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2. Booster dose of SARS-CoV-2 messenger RNA vaccines strengthens the specific immune response of patients with rheumatoid arthritis: A prospective multicenter longitudinal study

Author

Farroni, Chiara, Aiello, Alessandra, Picchianti-Diamanti, Andrea, Laganà, Bruno, Petruccioli, Elisa, Agrati, Chiara, Garbuglia, Anna Rosa, Meschi, Silvia, Lapa, Daniele, Cuzzi, Gilda, Petrone, Linda, Vanini, Valentina, Salmi, Andrea, Altera, Anna Maria Gerarda, Repele, Federica, Grassi, Germana, Bettini, Aurora, Vita, Serena, Mariano, Andrea, Damiani, Arianna, Infantino, Maria, Grossi, Valentina, Manfredi, Mariangela, Niccoli, Laura, Puro, Vincenzo, Rosa, Roberta Di, Salemi, Simonetta, Sesti, Giorgio, Scolieri, Palma, Bruzzese, Vincenzo, Benucci, Maurizio, Cantini, Fabrizio, Nicastri, Emanuele, and Goletti, Delia

Published
2022
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3. Multiparametric autoantibody analysis: a new paradigm for the diagnosis of connective tissue diseases

Author

Bizzaro, Nicola, Villalta, Danilo, Bini, Vittorio, Migliorini, Paola, Franceschini, Franco, Piantoni, Silvia, Garrafa, Emirena, Riccieri, Valeria, Fioravanti, Antonella, Bellisai, Francesca, Tampoia, Marilina, Fornaro, Marco, Iannone, Florenzo, Ghirardello, Anna, Zen, Margherita, Palterer, Boaz, Parronchi, Paola, Infantino, Maria, Benucci, Maurizio, Rigon, Amelia, Arcarese, Luisa, Del Rosso, Stefania, Canti, Valentina, Bartoloni, Elena, and Gerli, Roberto

Published
2022
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4. Secukinumab for the Treatment of Axial Spondyloarthritis: Long-Term Real-Life Data from Five Italian Referral Centers.

Author

Gentileschi, Stefano, Cannistrà, Carlo, Gaggiano, Carla, Damiani, Arianna, Carli, Linda, Benucci, Maurizio, Cantini, Fabrizio, Niccoli, Laura, Vitale, Antonio, Baldi, Caterina, Delle Sedie, Andrea, Cantarini, Luca, Mosca, Marta, Frediani, Bruno, and Guiducci, Serena

Abstract

Background: This study aimed to evaluate the effectiveness and drug retention rate of secukinumab (SCK) in axial spondyloarthritis (ax-SpA) within a multicentric real-life cohort. Methods: Data from patients with ax-SpA treated with SCK at five Italian centers were collected retrospectively, excluding those with a diagnosis of Psoriatic Arthritis. Evaluations were conducted at baseline and at 3, 6, 12, 18, and 24 months. Assessments included C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), BASDAI, and ASDAS-CRP. Results: Seventy-one ax-SpA patients (57.7% female, mean age: 53.86 ± 12.67 years) were enrolled. Baseline mean BASDAI was 6.2 ± 1.4 and ASDAS-CRP was 2.9 ± 1.3. Significant improvements in BASDAI and ASDAS-CRP were observed over time, with BASDAI reducing to 3.5 ± 1.9 (p < 0.0001) and ASDAS-CRP to 1.7 ± 0.9 (p < 0.0001) at 24 months. The follow-up duration averaged 20.46 ± 13.46 months. By the end of follow-up, 29.5% of patients discontinued SCK. The two-year retention rate was 72%. Dropout risk was higher in patients with fibromyalgia (HR: 2.896, p = 0.026). No significant retention differences were found based on sex, age, enthesitis, radiographic disease, combination with cDMARDs, SCK dosage, or previous bDMARD exposure. Lower ASDAS-CRP at the study's end was noted in patients without fibromyalgia (1.4 vs. 2.5, p < 0.001). Conclusions: SCK showed rapid and lasting effectiveness for ax-SpA with a favorable retention rate, though fibromyalgia may reduce treatment persistence. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Efficacy and Safety of Filgotinib in Rheumatoid Arthritis Patients Aged over and under 65 Years (ENANTIA-65).

Author

Benucci, Maurizio, Bardelli, Marco, Cazzato, Massimiliano, Bartoli, Francesca, Damiani, Arianna, Li Gobbi, Francesca, Bandinelli, Francesca, Panaccione, Anna, Di Cato, Luca, Niccoli, Laura, Frediani, Bruno, Mosca, Marta, Guiducci, Serena, and Cantini, Fabrizio

Subjects
*OLDER patients, *AGE differences, *MEDIAN (Mathematics), *AGE groups, *THROMBOEMBOLISM
Abstract

Background: According to recent data, the age of patients could represent an important risk factor for MACE (major cardiovascular events), cancer, and VTE (venous thromboembolism) during treatment with JAK inhibitors in rheumatoid arthritis. We decided to analyze the population involved in the ReLiFiRa study by identifying two groups of patients: 65 years or more and less than 65 years of age, evaluating the efficacy and tolerability of 200 mg of Filgotinib daily. Methods: Of the 120 ReLiFiRa patients, 54 were younger than 65 years old and 66 patients were 65 years old or older. The data of efficacy and tolerability of treatment with FIL 200 mg daily for 6 months were evaluated. Results: After six months of treatment, FIL was effective in both age groups. In both groups, the median values of steroid DAS28, CDAI, ERS, PCR, tender joints, swollen joints, VAS, HAQ, PGA patients, and PGA physicians were reduced with a statistically significant difference comparing these values with the baseline values. The difference in age did not impact the effectiveness of the drug. The lipid profile data also did not demonstrate significant differences between the two age groups; however, the comparison between younger vs. older patients' populations regarding the total cholesterol/HDL ratio and LDL/HDL ratio shows a statistically significant difference: total cholesterol/HDL 3.4 (2.12–3.66) vs. 3.64 (3.36–4.13) p = 0.0004, LDL/HDL 1.9 (0.98–2.25) vs. 2.41 (2.04–2.73) p = 0.0002. There are no differences regarding the atherogenic index (LDL-C/HDL-C) and coronary risk index (TC/HDL-C) compared to baseline. Conclusions: After six months of treatment with FIL, the older population group showed a higher level of LDL and a lower level of HDL compared to younger patients. The atherogenic index and coronary risk index are higher in patients aged ≥ 65 years, but interestingly, there were no differences when comparing the 6-month data to baseline values. This condition highlights the impact of typical risk factors that act independently of treatment with Filgotinib. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Do Ultrasound Lung Abnormalities Correlate to Biomarkers and Male Gender in Rheumatoid Arthritis Patients? A Monocentric Cross-Sectional Study.

Author

Bandinelli, Francesca, Benucci, Maurizio, Mallia, Ilenia, Mauro, Ilaria, Pecani, Nikita, Li Gobbi, Francesca, Manfredi, Mariangela, Guiducci, Serena, Lari, Barbara, Grossi, Valentina, Infantino, Maria, and Giannasi, Gianfranco

Subjects
*LUNGS, *RHEUMATOID arthritis, *BIOMARKERS, *SMOKING, *RHEUMATOID factor, *ULTRASONIC imaging
Abstract

Background: Lung ultrasound (LUS) is a tool of growing interest in Rheumatoid Arthritis (RA) oligo- symptomatic ILD to avoid. Objective: We aimed to evaluate (i) the prevalence of pleural (PLUS) and parenchymal (PAUS) abnormalities in LUS in the RA population and their possible correlation to biomarkers; (ii) the predictivity of gender, smoking habits, previous infections (past COVID-19 tuberculosis), and treatments; (iii) the differences in LUS between sexes. Methods: We collected the data of 155 (15 early and 140 late) RA patients with mild respiratory symptoms, evaluating PLUS and PAUS, in fourteen lung areas and also summing the scores (LUS-T). Results: Only 13/155 (8.4%) were completely negative; LUS correlated to age (all parameters p 0.0001), rheumatoid factor IgM (PLUS p 0.0006, PAUS p 0.02, LUS-T p 0.001) and ACPA (p 0.001, 0.006, 0.001, respectively), and PLUS also correlated to IL6 (p 0.02). The male gender was predictive of all LUS evaluations (p 0.001, 0.05, 0.001, respectively), which were higher than in women (p 0.001, 0.01, 0.001, respectively). Other potential risk factors were independent, except biological treatments, which showed a low predictivity to PLUS (p < 0.05). Conclusions: We can conclude that LUS is a useful technique in RA low respiratory symptoms and correlates with age, the most important RA biomarkers, and male sex. [ABSTRACT FROM AUTHOR]

Published
2024
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7. Real-Life Comparison of Four JAK Inhibitors in Rheumatoid Arthritis (ELECTRA- i Study).

