 12.8/53.8% and 21.6/51.3% patients, respectively. The csDMARD co-treatment was independently associated with remission/LDA at 3 months. Safety-related drop-outs were in line with literature data. The steroid dosage was associated with AE development at 6 months. Conclusion: The real-life data, also obtained with US evaluation, confirmed the Baricitinib efficacy in RA disease control, as well as the utility of assessment during the follow up of disease activity.
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- 2021
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4. The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases
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Cosimo Bruni, Stefano Gentileschi, Giovanni Pacini, Caterina Baldi, Marco Capassoni, Lorenzo Tofani, Marco Bardelli, Laura Cometi, Luca Cantarini, Francesca Nacci, Michele Vietri, Francesca Bartoli, Ginevra Fiori, Bruno Frediani, and Marco Matucci-Cerinic
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Diseases of the musculoskeletal system ,RC925-935 - Abstract
Aims: Switching from originator to biosimilar is part of current practice in inflammatory rheumatic musculoskeletal diseases (iRMDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA), with evidences derived from both etanercept (ETN) to SB4-switching randomized controlled trials and real-life registries. We investigated the safety and treatment persistence of ETN/SB4 in a multi-iRMD cohort derived from two rheumatology departments in our region. Methods: Adult patients with iRMDs, treated with ETN for at least 6 months and switched to SB4 in stable clinical condition, were eligible for this retrospective evaluation. Retrospective data on adverse events, loss of efficacy and persistence on treatment were collected until latest available follow-up. Results: A total of 220 patients (85 RA, 81 PsA, 33 axSpA, 14 juvenile idiopathic arthritis and seven other conditions; 142 females, mean age 58 ± 7 years, disease duration 12 ± 4 years, ETN duration 7 ± 4 years) were enrolled, with median follow-up of 12.1 (9.7–15.8) months. A total of 50 patients (22.7%) presented with at least one adverse event, with 36 (16.4%) disease flares and 30 (13.6%: 11 for safety and 19 loss of efficacy) SB4 withdrawals. Cumulative SB4 treatment persistence was 99.1%, 88.6% and 64.6% at 6, 12 and 18 months respectively. Back-switch to ETN was performed in 17/30 cases, the remaining cases were managed with change of biologic disease modifying or conventional synthetic anti-rheumatic drug. Age was the only significant predictor of SB4 interruption at 6 months. Conclusion: Our real-life data confirm the safety profile of switching from ETN to SB4, with slightly higher treatment persistence rates compared with other real-life registries.
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- 2020
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5. Safety and efficacy of biological therapy with TNF-inhibitors and non TNF-inhibitors in a cohort of young adults affected by juvenile idiopathic arthritis (JIA): data from a single centre experience
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Marco Matucci, Serena Capannini, Ginevra Fiori, Fernanda Falcini, and Lorenzo Ceri
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Pediatrics ,RJ1-570 ,Diseases of the musculoskeletal system ,RC925-935 - Published
- 2011
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6. The positive side of the coin: Sars-Cov-2 pandemic has taught us how much Telemedicine is useful as standard of care procedure in real life
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Laura Cometi, Maria Letizia Conforti, Martina Orlandi, Khadija El Aoufy, Laura Rasero, Francesca Bartoli, Francesca Nacci, Jelena Blagojevic, Serena Guiducci, Alberto Moggi-Pignone, Marco Matucci-Cerinic, Maria Ramona Melis, Ginevra Fiori, Cosimo Bruni, and Silvia Bellando Randone
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Sars-Cov-2 ,Telemedicine ,Standard of care ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Risk of infection ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,COVID-19 ,Standard of Care ,General Medicine ,medicine.disease ,Rheumatic and Musculoskeletal Diseases ,Rheumatology ,Pandemic ,Communicable Disease Control ,Outpatient clinic ,Medicine ,In real life ,Humans ,Medical emergency ,business ,Perspectives in Rheumatology ,Pandemics ,Retrospective Studies - Abstract
Patients and health workers were at high risk of infection during the Sars-Cov-2 pandemic lockdown. For this reason, other medical and clinical approaches such as Telemedicine were necessary. Despite Telemedicine was born before COVID-19, the pandemic was the opportunity to accelerate a process already underway for at least a decade and to blow all the barriers away. Our aim is to describe the experience of Telemedicine during and immediately after the first lockdown to assure the follow-up in a 'virtual' outpatient clinic dedicated to Rheumatic and Musculoskeletal Diseases (RMDs) and to give an overview of Telemedicine in the rheumatology field. We retrospectively evaluated the patient flow to our rheumatology division from March to September 2020 and, in accordance with local restrictions, three periods were selected. In the 1st period, 96.96% of the outpatient clinic cases were shifted to Telemedicine; these decreased to 52.45% in the 2nd period, while the 3rd period was characterized by the return of the patients at the clinic (97.6%). Diagnostic procedures were postponed during the 1st period, reduced drastically during the 2nd and performed regularly during the third period. Intravenous infusions were maintained as much as possible during the three periods, to assure therapeutic continuity. Shifting stable patients to Telemedicine has the potential to allow continuity of care, while reducing the risk of contagion during a pandemic. In the next future, the integration of Telemedicine as standard of care for specific clinical applications might assure assistance for RMDs patients also in non-pandemic conditions.
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- 2021
7. Persistence of remission after lengthening of golimumab in inflammatory joint diseases
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Arianna, Damiani, Francesca, Bartoli, Giovanni, Pacini, Davide, Carboni, Silvia, Bellando Randone, Ginevra, Fiori, Marco, Matucci-Cerinic, and Serena, Guiducci
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Rheumatology ,Immunology ,Immunology and Allergy - Abstract
In refractory inflammatory joint diseases (IJDs) biological disease-modifying anti-rheumatic drugs (bDMARDs) may achieve remission. EULAR recommends bDMARD tapering when remission persists. However, guidelines on tapering modalities and criteria for patient selection are lacking. We aimed to evaluate remission persistency after lengthening the time between injections of golimumab in patients affected by IJD and to identify any patient or disease characteristics associated to flare after lengthening.Patients affected by rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and juvenile idiopathic arthritis (JIA) treated with golimumab were enrolled in a retrospective observational study. Demographic data, ESR, cRP, DAS28/ BASDAI, were collected at baseline and during the follow-up (T1- defined as a medical check-up after 1 year of treatment or, for patients with longerg exposure, the first medical check-up in 2016, when at our unit we began to experience drug tapering- and T2- 12 months after the lengthening was started). In 22/80 patients in remission at T1, injection time was lengthened.Eighty patients were enrolled, 34 AS, 33 PsA, 9RA and 4 JIA. At baseline, all had an active disease. At T1, 60/80 patients reached remission and 22/60 patients started tapering. At T2, 20/22 pts (91%) were in remission. At T1 BASDAI was higher (2.2, SD 0.28 vs. 0.58, SD 0.47; p0.001) in patients who lost remission at T2.Patients who flared recovered remission once taken back to a 28-day interval. 4/38 patients maintained at the standard dose flared up and switched/swapped bDMARD. The difference in retention rate toward patients on reduced dose was not significant.Results show that golimumab lengthening is safe and successfully maintains remission. In patients who experienced a flare after lengthening, the standard regimen promptly restored remission.
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- 2022
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8. The switch from etanercept originator to SB4: data from a real-life experience on tolerability and persistence on treatment in joint inflammatory diseases
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Michele Vietri, Francesca Bartoli, Marco Matucci-Cerinic, Bruno Frediani, Ginevra Fiori, Cosimo Bruni, Laura Cometi, Lorenzo Tofani, Caterina Baldi, Marco Bardelli, Giovanni Pacini, Marco Capassoni, Francesca Nacci, Stefano Gentileschi, and Luca Cantarini
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0301 basic medicine ,safety ,etanercept ,persistence ,rheumatic diseases ,SB4 ,switch ,medicine.medical_specialty ,The Role of Biosimilars in the Management of Rheumatic Diseases ,Diseases of the musculoskeletal system ,Etanercept ,Persistence (computer science) ,03 medical and health sciences ,Psoriatic arthritis ,0302 clinical medicine ,Rheumatology ,Internal medicine ,medicine ,Orthopedics and Sports Medicine ,Original Research ,030203 arthritis & rheumatology ,business.industry ,Biosimilar ,medicine.disease ,030104 developmental biology ,RC925-935 ,Tolerability ,Current practice ,Rheumatoid arthritis ,business ,medicine.drug - Abstract
Aims: Switching from originator to biosimilar is part of current practice in inflammatory rheumatic musculoskeletal diseases (iRMDs) such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (axSpA), with evidences derived from both etanercept (ETN) to SB4-switching randomized controlled trials and real-life registries. We investigated the safety and treatment persistence of ETN/SB4 in a multi-iRMD cohort derived from two rheumatology departments in our region. Methods: Adult patients with iRMDs, treated with ETN for at least 6 months and switched to SB4 in stable clinical condition, were eligible for this retrospective evaluation. Retrospective data on adverse events, loss of efficacy and persistence on treatment were collected until latest available follow-up. Results: A total of 220 patients (85 RA, 81 PsA, 33 axSpA, 14 juvenile idiopathic arthritis and seven other conditions; 142 females, mean age 58 ± 7 years, disease duration 12 ± 4 years, ETN duration 7 ± 4 years) were enrolled, with median follow-up of 12.1 (9.7–15.8) months. A total of 50 patients (22.7%) presented with at least one adverse event, with 36 (16.4%) disease flares and 30 (13.6%: 11 for safety and 19 loss of efficacy) SB4 withdrawals. Cumulative SB4 treatment persistence was 99.1%, 88.6% and 64.6% at 6, 12 and 18 months respectively. Back-switch to ETN was performed in 17/30 cases, the remaining cases were managed with change of biologic disease modifying or conventional synthetic anti-rheumatic drug. Age was the only significant predictor of SB4 interruption at 6 months. Conclusion: Our real-life data confirm the safety profile of switching from ETN to SB4, with slightly higher treatment persistence rates compared with other real-life registries.
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- 2020
9. Efficacy and safety of switching from reference adalimumab to SB5 in a real-life cohort of inflammatory rheumatic joint diseases
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Francesca Bartoli, Roberta Bitti, Marco Matucci-Cerinic, Francesca Nacci, Ginevra Fiori, Cosimo Bruni, Lorenzo Tofani, and Laura Cometi
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Adult ,medicine.medical_specialty ,Arthritis ,law.invention ,Arthritis, Rheumatoid ,03 medical and health sciences ,Psoriatic arthritis ,0302 clinical medicine ,Rheumatology ,Randomized controlled trial ,law ,Internal medicine ,Psoriasis ,medicine ,Adalimumab ,Humans ,030212 general & internal medicine ,skin and connective tissue diseases ,Adverse effect ,Biosimilar Pharmaceuticals ,Aged ,030203 arthritis & rheumatology ,business.industry ,Arthritis, Psoriatic ,General Medicine ,Middle Aged ,medicine.disease ,Treatment Outcome ,Rheumatoid arthritis ,Antirheumatic Agents ,Female ,business ,medicine.drug - Abstract
SB5 showed comparable efficacy and safety profile in respect to adalimumab originator (ADA) in randomized clinical trials of rheumatoid arthritis (RA) and psoriasis. We aimed to describe the efficacy and safety of SB5 after switching from ADA in RA, axial spondyloarthritis (axSpA), psoriatic arthritis (PsA) and juvenile idiopathic arthritis (JIA) patients.Adult RA, PsA, axSpA, JIA patients treated with ADA for at least 6 months, switched to SB5 in stable clinical conditions, were eligible. Data on safety, activity indexes and patient-reported outcomes were collected at baseline, 3 and 6 months after switching.Eighty-two patients (19 RA, 28 PsA, 32 axSpA and 3 JIA; 45 females, mean age 54 ± 14 years, disease duration 13 ± 7 years, ADA duration 6 ± 3 years) were enrolled. RA patients showed stable conditions, while PsA patients showed an increase in both HAQ, DAS28(CRP) and DAPSA and axSpA patients an increase in VAS pain, VAS patient disease activity and ASDAS, both at 3 months. There were changes in the concomitant medications profile, with regression of activity indexes increases at 6 months. Adverse events were reported by 33.7% patients at 3 months and 16.6% patients at 6 months, mostly disease flares and infectious events. Two patients stopped SB5.Despite temporary changes in the concomitant medication profile for mild disease flares, our real-life data replicate the safety profile of switching from ADA to SB5 in RA, with additional data for its applicability in PsA and axSpA patients, further supporting switching to biosimilars in treating inflammatory rheumatic conditions. Key Points • Switching from adalimumab originator to SB5 is feasible in real life rheumatic inflammatory joint diseases. • Mild disease flares can present after switching from originator adalimumab to SB5, in particular in axial spondyloarthritis and psoriatic arthritis. • Changes in concomitant medications profile allows the control of minor disease flares presenting after switching from adalimumab originator to SB5.