Author

Benucci, Maurizio, Li Gobbi, Francesca, Damiani, Arianna, Russo, Edda, Guiducci, Serena, Manfredi, Mariangela, Lari, Barbara, Grossi, Valentina, and Infantino, Maria

Subjects
*CALPROTECTIN, *RHEUMATOID arthritis, *MAJOR adverse cardiovascular events, *PLASMINOGEN activators, *HERPES zoster
Abstract

Background: Real-world evidence of the efficacy and adverse events of JAK inhibitor treatment (Tofacitinib, Baricitinib, Upadacitinib, and Filgotinib) in rheumatoid arthritis is still limited. Methods: We studied 115 patients from the Rheumatology Unit of S. Giovanni di Dio Hospital affected by D2T-RA, according to the 2010 EULAR criteria. Out of the 115 patients, 17 had been treated with Baricitinib 8 mg/daily, 32 with Filgotinib 200 mg/daily, 21 with Tofacitinib 10 mg/daily, and 45 with Upadacitinib 15 mg/daily. We evaluated the clinical response after 3, 6, and 12 months of treatment and the follow-up from September 2022 to September 2023. All patients were evaluated according to the number of tender joints (NTJs), number of swollen joints (NSJs), visual analog scale (VAS), global assessment (GA), health assessment questionnaire (HAQ), Disease Activity Score (DAS28), and CDAI. Furthermore, laboratory parameters of efficacy and tolerability were evaluated. Results: All treatments demonstrated a statistically significant decrease in the DAS28 and CDAI scores, tender and swollen joint counts, VAS, HAQ, and patient global assessment (PGA) after 3, 6, and 12 months of treatment. All treatments showed similar behavior, and statistically significant decreases in circulating calprotectin, TNFα, and IL-6 were observed for all drugs after 12 months of treatment. In addition, soluble urokinase plasminogen activator receptor (suPAR) values showed significant differences at baseline and after 12 months of treatment for Filgotinib: 4.87 ± 4.53 vs. 3.61 ± 0.9 (0.009) and Upadacitinib: 6.64 ± 7.12 vs. 4.06 ± 3.61 (0.0003), while no statistically significant differences were found for Baricitinib: 3.4 ± 0.1 vs. 3.78 ± 0.1 and Tofacitinib: 3.95 ± 1.77 vs. 2.58 ± 0.1. The TC/HDL-C ratio (atherogenic index) showed significant differences when comparing Baricitinib vs. Filgotinib (0.0012), Filgotinib vs. Tofacitinib (0.0095), and Filgotinib vs. Upadacitinib (0.0001); furthermore, the LDL-C/HDL-C ratio in the Filgotinib group did not change (2.37 ± 0.45 vs. 2.35 ± 2.13 (NS)) after 12 months of treatment. Venous Thrombotic Events (VTEs) and major adverse cardiovascular events (MACEs) accounted for 1% of adverse events after treatment with Baricitinib. Herpes zoster reactivation accounted for 1% of adverse events after treatment with Filgotinib and Tofacitinib, while non-melanoma skin cancer (NMSC) accounted for 1% of adverse events after Upadacitinib treatment. Conclusions: Our real-world data from patients with RA show differences in some laboratory parameters and in the impact of lipid metabolism in JAK inhibitor treatment. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Older Age, a High Titre of Neutralising Antibodies and Therapy with Conventional DMARDs Are Associated with Protection from Breakthrough Infection in Rheumatoid Arthritis Patients after the Booster Dose of Anti-SARS-CoV-2 Vaccine

Author

Picchianti-Diamanti, Andrea, primary, Navarra, Assunta, additional, Aiello, Alessandra, additional, Laganà, Bruno, additional, Cuzzi, Gilda, additional, Salmi, Andrea, additional, Vanini, Valentina, additional, Maggi, Fabrizio, additional, Meschi, Silvia, additional, Matusali, Giulia, additional, Notari, Stefania, additional, Agrati, Chiara, additional, Salemi, Simonetta, additional, Di Rosa, Roberta, additional, Passarini, Damiano, additional, Di Gioia, Valeria, additional, Sesti, Giorgio, additional, Conti, Fabrizio, additional, Spinelli, Francesca Romana, additional, Corpolongo, Angela, additional, Chimenti, Maria Sole, additional, Ferraioli, Mario, additional, Sebastiani, Gian Domenico, additional, Benucci, Maurizio, additional, Li Gobbi, Francesca, additional, Santoro, Anna Paola, additional, Capri, Andrea, additional, Puro, Vincenzo, additional, Nicastri, Emanuele, additional, and Goletti, Delia, additional

Published
2023
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9. ReLiFiRa (Real Life Filgotinib in Rheumatoid Arthritis): Retrospective Study of Efficacy and Safety in Common Clinical Practice

Author

Benucci, Maurizio, primary, Bardelli, Marco, additional, Cazzato, Massimiliano, additional, Laurino, Elenia, additional, Bartoli, Francesca, additional, Damiani, Arianna, additional, Li Gobbi, Francesca, additional, Panaccione, Anna, additional, Di Cato, Luca, additional, Niccoli, Laura, additional, Frediani, Bruno, additional, Mosca, Marta, additional, Guiducci, Serena, additional, and Cantini, Fabrizio, additional

Published
2023
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10. Management of psoriatic arthritis: a consensus opinion by expert rheumatologists.

Author

D'Angelo, Salvatore, Atzeni, Fabiola, Benucci, Maurizio, Bianchi, Gerolamo, Cantini, Fabrizio, Felice Caporali, Roberto, Carlino, Giorgio, Caso, Francesco, Cauli, Alberto, Ciccia, Francesco, D'Agostino, Maria Antonietta, Dagna, Lorenzo, Dejaco, Christian, Massimiliano Epis, Oscar, Ferrucci, Maria Grazia, Franceschini, Franco, Fusaro, Enrico, Gabini, Marco, Gerli, Roberto, and Giacomelli, Roberto

Published
2023
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11. Soluble Urokinase Plasminogen Activator Receptor (suPAR) in Autoimmune Rheumatic and Non Rheumatic Diseases

Author

Manfredi, Mariangela, primary, Van Hoovels, Lieve, additional, Benucci, Maurizio, additional, De Luca, Riccardo, additional, Coccia, Carmela, additional, Bernardini, Pamela, additional, Russo, Edda, additional, Amedei, Amedeo, additional, Guiducci, Serena, additional, Grossi, Valentina, additional, Bossuyt, Xavier, additional, Perricone, Carlo, additional, and Infantino, Maria, additional

Published
2023
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12. The Third Dose of BNT162b2 COVID-19 Vaccine Does Not “Boost” Disease Flares and Adverse Events in Patients with Rheumatoid Arthritis

Author

Picchianti Diamanti, Andrea, primary, Navarra, Assunta, additional, Cuzzi, Gilda, additional, Aiello, Alessandra, additional, Salemi, Simonetta, additional, Di Rosa, Roberta, additional, De Lorenzo, Chiara, additional, Vio, Daniele, additional, Sebastiani, Giandomenico, additional, Ferraioli, Mario, additional, Benucci, Maurizio, additional, Li Gobbi, Francesca, additional, Cantini, Fabrizio, additional, Polidori, Vittoria, additional, Simmaco, Maurizio, additional, Cialdi, Esmeralda, additional, Scolieri, Palma, additional, Bruzzese, Vincenzo, additional, Nicastri, Emanuele, additional, D’Amelio, Raffaele, additional, Laganà, Bruno, additional, and Goletti, Delia, additional

Published
2023
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13. Correction: Benucci et al. Predicting Loss of Efficacy after Non-Medical Switching: Correlation between Circulating TNF-α Levels and SB4 in Etanercept to SB4 Switchers and Naïve Patients with Rheumatic Disease. J. Pers. Med. 2022, 12, 1174

Author

Benucci, Maurizio, primary, Damiani, Arianna, additional, Bandinelli, Francesca, additional, Russo, Edda, additional, Li Gobbi, Francesca, additional, Grossi, Valentina, additional, Amedei, Amedeo, additional, Infantino, Maria, additional, and Manfredi, Mariangela, additional

Published
2023
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14. The Association of uPA, uPAR, and suPAR System with Inflammation and Joint Damage in Rheumatoid Arthritis: suPAR as a Biomarker in the Light of a Personalized Medicine Perspective

Author

Benucci, Maurizio, primary, Damiani, Arianna, additional, Russo, Edda, additional, Guiducci, Serena, additional, Li Gobbi, Francesca, additional, Fusi, Paola, additional, Grossi, Valentina, additional, Amedei, Amedeo, additional, Manfredi, Mariangela, additional, and Infantino, Maria, additional

Published
2022
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15. Assessing T-Cell Immunity in Kidney Transplant Recipients with Absent Antibody Production after a 3rd Dose of the mRNA-1273 Vaccine

Author

Infantino, Maria, primary, Tsalouchos, Aris, additional, Russo, Edda, additional, Laudicina, Selene, additional, Grossi, Valentina, additional, Lari, Barbara, additional, Benucci, Maurizio, additional, Stacchini, Lorenzo, additional, Amedei, Amedeo, additional, Casprini, Patrizia, additional, Villalta, Danilo, additional, Dattolo, Pietro Claudio, additional, and Manfredi, Mariangela, additional

Published
2022
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16. Circulating immune-complexes of IgG/IgM bound to B2-glycoprotein-I associated with complement consumption and thrombocytopenia in antiphospholipid syndrome

Author

Naranjo, Laura, primary, Stojanovich, Ljudmila, additional, Djokovic, Aleksandra, additional, Andreoli, Laura, additional, Tincani, Angela, additional, Maślińska, Maria, additional, Sciascia, Savino, additional, Infantino, Maria, additional, Garcinuño, Sara, additional, Kostyra-Grabczak, Kinga, additional, Manfredi, Mariangela, additional, Regola, Francesca, additional, Stanisavljevic, Natasa, additional, Milanovic, Milomir, additional, Saponjski, Jovica, additional, Roccatello, Dario, additional, Cecchi, Irene, additional, Radin, Massimo, additional, Benucci, Maurizio, additional, Pleguezuelo, Daniel, additional, Serrano, Manuel, additional, Shoenfeld, Yehuda, additional, and Serrano, Antonio, additional