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- 2020
10. AB0256 BARICITINIB (BARI) VERSUS BIOLOGICS IMPACT ON STEROID TAPERING IN RHEUMATOID ARTHRITIS (RA)
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C. Bruni, Laura Cometi, Francesca Bartoli, Ginevra Fiori, M. Matucci-Cerinic, Francesca Nacci, Giulia Tesei, and Lorenzo Tofani
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medicine.medical_specialty ,education.field_of_study ,business.industry ,Abatacept ,Immunology ,Population ,medicine.disease ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,chemistry.chemical_compound ,Tocilizumab ,Rheumatology ,chemistry ,Prednisone ,Rheumatoid arthritis ,Internal medicine ,medicine ,Adalimumab ,Immunology and Allergy ,business ,education ,medicine.drug ,Janus kinase inhibitor - Abstract
Background:Biologic and target synthetic disease modifying anti-rheumatic drugs (bDMARDs and tcDMARDs) are recommended to control RA disease activity, pain and steroid use. Following randomized clinical trials (RCTs) and their post-hoc analyses, the Janus Kinase Inhibitor tsDMARDs BARI was superior to reference bDMARD Adalimumab in reducing disease activity, pain and functional disability. In addition, BARI monotherapy also determined more significant pain reduction and functional improvement when compared to Tocilizumab monotherapy (3).Objectives:to confirm RCT results in a real-life clinical setting, with focus on disease activity, pain, functional disability and steroid tapering, when comparing BARI to bDMARDs for the treatment of active RA.Methods:RA patients starting BARI or a bDMARD for active RA were retrospectively evaluated from June 2019 to June 2020. Disease activity (DAS28CRP, SDAI, CDAI), pain visual analogic scale (pain_VAS), functional disability (HAQ) assessments and mean prednisone dosage (pred_dose) were collected at baseline (BL), 3 months (3M) and 6 months (6M) after BARI/bDMARD initiation. The changes of the outcome measures were evaluated between BL-3M, 3M-6M and BL-6M, as well as between BARI and bDMARDs groups. Finally, we assessed the variables associated with prednisone tapering in the whole population.Results:90 out of 100 RA patients evaluated (baseline: age 57±12 years, disease duration 131±100 months, DAS28PCR 4.8±1.0, pain_VAS 61±23 mm, prednisone dose 5.5±5.3 mg) were eligible for the study; 49 received BARI and 41 bDMARDs (17 abatacept, 12 TNF inhibitors, 11 tocilizumab, 1 rituximab). At BL, the two groups did not differ statistically in terms of age, sex, disease duration, disease activity, pain_VAS, previous bDMARD failure or ts/bDMARD naive, concomitant conventional synthetic DMARDs treatment, pred_dose. Both BARI and bDMARDs determined a significant reduction in activity scales and HAQ when comparing BL-3M and BL-6M, with only pain_VAS and pred_dose showing a significant decrease in the 3M-6M interval. When comparing the two groups, BARI showed a significantly higher reduction of pred_dose (-3.2±5.1 vs -1.7±3.7 mg at BL-3M, and -4.1±5.3 vs -1.9±4.6 mg at BL-6M), which was not significant after adjusting for BL pred_dose. No other difference was seen when the two groups, including the numerically higher reduction of pain_VAS in the BARI group (-29±28 vs -20±27 mm at BL-3M and -35±25 vs -30±28 mm at BL-6M comparison). The analysis of the predictors for steroid tapering (Δmean_pred) in the two intervals, showed that BL DAS28PCR, DAS28PCR BL-3M change and BL pred_dose were associated with BL-3M Δmean_pred, while 3M pain_VAS and 3M pred_dose were associated with 3M-6M Δmean_pred.Conclusion:Although limited by the small samples and the retrospective nature, our real-life comparison shows similar efficacy of BARI and bDMARDs in terms of disease activity control, functional disability and pain. In addition, the treatment with BARI or bDMARD did not influence the steroid tapering, which was driven mostly by its initial dose, disease activity and pain. Larger real-life multi-center studies are warranted to confirm our results.References:[1]Taylor PC et al. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662.[2]Fautrel B et al. Effect of Baricitinib and Adalimumab in Reducing Pain and Improving Function in Patients with Rheumatoid Arthritis in Low Disease Activity: Exploratory Analyses from RA-BEAM. J Clin Med. 2019 Sep 5;8(9):1394.[3]Fautrel B et al. Comparative effectiveness of improvement in pain and physical function for baricitinib versus adalimumab, tocilizumab and tofacitinib monotherapies in rheumatoid arthritis patients who are naïve to treatment withDisclosure of Interests:Laura Cometi: None declared, Cosimo Bruni Speakers bureau: Actelion, Consultant of: Eli Lilly, Grant/research support from: Fondazione Italiana Ricerca sull’Artrite (FIRA), Gruppo Italiano lotta alla Sclerodermia (GILS), New Horizon Fellowship, European Scleroderma Trials and Research (EUSTAR) group, Foundation for Research in Rheumatology (FOREUM)., Lorenzo Tofani: None declared, Giulia Tesei: None declared, Francesca Nacci: None declared, Ginevra Fiori: None declared, Francesca Bartoli: None declared, Marco Matucci-Cerinic Speakers bureau: Biogen Italia, Actelion, Bayer, Boehringer Ingelheim, CSL Behring, Eli-Lilly, Consultant of: Biogen Italia, Actelion, Bayer, Boehringer Ingelheim, CSL Behring, Eli-Lilly, Grant/research support from: Biogen Italia, Actelion, Bayer, Boehringer Ingelheim, CSL Behring, Eli-Lilly
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- 2021
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11. AB0361 EFFICACY AND SAFETY OF BARICITINIB (BARI) IN RHEUMATOID ARTHRITIS(RA): CLINICAL AND ULTRASOUND EVALUATION IN REAL LIFE
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Cosimo Bruni, Lorenzo Tofani, Riccardo Terenzi, Francesca Bartoli, Francesca Nacci, Marco Matucci-Cerinic, Ginevra Fiori, Marco Capassoni, Laura Cometi, and Giulia Tesei
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education.field_of_study ,medicine.medical_specialty ,Tenosynovitis ,business.industry ,medicine.drug_class ,Immunology ,Population ,Ultrasound ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,Rheumatology ,Synovitis ,Rheumatoid arthritis ,Internal medicine ,Concomitant ,Immunology and Allergy ,Medicine ,Corticosteroid ,business ,education ,Adverse effect - Abstract
Background:Remission or low disease activity (LDA) are the ultimate goals of both conventional synthetic (csDMARD), target synthetic and biologic disease-modifying anti-rheumatic drugs (bDMARD) in treating RA. Janus Kinase (JAK) inhibitors are nowadays part of tsDMARDs, with BARI as an oral selective JAK1-2 inhibitor. Ultrasound (US) is a valuable imaging tool for detecting inflammatory joint changes and monitoring RA patients. The US7 score (US7) is a semiquantitative score including grayscale (GS) and power Doppler (PD) measurements of synovitis and tenosynovitis in 7 joints of the clinically dominant hand and foot.Objectives:to evaluate real life efficacy and safety of BARI 4 mg in RA patients using clinical, clinimetric and US evaluation.Methods:adult RA patients starting BARI were eligible. DAS28ESR, CDAI, SDAI, painVAS, HAQ, COCHIN, laboratory parameters and US7 were performed/collected at baseline (BL) and after 3 and 6 months. Adverse events (AE) and concomitant medications were recorded. Responder/non responder status was determined using DAS28ESR improvement according to the EULAR Response Criteria at 3 months. Moreover, SDAI clinical remission or LDA (remission: SDAI≤3,3; LDA:3,3Results:43 patients (12 csDMARD and 31 bDMARD failure) were enrolled, with 30 patients starting BARI in combination with a csDMARDs. BL painVAS was 68±23mm and disease activity was moderate to severe according to DAS28VES, CDAI and SDAI. BARI determined a significant improvement of every disease activity composite score and US7 components, except tendon PD; steroid daily dosage was significantly reduced.28 patients were considered Responders at 3 months: responders used to have higher disease activity levels and synovitis scores at baseline.Table 1.Comparisons demographics and renal pathologies of responder and non-responder groupsBL3Mp value6Mp valueRNRRNRRNRpainVAS67,88±23,3758,18±22,7230,19±23,5245,64±25,48p=0.004030,19±20,4229,73±22,15p=0.2105Daily prednisone equivalent5,97±5,575,45±4,302,96±3,023,95±3,63p=0.22481,63±2,103,03±3,59p=0.1247GSS8,50±5,257,00±3,813,69±3,632,33±2,45p=0.93343,56±3,014,22±2,64p=0.2452GST2,88±2,333,11±2,090,88±0,891,56±1,59p=0.65011,00±1,372,78±1,72p=0.0831PDS8,00±7,113,33±3,463,00±3,482,44±3,36p=0.00663,25±3,135,00±4,56p=0,0006PDT2,81±2,462,44±3,360,88±1,541,33±1,50p=0.449901,06±1,533,78±3,19p=0.0156Erosions1,25±2,050,44±0,731,50±2,030,44±0,73p=0.07361,31±2,091,11±1,27p=0.0902Interestingly, painVAS and steroid dosage significantly decreased both in responders and non-responders, achieving similar value at 6 months. Non-responders showed both synovial and tendon involvement relapse at 6 months, with significantly higher PD score compared to responders. Remission was reached by 12,8% patients at 3 months and 21,6% at 6 months, while LDA patients were respectively 53,8% and 51,3%; combination with csDMARD was the only factor positively associated with remission/LDA at 3 months.The percentage of dropped-out patients due to AE was aligned with literature data (5% in 6 months) whereas the percentage of Herpes Zoster Virus (HZV) infections was higher (4,6% in 6 months in our population vs 4,3% in 1 year in RCTs). Corticosteroid dosage was directly associated with AE development at 6 months.Conclusion:Real life data confirmed BARI RCTs efficacy and safety data. Non responders showed both synovial and tendon PD disease relapse, despite painVAS and steroid reduction were comparable to responders. In our population, HZV infection prevalence was higher than in RCTs and corticosteroid dosage was positively associated with AE development at 6 months.Disclosure of Interests:Giulia Tesei: None declared, Cosimo Bruni Speakers bureau: Actelion, Eli Lilly, Laura Cometi: None declared, Francesca Nacci: None declared, Marco Capassoni: None declared, Riccardo Terenzi: None declared, Lorenzo Tofani: None declared, Francesca Bartoli: None declared, Ginevra Fiori: None declared, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Bristol-Myers Squibb, Speakers bureau: Acetelion, Lilly, Boehringer Ingelheim
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- 2020
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12. Effect of Dysmetabolisms and Comorbidities on the Efficacy and Safety of Biological Therapy in Chronic Inflammatory Joint Diseases
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Nicolò Chiti, Lorenzo Tofani, Serena Guiducci, Francesca Bartoli, Cosimo Bruni, Marco Matucci-Cerinic, Ginevra Fiori, Daniela Melchiorre, Laura Cometi, Francesca Nacci, and Silvia Bellando-Randone
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Drug ,rheumatoid arthritis ,medicine.medical_specialty ,arterial hypertension ,media_common.quotation_subject ,retention rate ,lcsh:Medicine ,030204 cardiovascular system & hematology ,Article ,03 medical and health sciences ,Psoriatic arthritis ,0302 clinical medicine ,Diabetes mellitus ,Internal medicine ,ankylosing spondylitis ,medicine ,cardiovascular diseases ,Adverse effect ,media_common ,030203 arthritis & rheumatology ,psoriatic arthritis ,Ankylosing spondylitis ,biology ,business.industry ,lcsh:R ,dyslipidemia ,Angiotensin-converting enzyme ,General Medicine ,angiotensin ,medicine.disease ,adverse events ,Rheumatoid arthritis ,biology.protein ,bDMARDs ,business ,Dyslipidemia - Abstract
In the present study we evaluated how systemic arterial hypertension (SAH), dyslipidemia and diabetes mellitus influence the efficacy, safety and retention rate of biological disease-modifying anti-rheumatic drug (bDMARD) treatment in rheumatic musculoskeletal disorders (RMDs). The charts of RMD patients treated with the first-line bDMARD were reviewed, collecting data on safety, efficacy and comorbidities at prescription (baseline, BL), after 6 months (6M) and at last observation on bDMARD (last observation time, LoT). In 383 RMD patients, a higher rate of adverse events at 6M (p = 0.0402) and at LoT (p = 0.0462) was present in dyslipidemic patients. Patients who developed dyslipidemia or SAH during bDMARD treatment had similar results (dyslipidemia p = 0.0007, SAH p = 0.0319) with a longer bDMARD retention as well (dyslipidemia p <, 0.0001, SAH p <, 0.0001). SAH patients on angiotensin converting enzyme inhibitors (ACEis) or angiotensin-II receptor blockers (ARBs) continued bDMARDs for longer than non-exposed patients (p = 0.001), with higher frequency of drug interruption for long-standing remission rather than inefficacy or adverse reactions (p = 0.0258). Similarly, dyslipidemic patients on statins had a better bDMARD retention than not-exposed patients (p = 0.0420). In conclusion, SAH and dyslipidemia may be associated with higher frequency of adverse events but a better drug retention of first-line bDMARD in RMDs, suggesting an additional effect of ACEis/ARBs or statins on the inflammatory process and supporting their use in RMD bDMARD patients with SAH/dyslipidemia.
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- 2020
13. AB0369 SAFETY, EFFICACY AND RETENTION RATE OF BIOLOGIC DISEASE MODIFYING ANTI-RHEUMATIC DRUGS (BDMARDS) IN ASSOCIATION WITH DENOSUMAB: COMPARISON OF COMBINATION AND MONO-THERAPY REGIMENS
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Silvia Bellando Randone, Cosimo Cigolini, Giulia Tesei, Cosimo Bruni, Serena Guiducci, Maria Letizia Conforti, Marco Matucci-Cerinic, Ginevra Fiori, and Francesca Bartoli
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medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,Osteoporosis ,Disease ,Retention rate ,medicine.disease ,Rheumatology ,Denosumab ,Internal medicine ,Erythrocyte sedimentation rate ,medicine ,business ,Adverse effect ,Complication ,medicine.drug - Abstract
Background Osteoporosis is a frequent complication of rheumatic muscle-skeletal diseases (RMD), with high impact from steroid treatment. It is known that bDMARD impact positively on patients’ prognosis and this is also known for Denosumab, a monoclonal antibody for osteoporosis. The combination treatment with two monoclonal antibodies, bDMARD & denosumab, has addressed the problem of safety and efficacy, with incomplete answers from the available literature. Objectives: to evaluate the impact of the combination treatment bDMARD+Denosumab (COMBO group), compared to mono-therapy with bDMARD (MONO group), on clinical efficacy, safety and treatment retention of bDMARD in patients with RMD. Methods RMD patients treated with COMBO therapy where enrolled from a single centre rheumatology unit; for each case, at least one MONO therapy control (matched per age±5 years, sex, bDMARD, RMD, without osteoporosis) was enrolled. Data on clinical efficacy (3-points Likert scale for physician and patient – improved/stable/worse), safety (locl reaction, serious and non-serious adverse events) and bDMARD treatment retention at 12, 18 and 24 months. Results Out of 129 eligible patients, 77 were enrolled in the protocol: 49 in the MONO and 28 in the COMBO group. The two groups were different of age (slightly higher in the COMBO group), for tender joint count, erythrocyte sedimentation rate and c-reactive protein (higher in the MONO group). Efficacy analysis showed higher percentage of clinical improvement at 12 months in the MONO group at 12 months, being not significant at 18 and 24 months (possibly explained by a different disease activity at baseline visit, corresponding to the overlap of denosumab on top of bDMARD in the COMBO and to the initiation of bDMARD in the MONO group). Between the 2 groups, no difference about safety and retention rate was found. Conclusion: the efficacy of COMBO treatment is similar to MONO therapy. Moreover, the data show that also safety and retention rate are similar. Therefore, the COMBO treatment with 2 different monoclonals can be safely employed in the treatment of RMDs and osteoporosis. Disclosure of Interests Cosimo Bruni: None declared, Cosimo Cigolini: None declared, Giulia Tesei: None declared, Francesca Bartoli: None declared, Ginevra Fiori: None declared, Maria Letizia Conforti: None declared, Silvia Bellando Randone: None declared, Serena Guiducci: None declared, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Pfizer, BMS, Chemomab, Sanipedia, Speakers bureau: Actelion, BMS; MSD, Janssen
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- 2019
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14. POS0618 PERSISTENCE OF REMISSION AFTER TAPERING OF GOLIMUMAB IN INFLAMMATORY JOINT DISEASE (IJD)
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Silvia Bellando-Randone, Serena Guiducci, Ginevra Fiori, Francesca Bartoli, V. Gori, M. Matucci-Cerinic, and A. Damiani
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Persistence (psychology) ,medicine.medical_specialty ,business.industry ,Immunology ,Tapering ,General Biochemistry, Genetics and Molecular Biology ,Golimumab ,Joint disease ,Rheumatology ,Internal medicine ,Immunology and Allergy ,Medicine ,business ,medicine.drug - Abstract
Background:In refractory IJD, remission may be obtained with antiTNFa drugs and other biological disease modifying anti-rheumatic drugs (bDMARDs). The last EULAR recommendations suggest tapering of bDMARD when remission persists1. However, best timing and modality of tapering are uncertain and specific knowledge on patients’ characteristics associated to a better outcome is still lacking.Objectives:To evaluate the persistency of remission after increasing the interval between injections of Golimumab in a group of patients affected by rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and juvenile idiopathic arthritis (JIA) and to identify any variables associated to disease flare after tapering.Methods:Between 2011 and July 2020, 80 patients affected by RA, PsA, AS and JIA treated with Golimumab were enrolled. Their demographic and clinical data, including inflammation (ESR and cRP) and clinimetric indices (DAS28 or BASDAI), were collected at baseline and during the follow up visit (T1). In 22/80 patients that reached clinical remission at T1, the time between Golimumab injections has been prolonged (mean time between injection: 43.7 days); ESR and cRP, DAS28/BASDAI, and time since the start of the tapering (weeks) were evaluated in the next control visit (T2).Results:80 patients were enrolled (32 male, mean age 50.6 years +/- 13.91), 34 AS, 33 PsA, 9 RA and 4 JIA. At baseline they have an active disease with a DAS 28 of 4.74+/-0.85 and a BASDAI of 5.23+/- 1.31. At T1, 60/80 patients were in remission (75%), with a mean DAS 28 of 1.84+/- 0.6 and an average BASDAI of 1.32+/-0.6, and 22/60 patients started drug tapering. At T2, 20/22 patients (91%) were in remission, (DAS 28 1.9+/-0.49, BASDAI of 0.8+/- 0, 67). A significantly higher BASDAI was observed at T1, even though in the range of absence of disease activity (2.2, +/- 0.28 vs 0.58, +/- 0.47; p vs reduced dose was not statistically significative.Conclusion:Tapering of Golimumab was successful in 91% of the cases without flare. Moreover, the prolongation of the increase of the treatment window provided the same result as that obtained in patients that continued in the standard time window. This evidence suggests that the extension of the gap between Golimumab administrations may be feasible and safely applied in practice.References:[1]Smolen JS, Landewé RBM, Bijlsma JWJ, et al EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update Annals of the Rheumatic Diseases 2020;79:685-699.Disclosure of Interests:None declared
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- 2021
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15. POS1495-HPR THE EXPERIENCE OF A RHEUMATOLOGY UNIT DURING THE COVID19 LOCKDOWN: TELEMEDICINE ALLOWS A SAFE FOLLOW UP OF PATIENTS WITH RHEUMATIC DISEASES