Published
2022
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19. Predicting Loss of Efficacy after Non-Medical Switching: Correlation between Circulating TNF-α Levels and SB4 in Etanercept to SB4 Switchers and Naïve Patients with Rheumatic Disease

Author

Benucci, Maurizio, primary, Damiani, Arianna, additional, Bandinelli, Francesca, additional, Russo, Edda, additional, Li Gobbi, Francesca, additional, Grossi, Valentina, additional, Amedei, Amedeo, additional, Infantino, Maria, additional, and Manfredi, Mariangela, additional

Published
2022
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20. Therapeutic Potential of Ixekizumab in the Treatment of Ankylosing Spondylitis: A Review on the Emerging Clinical Data

Author

Benucci, Maurizio, Damiani, Arianna, Li Gobbi, Francesca, Grossi, Valentina, Infantino, Maria, Manfredi, Mariangela, Niccoli, Laura, and Cantini, Fabrizio

Subjects
ixekizumab, ankylosing spondylitis, randomized control trials, Review
Abstract

Over the last 20 years, the greatly improved knowledges of underlying pathogenic mechanisms of AS, including the role of tumor necrosis factor (TNF), the interleukin 23/Th17 axis, and interleukin-17 (Il-17), constituted the rationale to develop biologics selectively inhibiting these pathways. For more than 10 years, anti-TNF biologics were successfully employed to treat AS, with marked improvement of signs and symptoms in around 60% of the patients. Recent knowledge of the pathophysiology of spondyloarthritis has highlighted the emerging role of the IL-17/IL-23 axis. New therapies with selective biological drugs have emerged in the treatment of this pathology. In this review, we evaluated the effects of ixekizumab, a new anti–IL-17A, that was licensed both by EMA and FDA in August 2019 for the treatment of ankylosing spondylitis. The review highlights the efficacy and safety data of the 3 randomized controlled trials (COAST V-COAST W-COAST X) and those of the extension to 52 weeks of COAST V and COAST W.

Published
2020

21. Vaccination for SARS-CoV-2 in Patients With Psoriatic Arthritis: Can Therapy Affect the Immunological Response?

Author

Benucci, Maurizio, primary, Damiani, Arianna, additional, Infantino, Maria, additional, Manfredi, Mariangela, additional, Lari, Barbara, additional, Grossi, Valentina, additional, Mariotti, Elena Biancamaria, additional, Corrà, Alberto, additional, Aimo, Cristina, additional, Quintarelli, Lavinia, additional, Verdelli, Alice, additional, Li Gobbi, Francesca, additional, Antiga, Emiliano, additional, and Caproni, Marzia, additional

Published
2022
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22. Performance evaluation of four surrogate Virus Neutralization Tests (sVNTs) in comparison to the in vivo gold standard test

Author

Pieri, Massimo, primary, Infantino, Maria, primary, Manfredi, Mariangela, primary, Nuccetelli, Marzia, primary, Grossi, Valentina, primary, Lari, Barbara, primary, Tomassetti, Flaminia, primary, Sarubbi, Serena, primary, Russo, Edda, primary, Amedei, Amedeo, primary, Benucci, Maurizio, primary, Casprini, Patrizia, primary, Stacchini, Lorenzo, primary, Castilletti, Concetta, primary, and Bernardini, Sergio, primary

Published
2022
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27. How to Manage COVID-19 Vaccination in Immune-Mediated Inflammatory Diseases: An Expert Opinion by IMIDs Study Group

Author

Ferretti, Francesca, Cannatelli, Rosanna, Benucci, Maurizio, Carmagnola, Stefania, Clementi, Emilio, Danelli, Piergiorgio, Dilillo, Dario, Fiorina, Paolo, Galli, Massimo, Gallieni, Maurizio, Genovese, Giovanni, Giorgi, Valeria, Invernizzi, Alessandro, Maconi, Giovanni, Maier, Jeanette A., Marzano, Angelo V., Morpurgo, Paola S., Nebuloni, Manuela, Radovanovic, Dejan, Riva, Agostino, Rizzardini, Giuliano, Sabiu, Gianmarco, Santus, Pierachille, Staurenghi, Giovanni, Zuccotti, Gianvincenzo, Sarzi-Puttini, Pier Carlo, and Ardizzone, Sandro

Subjects
Inflammation, Lung Diseases, COVID-19 Vaccines, Sars-CoV-2, Vaccination, Immunology, COVID-19, Inflammatory Bowel Diseases, Skin Diseases, Coronavirus, Europe, Uveitis, Glomerulonephritis, Immune System Diseases, prevention, Rheumatic Diseases, Hypothesis and Theory, vaccine, Diabetes Mellitus, Humans, Expert Testimony, Pandemics, IMIDs, chronic disease
Abstract

Since March 2020, the outbreak of Sars-CoV-2 pandemic has changed medical practice and daily routine around the world. Huge efforts from pharmacological industries have led to the development of COVID-19 vaccines. In particular two mRNA vaccines, namely the BNT162b2 (Pfizer-BioNTech) and the mRNA-1273 (Moderna), and a viral-vectored vaccine, i.e. ChAdOx1 nCoV-19 (AstraZeneca), have recently been approved in Europe. Clinical trials on these vaccines have been published on the general population showing a high efficacy with minor adverse events. However, specific data about the efficacy and safety of these vaccines in patients with immune-mediated inflammatory diseases (IMIDs) are still lacking. Moreover, the limited availability of these vaccines requires prioritizing some vulnerable categories of patients compared to others. In this position paper, we propose the point of view about the management of COVID-19 vaccination from Italian experts on IMIDs and the identification of high-risk groups according to the different diseases and their chronic therapy.

Published
2021

28. Laboratory Monitoring of Biological Therapies in Rheumatology: The Role of Immunogenicity

Author

Benucci, Maurizio, Grossi, Valentina, Manfredi, Mariangela, Damiani, Arianna, Infantino, Maria, Moscato, Paolo, Cinquanta, Luigi, Gremese, Elisa, Tolusso, Barbara, Petricca, Luca, Fedele, Anna Laura, Alivernini, Stefano, Atzeni, Fabiola, Minisola, Giovanni, Verna, Roberto, Gremese, Elisa (ORCID:0000-0002-2248-1058), Tolusso, Barbara (ORCID:0000-0002-9108-6609), Alivernini, Stefano (ORCID:0000-0002-7383-4212), Benucci, Maurizio, Grossi, Valentina, Manfredi, Mariangela, Damiani, Arianna, Infantino, Maria, Moscato, Paolo, Cinquanta, Luigi, Gremese, Elisa, Tolusso, Barbara, Petricca, Luca, Fedele, Anna Laura, Alivernini, Stefano, Atzeni, Fabiola, Minisola, Giovanni, Verna, Roberto, Gremese, Elisa (ORCID:0000-0002-2248-1058), Tolusso, Barbara (ORCID:0000-0002-9108-6609), and Alivernini, Stefano (ORCID:0000-0002-7383-4212)

Abstract

Biological drugs, such as proteins and immunogens, are increasingly used to treat various diseases, including tumors and autoimmune diseases, and biological molecules have almost completely replaced synthetic drugs in rheumatology. Although biological treatments such as anti-tumor necrosis factor (TNF) drugs seem to be quite safe, they cause some undesirable effects, such as the onset of infections due to weakening of the immune system. Given the biological nature of these drugs, they might be recognized as extraneous; this would induce an immune reaction that neutralizes their effectiveness or lead to more serious consequences. Laboratories play a pivotal role in appropriate therapeutic management. The aim of this review was to underline the production of anti-drug antibodies during treatment with biological drugs and highlight the role of laboratories in ensuring appropriate use of these drugs.

Published
2020

29. Therapeutic Potential of Ixekizumab in the Treatment of Ankylosing Spondylitis: A Review on the Emerging Clinical Data

Author

Benucci,Maurizio, Damiani,Arianna, Li Gobbi,Francesca, Grossi,Valentina, Infantino,Maria, Manfredi,Mariangela, Niccoli,Laura, Cantini,Fabrizio, Benucci,Maurizio, Damiani,Arianna, Li Gobbi,Francesca, Grossi,Valentina, Infantino,Maria, Manfredi,Mariangela, Niccoli,Laura, and Cantini,Fabrizio

Abstract

Maurizio Benucci,1 Arianna Damiani,2 Francesca Li Gobbi,1 Valentina Grossi,3 Maria Infantino,3 Mariangela Manfredi,3 Laura Niccoli,4 Fabrizio Cantini4 1Rheumatology Unit, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, Florence, Italy; 2Rheumatology Unit, University of Florence, Florence, Italy; 3Immunology and Allergology Laboratory Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, Florence, Italy; 4Rheumatology Unit, S. Stefano Hospital, Azienda USL-Toscana Centro, Prato, ItalyCorrespondence: Maurizio BenucciRheumatology Unit, Azienda Sanitaria USL-Toscana Centro, Hospital S. Giovanni di Dio, Via Torregalli 3, Florence 50143, ItalyTel +39-055-6932636Fax +39-055-6932099Email maurizio.benucci@uslcentro.toscana.itAbstract: Over the last 20 years, the greatly improved knowledges of underlying pathogenic mechanisms of AS, including the role of tumor necrosis factor (TNF), the interleukin 23/Th17 axis, and interleukin-17 (Il-17), constituted the rationale to develop biologics selectively inhibiting these pathways. For more than 10 years, anti-TNF biologics were successfully employed to treat AS, with marked improvement of signs and symptoms in around 60% of the patients. Recent knowledge of the pathophysiology of spondyloarthritis has highlighted the emerging role of the IL-17/IL-23 axis. New therapies with selective biological drugs have emerged in the treatment of this pathology. In this review, we evaluated the effects of ixekizumab, a new anti–IL-17A, that was licensed both by EMA and FDA in August 2019 for the treatment of ankylosing spondylitis. The review highlights the efficacy and safety data of the 3 randomized controlled trials (COAST V-COAST W-COAST X) and those of the extension to 52 weeks of COAST V and COAST W.Keywords: ixekizumab, ankylosing spondylitis, randomized control trials

Published
2020

30. The TTTT B Lymphocyte Stimulator Promoter Haplotype Is Associated With Good Response to Rituximab Therapy in Seropositive Rheumatoid Arthritis Resistant to Tumor Necrosis Factor Blockers

Author

Fabris, Martina, Quartuccio, Luca, Vital, Ed, Pontarini, Elena, Salvin, Sara, Fabro, Cinzia, Zabotti, Alen, Benucci, Maurizio, Manfredi, Mariangela, Ravagnani, Viviana, Biasi, Domenico, Atzeni, Fabiola, Sarzi-Puttini, Piercarlo, Morassi, Pia, Fischetti, Fabio, Bazzicchi, Laura, Saracco, Marta, Pellerito, Raffaele, Cimmino, Marco, Carraro, Valeria, Semeraro, Angelo, Schiavon, Franco, Caporali, Roberto, Bortolotti, Roberto, Govoni, Marcello, Fogolari, Federico, Tonutti, Elio, Bombardieri, Stefano, Emery, Paul, and De Vita, Salvatore

Published
2013
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34. Efficacy and Safety of High-Dose Immunoglobulin-Based Regimen in Statin-Associated Autoimmune Myopathy: A Multi-Center and Multi-Disciplinary Retrospective Study

Author

Treppo, Elena, primary, Infantino, Maria, additional, Benucci, Maurizio, additional, Ravagnani, Viviana, additional, Palterer, Boaz, additional, Fabris, Martina, additional, Tomietto, Paola, additional, Manfredi, Mariangela, additional, Giudizi, Maria Grazia, additional, Ligobbi, Francesca, additional, Cammelli, Daniele, additional, Grandis, Marina, additional, Parronchi, Paola, additional, De Vita, Salvatore, additional, and Quartuccio, Luca, additional

Published
2020
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35. Laboratory Monitoring of Biological Therapies in Rheumatology: The Role of Immunogenicity

Author

Benucci, Maurizio, primary, Grossi, Valentina, additional, Manfredi, Mariangela, additional, Damiani, Arianna, additional, Infantino, Maria, additional, Moscato, Paolo, additional, Cinquanta, Luigi, additional, Gremese, Elisa, additional, Tolusso, Barbara, additional, Petricca, Luca, additional, Fedele, Anna Laura, additional, Alivernini, Stefano, additional, Atzeni, Fabiola, additional, Minisola, Giovanni, additional, and Verna, Roberto, additional

Published
2020
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37. Timing of onset affects arthritis presentation pattern in antisyntethase syndrome

Author

González Gay, Miguel A., Montecucco, Carlomaurizio, Selva O Callaghan, Albert, Trallero Araguas, Ernesto, Molberg, Ovynd, Andersson, Helena, Rojas Serrano, Jorge, Perez Roman, Diana Isabel, Bauhammer, Jutta, Fiehn, Christoph, Neri, Rossella, Barsotti, Simone, Lorenz, Hannes M., Andrea Doria, anna ghirardello, Iannone, Florenzo, Giannini, Margherita, Franceschini, Franco, Cavazzana, Ilaria, Triantafyllias, Konstantinos, Benucci, Maurizio, Infantino, Maria, Manfredi, Mariangela, Conti, Fabrizio, Schwarting, Andreas, Sebastiani, Giandomenico, Iuliano, Annamaria, Emmi, Giacomo, Silvestri, Elena, Govoni, Marcello, Scirè, Carlo Alberto, Furini, Federica, Lopez Longo, Francisco Javier, Martínez Barrio, Julia, Sebastiani, Marco, Manfredi, Andreina, Bachiller Corral, Javier, Sifuentes Giraldo, Walter Alberto, Cimmino, Marco A., Cosso, Claudio, Belotti Masserini, Alessandro, Cagnotto, Giovanni, Codullo, Veronica, Romano, Mariaeva, Paolazzi, Giuseppe, Pellerito, Raffaele, Saketkoo, Lesley Ann, Ortego Centeno, Norberto, Quartuccio, Luca, Batticciotto, Alberto, Bartoloni Bocci, Elena, Gerli, Roberto, Specker, Christof, Bravi, Elena, Selmi, Carlo, Parisi, Simone, Salaffi, Fausto, Meloni, Federica, Marchioni, Enrico, Pesci, Alberto, Dei, Giulia, Confalonieri, Marco, Tomietto, Paola, Nuno, Laura, Bonella, Francesco, Pipitone, Nicolò, Mera Valera, Antonio, Perez Gomez, Nair, Gerzeli, Simone, Lopez Mejias, Raquel, Matos Costa, Carlo Jorge, Pereira Da Silva, Jose Antonio, Cifrian, José, Alpini, Claudia, Olivieri, Ignazio, Blázquez Cañamero, María Ángeles, Rodriguez Cambrón, Ana Belén, Castañeda, Santos, Cavagna, Lorenzo, González-Gay, M, Montecucco, C, Selva-O'Callaghan, A, Trallero-Araguas, E, Molberg, O, Andersson, H, Rojas-Serrano, J, Perez-Roman, D, Bauhammer, J, Fiehn, C, Neri, R, Barsotti, S, Lorenz, H, Doria, A, Ghirardello, A, Iannone, F, Giannini, M, Franceschini, F, Cavazzana, I, Triantafyllias, K, Benucci, M, Infantino, M, Manfredi, M, Conti, F, Schwarting, A, Sebastiani, G, Iuliano, A, Emmi, G, Silvestri, E, Govoni, M, Scirè, C, Furini, F, Lopez-Longo, F, Martínez-Barrio, J, Sebastiani, M, Manfredi, A, Bachiller-Corral, J, Sifuentes Giraldo, W, Cimmino, M, Cosso, C, Belotti Masserini, A, Cagnotto, G, Codullo, V, Romano, M, Paolazzi, G, Pellerito, R, Saketkoo, L, Ortego-Centeno, N, Quartuccio, L, Batticciotto, A, Bartoloni Bocci, E, Gerli, R, Specker, C, Bravi, E, Selmi, C, Parisi, S, Salaffi, F, Meloni, F, Marchioni, E, Pesci, A, Dei, G, Confalonieri, M, Tomietto, P, Nuno, L, Bonella, F, Pipitone, N, Mera-Valera, A, Perez-Gomez, N, Gerzeli, S, Lopez-Mejias, R, Matos-Costa, C, Pereira da Silva, J, Cifrian, J, Alpini, C, Olivieri, I, Blázquez Cañamero, M, Rodriguez Cambrón, A, Castañeda, S, Cavagna, L, González-Gay, Miguel A, Montecucco, Carlomaurizio, Selva-O'Callaghan, Albert, Trallero-Araguas, Ernesto, Molberg, Ovynd, Andersson, Helena, Rojas-Serrano, Jorge, Perez-Roman, Diana Isabel, Bauhammer, Jutta, Fiehn, Christoph, Neri, Rossella, Barsotti, Simone, Lorenz, Hannes M, Doria, Andrea, Ghirardello, Anna, Iannone, Florenzo, Giannini, Margherita, Franceschini, Franco, Cavazzana, Ilaria, Triantafyllias, Konstantino, Benucci, Maurizio, Infantino, Maria, Manfredi, Mariangela, Conti, Fabrizio, Schwarting, Andrea, Sebastiani, Giandomenico, Iuliano, Annamaria, Emmi, Giacomo, Silvestri, Elena, Govoni, Marcello, Scirè, Carlo Alberto, Furini, Federica, Lopez-Longo, Francisco Javier, Martínez-Barrio, Julia, Sebastiani, Marco, Manfredi, Andreina, Bachiller-Corral, Javier, Sifuentes Giraldo, Walter Alberto, Cimmino, Marco A, Cosso, Claudio, Belotti Masserini, Alessandro, Cagnotto, Giovanni, Codullo, Veronica, Romano, Mariaeva, Paolazzi, Giuseppe, Pellerito, Raffaele, Saketkoo, Lesley Ann, Ortego-Centeno, Norberto, Quartuccio, Luca, Batticciotto, Alberto, Bartoloni Bocci, Elena, Gerli, Roberto, Specker, Christof, Bravi, Elena, Selmi, Carlo, Parisi, Simone, Salaffi, Fausto, Meloni, Federica, Marchioni, Enrico, Pesci, Alberto, Dei, Giulia, Confalonieri, Marco, Tomietto, Paola, Nuno, Laura, Bonella, Francesco, Pipitone, Nicolò, Mera-Valera, Antonio, Perez-Gomez, Nair, Gerzeli, Simone, Lopez-Mejias, Raquel, Matos-Costa, Carlo Jorge, Pereira da Silva, Jose Antonio, Cifrian, José, Alpini, Claudia, Olivieri, Ignazio, Blázquez Cañamero, María Ángele, Rodriguez Cambrón, Ana Belén, Castañeda, Santo, and Cavagna, Lorenzo