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M. Matucci-Cerinic, M. R. Melis, Jelena Blagojevic, Laura Cometi, Ginevra Fiori, Francesca Nacci, K. El Aoufy, M L Conforti, Francesca Bartoli, Serena Guiducci, C. Bruni, A. Moggi Pignone, Laura Rasero, and S. Bellando Randone
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medicine.medical_specialty ,Telemedicine ,business.industry ,Immunology ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,Rheumatology ,Unit (housing) ,Patient flow ,Clinical trial ,Internal medicine ,medicine ,Immunology and Allergy ,Outpatient clinic ,Continuity of care ,Day hospital ,Medical emergency ,business - Abstract
Background:In March this year, most of the routine activities were cancelled during the streaming of the pandemic in Italy. This prompted a pragmatic reorganization of the traditional care model of nursing and medicine, to quickly give an efficient clinical response. During the first phase of the pandemic, outpatient visits dropped by more than 60%, forcefully shifting to telemedicine to assure continuity of care despite the lockdown.Objectives:The aim of the present work was to describe the strategy adopted during and immediately after the lockdown to assure the follow up of patients and the maintenance of their treatment in an outpatient “virtual” telemedicine clinic dedicated to RDs.Methods:the patient flow to a rheumatology division during the lockdown was evaluated retrospectively from March to September 2020 in accordance with local restrictions, and three periods are described.Results:653/913 (71.5%), 542/542 (100%) and 1.048/1.048 (100%) infusion activities scheduled were performed at the centre for daily infusion and pre-infusion assessment, respectively during the 1st, 2nd and 3rd period. In the outpatient clinic during the 1st period, 96.96% of the cases was shifted to Telemedicine, which decreased to 52.45% in the 2nd period; while in the 3rd period, 97.6% of the performances were carried out at the clinic. Diagnostic procedures, such as ultrasound, capillaroscopy, and joint injection were generally postponed during the 1st period, reduced drastically during the 2nd and performed regularly during 3rd period. Ulcer treatment and the Clinical Trial Unit never stopped their activity. The flow of the activity of the outpatient clinic and the day hospital is represented as monthly trends in graph 1 (See Graph 1).Conclusion:Our data show the feasibility of Telemedicine in a lockdown condition. Shifting stable patients to Telemedicine has the potentiality to minimize the risk of contagion and allow continuity of care. In the future, the use of Telemedicine for specific clinical uses might assure patient assistance also in non-pandemic conditions.References:[1]Rawaf S, Allen LN, Stigler FL et al. Lessons on the COVID-19 pandemic, for and by primary care professionals worldwide. Eur J Gen Pract. 2020 Dec;26(1):129-133. doi: 10.1080/13814788.2020.1820479. PMID: 32985278.[2]McDougall JA, Ferucci ED, Glover J, et al. Telerheumatology: A Systematic Review. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1546-1557. doi: 10.1002/acr.23153. Epub 2017 Aug 22. PMID: 27863164; PMCID: PMC5436947.[3]Romão VC, Cordeiro I, Macieira C, Oliveira-Ramos F, Romeu JC, Rosa CM, Saavedra MJ, Saraiva F, Vieira-Sousa E, Fonseca JE. Rheumatology practice amidst the COVID-19 pandemic: a pragmatic view. RMD Open. 2020 Jun;6(2):e001314. doi: 10.1136/rmdopen-2020-001314. PMID: 32584782; PMCID: PMC7425193.Characters from table content including title and footnotes:Graph 1.Monthly trend for telemedicine and visits during the SARS Cov2 emergencyAcknowledgements:The project (Telereuma) has been supported by an unrestricted grant of Biogen, BMS, and Novartis.Disclosure of Interests:None declared
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- 2021
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16. Assessment, Definition, and Classification of Lower Limb Ulcers in Systemic Sclerosis: A Challenge for the Rheumatologist
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Laura Benelli, Silvia Bellando Randone, Francesca Braschi, Serena Guiducci, Marco Matucci-Cerinic, Ginevra Fiori, Francesca Bartoli, Felice Galluccio, Sergio Castellani, Alberto Moggi Pignone, Guya Piemonte, Jelena Blagojevic, Francesco Epifani, Laura Rasero, Maria Boddi, and Laura Cometi
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Male ,medicine.medical_specialty ,Hyperkeratoses ,Arterial disease ,Immunology ,Hyperkeratosis ,030204 cardiovascular system & hematology ,Lower limb ,Microscopic Angioscopy ,Pathogenesis ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Calcinosis ,Internal medicine ,medicine ,Humans ,Immunology and Allergy ,Significant risk ,Ultrasonography, Doppler, Color ,Aged ,Aged, 80 and over ,030203 arthritis & rheumatology ,Scleroderma, Systemic ,business.industry ,Leg Ulcer ,Keratosis ,Middle Aged ,medicine.disease ,Dermatology ,digestive system diseases ,Surgery ,Lower limb ulcers ,Pathogenesis classification ,Systemic sclerosis ,Microvessels ,Female ,business - Abstract
Objective.To evaluate pathogenesis and clinical features of lower limb ulcers in systemic sclerosis (SSc) and to propose a classification that could be used in clinical practice.Methods.Charts of 60 patients with SSc who had lower limb cutaneous lesions were reviewed. All patients had videocapillaroscopy and arterial and venous lower limb color Doppler ultrasonography (US). Arteriography was performed if occlusive peripheral arterial disease was suspected.Results.The 554 lesions were classified as hyperkeratosis, ulcers, and gangrenes. There were 341 (61.6%) hyperkeratoses, 208 (37.5%) ulcers, and 5 (0.9%) gangrenes. Ulcers were divided into pure ulcers, ulcers associated with hyperkeratosis, and ulcers secondary to calcinosis. Involvement of arterial and venous macrocirculation as determined by color Doppler US was observed in 17 (18.3%) and 18 (30%) patients, respectively. Seventeen out of 37 patients with pure ulcers (45.9%) presented neither venous insufficiency nor hemodynamically significant macrovascular arterial disease. In these patients, pure ulcers were most likely caused by isolated SSc-related microvascular involvement (pure microvascular ulcers). The only significant risk factor for development of pure microvascular ulcers in the multivariate analysis was the history of lower limb ulcers (OR 26.67, 95% CI 2.75–259.28; p < 0.001).Conclusion.Results of our study indicate that lower limb ulcers in SSc often have a multifactorial pathogenesis that may be difficult to manage. Further studies are needed to validate the proposed classification and to assess the most appropriate management of lower limb ulcers in SSc.
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- 2016
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17. AB0239 EFFECTS OF DYSMETABOLISMS AND COMORBIDITIES ON THE EFFICACY, SAFETY AND RETENTION RATE OF BIOLOGICAL DMARDS (bDMARD) IN INFLAMMATORY JOINT DISEASES
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Lorenzo Tofani, Francesca Nacci, Laura Cometi, Cosimo Bruni, N. Chiti, Marco Matucci-Cerinic, Serena Guiducci, Ginevra Fiori, Francesca Bartoli, and S. Bellando Randone
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medicine.medical_specialty ,Ankylosing spondylitis ,business.industry ,Immunology ,Arthritis ,medicine.disease ,Angiotensin II ,General Biochemistry, Genetics and Molecular Biology ,Psoriatic arthritis ,Rheumatology ,Rheumatoid arthritis ,Internal medicine ,medicine ,Immunology and Allergy ,Glucose homeostasis ,business ,Adverse effect ,Dyslipidemia - Abstract
Background:bDMARDs have an effect on glucose homeostasis (1), lipoproteins profile (2; 3) and blood pressure (4). However, with the exception of obesity (5; 6), there are no clear data on how bDMARDs work in patients who already have or develop metabolic comorbidities and whether these conditions can impact on their efficacy and safety profile.Objectives:to evaluate, in chronic inflammatory joint diseases, the effect of arterial hypertension (AH), dyslipidemia (DYS) and diabetes mellitus (DM) on efficacy, safety and retention rate of first-line bDMARDs therapy.Methods:a retrospective observational study on the clinical charts of Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS), treated with first on-label bDMARD was performed. Data on adverse events, efficacy and comorbidities at the baseline visit in which the bDMARD was prescribed (BL), the visit performed after 6 months of therapy (6M), and the last visit on treatment (LoT) were collected.Results:383 patients (41,8% RA, 33,4% PsA and 24,8% AS) were included in the study, with the predominance of females (F: 67,36%, M: 32,64%; mean age 51,67 ± 15,11 years). Our data show that the presence of comorbidities had no influence on efficacy of bDMARD, while patients who had DYS at BL manifested a higher rate of systemic adverse events either in the first 6 months of therapy (58,9% vs 43,7%, p=0,040) and also later on (80,36% vs. 66,67%, p=0,046). In addition, patients who developed DYS and AH after the 6M visit reported a higher rate of systemic adverse events at LoT visit, compared to others (DYS: 97,8% vs 66,7%, pConclusion:our data suggest that AH and DYS may be associated with higher frequency of adverse events but a better drug retention. The combination of bDMARD and ACEi/ARB may determine a better control of the inflammatory process by inhibition of angiotensin II, favouring the achievement of remission. In AH patients on bDMARDs, ACEi and ARB could therefore represent an useful anti-hypertensive drug choice. Similarly, statins could be the treatment of choice in DYS patients.References:[1]Gonzalez-Gay MA, et al. Clin Exp Rheumatol. 2006.[2]Pollono EN, et al. Clin Rheumatol. 2010[3]van Sijl AM, et al. Semin Arthritis Rheum. 2011.[4]Yoshida S, et al. J Hum Hypertens. 2014.[5]Gremese E, et al. Arthritis Care Res (Hoboken). 2013.[6]Heimans L, et al. Arthritis Care Res (Hoboken). 2013.Disclosure of Interests:Laura Cometi: None declared, Cosimo Bruni Speakers bureau: Actelion, Eli Lilly, Nicolò Chiti: None declared, Lorenzo Tofani: None declared, Francesca Nacci: None declared, Francesca Bartoli: None declared, Silvia Bellando Randone: None declared, Ginevra Fiori: None declared, Serena Guiducci: None declared, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Bristol-Myers Squibb, Speakers bureau: Acetelion, Lilly, Boehringer Ingelheim
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- 2020
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18. THU0360 EFFICACY OF A SELF-TREATMENT PROTOCOL FOR FACE AND TEMPOROMANDIBULAR JOINTS REHABILITATION IN SYSTEMIC SCLEROSIS (SSC)
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Gemma Lepri, M. Mitola, Lorenzo Tofani, Jelena Blagojevic, M. Passalacqua, S. Bellando Randone, S. Maddali Bongi, C. Foggi, Cosimo Bruni, N. Mauro, Marco Matucci-Cerinic, Ginevra Fiori, K. El Aoufy, Francesca Bartoli, Serena Guiducci, and M. Gizduloch
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medicine.medical_specialty ,business.industry ,Immunology ,Interstitial lung disease ,Arthritis ,Antisynthetase syndrome ,Gold standard (test) ,Arteriosclerosis ,medicine.disease ,General Biochemistry, Genetics and Molecular Biology ,Rheumatology ,Internal medicine ,medicine ,Cardiology ,Immunology and Allergy ,business ,Myositis ,Subclinical infection - Abstract
Background:In SSc, skin involvement of the face is frequent and extremely disabling, resulting in limited mouth opening, an altered dentition, difficulty in teeth care, as well as having a strong impact on the emotional and psychological well-being, thus impairing quality of life.Objectives:to evaluate the efficacy of a self-treatment protocol (created by AMURR A Multidisciplinary Association of Rheumatological Rehabilitation) for face and tempomandibular joints (TMJs) rehabilitation with two devices used in the dental field.Methods:40 SSc patients (37 female and 3 male) with a mouth opening ≤ 40 mm, were recruited and randomized in two groups of treatment: Group 1 (20 patients: mean age 50,650 yrs ± 13,937 SD, mean disease duraton 10,45 yrs ± 7,877 SD, opening mouth 32,250 mm ± 5,590 SD) treated with a home self-treatment protocol consisting of 23 exercises carried out at home in front of a mirror, 22/23 exercises were performed once a day, one of these using a device to obtain uniform stretching of the buccal rhyme, another one usingused three times a day to reduce tension of muscles of the TMJs, facilitating the mouth opening; group 2 (20 patients: mean age 58,05 yrs ± 18,103 SD, mean disease duration 17,4 yrs ± 15,017 SD, opening mouth 34,950 mm ± 5,753) without physical rehabilitation, only drugs as treatments of SSc and its complications. All patients underwent a baseline (T0) and 45 days (T1) clinimetric assessment by self-assessment of quality of life with SF-36 (Short-Form 36 Health Survey), of the degree of disability of the mouth with MHISS (of the Mouth Handicap in Systemic Sclerosis scale), Muscle pain evaluated by numerical rating scale (NRS) of the temporomandibular joint with TMD (Temporo mandibular Disorders), evaluation of mouth opening and ROM of the cervical spine. Statistical analysis was performed using the t-test or the Mann-Whitney test for assessing changes in all measurement scales between treatment groups.Results:The protocol of home physiotherapy exercises resulted in a statistically significant improvement in the treated group compared to group 2 both for mouth opening (T0: 32,250 ± 5,590, T1: 35,650 ± 6,046) vs (T0: 34,950 ± 5,753 T1: 34,300 ± 6,001) (pConclusion:The use of the home exercises protocol associated with the two devices has shown a significant improvement of the disability linked to skin involvement of the face. This highlights the fundamental role that home rehabilitation self therapy has in practice. These data will need to be confirmed in a larger cohort of patientsDisclosure of Interests:Mauro Passalacqua: None declared, Cristian Foggi: None declared, Nicola Mauro: None declared, Lorenzo Tofani: None declared, Serena Guiducci: None declared, Cosimo Bruni Speakers bureau: Actelion, Eli Lilly, Gemma Lepri: None declared, Jelena Blagojevic: None declared, Khadija El Aoufy: None declared, Ginevra Fiori: None declared, Francesca Bartoli: None declared, Susanna Maddali Bongi: None declared, Marco Mitola: None declared, Marco Gizduloch: None declared, Marco Matucci-Cerinic Grant/research support from: Actelion, MSD, Bristol-Myers Squibb, Speakers bureau: Acetelion, Lilly, Boehringer Ingelheim, Silvia Bellando Randone: None declared
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- 2020
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19. The safety of iloprost in systemic sclerosis in a real-life experience
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M L Conforti, Silvia Bellando-Randone, Serena Guiducci, Alberto Moggi-Pignone, Gemma Lepri, Michele Colaci, Clodoveo Ferri, Cosimo Bruni, Marco Matucci-Cerinic, Amelia Spinella, Ginevra Fiori, Francesca Bartoli, and Dilia Giuggioli
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Adult ,Diarrhea ,Male ,Digital edema ,Iloprost ,Safety ,Systemic sclerosis ,Microscopic Angioscopy ,Fingers ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Nifedipine ,Drug tolerance ,Edema ,Skin Ulcer ,Medicine ,Humans ,030212 general & internal medicine ,Adverse effect ,Retrospective Studies ,030203 arthritis & rheumatology ,Scleroderma, Systemic ,business.industry ,Raynaud Disease ,General Medicine ,Skin ulcer ,Middle Aged ,Regimen ,Treatment Outcome ,Tolerability ,Anesthesia ,Female ,medicine.symptom ,business ,medicine.drug - Abstract
Iloprost (ILO) is employed intravenously for the treatment of severe Raynaud phenomenon (RP) and digital ulcers (DU) in systemic sclerosis (SSc). The aim of this study was to evaluate the safety and tolerability of the intravenous treatment with ILO in different phases of SSc. Eighty-one consecutive non-selected SSc patients, all on nifedipine, with moderate RP, treated with ILO infusion, were retrospectively evaluated. Patients were sub classified according to the edematous or fibrotic/atrophic cutaneous phase of the disease. ILO was infused with a progressive increase of the dosage up to the achievement of patient's tolerance, 1 day/week. In cases of slower infusion regimen due to adverse events (AE) at the beginning of the administration, patients received a lower dose of the drug (not possible to quantify precisely the final cumulative dosage). 16/81 SSc patients presented digital edema, 5 developed diarrhea, and 9 developed transient hypotension during the infusion at 20 ml/h that ameliorated when the drug was withdrawn. Moreover, 10/16 edematous patients experienced significant and painful digital swelling, unlike patients in the fibrotic group (p
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- 2018
20. The Kinetics of Antidrug Antibodies, Drug Levels, and Clinical Outcomes in Infliximab-Exposed Patients with Immune-Mediated Disorders
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Francesca Nencini, Monica Milla, Andrea Matucci, Siro Bagnoli, Enrico Maggi, Sara Pratesi, Francesca Prignano, Ginevra Fiori, Alessandra Vultaggio, Sergio Romagnani, and Daniele Cammelli
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Drug ,Adult ,Male ,congenital, hereditary, and neonatal diseases and abnormalities ,medicine.medical_specialty ,media_common.quotation_subject ,Disease ,Immunoglobulin E ,Inflammatory bowel disease ,Drug Hypersensitivity ,03 medical and health sciences ,0302 clinical medicine ,immune system diseases ,Internal medicine ,Immunology and Allergy ,Medicine ,Humans ,media_common ,Aged ,030203 arthritis & rheumatology ,biology ,medicine.diagnostic_test ,business.industry ,nutritional and metabolic diseases ,hemic and immune systems ,Middle Aged ,medicine.disease ,Prognosis ,Infliximab ,Immunity, Humoral ,Hypersensitivity reaction ,enzymes and coenzymes (carbohydrates) ,Treatment Outcome ,Immune System Diseases ,Therapeutic drug monitoring ,Antirheumatic Agents ,biology.protein ,030211 gastroenterology & hepatology ,Methotrexate ,Female ,Drug Monitoring ,business ,medicine.drug - Abstract
Background Hypersensitivity reactions (HRs) and loss of response (LOR) to infliximab (IFX) are related to drug immunogenicity characterized by antidrug antibodies (ADAs). Objective To analyze the timing of ADA appearance and its relationship with drug levels and clinical outcomes in IFX-treated patients with different diseases. Methods Samples were longitudinally collected before each infusion from 91 IFX-treated patients and were assayed for ADA and drug levels by enzyme-linked immunosorbent assay and for IgE by ImmunoCAP system. Clinical data regarding efficacy and safety of therapy were also monitored. Results The ADA onset occured quite early, irrespective of the type of disease, during the first year and more frequently and earlier during the second cycle of therapy. Patients with HR were more frequently ADA-positive and with higher ADA titers compared with other patient groups. ADA onset tends to precede HRs and LOR; all HRs that occur after a period of drug interruption are preceded by ADA development. Before ADA detection, a progressive decline in IFX levels until a complete disappearance was observed. The ADA titer was maintained for years both in patients with ongoing therapy and in those who interrupted it. IgE ADAs are more frequently developed in patients with higher ADA levels and earlier ADA onset, but their rate of negativization is faster. Conclusion The present data suggest that most IFX-exposed patients develop ADAs within the first year of treatment irrespective of disease type. The clinical outcome to the treatment is preceded by ADA development, which in turn is associated with the reduction in drug serum levels. Both ADA evaluation and therapeutic drug monitoring may have a relevant impact on clinical practice, giving new insights to predict LOR and HRs.