Subjects
Adult, Male, Time Factors, phenotype, autoantibodies, prevalence, Medizin, Antisynthetase syndrome, Arthritis pattern, Timing of onset, Arthritis, Autoantibodies, Biomarkers, Europe, Female, Humans, Mexico, Middle Aged, Myositis, Phenotype, Prevalence, Prognosis, Retrospective Studies, Risk Factors, NO, antisynthetase syndrome, arthritis, pulmonary disease, male, middle aged, risk factors, humans, adult, biomarkers, timefFactors, arthriti, retrospective studies, female, arthritis, antisyntethase syndrome, prognosis, myositis
Abstract

Objective To evaluate if the timing of appearance with respect to disease onset may influence the arthritis presentation pattern in antisynthetase syndrome (ASSD). Methods The patients were selected from a retrospective large international cohort of ASSD patients regularly followed-up in centres referring to AENEAS collaborative group. Patients were eligible if they had an antisynthetase antibody testing positive in at least two determinations along with arthritis occurring either at ASSD onset (Group 1) or during the course of the disease (Group 2). Results 445 (70%; 334 females, 110 males, 1 transsexual) out of the 636 ASSD we collected had arthritis, in the majority of cases (367, 83%) from disease onset (Group 1). Patients belonging to Group 1 with respect to Group 2 had an arthritis more commonly polyarticular and symmetrical (p=0.015), IgM-Rheumatoid factor positive (p=0.035), erosions at hands and feet plain x-rays (p=0.036) and more commonly satisfying the 1987 revised classification criteria for rheumatoid arthritis (RA) (p=0.004). Features such as Raynaud's phenomenon, mechanic's hands and fever (e.g. accompanying findings) were more frequently reported in Group 2 (p=0.005). Conclusion In ASSD, the timing of appearance with respect to disease onset influences arthritis characteristics. In particular, RA features are more common when arthritis occurs from ASSD onset, suggesting an overlap between RA and ASSD in these patients. When arthritis appears during the follow-up, it is very close to a connective tissue disease-related arthritis. Also, the different prevalence of accompanying features between these two groups is in line with this possibility

Published
2018

39. Abatacept: from a budget impact model to cost-effectiveness analysis – data from RCT and real life

Author

Benucci,Maurizio, Damiani,Arianna, Manfredi,Mariangela, Infantino,Maria, Grossi,Valentina, and Li Gobbi,Francesca

Subjects
musculoskeletal diseases, ClinicoEconomics and Outcomes Research
Abstract

Maurizio Benucci,1 Arianna Damiani,1 Mariangela Manfredi,2 Maria Infantino,2 Valentina Grossi,2 Francesca Li Gobbi11Rheumatology Unit, S.Giovanni di Dio Hospital, Florence, Italy; 2Immunology and Allergology Laboratory Unit, S.Giovanni di Dio Hospital, Azienda USL-Toscana Centro, Florence, ItalyAbstract: Rheumatoid arthritis (RA) is a chronic inflammatory disorder that affects joints with swelling and progressive joint destruction. The pathology leads to a progressive disability with an impact on the quality of life of the patients. Strategies to reduce in-patient care costs could have a considerable impact on lowering the direct medical costs of RA in Italy. Abatacept, a selective T-cell costimulation modulator, is a valuable treatment option for patients with moderate-to-severe RA. A search using the keywords “cost-effectiveness analysis", "budget impact model", "abatacept", and "rheumatoid arthritis” was carried out on PubMed. Abatacept in the first- and second-treatment lines has been evaluated in our research. We evaluated patients with inadequate MTX response, inadequate anti-TNF agents response, switch studies and real-world data. Furthermore, in our research, we evaluated the main head-to-head studies published.Keywords: abatacept, budget impact model, cost-effectiveness analysis, rheumatoid arthritis

Published
2019

40. Influence of Antisynthetase Antibodies Specificities on Antisynthetase Syndrome Clinical Spectrum Time Course

Author

Cavagna, Lorenzo, Trallero-Araguás, Ernesto, Meloni, Federica, Cavazzana, Ilaria, Rojas-Serrano, Jorge, Feist, Eugen, Zanframundo, Giovanni, Morandi, Valentina, Meyer, Alain, Pereira da Silva, Jose Antonio, Matos Costa, Carlo Jorge, Molberg, Oyvind, Andersson, Helena, Codullo, Veronica, Mosca, Marta, Barsotti, Simone, Neri, Rossella, Scirè, Carlo, Govoni, Marcello, Furini, Federica, Lopez-Longo, Francisco Javier, Martinez-Barrio, Julia, Schneider, Udo, Lorenz, Hanns-Martin, Doria, Andrea, Ghirardello, Anna, Ortego-Centeno, Norberto, Confalonieri, Marco, Tomietto, Paola, Pipitone, Nicolò, Rodriguez Cambron, Ana Belen, Blázquez Cañamero, María Ángeles, Voll, Reinhard Edmund, Wendel, Sarah, Scarpato, Salvatore, Maurier, Francois, Limonta, Massimiliano, Colombelli, Paolo, Giannini, Margherita, Geny, Bernard, Arrigoni, Eugenio, Bravi, Elena, Migliorini, Paola, Mathieu, Alessandro, Piga, Matteo, Drott, Ulrich, Delbrueck, Christiane, Bauhammer, Jutta, Cagnotto, Giovanni, Vancheri, Carlo, Sambataro, Gianluca, De Langhe, Ellen, Sainaghi, Pier Paolo, Monti, Cristina, Gigli Berzolari, Francesca, Romano, Mariaeva, Bonella, Francesco, Specker, Christof, Schwarting, Andreas, Villa Blanco, Ignacio, Selmi, Carlo, Ceribelli, Angela, Nuno, Laura, Mera-Varela, Antonio, Perez Gomez, Nair, Fusaro, Enrico, Parisi, Simone, Sinigaglia, Luigi, Del Papa, Nicoletta, Benucci, Maurizio, Cimmino, Marco Amedeo, Riccieri, Valeria, Conti, Fabrizio, Sebastiani, Gian Domenico, Iuliano, Annamaria, Emmi, Giacomo, Cammelli, Daniele, Sebastiani, Marco, Manfredi, Andreina, Bachiller-Corral, Javier, Sifuentes Giraldo, Walter Alberto, Paolazzi, Giuseppe, Saketkoo, Lesley Ann, Giorgi, Roberto, Salaffi, Fausto, Cifrián, José Manuel, Caporali, Roberto, Locatelli, Francesco, Marchioni, Enrico, Pesci, Alberto, Dei, Giulia, Pozzi, Maria Rosa, Claudia, Lomater, Distler, Jorg, Knitza, Johannes, Schett, George, Iannone, Florenzo, Fornaro, Marco, Franceschini, Franco, Quartuccio, Luca, Gerli, Roberto, Bartoloni, Elena, Bellando Randone, Silvia, Zampogna, Giuseppe, Gonzalez Perez, Montserrat I., Mejia, Mayra, Vicente, Esther, Triantafyllias, Konstantinos, Lopez-Mejias, Raquel, Matucci-Cerinic, Marco, Selva-O'Callaghan, Albert, Castañeda, Santos, Montecucco, Carlomaurizio, González-Gay, Miguel A., Universitat Autònoma de Barcelona, Universidad de Cantabria, Cavagna, L, Trallero-Araguás, E, Meloni, F, Cavazzana, I, Rojas-Serrano, J, Feist, E, Zanframundo, G, Morandi, V, Meyer, A, Pereira da Silva, J, Matos Costa, C, Molberg, O, Andersson, H, Codullo, V, Mosca, M, Barsotti, S, Neri, R, Scirè, C, Govoni, M, Furini, F, Lopez-Longo, F, Martinez-Barrio, J, Schneider, U, Lorenz, H, Doria, A, Ghirardello, A, Ortego-Centeno, N, Confalonieri, M, Tomietto, P, Pipitone, N, Rodriguez Cambron, A, Blázquez Cañamero, M, Voll, R, Wendel, S, Scarpato, S, Maurier, F, Limonta, M, Colombelli, P, Giannini, M, Geny, B, Arrigoni, E, Bravi, E, Migliorini, P, Mathieu, A, Piga, M, Drott, U, Delbrueck, C, Bauhammer, J, Cagnotto, G, Vancheri, C, Sambataro, G, De Langhe, E, Sainaghi, P, Monti, C, Gigli Berzolari, F, Romano, M, Bonella, F, Specker, C, Schwarting, A, Villa Blanco, I, Selmi, C, Ceribelli, A, Nuno, L, Mera-Varela, A, Perez Gomez, N, Fusaro, E, Parisi, S, Sinigaglia, L, Del Papa, N, Benucci, M, Cimmino, M, Riccieri, V, Conti, F, Sebastiani, G, Iuliano, A, Emmi, G, Cammelli, D, Sebastiani, M, Manfredi, A, Bachiller-Corral, J, Sifuentes Giraldo, W, Paolazzi, G, Saketkoo, L, Giorgi, R, Salaffi, F, Cifrian, J, Caporali, R, Locatelli, F, Marchioni, E, Pesci, A, Dei, G, Pozzi, M, Claudia, L, Distler, J, Knitza, J, Schett, G, Iannone, F, Fornaro, M, Franceschini, F, Quartuccio, L, Gerli, R, Bartoloni, E, Bellando Randone, S, Zampogna, G, Gonzalez Perez, M, Mejia, M, Vicente, E, Triantafyllias, K, Lopez-Mejias, R, Matucci-Cerinic, M, Selva-O'Callaghan, A, Castañeda, S, Montecucco, C, and Gonzalez-Gay, M

Subjects
medicine.medical_specialty, antisynthetase antibodies, antisynthetase syndrome, arthritis, interstitial lung disease, myositis, Medizin, Arthritis, lcsh:Medicine, Antisynthetase syndrome, Interstitial lung disease, Article, NO, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, antisynthetase antibodies, antisynthetase syndrome, arthritis, interstitial lung disease, myositis, ddc:610, Myositis, 030203 arthritis & rheumatology, Antisynthetase antibodies, biology, business.industry, lcsh:R, Autoantibody, General Medicine, medicine.disease, arthriti, 030228 respiratory system, Time course, Cohort, biology.protein, Antibody, business, antisynthetase antibodie
Abstract

Antisynthetase syndrome (ASSD) is a rare clinical condition that is characterized by the occurrence of a classic clinical triad, encompassing myositis, arthritis, and interstitial lung disease (ILD), along with specific autoantibodies that are addressed to different aminoacyl tRNA synthetases (ARS). Until now, it has been unknown whether the presence of a different ARS might affect the clinical presentation, evolution, and outcome of ASSD. In this study, we retrospectively recorded the time of onset, characteristics, clustering of triad findings, and survival of 828 ASSD patients (593 anti-Jo1, 95 anti-PL7, 84 anti-PL12, 38 anti-EJ, and 18 anti-OJ), referring to AENEAS (American and European NEtwork of Antisynthetase Syndrome) collaborative group's cohort. Comparisons were performed first between all ARS cases and then, in the case of significance, while using anti-Jo1 positive patients as the reference group. The characteristics of triad findings were similar and the onset mainly began with a single triad finding in all groups despite some differences in overall prevalence. The "ex-novo" occurrence of triad findings was only reduced in the anti-PL12-positive cohort, however, it occurred in a clinically relevant percentage of patients (30%). Moreover, survival was not influenced by the underlying anti-aminoacyl tRNA synthetase antibodies' positivity, which confirmed that antisynthetase syndrome is a heterogeneous condition and that antibody specificity only partially influences the clinical presentation and evolution of this condition. ispartof: JOURNAL OF CLINICAL MEDICINE vol:8 issue:11 ispartof: location:Switzerland status: published

Published
2019

41. Sjögrenʼs syndrome disease damage index and disease activity index: Scoring systems for the assessment of disease damage and disease activity in Sjögrenʼs syndrome, derived from an analysis of a cohort of Italian patients

Author

Vitali, Claudio, Palombi, Gianluigi, Baldini, Chiara, Benucci, Maurizio, Bombardieri, Stefano, Covelli, Michele, Del Papa, Nicoletta, De Vita, Salvatore, Epis, Oscar, Franceschini, Franco, Gerli, Roberto, Govoni, Marcello, Bongi, Susanna Maddali, Maglione, Wanda, Migliaresi, Sergio, Montecucco, Carlomaurizio, Orefice, Maddalena, Priori, Roberta, Tavoni, Antonio, and Valesini, Guido

Published
2007

43. Influence of Antisynthetase Antibodies Specificities on Antisynthetase Syndrome Clinical Spectrum Time Course

Author

Cavagna, L, Trallero-Araguás, E, Meloni, F, Cavazzana, I, Rojas-Serrano, J, Feist, E, Zanframundo, G, Morandi, V, Meyer, A, Pereira da Silva, J, Matos Costa, C, Molberg, O, Andersson, H, Codullo, V, Mosca, M, Barsotti, S, Neri, R, Scirè, C, Govoni, M, Furini, F, Lopez-Longo, F, Martinez-Barrio, J, Schneider, U, Lorenz, H, Doria, A, Ghirardello, A, Ortego-Centeno, N, Confalonieri, M, Tomietto, P, Pipitone, N, Rodriguez Cambron, A, Blázquez Cañamero, M, Voll, R, Wendel, S, Scarpato, S, Maurier, F, Limonta, M, Colombelli, P, Giannini, M, Geny, B, Arrigoni, E, Bravi, E, Migliorini, P, Mathieu, A, Piga, M, Drott, U, Delbrueck, C, Bauhammer, J, Cagnotto, G, Vancheri, C, Sambataro, G, De Langhe, E, Sainaghi, P, Monti, C, Gigli Berzolari, F, Romano, M, Bonella, F, Specker, C, Schwarting, A, Villa Blanco, I, Selmi, C, Ceribelli, A, Nuno, L, Mera-Varela, A, Perez Gomez, N, Fusaro, E, Parisi, S, Sinigaglia, L, Del Papa, N, Benucci, M, Cimmino, M, Riccieri, V, Conti, F, Sebastiani, G, Iuliano, A, Emmi, G, Cammelli, D, Sebastiani, M, Manfredi, A, Bachiller-Corral, J, Sifuentes Giraldo, W, Paolazzi, G, Saketkoo, L, Giorgi, R, Salaffi, F, Cifrian, J, Caporali, R, Locatelli, F, Marchioni, E, Pesci, A, Dei, G, Pozzi, M, Claudia, L, Distler, J, Knitza, J, Schett, G, Iannone, F, Fornaro, M, Franceschini, F, Quartuccio, L, Gerli, R, Bartoloni, E, Bellando Randone, S, Zampogna, G, Gonzalez Perez, M, Mejia, M, Vicente, E, Triantafyllias, K, Lopez-Mejias, R, Matucci-Cerinic, M, Selva-O'Callaghan, A, Castañeda, S, Montecucco, C, Gonzalez-Gay, M, Cavagna, Lorenzo, Trallero-Araguás, Ernesto, Meloni, Federica, Cavazzana, Ilaria, Rojas-Serrano, Jorge, Feist, Eugen, Zanframundo, Giovanni, Morandi, Valentina, Meyer, Alain, Pereira da Silva, Jose Antonio, Matos Costa, Carlo Jorge, Molberg, Oyvind, Andersson, Helena, Codullo, Veronica, Mosca, Marta, Barsotti, Simone, Neri, Rossella, Scirè, Carlo, Govoni, Marcello, Furini, Federica, Lopez-Longo, Francisco Javier, Martinez-Barrio, Julia, Schneider, Udo, Lorenz, Hanns-Martin, Doria, Andrea, Ghirardello, Anna, Ortego-Centeno, Norberto, Confalonieri, Marco, Tomietto, Paola, Pipitone, Nicolò, Rodriguez Cambron, Ana Belen, Blázquez Cañamero, María Ángeles, Voll, Reinhard Edmund, Wendel, Sarah, Scarpato, Salvatore, Maurier, Francois, Limonta, Massimiliano, Colombelli, Paolo, Giannini, Margherita, Geny, Bernard, Arrigoni, Eugenio, Bravi, Elena, Migliorini, Paola, Mathieu, Alessandro, Piga, Matteo, Drott, Ulrich, Delbrueck, Christiane, Bauhammer, Jutta, Cagnotto, Giovanni, Vancheri, Carlo, Sambataro, Gianluca, De Langhe, Ellen, Sainaghi, Pier Paolo, Monti, Cristina, Gigli Berzolari, Francesca, Romano, Mariaeva, Bonella, Francesco, Specker, Christof, Schwarting, Andreas, Villa Blanco, Ignacio, Selmi, Carlo, Ceribelli, Angela, Nuno, Laura, Mera-Varela, Antonio, Perez Gomez, Nair, Fusaro, Enrico, Parisi, Simone, Sinigaglia, Luigi, Del Papa, Nicoletta, Benucci, Maurizio, Cimmino, Marco Amedeo, Riccieri, Valeria, Conti, Fabrizio, Sebastiani, Gian Domenico, Iuliano, Annamaria, Emmi, Giacomo, Cammelli, Daniele, Sebastiani, Marco, Manfredi, Andreina, Bachiller-Corral, Javier, Sifuentes Giraldo, Walter Alberto, Paolazzi, Giuseppe, Saketkoo, Lesley Ann, Giorgi, Roberto, Salaffi, Fausto, Cifrian, Jose, Caporali, Roberto, Locatelli, Francesco, Marchioni, Enrico, Pesci, Alberto, Dei, Giulia, Pozzi, Maria Rosa, Claudia, Lomater, Distler, Jorg, Knitza, Johannes, Schett, George, Iannone, Florenzo, Fornaro, Marco, Franceschini, Franco, Quartuccio, Luca, Gerli, Roberto, Bartoloni, Elena, Bellando Randone, Silvia, Zampogna, Giuseppe, Gonzalez Perez, Montserrat I, Mejia, Mayra, Vicente, Esther, Triantafyllias, Konstantinos, Lopez-Mejias, Raquel, Matucci-Cerinic, Marco, Selva-O'Callaghan, Albert, Castañeda, Santos, Montecucco, Carlomaurizio, Gonzalez-Gay, Miguel Angel, Cavagna, L, Trallero-Araguás, E, Meloni, F, Cavazzana, I, Rojas-Serrano, J, Feist, E, Zanframundo, G, Morandi, V, Meyer, A, Pereira da Silva, J, Matos Costa, C, Molberg, O, Andersson, H, Codullo, V, Mosca, M, Barsotti, S, Neri, R, Scirè, C, Govoni, M, Furini, F, Lopez-Longo, F, Martinez-Barrio, J, Schneider, U, Lorenz, H, Doria, A, Ghirardello, A, Ortego-Centeno, N, Confalonieri, M, Tomietto, P, Pipitone, N, Rodriguez Cambron, A, Blázquez Cañamero, M, Voll, R, Wendel, S, Scarpato, S, Maurier, F, Limonta, M, Colombelli, P, Giannini, M, Geny, B, Arrigoni, E, Bravi, E, Migliorini, P, Mathieu, A, Piga, M, Drott, U, Delbrueck, C, Bauhammer, J, Cagnotto, G, Vancheri, C, Sambataro, G, De Langhe, E, Sainaghi, P, Monti, C, Gigli Berzolari, F, Romano, M, Bonella, F, Specker, C, Schwarting, A, Villa Blanco, I, Selmi, C, Ceribelli, A, Nuno, L, Mera-Varela, A, Perez Gomez, N, Fusaro, E, Parisi, S, Sinigaglia, L, Del Papa, N, Benucci, M, Cimmino, M, Riccieri, V, Conti, F, Sebastiani, G, Iuliano, A, Emmi, G, Cammelli, D, Sebastiani, M, Manfredi, A, Bachiller-Corral, J, Sifuentes Giraldo, W, Paolazzi, G, Saketkoo, L, Giorgi, R, Salaffi, F, Cifrian, J, Caporali, R, Locatelli, F, Marchioni, E, Pesci, A, Dei, G, Pozzi, M, Claudia, L, Distler, J, Knitza, J, Schett, G, Iannone, F, Fornaro, M, Franceschini, F, Quartuccio, L, Gerli, R, Bartoloni, E, Bellando Randone, S, Zampogna, G, Gonzalez Perez, M, Mejia, M, Vicente, E, Triantafyllias, K, Lopez-Mejias, R, Matucci-Cerinic, M, Selva-O'Callaghan, A, Castañeda, S, Montecucco, C, Gonzalez-Gay, M, Cavagna, Lorenzo, Trallero-Araguás, Ernesto, Meloni, Federica, Cavazzana, Ilaria, Rojas-Serrano, Jorge, Feist, Eugen, Zanframundo, Giovanni, Morandi, Valentina, Meyer, Alain, Pereira da Silva, Jose Antonio, Matos Costa, Carlo Jorge, Molberg, Oyvind, Andersson, Helena, Codullo, Veronica, Mosca, Marta, Barsotti, Simone, Neri, Rossella, Scirè, Carlo, Govoni, Marcello, Furini, Federica, Lopez-Longo, Francisco Javier, Martinez-Barrio, Julia, Schneider, Udo, Lorenz, Hanns-Martin, Doria, Andrea, Ghirardello, Anna, Ortego-Centeno, Norberto, Confalonieri, Marco, Tomietto, Paola, Pipitone, Nicolò, Rodriguez Cambron, Ana Belen, Blázquez Cañamero, María Ángeles, Voll, Reinhard Edmund, Wendel, Sarah, Scarpato, Salvatore, Maurier, Francois, Limonta, Massimiliano, Colombelli, Paolo, Giannini, Margherita, Geny, Bernard, Arrigoni, Eugenio, Bravi, Elena, Migliorini, Paola, Mathieu, Alessandro, Piga, Matteo, Drott, Ulrich, Delbrueck, Christiane, Bauhammer, Jutta, Cagnotto, Giovanni, Vancheri, Carlo, Sambataro, Gianluca, De Langhe, Ellen, Sainaghi, Pier Paolo, Monti, Cristina, Gigli Berzolari, Francesca, Romano, Mariaeva, Bonella, Francesco, Specker, Christof, Schwarting, Andreas, Villa Blanco, Ignacio, Selmi, Carlo, Ceribelli, Angela, Nuno, Laura, Mera-Varela, Antonio, Perez Gomez, Nair, Fusaro, Enrico, Parisi, Simone, Sinigaglia, Luigi, Del Papa, Nicoletta, Benucci, Maurizio, Cimmino, Marco Amedeo, Riccieri, Valeria, Conti, Fabrizio, Sebastiani, Gian Domenico, Iuliano, Annamaria, Emmi, Giacomo, Cammelli, Daniele, Sebastiani, Marco, Manfredi, Andreina, Bachiller-Corral, Javier, Sifuentes Giraldo, Walter Alberto, Paolazzi, Giuseppe, Saketkoo, Lesley Ann, Giorgi, Roberto, Salaffi, Fausto, Cifrian, Jose, Caporali, Roberto, Locatelli, Francesco, Marchioni, Enrico, Pesci, Alberto, Dei, Giulia, Pozzi, Maria Rosa, Claudia, Lomater, Distler, Jorg, Knitza, Johannes, Schett, George, Iannone, Florenzo, Fornaro, Marco, Franceschini, Franco, Quartuccio, Luca, Gerli, Roberto, Bartoloni, Elena, Bellando Randone, Silvia, Zampogna, Giuseppe, Gonzalez Perez, Montserrat I, Mejia, Mayra, Vicente, Esther, Triantafyllias, Konstantinos, Lopez-Mejias, Raquel, Matucci-Cerinic, Marco, Selva-O'Callaghan, Albert, Castañeda, Santos, Montecucco, Carlomaurizio, and Gonzalez-Gay, Miguel Angel