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- 2017
21. The challenge of pet therapy in systemic sclerosis: evidence for an impact on pain, anxiety, neuroticism and social interaction
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Ginevra, Fiori, Tessa, Marzi, Francesca, Bartoli, Cosimo, Bruni, Carlo, Ciceroni, Michela, Palomba, Michela, Zolferino, Elena, Corsi, Marcello, Galimberti, Alberto, Moggi Pignone, Maria Pia, Viggiano, Serena, Guiducci, Monica, Calamai, and Marco, Matucci-Cerinic
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Male ,Neuroticism ,Scleroderma, Systemic ,Vasodilator Agents ,Pain ,Anxiety ,Middle Aged ,Combined Modality Therapy ,Dogs ,Mental Health ,Treatment Outcome ,Animal Assisted Therapy ,Animals ,Humans ,Female ,Interpersonal Relations ,Iloprost ,Infusions, Intravenous ,Aged - Abstract
The aim of our study was to evaluate the effect of animal-assisted intervention (AAI), a complementary support to traditional therapies focused on the interaction between animals and human beings, in improving psychological trait, anxiety and pain in a cohort of systemic sclerosis (SSc) patients.42 SSc patients, undergoing iloprost intravenous infusion, were divided in three groups: 1) 14 patients submitted to 20 AAI sessions; 2) 14 patients engaged in alternative social activity (control group 1 - C1); and 3) 14 patients without any alternative activity (control group 2 - C2). All patients underwent Visual Analog Scale (VAS), the State-anxiety (STAI-S) and emotional faces at the beginning (s0) and at the end (s1) of each single session, while General Anxiety State-Trait Anxiety Inventory (STAI-T), Beck Depression Inventory (BDI), Social Interaction Anxiety Scale (SIAS), Eysenck Personality Questionnaire-Revised (EPQ-R), the Social Phobia Scale (SPS), the Toronto Alexythymia Scale (TAS-20), the Thought Control Questionnaire (TCQ) were administered at baseline (t0) and at the end of the project (t1).AAI group showed a significant decrease of the anxiety state level in respect to the two control groups (p0.001). VAS scale resulted lower both in AAI (p0.001) and C1 group (p0.01). Moreover, STAI-T and TAS scores were significantly reduced in AAI group (p0.001). TCQ scale showed that patients treated with AAI, compared to control group C2, had greater capacity to avoid unpleasant and unwanted thoughts (p0.05). In AAI group, the EPQ-R test revealed an enhancement of extroversion trait compared to both control groups (p0.05).Our data show that AAI significantly reduces pain perception, anxiety, neuroticism and ameliorates patients' social interaction, therefore it may be a useful to allow a better compliance to traditional therapies.
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- 2017
22. Disease Activity Improvement in Rheumatoid Arthritis Treated with Tumor Necrosis Factor-α Inhibitors Correlates with Increased Soluble Fas Levels
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Silvia Bellando-Randone, F. Peruzzi, Francesca Nacci, Mirko Manetti, Riccardo Terenzi, Marco Matucci-Cerinic, Eloisa Romano, Ginevra Fiori, and Serena Guiducci
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Adult ,Male ,medicine.medical_specialty ,Fas Ligand Protein ,Immunology ,Apoptosis ,Inflammation ,Fas ligand ,Arthritis, Rheumatoid ,Rheumatology ,Internal medicine ,medicine ,Adalimumab ,Humans ,Immunology and Allergy ,fas Receptor ,Aged ,Tumor Necrosis Factor-alpha ,business.industry ,Middle Aged ,Hyperplasia ,medicine.disease ,Infliximab ,Treatment Outcome ,Endocrinology ,Antirheumatic Agents ,Rheumatoid arthritis ,Female ,Tumor necrosis factor alpha ,medicine.symptom ,business ,medicine.drug - Abstract
Objective.Rheumatoid arthritis (RA) is characterized by chronic synovial inflammation and hyperplasia. Tumor necrosis factor-α (TNF-α) plays a pivotal role in RA by interfering with the Fas–Fas ligand (FasL) proapoptotic pathway. We investigated the circulating levels of soluble Fas (sFas) and soluble FasL (sFasL), and their possible correlation with disease activity and improvement after anti-TNF-α treatment in RA.Methods.Serum levels of sFas and sFasL were measured by quantitative ELISA in 52 patients with RA before and after 3 months of anti-TNF-α treatment (adalimumab, n = 32; infliximab, n = 20). Disease activity measures [Disease Activity Score at 28 joints-erythrocyte sedimentation rate (DAS28-ESR), C-reactive protein (CRP)] were recorded before and after treatment. Forty age-matched and sex-matched healthy subjects served as controls.Results.No significant differences in serum sFas levels were detected between anti-TNF-α-naive patients with RA and controls. After anti-TNF-α treatment, serum sFas levels significantly increased in patients with RA compared to both anti-TNF-α-naive patients and controls. Increased sFas levels inversely correlated with disease activity variables (DAS28-ESR: r = −0.739, CRP: r = −0.636, both p < 0.001). No significant differences in sFasL levels were detected in patients with RA before and after anti-TNF-α treatment.Conclusion.In RA, an increase in sFas levels closely correlates with improvement in disease activity induced by TNF-α inhibitors, suggesting their ability to modulate Fas-mediated synoviocyte apoptosis.
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- 2014
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23. Long-term treatment of scleroderma-related digital ulcers with iloprost: a cohort study
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Michele, Colaci, Federica, Lumetti, Dilia, Giuggioli, Serena, Guiducci, Silvia, Bellando-Randone, Ginevra, Fiori, Marco, Matucci-Cerinic, and Clodoveo, Ferri
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Adult ,Cohort Studies ,Male ,Scleroderma, Systemic ,Skin Ulcer ,Digital ulcers ,Iloprost ,Systemic sclerosis ,Humans ,Female ,Middle Aged ,Retrospective Studies - Abstract
Raynaud's phenomenon and chronic/recurrent digital ulcers (DU) are main features of systemic sclerosis (SSc). Their treatment includes both systemic (i.e., iloprost) and local therapies. We report the therapeutic effects of iloprost in a cohort of SSc patients during a long-lasting follow-up period.Fifty consecutive SSc patients (M/F 7/43, age at SSc diagnosis 43.5±12.7SD years) received iloprost infusions for 10±4.2SD years. Iloprost schedule consisted in monthly infusion at 0.8-1 ng/kg body weight/min (average cumulative dose 25 μg), according to patients' tolerance. For recalcitrant cases, continuous infusion of iloprost (3 days, average 0.2 mg) was administered.31/50 (62%) patients showed DU at the beginning of iloprost therapy: among them, 22 (71%) resolved during the follow-up, while the other 9 presented recurrent or chronic DU, despite the treatment. With regards the 19/50 patients without DU at baseline, only one developed skin lesions at the end of 10-year follow-up, when severe pulmonary hypertension developed, which lead to exitus. Considering the 31 patients with DU at baseline, a diffuse skin subset was present in 3/22 patients with healed DU, and in 5/9 who did not (13.6% vs. 55.5%; p=0.027).Iloprost is a long-term effective treatment to achieve healing and prevention in SSc-related DU. Besides the possible problems concerning patients' tolerability or clinical management, iloprost therapy may be considered of great help in the therapeutic strategy of SSc-related ischaemic manifestations.
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- 2017
24. Lidocaine controls pain and allows safe wound bed preparation and debridement of digital ulcers in systemic sclerosis: a retrospective study
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Claudia Fantauzzo, Cosimo Bruni, Marco Matucci-Cerinic, Laura Rasero, Ginevra Fiori, Amato de Paulis, Francesca Bartoli, Francesca Braschi, Lucia Paganelli, Braschi, Francesca, Bartoli, Francesca, Bruni, Cosimo, Fiori, Ginevra, Fantauzzo, Claudia, Paganelli, Lucia, DE PAULIS, Amato, Rasero, Laura, and Matucci Cerinic, M.
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Male ,medicine.medical_specialty ,Lidocaine ,medicine.drug_class ,medicine.medical_treatment ,Pain ,Fingers ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Pain control ,Wound bed preparation ,Internal medicine ,Skin Ulcer ,medicine ,Humans ,Pain Management ,030212 general & internal medicine ,Anesthetics, Local ,Adverse effect ,Systemic Sclerosi ,Aged ,Pain Measurement ,Retrospective Studies ,Ulcers ,030203 arthritis & rheumatology ,Wound Healing ,Debridement ,Scleroderma, Systemic ,Local anesthetic ,business.industry ,Retrospective cohort study ,General Medicine ,Middle Aged ,Surgery ,Anesthesia ,Female ,business ,medicine.drug - Abstract
In Systemic Sclerosis (SSc), digital ulcers (DU) are painful, difficult to heal, and frequently infected. To reduce the risk of bacterial infection and to prevent chronicity, it is essential to carefully remove necrotic tissue from DU, with maximum patient comfort. Debridement, although very efficacious, is invasive and causes local pain: lidocaine is a local anesthetic commonly used as to fight pain during debridement procedures. The aim of the study was to evaluate the efficacy of lidocaine 4 % in pain control during debridement procedure of DU in SSc. One hundred eight DU characterized by pain Numeric Rating Scale (NRS) >3/10 before starting the procedure were treated with lidocaine 4 % (lidocaine cloridrate 200 mg in 5 ml of injecting solution). Pain was measured with NRS (0-10) before starting debridement, after 15 min of lidocaine application and at the end of the procedure. In DU, in respect to baseline (mean NRS 6.74 ± 2.96), pain after application of lidocaine 4 % for 15 min was significantly lower (mean NRS 2.83 ± 2.73) (p
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- 2016
25. Premedication prevents infusion reactions and improves retention rate during infliximab treatment
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Felice Galluccio, Francesca Bartoli, Cosimo Bruni, Daniel E. Furst, Jelena Blagojevic, Lorenzo Tofani, Ginevra Fiori, Marco Matucci Cerinic, and Laura Cometi
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Adult ,Male ,Chlorpheniramine ,Drug-Related Side Effects and Adverse Reactions ,Hydrocortisone ,Premedication ,Ranitidine ,Methylprednisolone ,Esomeprazole ,Arthritis, Rheumatoid ,03 medical and health sciences ,Psoriatic arthritis ,0302 clinical medicine ,Rheumatology ,medicine ,Humans ,Spondylitis, Ankylosing ,Infusions, Intravenous ,Chlorpheniramine Maleate ,Acetaminophen ,Aged ,Retrospective Studies ,030203 arthritis & rheumatology ,Hydroxyzine ,business.industry ,Tumor Necrosis Factor-alpha ,Arthritis, Psoriatic ,General Medicine ,Middle Aged ,medicine.disease ,Infliximab ,Treatment Outcome ,Rheumatoid arthritis ,Anesthesia ,Antirheumatic Agents ,030211 gastroenterology & hepatology ,Drug Therapy, Combination ,Female ,business ,medicine.drug - Abstract
Infliximab (IFX) is an anti-tumor necrosis factor-alpha antibody used to treat inflammatory joint diseases. Infusion reactions (IR) can occur during and after intravenous administration and often require discontinuation of IFX therapy. This retrospective study aimed at evaluating the incidence of IR in patients with joint inflammatory diseases receiving IFX with and without premedication. Clinical charts of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients receiving IFX from January 2002 to December 2014 were reviewed. Patients receiving only one premedication protocol over time were enrolled and clustered based on the type of premedication as follows: group 1 received no premedication; group 2 received paracetamol, esomeprazole, hydrocortisone, and chlorpheniramine maleate; group 3 received paracetamol, hydoxyzine, ranitidine, and 6-methylprednisolone. Adverse events were recorded during the infusion, in the following hours and at control visits. The charts of 105 patients treated with IFX were selected. IR were observed in 23/51 patients of group 1, in 7/35 patients of group 2, and none of 19 patients in group 3. IR incidence was significantly lower in the second (p = 0.021) and third (p
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- 2016
26. Bone marrow-derived mesenchymal stem cells from early diffuse systemic sclerosis exhibit a paracrine machinery and stimulate angiogenesis in vitro
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Serena Guiducci, Eloisa Romano, Claudia Ceccarelli, Benedetta Mazzanti, Silvia Bellando-Randone, Mirko Manetti, Simone Dal Pozzo, Marco Matucci-Cerinic, Ginevra Fiori, Anna Franca Milia, Maria Letizia Conforti, Riccardo Saccardi, and Lidia Ibba-Manneschi
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Adult ,Vascular Endothelial Growth Factor A ,Receptors, CXCR4 ,Pathology ,medicine.medical_specialty ,Stromal cell ,Adolescent ,Angiogenesis ,Immunology ,Receptor, Transforming Growth Factor-beta Type I ,Bone Marrow Cells ,Protein Serine-Threonine Kinases ,Biology ,General Biochemistry, Genetics and Molecular Biology ,Immunophenotyping ,Colony-Forming Units Assay ,Young Adult ,Paracrine signalling ,chemistry.chemical_compound ,Rheumatology ,Paracrine Communication ,medicine ,Humans ,Immunology and Allergy ,Cells, Cultured ,Skin ,Matrigel ,Neovascularization, Pathologic ,integumentary system ,Mesenchymal stem cell ,Receptor, Transforming Growth Factor-beta Type II ,Endothelial Cells ,Cell Differentiation ,Mesenchymal Stem Cells ,Chemokine CXCL12 ,Endothelial stem cell ,Vascular endothelial growth factor ,chemistry ,Culture Media, Conditioned ,Scleroderma, Diffuse ,Cancer research ,Female ,Receptors, Transforming Growth Factor beta ,Cell Division ,Transforming growth factor - Abstract
Objective To characterise bone marrow-derived mesenchymal stem cells (MSCs) from patients with systemic sclerosis (SSc) for the expression of factors implicated in MSC recruitment at sites of injury, angiogenesis and fibrosis. The study also analysed whether the production/release of bioactive mediators by MSCs were affected by stimulation with cytokines found upregulated in SSc serum and tissues, and whether MSCs could modulate dermal microvascular endothelial cell (MVEC) angiogenesis. Methods MSCs obtained from five patients with early severe diffuse SSc (SSc-MSCs) and five healthy donors (H-MSCs) were stimulated with vascular endothelial growth factor (VEGF), transforming growth factor β (TGFβ) or stromal cell-derived factor-1 (SDF-1). Transcript and protein levels of SDF-1 and its receptor CXCR4, VEGF, TGFβ 1 and receptors TβRI and TβRII were evaluated by quantitative real-time PCR, western blotting and confocal microscopy. VEGF, SDF-1 and TGFβ 1 secretion in culture supernatant was measured by ELISA. MVEC capillary morphogenesis was performed on Matrigel with the addition of MSC-conditioned medium. Results In SSc-MSCs the basal expression of proangiogenic SDF-1/CXCR4 and VEGF was significantly increased compared with H-MSCs. SSc-MSCs constitutively released higher levels of SDF-1 and VEGF. SDF-1/CXCR4 were upregulated after VEGF stimulation and CXCR4 redistributed from the cytoplasm to the cell surface. VEGF was increased by SDF-1 challenge. VEGF, TGFβ and SDF-1 stimulation upregulated TGFβ 1 , TβRI and TβRII in SSc-MSCs. TβRII redistributed from the cytoplasm to focal adhesion contacts. SSc-MSC-conditioned medium showed a greater proangiogenic effect on MVECs than H-MSCs. Experiments with blocking antibodies showed that MSC-derived cytokines were responsible for this potent proangiogenic effect. Conclusion SSc-MSCs constitutively overexpress and release bioactive mediators/proangiogenic factors and potentiate dermal MVEC angiogenesis.