Abstract

Antisynthetase syndrome (ASSD) is a rare clinical condition that is characterized by the occurrence of a classic clinical triad, encompassing myositis, arthritis, and interstitial lung disease (ILD), along with specific autoantibodies that are addressed to different aminoacyl tRNA synthetases (ARS). Until now, it has been unknown whether the presence of a different ARS might affect the clinical presentation, evolution, and outcome of ASSD. In this study, we retrospectively recorded the time of onset, characteristics, clustering of triad findings, and survival of 828 ASSD patients (593 anti-Jo1, 95 anti-PL7, 84 anti-PL12, 38 anti-EJ, and 18 anti-OJ), referring to AENEAS (American and European NEtwork of Antisynthetase Syndrome) collaborative group's cohort. Comparisons were performed first between all ARS cases and then, in the case of significance, while using anti-Jo1 positive patients as the reference group. The characteristics of triad findings were similar and the onset mainly began with a single triad finding in all groups despite some differences in overall prevalence. The "ex-novo" occurrence of triad findings was only reduced in the anti-PL12-positive cohort, however, it occurred in a clinically relevant percentage of patients (30%). Moreover, survival was not influenced by the underlying anti-aminoacyl tRNA synthetase antibodies' positivity, which confirmed that antisynthetase syndrome is a heterogeneous condition and that antibody specificity only partially influences the clinical presentation and evolution of this condition.

Published
2019

44. Personalization of biologic therapy in patients with rheumatoid arthritis: less frequently accounted choice-driving variables

Author

Niccoli,Laura, Nannini,Carlotta, Blandizzi,Corrado, Mantarro,Stefania, Mosca,Marta, Di Munno,Ombretta, Goletti,Delia, Benucci,Maurizio, Li Gobbi,Francesca, Cassarà ,Emanuele, Kaloudi,Olga, and Cantini,Fabrizio

Subjects
Therapeutics and Clinical Risk Management
Abstract

Laura Niccoli,1 Carlotta Nannini,1 Corrado Blandizzi,2 Stefania Mantarro,2 Marta Mosca,3 OmbrettaDi Munno,3 Delia Goletti,4 Maurizio Benucci,5 FrancescaLi Gobbi,5 Emanuele Cassarà,1 Olga Kaloudi,1 Fabrizio Cantini1 1Department of Rheumatology, Hospital of Prato, Prato, Italy; 2Section of Pharmacology and Pharmacovigilance, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; 3Division of Rheumatology, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy; 4Translational Research Unit, Department of Epidemiology and Preclinical Research, National Institute for Infectious Diseases, Rome, Italy; 5Rheumatology Unit, Hospital S. Giovanni di Dio, Florence, Italy Objective: To propose appropriate statements that drive the choice of biologic therapies in patients with rheumatoid arthritis (RA), factoring in their impact on the following issues: anti-drug antibody (ADAb) formation, suspicion and management of infections, lupus-like syndrome (LLS), effects on bone mass and sexual sphere, and relationship between RA and periodontal disease (PD). Methods: An overview of existing evidence was undertaken by an expert panel on behalf of the Italian board for the TAilored BIOlogic therapy (ITABIO). Data were extracted from controlled trials, national registries, national health care databases, post-marketing surveys, and, when required by the paucity of controlled studies, from open-label clinical series. Anti-tumor necrosis factor (anti-TNF) and non-anti-TNF-targeted biologics approved for RA were investigated. Results: ADAb formation is chiefly associated with anti-TNFs, and it is reduced by combination therapy with methotrexate. To date, ADAb titration is not advisable for clinical practice, and, in case of anti-TNF secondary failure, a non-anti-TNF biologic is indicated. LLS is observed in anti-TNF receivers and, in most cases, resolves without anti-TNF withdrawal. A non-anti-TNF biologic is advisable in patients experiencing LLS. Non-anti-TNFs demonstrated a low or absent infection risk and are preferable in patients with comorbidities. Due to their positive effects on bone mass, anti-TNFs are indicated in women at osteoporosis risk, whereas non-anti-TNF have been poorly investigated. The emerging evidence of the relationship between RA and PD and the effects on anti-TNF efficacy should lead clinicians to consider the periodontal status in RA patients. Anti-TNFs may exert a positive effect on fertility and sexuality, and clinicians should explore these aspects in RA patients. Conclusion: The optimization of biologic therapies by taking into proper account the above issues would improve patient outcomes. Keywords: biologics, immunogenicity, infections, lupus-like syndrome, osteoporosis, periodontal disease, sexuality