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- 2011
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27. QuantiFERON-TB Gold and the TST are both useful for latent tuberculosis infection screening in autoimmune diseases
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Sonia Vicidomini, Antonia Mantella, Enrico Tortoli, Alessandro Bartoloni, Delia Goletti, Ginevra Fiori, Enrico Girardi, Daniela Melchiorre, M. Matucci Cerinic, Costanza Fiorelli, Maurizio Benucci, and Filippo Bartalesi
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Adult ,Male ,Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,Tuberculosis ,Population ,Tuberculin ,Autoimmune Diseases ,Tuberculosis diagnosis ,Internal medicine ,Immunopathology ,medicine ,Humans ,Prospective Studies ,education ,Aged ,Inflammation ,Tuberculina ,education.field_of_study ,Latent tuberculosis ,biology ,Tuberculin Test ,Tumor Necrosis Factor-alpha ,business.industry ,Middle Aged ,bacterial infections and mycoses ,medicine.disease ,biology.organism_classification ,Vaccination ,Multivariate Analysis ,Immunology ,BCG Vaccine ,Female ,business ,Immunosuppressive Agents - Abstract
Screening for active tuberculosis (TB) and latent TB infection (LTBI) is mandatory prior to the initiation of tumour necrosis factor-alpha inhibitor therapy. However, no agreement exists on the best strategy for detecting LTBI in this population. The aim of the present study was to analyse the performance of the tuberculin skin test (TST) and QuantiFERON-TB Gold in-tube (QFT-GIT) on LTBI detection in subjects with immunomediated inflammatory diseases (IMID). The TST and QFT-GIT were prospectively performed in 398 consecutive IMID subjects, 310 (78%) on immunosuppressive therapy and only 16 (4%) had been bacillus Calmette-Guérin (BCG) vaccinated. Indeterminate results to QFT-GIT were found in five (1.2%) subjects. Overall, 74 (19%) out of 393 subjects were TST-positive and 52 (13%) were QFT-GIT-positive. Concordance between TST and QFT-GIT results was good (87.7%): 13 were QFT-GIT-positive/TST-negative and 35 QFT-GIT-negative/TST-positive. By multivariate analysis both tests were significantly associated with older age. Only the TST was associated with BCG vaccination and radiological lesions of past TB. Use of immunosuppressive drugs differently modulated QFT-GIT or TST scoring. Use of the QuantiFERON-TB Gold in-tube, as a screening tool for latent tuberculosis among immunomediated inflammatory disease subjects, is feasible. Until further data will elucidate discordant tuberculin skin test/QuantiFERON-TB Gold in-tube results, a strategy of simultaneous tuberculin skin and QuantiFERON-TB Gold in-tube testing in a low prevalence bacillus Calmette-Guérin vaccinated population, should maximise potentials of latent tuberculosis diagnosis.
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- 2008
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28. Autologous stem cell transplantation improves microcirculation in systemic sclerosis
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I Miniati, Alberto Bosi, Stefano Guidi, Alan Tyndall, M Cinelli, Marco Matucci-Cerinic, Ginevra Fiori, Veronica Rogai, M L Conforti, Serena Guiducci, and Riccardo Saccardi
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Adult ,Male ,Systemic disease ,medicine.medical_specialty ,Cyclophosphamide ,medicine.medical_treatment ,Immunology ,Video Recording ,Hematopoietic stem cell transplantation ,Transplantation, Autologous ,Gastroenterology ,Drug Administration Schedule ,Statistics, Nonparametric ,General Biochemistry, Genetics and Molecular Biology ,Scleroderma ,Microscopic Angioscopy ,Autologous stem-cell transplantation ,Rheumatology ,Internal medicine ,Humans ,Immunology and Allergy ,Medicine ,Prospective Studies ,business.industry ,Microcirculation ,Hematopoietic Stem Cell Transplantation ,Middle Aged ,medicine.disease ,Connective tissue disease ,Surgery ,Transplantation ,Regimen ,Nails ,Regional Blood Flow ,Scleroderma, Diffuse ,Female ,business ,Immunosuppressive Agents ,medicine.drug - Abstract
Background:In systemic sclerosis (SSc) reduced capillary density decreases blood flow and leads to tissue ischaemia and fingertip ulcers. Nail fold videocapillaroscopy (NVC) is a diagnostic and follow-up parameter useful to evaluate the severity, activity and the stage of SSc microvascular damage. Autologous haemopoietic stem cell transplantation (HSCT) is a new treatment for patients with severe diffuse cutaneous systemic sclerosis (dcSSc) refractory to conventional therapies. We aimed to evaluate the improvement of microvasculature after HSCT using NVC.Methods:A total of 16 patients with severe dcSSc with a “late” videocapillaroscopy pattern underwent an immunesuppressive treatment: 6 were treated with HSCT and 10 with monthly pulse cyclophosphamide (CYC) 1 g for 6 months and then orally with 50 mg/day for further 6 months.NVC was performed before and after 3 months from the beginning of each treatment and then repeated every 3 months.Results:In all patients, before HSCT NVC showed large avascular areas and ramified capillaries and vascular architectural disorganisation (“late” pattern). At 3 months after HSCT, the NVC pattern changed from “late” into “active”, showing frequent giant capillaries (>6/mm) and haemorrhages, absence of avascular areas and angiogenesis phenomena; 1 year after HSCT, microvascular abnormalities were still in the “active” pattern. In patients treated with CYC, no NVC modifications were observed during 24 months of follow-up and the pattern always remained “late”.Conclusions:These results indicate that HSCT with a high dose CYC regimen may foster vascular remodelling, while CYC at lower doses and with a chronic regimen does not influence the microvasculature.
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- 2008
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29. Therapeutic Challenges for Systemic Sclerosis: Facts and Future Targets
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R. Livi, Alessio Tempestini, Alberto Moggi Pignone, Perfetto Federico, Angela Del Rosso, Ginevra Fiori, Jelena Blagojevic, Francesca Bartoli, and M. Cerinic Matucci
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Scleroderma, Systemic ,Ambrisentan ,business.industry ,Sildenafil ,Endothelin receptor antagonist ,Hypertension, Pulmonary ,General Neuroscience ,Pulmonary Artery ,Pharmacology ,General Biochemistry, Genetics and Molecular Biology ,Bosentan ,Beraprost ,chemistry.chemical_compound ,History and Philosophy of Science ,chemistry ,Vardenafil ,medicine ,Humans ,business ,Algorithms ,medicine.drug ,Iloprost ,Treprostinil - Abstract
Pulmonary arterial hypertension (PAH) is an important cause of death in systemic sclerosis (SSc), despite the improvement of therapies. An early diagnosis and the use of drugs interfering with the main pathogenic pathways of PAH is pivotal for the improvement of prognosis in primary PAH and PAH secondary to autoimmune rheumatic diseases, mainly SSc. Lately, new specific therapies have been developed targeting prostacyclin, endothelin, and nitric oxide pathways, the major pathogenic pathways leading to endothelial dysfunction in PAH. Epoprostenol improved life expectancy of patients with primary and secondary PAH, but its continuous intravenous administration requires experienced centers. More stable analogues of prostacyclin, administrated by intravenous (iloprost, treprostinil), subcutaneous, inhalatory (treprostinil, iloprost), and oral route (Beraprost) have shown efficacy in PAH. Bosentan, the first oral endothelin receptor antagonist (with affinity for endothelin A and B receptors) improves exercise function and survival in PAH, both primary and secondary to autoimmune rheumatic diseases. This is confirmed also for Sitaxsentan and Ambrisentan, selective A receptor antagonists. Because of its short half-life and systemic side effects, short-term NO inhalation is used only in short-term management of PAH in critically ill adults. Inhibitors of NO degradation, such as sildenafil, a phosphodiesterase (PDE) type 5 inhibitor, improved functional and hemodynamic parameters without significant side effects. Vardenafil and taladafil, longer-acting PDE inhibitors, also have vascular pulmonary selectivity. All these drugs may be used in combination, to maximize their clinical benefit not only in patients unresponsive to single drugs, but also potentially as initial therapy of PAH.
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- 2007
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30. Exercise Doppler Echocardiography Identifies Preclinic Asymptomatic Pulmonary Hypertension in Systemic Sclerosis
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Ginevra Fiori, Alberto Moggi Pignone, Roberto Fedi, Leonardo Gramigna, Angela Del Rosso, Sergio Generini, Andrea Oddo, Chiara Arcangeli, Alessio Tempestini, R. Livi, Pasquale Bernardo, Maria Letizia Conforti, Martina Minelli, Francesco Pieri, Marco Matucci Cerinic, Federico Perfetto, A Becucci, M Cinelli, Chiara Benvenuti, Serena Guiducci, Gianna Galeota, and Fabio Mori
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Male ,Clinical tests ,medicine.medical_specialty ,Supine position ,Hypertension, Pulmonary ,Pulmonary Artery ,Doppler echocardiography ,Asymptomatic ,General Biochemistry, Genetics and Molecular Biology ,History and Philosophy of Science ,medicine.artery ,Internal medicine ,medicine ,Humans ,Subclinical infection ,Scleroderma, Systemic ,Lung ,medicine.diagnostic_test ,business.industry ,General Neuroscience ,Middle Aged ,medicine.disease ,Pulmonary hypertension ,Echocardiography, Doppler ,medicine.anatomical_structure ,Pulmonary artery ,Exercise Test ,Cardiology ,Female ,medicine.symptom ,business - Abstract
In systemic sclerosis (SSc), the involvement of the interstitium or vascular system of the lung may lead to pulmonary arterial hypertension (PAH). PAH is often asymptomatic or oligosymptomatic in early SSc and, when it becomes symptomatic, pulmonary vascular system is already damaged. Exercise echocardiography (ex-echo), measuring pulmonary artery pressure (PAP) during exercise and allowing to differentiate physiologic from altered PAP responses, may identify subclinical PAH. Our aims were (a) to evaluate by ex-echo the change of PAP in patients with SSc without lung involvement; and (b) to correlate PAP during exercise (ex-PAP) values to clinical and biohumoral parameters of PAH. Twenty-seven patients with limited SSc (ISSc) without interstitial lung involvement were studied. Patients underwent rest and exercise two-dimensional and Doppler echocardiography by supine cycloergometer. Systolic PAP was calculated using the maximum systolic velocity of the tricuspid regurgitant jet at rest and during exercise values of systolic PAP exceeding 40 mmHg at ex-echo were considered as abnormal, and biohumoral markers potentially related to PAH were assessed. Eighteen of 27 SSc patients presented an ex-PAP > 40 mmHg, while in 9 of 27 patients ex-PAP values remained < 40 mmHg (48.8 +/- 4.5 mmHg versus 36.2 +/- 3.1 mmHg; P < 0.001). Other echocardiographic and ergometric parameters, clinical tests, and biohumoral markers were not different in the two groups. Ex-PAP significantly correlated with D-dimer (P = 0.0125; r2 = 0.2029). Ex-echo identifies a cluster of SSc patients with subclinical PAH that may develop PAH. This group should be followed up and may be considered for specific therapies to prevent disease evolution.
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- 2007
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31. Flow-Mediated Vasodilation and Carotid Intima-Media Thickness in Systemic Sclerosis
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Federico Perfetto, Ginevra Fiori, Maria Letizia Conforti, Francesca Bartoli, Angela Del Rosso, Jelena Blagojevic, Marco Matucci Cerinic, I. Miniati, Alberto Moggi Pignone, Alessio Tempestini, Mauro Di Chicco, Serena Guiducci, Marzia Bacci, and Sergio Castellani
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Male ,medicine.medical_specialty ,Brachial Artery ,Vasodilation ,Disease ,General Biochemistry, Genetics and Molecular Biology ,History and Philosophy of Science ,medicine.artery ,Internal medicine ,medicine ,Humans ,Vascular Diseases ,cardiovascular diseases ,Brachial artery ,Prospective cohort study ,Ultrasonography ,Macrovascular disease ,Scleroderma, Systemic ,business.industry ,General Neuroscience ,Middle Aged ,medicine.disease ,Carotid Arteries ,Endocrinology ,Intima-media thickness ,cardiovascular system ,Cardiology ,Female ,Tunica Intima ,Tunica Media ,business ,Dyslipidemia ,Flow-Mediated Vasodilation - Abstract
Increased evidence suggests an accelerated macrovascular disease in systemic sclerosis (SSc). Brachial artery flow-mediated vasodilation (FMD) and carotid intima-media thickness (IMT) are two indicators of subclinic cardiovascular disease and are frequently used as surrogate measures of subclinic atherosclerosis. The aim of this study was to evaluate macrovascular involvement in SSc. We studied 35 SSc patients (6 males and 29 females; 11 with diffuse and 24 with limited disease) and 20 healthy controls. Brachial artery FMD was assessed by method described by Celermajer in all patients and 13 control subjects. IMT was measured using high-resolution B-mode ultrasonography in patients and controls. Traditional risk factors for atherosclerosis (hypertension, dyslipidemia, and smoke) were also assessed. FMD was significantly impaired (3.41% +/- 4.56% versus 7.66% +/- 4.24%; P < 0.037) and IMT was significantly elevated compared with healthy controls (0.93 +/- 0.29 mm versus 0.77 +/- 0.13 mm; P < 0.005). FMD was not significantly different in SSc with increased IMT compared with those with normal IMT). No correlation was found between risk factors for atherosclerosis and the impairment of FMD or IMT in SSc patients. The impairment of endothelial function and structural changes of large vessels are evident in SSc, but do not seem associated with traditional risk factors for atherosclerosis. Prospective studies including also clinical outcomes are needed to assess the features and significance of macrovacular involvement in SSc.
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- 2007
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32. Angiotensin-converting enzyme I/D polymorphism and macrovascular disease in systemic sclerosis
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M. Matucci Cerinic, N. Damjanov, Ginevra Fiori, Jelena Blagojevic, Francesca Bartoli, Alberto Moggi Pignone, Simona Rednic, Chiara Angotti, Sergio Generini, M L Conforti, Serena Guiducci, Daniela Melchiorre, Sergio Castellani, Cinzia Fatini, and Rosanna Abbate
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Adult ,Male ,medicine.medical_specialty ,Brachial Artery ,Arteriosclerosis ,Carotid Artery, Common ,Blood Pressure ,Peptidyl-Dipeptidase A ,Systemic scleroderma ,Gastroenterology ,Gene Frequency ,Rheumatology ,medicine.artery ,Internal medicine ,Genotype ,medicine ,Humans ,Genetic Predisposition to Disease ,Pharmacology (medical) ,Brachial artery ,Allele frequency ,Aged ,Ultrasonography ,Macrovascular disease ,Polymorphism, Genetic ,Scleroderma, Systemic ,biology ,business.industry ,Angiotensin-converting enzyme ,Middle Aged ,medicine.disease ,Endocrinology ,Blood pressure ,Intima-media thickness ,biology.protein ,Female ,Tunica Intima ,Tunica Media ,business - Abstract
Systemic sclerosis (SSc) is characterized by microvascular and macrovascular alterations. The D allele of the ACE I/D polymorphism is known to be associated with an increased incidence of atherosclerosis and has been recently proposed as associated with increased risk of SSc. This study evaluates the relationship between intima-media thickness (IMT), ankle-brachial pressure measurements (ABPI) and ACE I/D polymorphism in SSc patients.According to the presence of ACE D allele (analysed by PCR), 53 SSc patients (47 females and 6 males; median age was 60.4 +/- 10.68 yrs; range 40-75 yrs) were divided in carriers of the D allele (DD + ID) (n = 46) and carriers of the I allele (II) (n = 7). In these patients, IMT and ABPI [calculated as the posterior tibial artery pressure (mmHg) divided by the brachial pressure] were obtained. Forty-three healthy controls (40 women and 13 men; median age 56.3 +/- 10.23; range 40-70 yrs) of the same ethnicity were recruited.SSc patients had IMT significantly higher than controls (0.85 +/- 0.03 vs 0. 68 +/- 0.01; P0.03). No significant differences (P0.3) in ABPI values between patients (1.018 +/- 0.10) and controls (1.091 +/- 0.11) were found. SSc patients with ACE DD and ID genotype showed an IMT significantly greater (0.89 +/- 0.03) than those carrying the II genotype (0.61 +/- 0.01) (P0.04). ABPI was not different among ACE gene genotypes.Our findings confirm an increased prevalence of macrovascular disease in SSc patients and show that IMT is greater in patients carrying the ACE DD and ID genotype in comparison with II homozygotes. This suggests that, in SSc, the presence of ACE D allele may predispose to an involvement of the macrovascular system.
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- 2007
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33. Calcinosis in systemic sclerosis: subsets, distribution and complications
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Francesca Braschi, Francesco Epifani, Carolina de Souza Mueller, Daniel E. Furst, Francesca Bartoli, Laura Cometi, Laura Amanzi, Laura Rasero, Cosimo Bruni, Silvia Bellando-Randone, Marco Matucci-Cerinic, Ginevra Fiori, Serena Guiducci, and Jelena Blagojevic
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Male ,medicine.medical_specialty ,Visual analogue scale ,Hypertension, Pulmonary ,Pain ,Physical examination ,Systemic scleroderma ,03 medical and health sciences ,0302 clinical medicine ,Rheumatology ,Calcinosis ,Risk Factors ,Skin Ulcer ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Retrospective Studies ,030203 arthritis & rheumatology ,Scleroderma, Systemic ,medicine.diagnostic_test ,business.industry ,Retrospective cohort study ,Skin ulcer ,Middle Aged ,medicine.disease ,Pulmonary hypertension ,Dermatology ,Cohort ,Female ,medicine.symptom ,business - Abstract
Objective To retrospectively analyse the features of calcinosis in a cohort of SSc patients. Methods Charts of SSc patients attending the Ulcer Unit of the Rheumatology Department, University of Florence and presenting a clinical suspicion of calcinosis were considered in the study. Data on clinical history, including recent skin changes, and clinical examination of all areas with suspected calcinosis, radiological imaging of the calcinotic area, demographics and SSc-related organ involvement and pain measured by a visual analogue scale were recorded. Results In 52 of 112 SSc patients, a total of 316 calcinoses were recorded and were divided into visible and palpable {154 [47.4%], clustered according to their macroscopic features as mousse [49 (31.8%)] and stone [: 105 (68.2%)]} and non-visible but palpable {: 162 [52.6%]: net [5 (3%)], plate [22 (13.8%)] and stone [135 (83.2%)]}. The X-ray-based classification of all calcinoses, both visible and non-visible, was as follows: stone, 289 (91.4%); net, 12 (3.8%) and plate, 15 (4.8%). Skin ulcers complicated 154 of 316 calcinoses (48.7%). Mousse calcinosis was associated with pulmonary arterial hypertension, the stone subset was suggestive of pulmonary involvement and justified further investigation and the net subset was the slowest to heal. Conclusion Our data indicate that calcinosis may be classified in SSc as mousse, stone, net and plate according to its clinical and X-ray features. This classification awaits validation for a possible use in clinical practice and to support early treatment and prevention of complications.
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- 2015
34. Melatonin is a safe and effective treatment for chronic pulmonary and extrapulmonary sarcoidosis
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Sergio Generini, Leonardo Gramigna, Anna Maria Carossino, Federico Perfetto, R. Livi, A Becucci, Alessio Tempestini, Maria Letizia Conforti, Chiara Benvenuti, Marco Matucci-Cerinic, Alberto Moggi Pignone, Ginevra Fiori, and Angela Del Rosso
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Adult ,Male ,medicine.medical_specialty ,Systemic disease ,Sarcoidosis ,medicine.drug_class ,Pilot Projects ,Peptidyl-Dipeptidase A ,Scintigraphy ,Skin Diseases ,Gastroenterology ,Pulmonary function testing ,Melatonin ,Electrocardiography ,Endocrinology ,Sarcoidosis, Pulmonary ,Adrenal Cortex Hormones ,Internal medicine ,medicine ,Humans ,Pulmonary pathology ,Skin ,Lung ,medicine.diagnostic_test ,business.industry ,Middle Aged ,medicine.disease ,Echocardiography, Doppler ,Respiratory Function Tests ,Surgery ,medicine.anatomical_structure ,Corticosteroid ,Female ,business ,Immunosuppressive Agents ,medicine.drug - Abstract
Chronic sarcoidosis (CS) is often unresponsive to usual treatments. Melatonin, an immunoregulatory drug, was employed in CS patients in whom usual treatments were ineffective or induced severe side effects. Melatonin was given for 2 yr (20 mg/day in the first year, 10 mg/day in the second year) to 18 CS patients. Pulmonary function tests, chest X rays, pulmonary computed tomography, Ga(67) scintigraphy and angiotensin-converting enzyme (ACE) were assayed at baseline and in the follow-up. Normalization of ACE, improvement of pulmonary parameters and resolution of skin involvement were found in the patients given melatonin. After 24 months of melatonin therapy, hylar adenopathy completely resolved in eight patients and parenchymal lesions were markedly improved in all patients; in the five patients with reduced diffusion capacity of the lung for carbon monoxide, the values normalized after 6 months of therapy and remained stable until month 24. After 24 months, Ga(67) pulmonary and extra-pulmonary uptake was totally normalized in seven patients and, at month 12 months, ACE was normalized in six patients in which the values were high at the baseline. Skin lesions, present in three patients, completely disappeared at month 24 months. No side effects were experienced and no disease relapse was observed during melatonin treatment. Melatonin may be an effective and safe therapy for CS when other treatments fail or cause side effects.
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- 2006
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35. Pulmonary arterial hypertension in systemic sclerosis: diagnostic pathway and therapeutic approach
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L Robertson, Otylia Kowal-Bielecka, Alberto Moggi Pignone, Marco Matucci-Cerinic, Ginevra Fiori, and Christopher P. Denton
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medicine.medical_specialty ,Hypertension, Pulmonary ,Immunology ,Doppler echocardiography ,General Biochemistry, Genetics and Molecular Biology ,Rheumatology ,medicine.artery ,Internal medicine ,Humans ,Immunology and Allergy ,Medicine ,Lesson of the Month ,Aged ,Scleroderma, Systemic ,medicine.diagnostic_test ,business.industry ,Respiratory disease ,Interstitial lung disease ,Middle Aged ,medicine.disease ,Pulmonary hypertension ,medicine.anatomical_structure ,Ventricle ,Pulmonary artery ,Cardiology ,Female ,Crackles ,Radiology ,medicine.symptom ,Lung Diseases, Interstitial ,business ,Artery - Abstract
Case 1 A 63 year old white woman was admitted to hospital in February 2000 owing to rapidly increasing dyspnoea on exertion (NYHA III), chest pain, and fever. The presence of sclerodactyly with loss of distal parts of the fingers, and megacapillaries at capillaroscopy, allowed the diagnosis of limited cutaneous systemic sclerosis (fig 1). Physical examination also disclosed crackles in the lower lobes of the lungs, systolic murmur with loud pulmonary second sound, and feet oedema. Figure 1 Case 1. (A) Chest x ray findings show bibasilar reticular opacities, cardiomegaly with accentuation of the right ventricle, and enlargement of the pulmonary artery, which are consistent with interstitial lung disease and pulmonary hypertension. (B) High resolution CT of the lungs discloses features of interstitial lung disease with “ground glass” opacities and widening of the central blood vessels. (C) Doppler echocardiography shows blood regurgitation through the tricuspid valve, which allows estimation of PASP. (D) Perfusion scintigraphy of the lungs carried out in February 2000 (D/1) shows redistribution of the blood flow into the upper parts of the lungs and irregular areas of diminished blood flow in the peripheral parts of the lungs consistent with PAH and pulmonary thromboembolism. For comparison, perfusion scintigraphy of the lungs carried out in June 2000 (D/2) shows a significant increase in blood flow in the lower parts of both lungs, which paralleled a decrease in PASP as measured with Doppler echocardiography. Laboratory tests included high erythrocyte sedimentation rate (145 mm/1st h), C reactive protein (2530 mg/l, normal
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- 2005
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36. The pathogenesis of inflammatory muscle diseases
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Marco Matucci-Cerinic, Angela Del Rosso, Ginevra Fiori, Alberto Moggi Pignone, and Sergio Generini
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Programmed cell death ,Immunology ,Skeletal muscle ,Dermatomyositis ,Biology ,medicine.disease ,Polymyositis ,Pathogenesis ,Immune system ,medicine.anatomical_structure ,Apoptosis ,medicine ,Immunology and Allergy ,Cytotoxic T cell - Abstract
Inflammatory muscle diseases (IMD), including dermatomyositis (DM) and polymyositis (PM), affect skeletal muscle, leading to profound tissue modification. The etiology of IMD is unknown, but multiple steps of the disease pathogenesis have been identified. The main alterations involve the immune response. Cellular infiltrates found in the muscle provide strong evidence for the involvement of a preferential immune mechanism of muscle damage. The pathologic differences found between PM and DM indicate a different role played by cell-mediated and humoral immune alterations. It is well accepted that in the pathogenetic pathway both host genes and environmental factors are involved. Apoptosis, or programmed cell death, is a complex process that plays a key role in many physiological events. It regulates the turnover of immune cells and is one of the mechanisms involved in ensuring a competent, non-autoreactive repertoire of lymphocytes. Apoptosis as a mechanism of muscle fibre death has been described in several neuromuscular disorders and muscular dystrophies, and evidence of a lack of apoptosis in IMD suggests a failure of apoptotic clearance of inflammatory cells playing a role in the maintenance of chronic cytotoxic muscle fibre damage. Most likely, the failure of apoptosis seems to be the main hallmark of the pathogenesis of IMD.
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- 2002
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37. Intravenous immunoglobulins improve the function and ameliorate joint involvement in systemic sclerosis: a pilot study
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Daniela Melchiorre, I. Miniati, T Sapir, M L Conforti, Yehuda Shoenfeld, D Martinovic, Francesca Nacci, Miri Blank, A Righi, M. Matucci Cerinic, Ginevra Fiori, and A. Moggi Pignone
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Adult ,musculoskeletal diseases ,medicine.medical_specialty ,Systemic disease ,Concise Report ,Cyclophosphamide ,Hand Joints ,Immunology ,Pilot Projects ,General Biochemistry, Genetics and Molecular Biology ,Scleroderma ,Cohort Studies ,Rheumatology ,Scleroderma, Limited ,Internal medicine ,Immunopathology ,medicine ,Humans ,Immunology and Allergy ,skin and connective tissue diseases ,Aged ,Scleroderma, Systemic ,integumentary system ,business.industry ,Immunoglobulins, Intravenous ,Middle Aged ,medicine.disease ,Arthralgia ,Connective tissue disease ,Surgery ,Tenderness ,Treatment Outcome ,Immnoglobulins ,systemic sclerosis ,joint ,Joint pain ,Scleroderma, Diffuse ,Female ,Methotrexate ,medicine.symptom ,business ,medicine.drug - Abstract
Background: In systemic sclerosis (SSc), joint involvement may reduce the functional capacity of the hands. Intravenous immunoglobulins have previously been shown to benefit patients with SSc. Aim: To verify the efficacy of intravenous immunoglobulins on joint involvement and function in SSc. Patients and Methods: 7 women with SSc, 5 with limited and 2 with diffuse SSc, with a severe and refractory joint involvement were enrolled in the study. Methotrexate and cyclophosphamide pulse therapy did not ameliorate joint symptoms. Hence, intravenous immunoglobulins therapy was prescribed at a dosage of 2 g/kg body weight during 4 days/month for six consecutive courses. The presence of joint tenderness and swelling, and articular deformities (due to primary joint involvement and not due to skin and subcutaneous changes) were evaluated. Before and after 6 months of treatment, patients were subjected to (1) Ritchie Index (RI) evaluation of joint involvement ; (2) Dreiser Algo-Functional Index (IAFD) evaluation of hand joint function ; (3) pain visual analogue scale (VAS) to measure joint pain ; (4) Health Assessment Questionnaire (HAQ) to evaluate the limitations in everyday living and physical disability ; and (5) modified Rodnan Skin Score for skin involvement. Results: After 6 months of intravenous immunoglobulins therapy, joint pain and tenderness, measured with the VAS, decreased significantly (p
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- 2007
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38. Digital ulcers as a sentinel sign for early internal organ involvement in very early systemic sclerosis
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Serena Guiducci, Cosimo Bruni, Silvia Bellando-Randone, Francesca Braschi, Francesca Bartoli, F. Peruzzi, Jelena Blagojevic, Marco Matucci-Cerinic, Gemma Lepri, and Ginevra Fiori
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Adult ,Lung Diseases ,Male ,medicine.medical_specialty ,Gastrointestinal Diseases ,Population ,Scars ,Systemic scleroderma ,Gastroenterology ,Cohort Studies ,Fingers ,Necrosis ,Rheumatology ,Calcinosis ,Predictive Value of Tests ,Risk Factors ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,digital ulcers in Systemic sclerosis ,education ,Ulcer ,Retrospective Studies ,Gangrene ,education.field_of_study ,Scleroderma, Systemic ,business.industry ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Surgery ,Early Diagnosis ,Nails ,Predictive value of tests ,Female ,medicine.symptom ,business ,Cohort study - Abstract
OBJECTIVE: The aim of this study was to evaluate the presence of digital lesions in very early diagnosis of SSc (VEDOSS) patients and its possible association with internal organ involvement. METHODS: One hundred and ten VEDOSS patients were investigated for the presence of digital ulcers (DUs), digital pitting scars, calcinosis, necrosis or gangrene, nailfold videocapillaroscopic abnormalities, disease-specific autoantibodies (ACA and anti-topo I) and internal organ involvement. RESULTS: Four patients reported a history of digital pitting scars, while 25 patients presented an active DU or reported a history of DUs. In particular, 16 patients presented with active DUs (14/16 also reporting a history of previous DUs), while the other 9 patients reported a history of DUs only. A statistically significant association between DUs and oesophageal manometry alteration was found in the whole DU population, as well as in the history of DU and the presence of active DU with/without a history of DU subgroups (P < 0.01, P = 0.01 and P < 0.05, respectively). DUs were observed in VEDOSS patients with internal organ involvement but not in those without organ involvement. CONCLUSION: DUs are already present in VEDOSS patients characterized by internal organ involvement, significantly correlating and associating with gastrointestinal involvement. DUs may be a sentinel sign for early organ involvement in VEDOSS patients.
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- 2014
39. Serial QuantiFERON TB-Gold in-tube testing during LTBI therapy in candidates for TNFi treatment
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Maurizio Benucci, Letizia Attala, Francesca Li Gobbi, Delia Goletti, Filippo Bartalesi, Alessandro Bartoloni, Marco Matucci Cerinic, Francesca Prignano, Annalisa Cavallo, Jessica Mencarini, Antonia Mantella, Michele Spinicci, Enrico Girardi, Nicola Pimpinelli, and Ginevra Fiori
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Male ,Microbiology (medical) ,medicine.medical_specialty ,Multivariate analysis ,QUANTIFERON-TB GOLD ,T-Lymphocytes ,Mycobacterium tuberculosis ,Interferon-gamma ,Ltbi treatment ,Latent Tuberculosis ,Statistical significance ,Internal medicine ,Female patient ,medicine ,Humans ,Mass Screening ,Interferon-gamma release assay, Latent tuberculosis infection therapy, Rheumatic diseases, Tumor necrosis factor inhibitors, QuantiFERON-TB Gold ,Aged ,Antigens, Bacterial ,biology ,Latent tuberculosis ,Tumor Necrosis Factor-alpha ,business.industry ,Middle Aged ,bacterial infections and mycoses ,biology.organism_classification ,medicine.disease ,Clinical Practice ,Treatment Outcome ,Infectious Diseases ,Immunology ,Female ,business ,Interferon-gamma Release Tests - Abstract
Summary Objectives To evaluate the T-cell interferon (IFN)-γ response to Mycobacterium tuberculosis -specific antigens during latent tuberculosis infection (LTBI) therapy in candidates for tumor necrosis factor-α inhibitors (TNFi). Methods 1490 Patients were screened for LTBI. One-hundred and sixty-six of them were treated for LTBI and followed-up with QuantiFERON-TB Gold (QFT-IT) testing at baseline (T0) and therapy completion (T1); 92 subjects were also tested 3–6 months after therapy completion (T2). Results At T1 the QFT-IT reversion and conversion rates were 24% (27/111) and 18% (10/55), respectively. By multivariate analysis, the likelihood of reversion significantly decreased with older age (>50–60), larger TST size (>15 mm) and higher IFN-γ value at T0 (>1 IU/ml); the likelihood of conversion increased with higher IFN-γ levels at T0 (1 IU/ml) and in female patients. Quantitative data among those who scored QFT-IT-positive at T0 showed a decreasing trend of IFN-γ levels between T0 and T1 that reached statistical significance when T0 was compared to T2, and T1 to T2. Conclusions The data confirm the difficulty of interpreting the modulation of IFN-γ levels during LTBI therapy. Currently, there is no evidence to support the use of QFT-IT in the clinical practice of monitoring LTBI treatment in candidates for TNFi.
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- 2013
40. AB0623 Treatment of Scleroderma-Related Digital Ulcers with Iloprost: A Cohort Study
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Marco Matucci-Cerinic, Michele Colaci, Ginevra Fiori, Serena Guiducci, Clodoveo Ferri, Federica Lumetti, Dilia Giuggioli, and S. Ballando Randone
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Gangrene ,medicine.medical_specialty ,business.industry ,Immunology ,medicine.disease ,Pulmonary hypertension ,General Biochemistry, Genetics and Molecular Biology ,Bosentan ,Surgery ,Regimen ,Rheumatology ,Concomitant ,Internal medicine ,Cohort ,Immunology and Allergy ,Medicine ,business ,Iloprost ,medicine.drug ,Cohort study - Abstract
Background SSc is characterized by diffuse microangiopathy leading digital ulcers (DU) in almost 50% of patients. The treatment of non-healing DU is often very difficult. It includes both systemic (prostanoids, bosentan) and local (wound care) therapies. In clinical practice, therapy of DU should be tailored mainly on clinical symptoms and according to specific clinician9s experience. At the moment, no guidelines for the use iloprost, a stable prostacyclin-analogue used for the management of DU in SSc, are not yet available. Objectives We report the therapeutical effects of our regimen for the use of iloprost in a cohort of SSc patients during a long-lasting follow-up period. Methods Fifty consecutive SSc patients recruited at two Rheumatology Units since January 2003, who received iloprost infusions for a time period >2 years were included in the analysis. Patients9 features were: males/females ratio 7/43; mean age at SSc diagnosis 43.5±12.7SD years; median disease duration at the beginning of therapy 2 years (range 0–18); mean follow-up with iloprost treatment 10±4.2SD years; diffuse SSc cutaneous subset in 13/50 (30%) patients; anti-Scl70 and anticentromere autoantibodies in 25 (50%), and 14 (28%) subjects, respectively. For all patients epidemiological, clinical, laboratory, and instrumental data were available for the study period. Iloprost schedule consisted in monthly i.v. infusion at 0.8–1 ng/kg body weight/min with average cumulative dosage per each session of 25 μg, according to patients9 tolerance. At the beginning of the treatment and in the presence of recent onset, severe and/or multiple DU at high risk of gangrene, patients were hospitalized for continuous infusion of iloprost (3 days, average 0.2 mg). Results 31/50 (62%) patients showed DU at the beginning of iloprost therapy: among them, 22 (71%) resolved during the follow-up, while the other 9 presented recurrent or chronic DU, despite the treatment. With regards the 19/50 patients without DU at baseline, only one developed skin lesions at the end of very long follow-up (8 years), when a general deterioration of clinical conditions, in particular severe pulmonary hypertension, lead to exitus. Considering the 31 SSc patients with DU at baseline, a diffuse skin subset was present in 3 out of 22 patients with healed DU, and in 5 out of 9 who did not (13.6% vs 55.5%, Fisher9s p=0.027); no other significant correlations were observed as regards visceral organ involvement and serological alterations. Finally, the concomitant administration of other vasoactive therapies seems to be scarcely relevant on the DU outcome. Conclusions Our data suggest that long term administration of iloprost seems to be effective for DU healing in SSc. Comparative studies with different treatment regimens are warranted to reach a consensus on standardized guidelines for the use of Iloprost for DU healing in SSc. Disclosure of Interest None declared
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- 2016
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41. THU0641-HPR The Challenge of Pet Therapy in Rheumatology: Evidence for The Improvement of Patients Compliance in Systemic Sclerosis
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Francesca Bartoli, Tessa Marzi, Cosimo Bruni, M. Matucci-Cerinic, Gemma Lepri, V. Denaro, Ginevra Fiori, Giulia Tesei, Serena Guiducci, and Silvia Bellando-Randone
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medicine.medical_specialty ,business.industry ,Visual analogue scale ,media_common.quotation_subject ,Immunology ,Beck Depression Inventory ,General Biochemistry, Genetics and Molecular Biology ,Psychological evaluation ,Rheumatology ,Quality of life ,Cohort ,Physical therapy ,Immunology and Allergy ,Medicine ,Personality ,Anxiety ,medicine.symptom ,business ,Psychosocial ,media_common - Abstract
Background “Pet Therapy”, better defined as Animal-assisted Intervention (AAI), is based on the interaction between animal and human being and is a tool which may complement and support traditional therapies. It can be used on patients affected by different diseases, improving their quality of life from behavioral, physical and psychosocial point of view. Objectives The aim of our study was to evaluate the effect of AAI in improving quality of life and compliance to standard pharmacological treatment in a cohort of Systemic Sclerosis (SSc) patients. Methods 42 SSc patients attending at Scleroderma Unit and undergoing iloprost intravenous infusion were divided in three groups: 1) 14 SSc patients (mean age 60.4±8.6 yrs) submitted to 20 AAI sessions with a professional team (doctor, nurse, couple of animal-handler); 2)control (C1) 14 SSc patients (mean age 63.4±5.3 yrs) engaged in alternative social activity as create a cookbook; 3)control (C0) 14 SSc patients (mean age 62.3±6.8 yrs) without any alternative activity. All patients underwent psychological evaluation at baseline (t0) and at the end of project of AAI (t1); moreover the following test (italian standardized version) was performed at the beginning (s0) and at the end (s1) of each single session: General Anxiety State-Trait Anxiety Inventory (STAI-T), Beck Depression Inventory (BDI), Social Interaction Anxiety Scale (SIAS), Eysenck Personality Questionnaire-Revised (EPQ-R), the Social Phobia Scale (SPS), the Toronto Alexythymia Scale (TAS-20), the Thought Control Questionnaire (TCQ), the Visual Analog Scale (VAS), the State-anxiety (STAI-S). Results At the end of each session, AAI group showed a decrease of the anxiety state level while it was higher in the two control groups ( p s p s Conclusions In agreement with literature [1], our work showed that AAI might be a crucial tool to support the traditional therapies thanks to the creation of a different relationship between patient and doctor. This may allow a better compliance to the therapy in a chronic disease like SSc, where patient9s compliance is usually low. References Matuszek S. Animal-facilitated therapy in various patient populations: systematic literature review. Holist Nurs Pract. 2010 Jul-Aug;24(4):187–203. Disclosure of Interest None declared
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- 2016
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42. SAT0582 Incidence of Malignancies in Patients with Inflammatory Rheumatic Diseases and Biological Drugs: Experience from One Center in Italy
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Lorenzo Antonuzzo, Francesca Nacci, Cosimo Bruni, Giulia Tesei, V. Denaro, F. Di Costanzo, Marco Matucci-Cerinic, Ginevra Fiori, and Francesca Bartoli
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0301 basic medicine ,medicine.medical_specialty ,Immunology ,General Biochemistry, Genetics and Molecular Biology ,Etanercept ,03 medical and health sciences ,chemistry.chemical_compound ,Psoriatic arthritis ,0302 clinical medicine ,Tocilizumab ,Rheumatology ,Internal medicine ,Adalimumab ,medicine ,Immunology and Allergy ,030203 arthritis & rheumatology ,business.industry ,Cancer ,Squamous cell skin cancer ,medicine.disease ,Golimumab ,Infliximab ,Surgery ,030104 developmental biology ,chemistry ,business ,medicine.drug - Abstract
Background Over the past decade, it has been frequently suggested that the risk of cancer may be increased in patients with inflammatory rheumatic diseases treated with biologics. These drug have been considered as reducing immune surveillance. However, data from registries from different continents reported that treatment with TNF inhibitors did not increase the risk of malignancies, except for skin cancer (1). Objectives To evaluate the incidence of malignancies in a cohort of our patients with inflammatory rheumatic diseases treated with biological drugs. Methods The charts of 1468 patients with Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis treated with Adalimumab, Etanercept, Infliximab, Certolizumab, Golimumab, Tocilizumab and Abatacept followed up from 2005 to 2015 at the Department of Rheumatology, University of Florence, were reviewed. Patients who developed a cancer (excluding basal cell skin cancer) during biological therapy were identified. The incidence of malignancies in our patients was compared to the incidence of cancer in the general population in the same period, same geographic area and with same age. Results Out of 1468 patients, 828 (56,4%) were affected by Rheumatoid Arthritis, 290 (19.7%) by Ankylosing Spondylitis and 350 (23.9%) by Psoriatic Arthritis. Twenty-five out of 1468 patients (1.7%) (mean age 65±9 years), developed cancer: in details, we found 5 (20%) lung cancer, 5 (20%) melanoma, 2 (8%) breast cancer, 1 (4%) liposarcoma, 1 (4%) tongue cancer, 1 (4%) colo-rectal cancer, 1 (4%) liver cancer, 1 (4%) squamous cell skin cancer, 1 (4%) intestinal lymphoma, 1 (4%) myeloid leukemia, 1 (4%) endometrial cancer, 1 (4%) cervical intraepithelial neoplasia (CIN III), 1 (4%) gastric cancer, 1 (4%) bladder cancer, 1 (4%) laryngeal carcinoma and 1 (4%) follicular NHL of parotid gland. Incidence among patients resulted as follows: 2,05% Rheumatoid Arthritis, 1,37% Ankylosing Spondylitis and 1,14% Psoriatic Arthritis. The percentage of cancer in patients was respectively: Etanercept 2,31%, Adalimumab 1,46%, Infliximab 1,18%, Golimumab 1%, Abatacept 1%, Tocilizumab 3,92% and Certolizumab 2,43%. From 2005 to 2010, the incidence of malignancies (excluding basal cell skin cancer), in general population between the age of 60 and 70 years in the Florence area was 0.39%. Conclusions Our data suggest that in patients with inflammatory rheumatic diseases treated with biological drugs, cancer is increased of 289% compared to the general population. In these patients, the risk of malignancy still remains to be verified in larger cohorts in our area with a long-term controlled registry. References Codreanu C, Damjanov N. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries. Biologics. 2015 Jan 27;9:1–6. doi:10.2147/BTT.S68949. eCollection 2015. Review. Disclosure of Interest None declared
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- 2016
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43. AB0637 Iloprost (ILO) in Systemic Sclerosis (SSC): The Safety Experience of Two Italian Centres
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Marco Matucci-Cerinic, Ginevra Fiori, Francesca Bartoli, Dilia Giuggioli, Federica Lumetti, Silvia Bellando-Randone, Cosimo Bruni, Michele Colaci, Clodoveo Ferri, Gemma Lepri, and Serena Guiducci
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business.industry ,Immunology ,Prostacyclin ,Vasodilation ,General Biochemistry, Genetics and Molecular Biology ,Raynaud phenomenon ,Regimen ,Diarrhea ,Rheumatology ,Edema ,Anesthesia ,Cohort ,medicine ,Immunology and Allergy ,medicine.symptom ,business ,medicine.drug ,Iloprost - Abstract
Background Iloprost (ILO) is a synthetic analogue of prostacyclin PGI 2 with a potent vasodilator action, an anti-proliferative effect on smooth muscle cells and inhibition of platelet aggregation. ILO is employed intravenously for the control of Raynaud Phenomenon and digital ulcers. Up to now, no agreement has been reached on the regimen (dosage and frequency) to be used in SSc patients. Objectives To identify the most common side effects that are developed during ILO infusion in SSc. Methods 81 SSc patients, classified according to ACR EULAR criteria, derived from two Italian centers, were submitted to ILO infusion: patients were subclassified according to the edematous or fibrotic/atrophic phase of the disease. ILO was infused (6–8 hour infusion, dose ranging from 0.5 to 1.0 ng/kg/ min) (1) with a progressive increase of the dosage up to the achievement of patient9s tolerance: the infusion on pump was started at 5 ml/hour and increased every half an hour up to 20 ml/hour (a dose of 4 mcg/h which corresponds to 1ng/kg)according to patients tolerance and appearance of side effects. Results Out of 81 patients, 16 were in the edematous phase with puffy fingers (digital edema). In this cohort, 5 individuals (31.2%) developed diarrhea and 9 (56.2%) developed hypotension during the infusion. When the drug was withdrawn patients had an immediate amelioration but when ILO was restarted, they again developed diarrhea or hypotension that led to definitive interruption of the treatment. Moreover, 10/16 patients (62.5%) experienced significant and painful digital swelling which led to the tapering of the infusion dosage below 10 ml/hr (which corresponds to 0.5 ng/kg per min); out of 10 patients, only one could continue the treatment while the other 9 had to be withdrawn due to the maintenance of the intense digital pain due to vasodilation. Finally, 11 patients (68.7%) reported flushing and 7 (43.7%) headache, but they were always controlled with the reduction of the infusion below 10 ml/hr. Out of 81 patients, 65 were in the atrophic/ fibrotic phase: 10 patients (15.3%) developed diarrhea and 24 pts (37%) hypotension that led to temporary withdrawal: when ILO was restarted and kept below 10 ml /hr, no side effects were experienced. In 23 cases (35.3%) flushing and in 8 cases (12.3%) headache were experienced, but were well controlled with infusion reduction below 10 ml/hr. Conclusions ILO was well tolerated in SSc patients characterized by fibrotic phase, where side effects could be managed by reducing/modulating the infusion rate. In edematous patients, ILO infusion should be decided in case where the severity of Raynaud9s phenomenon or the presence of digital ulcers strongly suggests its use. References Wigley FM, et a Intravenous iloprost infusion in patients with Raynaud phenomenon secondary to systemic sclerosis. A multicenter, placebo-controlled, double-blind study Ann Intern Med. 1994;120:199–206 Disclosure of Interest None declared
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- 2016
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44. The treatment of skin ulcers in patients with systemic sclerosis
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Laura Amanzi, Marco Matucci-Cerinic, Ginevra Fiori, A Moggi Pignone, and Francesca Braschi
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Male ,Vascular Alterations ,lcsh:Internal medicine ,medicine.medical_specialty ,Vasodilator Agents ,medicine.medical_treatment ,Complex disease ,Administration, Oral ,lcsh:Medicine ,Connective tissue ,Disease ,Rheumatology ,Fibrosis ,Skin Ulcer ,medicine ,Humans ,Prostaglandins I ,In patient ,Iloprost ,lcsh:RC31-1245 ,Gangrene ,Scleroderma, Systemic ,business.industry ,lcsh:R ,medicine.disease ,Dermatology ,Anti-Bacterial Agents ,Surgery ,medicine.anatomical_structure ,Amputation ,Quality of Life ,Female ,business ,Fluoroquinolones - Abstract
Systemic Sclerosis (Ssc) is a complex disease of the connective tissue, characterized by progressive thickening and fibrosis of the skin and the internal organs and by diffused damage of the microvascular system. The fibrosis ones of the skin associated to the characteristic vascular alterations lead to the genesis of ulcers, more or less extended, often multiple, peripheral localization, chronic course, painful, able to influence patient's quality of life. Indeed, immunity reactivity, the thinning and the loss of elasticity of the skin, the peripheral neurological damage and the eventual drug assumption that can reduce regenerative/reparative abilities, can easily make an ulcer chronic and become infected complicating still more the patient disease, rendering more difficult the cure often, ulcer evolves to gangrene, and in some cases, in amputation too. For all these reasons, we have begun to study ulcers therapy (local and systemic), considering this activity it leave integrating of the charitable distance of the sclerodermic patient, putting to point on strategy both diagnostic and therapeutic, but above all with the primary scope, if possible, is to prevent ulcers, in contrary case, to alleviate the pain and to render the quality of the life of the patient better.
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- 2011
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45. Autologous mesenchymal stem cells foster revascularization of ischemic limbs in systemic sclerosis: a case report
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Serena Guiducci, Simone Dal Pozzo, Lidia Ibba-Manneschi, Mirko Manetti, Francesco Porta, Marco Matucci-Cerinic, Francesca Braschi, Ginevra Fiori, I. Miniati, Rossana Fontana, Benedetta Mazzanti, Stefano Guidi, Anna Franca Milia, Riccardo Saccardi, Laura Amanzi, Silvia Bellando-Randone, and Alberto Bosi
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Adult ,Pathology ,medicine.medical_specialty ,Angiogenesis ,medicine.medical_treatment ,Ischemia ,Neovascularization, Physiologic ,Systemic scleroderma ,Revascularization ,Mesenchymal Stem Cell Transplantation ,Necrosis ,Internal Medicine ,medicine ,Humans ,Gangrene ,Leg ,Scleroderma, Systemic ,business.industry ,Mesenchymal stem cell ,Mesenchymal Stem Cells ,General Medicine ,Critical limb ischemia ,medicine.disease ,Surgery ,Arm ,Female ,medicine.symptom ,Stem cell ,business - Abstract
Background Mesenchymal stem cells can differentiate into endothelial cells and participate in angiogenesis in adults. In experimental models of acute myocardial infarction, mesenchymal stem cells led to the recovery of cardiac function through the formation of a new vascular network. Objective To describe treatment with intravenous infusions of expanded autologous mesenchymal stem cells in 1 patient with critical limb ischemia due to systemic sclerosis. Design Case report. Setting The rheumatology unit at the University of Florence, Florence, Italy. Patient A woman, aged 34 years, with systemic sclerosis who developed acute gangrene of the upper and lower limbs. Intervention 3 intravenous pulses of expanded autologous mesenchymal stem cells. Measurements Angiography, skin histopathology, and immunohistochemistry. Results Areas of necrotic skin were reduced after the first mesenchymal stem-cell infusion. After the third infusion, angiography showed revascularization of the patient's extremities. Skin section analysis revealed cell clusters with tubelike structures, and angiogenic factors were strongly expressed. Limitation Causality cannot be established by a single case. Conclusion In patients with systemic sclerosis who have severe peripheral ischemia, intravenous infusion of expanded autologous mesenchymal stem cells may foster the recovery of the vascular network, restore blood flow, and reduce skin necrosis. Primary funding source Fondazione Cassa di Risparmio di Pistoia e Pescia (partial funding).
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- 2010
46. Digital ulcers in scleroderma: staging, characteristics and sub-setting through observation of 1614 digital lesions
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Antonio Candelieri, Felice Galluccio, Marco Matucci-Cerinic, I. Miniati, Maria-Letizia Conforti, Ginevra Fiori, Olga Kaloudi, Serena Guiducci, Francesca Nacci, Oana Sacu, Domenico Conforti, Alberto Moggi Pignone, Francesca Braschi, Laura Amanzi, Laura Rasero, Amanzi, L, Braschi, F, Fiori, G, Galluccio, F, Miniati, I, Guiducci, S, Conforti, M, Kaloudi, O, Nacci, F, Sacu, O, Candelieri, A, Pignone, A, Rasero, L, Conforti, D, and Matucci-Cerinic, M
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Male ,medicine.medical_specialty ,Time Factors ,Time Factor ,Statistics as Topic ,Digital ulcer ,Systemic scleroderma ,Severity of Illness Index ,Scleroderma ,Cohort Studies ,Gangrene ,Systemic sclerosi ,Rheumatology ,Calcinosis ,Skin Ulcer ,medicine ,Humans ,Pharmacology (medical) ,Natural course ,Scleroderma, Systemic ,business.industry ,Extremities ,Skin ulcer ,medicine.disease ,Connective tissue disease ,Surgery ,Digital pitting scar ,Calcinosi ,Female ,Radiology ,Doppler ultrasound ,Cohort Studie ,medicine.symptom ,business ,Extremitie ,Human - Abstract
Objective. To evaluate in SSc, the frequency of digital lesions and the morphology, characteristics, natural course and time to healing of 1614 digital ulcers (DUs). Methods. One hundred SSc patients were followed up for 4 years. In the first step, the digital lesions were observed and classified at the time of presentation [digital pitting scar (DPS); DU; calcinosis; gangrene]. In the second step, DUs were divided into subsets according to their origin and main features. In the third step, the time to healing was recorded for each DU and the influence of DU main characteristics on time to healing was also evaluated. Results. In the first step, 1614 digital lesions were observed: DPS, 712 (44.1%) lesions; DU, 785 (48.6%); calcinosis, 110 (6.8%); and gangrene, 7 (0.8%). In the second step, DUs were subsetted as follows: DU developed on DPS (8.8%), pure DU; DU developed on calcinosis (60%); DU derived from gangrene. In the third step, the mean time to healing was 25.6 (15.6) days in DPS, 76.2 (64) days in pure DU, 93.6 (59.2) days in calcinosis ulcers and 281.1 (263.3) in gangrene. Conclusions. In SSc, digital lesions are represented by DPS, DU, calcinosis and gangrene, and provide an evidence-based DU subsetting according to their origin and main characteristics. Subsetting may be helpful for a precise DU evaluation and staging, and in randomized controlled trials for a precise identification of those DUs that are to be included in therapeutic studies. © The Author 2010. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org
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- 2010
47. Transitional Connective Tissue Diseases: Description of Four Cases
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Susanna, Cappelli, primary, Philippe, Guilpain, additional, Silvia, Bellando-Randone, additional, Ginevra, Fiori, additional, Francesca, Bartoli, additional, Jelena, Blagojevic, additional, Francesca, Nacci, additional, Letizia, Conforti, additional, Francesca, Braschi, additional, Loic, Guillevin, additional, and Marco, Matucci-Cerinic, additional
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- 2015
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48. Reduced circulating levels of angiotensin-(1--7) in systemic sclerosis: a new pathway in the dysregulation of endothelial-dependent vascular tone control
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Ginevra Fiori, Francesca Bartoli, Sergio Generini, R. Livi, Alberto Moggi Pignone, Alessio Tempestini, Veronica Rogai, Angela Del Rosso, Carlos M. Ferrario, Serena Guiducci, M Cinelli, K. Bridget Brosnihan, Federico Perfetto, and Marco Matucci Cerinic
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Male ,medicine.medical_specialty ,Endothelium ,Immunology ,Prostaglandin ,Vasodilation ,Peptidyl-Dipeptidase A ,Nitric Oxide ,General Biochemistry, Genetics and Molecular Biology ,Nitric oxide ,chemistry.chemical_compound ,Rheumatology ,Internal medicine ,Renin–angiotensin system ,Immunology and Allergy ,Medicine ,Humans ,Vasoconstrictor Agents ,Neprilysin ,Antihypertensive Agents ,Scleroderma, Systemic ,business.industry ,Angiotensin II ,Middle Aged ,Epoprostenol ,Peptide Fragments ,Extended Report ,Endocrinology ,medicine.anatomical_structure ,chemistry ,cardiovascular system ,Female ,Angiotensin I ,business ,hormones, hormone substitutes, and hormone antagonists ,Blood vessel - Abstract
Systemic sclerosis (SSc) impairs endothelium-dependent vasodilatation. Among angiotensin I (Ang I)-derived compounds, vasoconstrictor angiotensin II (Ang II) and vasodilator angiotensin-(1-7) (Ang-(1-7)), cleaved from ACE and neutral endopeptidase (NEP) 24.11, respectively, play an important role in vascular tone regulation. Ang-(1-7) may act independently or by activating other vasodilating molecules, such as nitric oxide (NO) or prostaglandin I2 (PGI2). Our aim was to assess, in patients with SSc, circulating levels of Ang I, Ang II and Ang-(1-7), with their metabolising enzymes ACE and NEP, and levels of NO and PGI2, and to correlate them to the main characteristics of SSc.Levels of Ang I, Ang II, Ang-(1-7), NEP, ACE, NO and PGI2 were measured in 32 patients with SSc, who were also assessed for humoral and clinical characteristics, and 55 controls.Plasma Ang I, Ang II and Ang-(1-7) levels were lower in patients with SSc than in controls (p0.001in all cases). When Ang II and Ang-(1-7) levels were expressed as a function of the available Ang I, lower Ang-(1-7) levels in patients with SSc than in controls were confirmed (p0.001), while no difference was found for Ang II levels. In patients with SSc, the Ang II/Ang-(1-7) ratio indicated a prevalence of Ang II over Ang-(1-7), while in controls Ang-(1-7) was prevalent (p0.001). Levels of ACE, NEP, NO and PGI2 were lower in patients with SSc than in controls (p0.05 in all cases).In patients with SSc, prevalence of the vasoconstricting Ang II over the vasodilator Ang-(1-7) suggests a dysfunction of the angiotensin-derived cascade that may contribute to dysregulation of vascular tone.
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- 2007
49. FRI0465 Animal (PET)-Assisted Therapy Helps in Reducing Pain and Promotes Social-Affective Regulation in Systemic Sclerosis (SSC)
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M. Palomba, Tessa Marzi, Ginevra Fiori, E. Corsi, M. Galimberti, Francesca Bartoli, M. Zolferino, M. Matucci Cerinic, and C. Ciceroni
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medicine.medical_specialty ,business.industry ,Immunology ,Psychological intervention ,Animal pet ,General Biochemistry, Genetics and Molecular Biology ,Distress ,Mood ,Rheumatology ,Pain control ,Physical therapy ,Immunology and Allergy ,Medicine ,Anxiety ,medicine.symptom ,business ,Assisted therapy ,Psychosocial - Abstract
Background Recently, the affective relationship between humans and animals has shown a potentially beneficial effects in clinical domains. However, the claim of different studies of the benefits of animal-assisted activities (AAA) is still lacking evidence base data. Objectives To gain insights into the effectiveness of AAA, physiotherapy and psychological support in SSc. Methods 12 SSc female patients (mean age of 60.52±8.3) were treated once a week by a team made of a dog-handler a rheumatologist and a psychologist. They underwent 10 dog-assisted interventions. At onset and after 3 months, the questionnaires and self reports were completed: pain evaluation (VAS 0-100), emotional and affective evaluation (Happy Face-Sad Face Scale), state anxiety (STAI), and a specific designed self report on the liking and satisfaction of the AAA interventions (AAA-Q). Results Significant improvements were reported for pain perception, mood, and other measures of distress among patients after AAA. Pain decreased significantly (p 76±7.5 vs 62±4.3) significantly different before and after AAA (p Conclusions This is the first study measuring the efficacy of AAA (with dogs) on the physiological, emotional, social well-being and pain perception in SSc. The study provides the evidence for pain control with enhancement of the psychosocial well-being. AAA integrated with the traditional medical approach may provide a good support for SSc patients. Disclosure of Interest None declared
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- 2015
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50. The pathogenesis of inflammatory muscle diseases: on the cutting edge among the environment, the genetic background, the immune response and the dysregulation of apoptosis
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Alberto, Pignone, Ginevra, Fiori, Angela, Del Rosso, Sergio, Generini, and Marco, Matucci-Cerinic
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Risk Factors ,Muscle Fibers, Skeletal ,Humans ,Apoptosis ,Environment ,Dermatomyositis ,Polymyositis - Abstract
Inflammatory muscle diseases (IMD), including dermatomyositis (DM) and polymyositis (PM), affect skeletal muscle, leading to profound tissue modification. The etiology of IMD is unknown, but multiple steps of the disease pathogenesis have been identified. The main alterations involve the immune response. Cellular infiltrates found in the muscle provide strong evidence for the involvement of a preferential immune mechanism of muscle damage. The pathologic differences found between PM and DM indicate a different role played by cell-mediated and humoral immune alterations. It is well accepted that in the pathogenetic pathway both host genes and environmental factors are involved. Apoptosis, or programmed cell death, is a complex process that plays a key role in many physiological events. It regulates the turnover of immune cells and is one of the mechanisms involved in ensuring a competent, non-autoreactive repertoire of lymphocytes. Apoptosis as a mechanism of muscle fibre death has been described in several neuromuscular disorders and muscular dystrophies, and evidence of a lack of apoptosis in IMD suggests a failure of apoptotic clearance of inflammatory cells playing a role in the maintenance of chronic cytotoxic muscle fibre damage. Most likely, the failure of apoptosis seems to be the main hallmark of the pathogenesis of IMD.
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- 2003
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