Published
2018

45. Influence of Antisynthetase Antibodies Specificities on Antisynthetase Syndrome Clinical Spectrum Time Course

Author

Cavagna, Lorenzo, primary, Trallero-Araguás, Ernesto, additional, Meloni, Federica, additional, Cavazzana, Ilaria, additional, Rojas-Serrano, Jorge, additional, Feist, Eugen, additional, Zanframundo, Giovanni, additional, Morandi, Valentina, additional, Meyer, Alain, additional, Pereira da Silva, Jose, additional, Matos Costa, Carlo, additional, Molberg, Oyvind, additional, Andersson, Helena, additional, Codullo, Veronica, additional, Mosca, Marta, additional, Barsotti, Simone, additional, Neri, Rossella, additional, Scirè, Carlo, additional, Govoni, Marcello, additional, Furini, Federica, additional, Lopez-Longo, Francisco, additional, Martinez-Barrio, Julia, additional, Schneider, Udo, additional, Lorenz, Hanns-Martin, additional, Doria, Andrea, additional, Ghirardello, Anna, additional, Ortego-Centeno, Norberto, additional, Confalonieri, Marco, additional, Tomietto, Paola, additional, Pipitone, Nicolò, additional, Rodriguez Cambron, Ana, additional, Blázquez Cañamero, María, additional, Voll, Reinhard, additional, Wendel, Sarah, additional, Scarpato, Salvatore, additional, Maurier, Francois, additional, Limonta, Massimiliano, additional, Colombelli, Paolo, additional, Giannini, Margherita, additional, Geny, Bernard, additional, Arrigoni, Eugenio, additional, Bravi, Elena, additional, Migliorini, Paola, additional, Mathieu, Alessandro, additional, Piga, Matteo, additional, Drott, Ulrich, additional, Delbrueck, Christiane, additional, Bauhammer, Jutta, additional, Cagnotto, Giovanni, additional, Vancheri, Carlo, additional, Sambataro, Gianluca, additional, De Langhe, Ellen, additional, Sainaghi, Pier, additional, Monti, Cristina, additional, Gigli Berzolari, Francesca, additional, Romano, Mariaeva, additional, Bonella, Francesco, additional, Specker, Christof, additional, Schwarting, Andreas, additional, Villa Blanco, Ignacio, additional, Selmi, Carlo, additional, Ceribelli, Angela, additional, Nuno, Laura, additional, Mera-Varela, Antonio, additional, Perez Gomez, Nair, additional, Fusaro, Enrico, additional, Parisi, Simone, additional, Sinigaglia, Luigi, additional, Del Papa, Nicoletta, additional, Benucci, Maurizio, additional, Cimmino, Marco, additional, Riccieri, Valeria, additional, Conti, Fabrizio, additional, Sebastiani, Gian, additional, Iuliano, Annamaria, additional, Emmi, Giacomo, additional, Cammelli, Daniele, additional, Sebastiani, Marco, additional, Manfredi, Andreina, additional, Bachiller-Corral, Javier, additional, Sifuentes Giraldo, Walter, additional, Paolazzi, Giuseppe, additional, Saketkoo, Lesley, additional, Giorgi, Roberto, additional, Salaffi, Fausto, additional, Cifrian, Jose, additional, Caporali, Roberto, additional, Locatelli, Francesco, additional, Marchioni, Enrico, additional, Pesci, Alberto, additional, Dei, Giulia, additional, Pozzi, Maria, additional, Claudia, Lomater, additional, Distler, Jorg, additional, Knitza, Johannes, additional, Schett, George, additional, Iannone, Florenzo, additional, Fornaro, Marco, additional, Franceschini, Franco, additional, Quartuccio, Luca, additional, Gerli, Roberto, additional, Bartoloni, Elena, additional, Bellando Randone, Silvia, additional, Zampogna, Giuseppe, additional, Gonzalez Perez, Montserrat, additional, Mejia, Mayra, additional, Vicente, Esther, additional, Triantafyllias, Konstantinos, additional, Lopez-Mejias, Raquel, additional, Matucci-Cerinic, Marco, additional, Selva-O’Callaghan, Albert, additional, Castañeda, Santos, additional, Montecucco, Carlomaurizio, additional, and Gonzalez-Gay, Miguel, additional

Published
2019
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46. Spondylarthritis presenting with an allergic immediate systemic reaction to adalimumab in a woman: a case report

Author

Valentini Maurizio, Iorno Maria L, Testi Sergio, Manfredi Mariangela, Benucci Maurizio, Soldaini Francesca, and Campi Paolo

Subjects
Medicine
Abstract

Abstract Introduction The efficacy of adalimumab, a fully human anti-tumor necrosis factor α recombinant antibody, has dramatically improved the quality of life of patients with rheumatoid and psoriatic arthritis and Crohn's disease. Because it is fully human, one should not expect immune reactions to this molecule. Adverse reactions to adalimumab are limited mainly to injection site reactions and are very common. Immediate systemic reactions are rarely reported. Case presentation We report the case of a 61-year-old Caucasian woman who was treated with adalimumab for spondylarthritis and developed injection site reactions after the sixth dose. After a two-month suspension, she recommenced therapy and experienced two systemic reactions. The first occurred after one hour with itching of the palms and soles and angioedema of the tongue and lips. Thirty minutes after the next dose the patient had itching of the palms and soles with diffusion to her whole body, angioedema of the lips, dizziness and visual disturbances. A skin-prick test and intra-dermal tests with adalimumab gave strong positive results at the immediate reading. However, serum-specific immunoglobulin E (IgE) to adalimumab were not detectable by using Phadia solid phase, especially harvested for this case, in collaboration with our Immunology and Allergy Laboratory Unit. Her total IgE concentration was 6.4 kU/L. Conclusion We describe what is, to the best of our knowledge, the first reported case of immediate systemic reaction to adalimumab studied with a skin test giving positive results and a serum-specific IgE assay giving negative results. The mechanism of the reaction must be immunologic but not IgE-mediated.

Published
2011
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47. Factors correlated with the improvement of endothelial dysfunction during Abatacept therapy in patients with rheumatoid arthritis

Author

Benucci,Maurizio, Bandinelli,Francesca, Damiani,Arianna, Li Gobbi,Francesca, Infantino,Maria, Grossi,Valentina, Manfredi,Mariangela, Benucci,Maurizio, Bandinelli,Francesca, Damiani,Arianna, Li Gobbi,Francesca, Infantino,Maria, Grossi,Valentina, and Manfredi,Mariangela

Abstract

Maurizio Benucci,1 Francesca Bandinelli,1 Arianna Damiani,1 Francesca Li Gobbi,1 Maria Infantino,2 Valentina Grossi,2 Mariangela Manfredi2 1Rheumatology Unit, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, Florence, Italy; 2Immunology and Allergology Laboratory Unit, Hospital S. Giovanni di Dio, Azienda USL-Toscana Centro, Florence, Italy Background: Rheumatoid arthritis patients are exposed to a high risk of cardiovascular morbidity and mortality even in the early phases of the disease. Methods: We evaluated carotid common carotid intimal media thickness (ccIMT) intimal thickness and brachial flow-mediated dilation (FMD) of 45 rheumatoid arthritis patients without known cardiovascular risk factors or heart disease on a stable dose of prednisone 5.2±1.2 mg/day and Methotrexate 11.5±2.1 mg at baseline (T0) and after 12 months (T1) of treatment with Abatacept 125 mg/week. The comparison between T0 and T1 (t- and Mann–Whitney test), correlation (Spearman r), and predictivity (linear regression) of FMD, ccIMT vs clinical and laboratory parameters (disease activity 28 score, tumor necrosis factor alpha [TNFα], interleukin-6, erythrocyte sedimentation rate, C-reactive protein (CRP), CD3+, CD3+/CD4+, CD3+/CD8+, CD19+(B), CD20+(B), NK CD3-CD56+CD16+, CD14+ HLA DR+, CD4+CD28+, CD4+CD28, rheumatoid factor IgM, IgA, RF IgG, anti-citrullinated peptide antibodies) were also evaluated. Results: During Abatacept treatment, ccIMT and FMD remained stable and disease activity 28 score, CRP, erythrocyte sedimentation rate, and interleukin-6 decreased significantly (p=0.0001, 0.002, 0.0002, 0.0001 respectively). At T0, only ccIMT resulted as correlated with baseline TNFα values (p=0.0245) in an inverse proportion. At T1, ccIMT correlated with CD3/CD8+ lymphocytes number (p=0.0351) and FMD with CRP (p=0.0075). In regression analysis, baseline ccIMT and FMD had a low predictivity for TNFα (p=0.011) and CRP (p=0.049)

Published
2018

48. Timing of onset affects arthritis presentation pattern in antisyntethase syndrome

Author

González-Gay, M, Montecucco, C, Selva-O'Callaghan, A, Trallero-Araguas, E, Molberg, O, Andersson, H, Rojas-Serrano, J, Perez-Roman, D, Bauhammer, J, Fiehn, C, Neri, R, Barsotti, S, Lorenz, H, Doria, A, Ghirardello, A, Iannone, F, Giannini, M, Franceschini, F, Cavazzana, I, Triantafyllias, K, Benucci, M, Infantino, M, Manfredi, M, Conti, F, Schwarting, A, Sebastiani, G, Iuliano, A, Emmi, G, Silvestri, E, Govoni, M, Scirè, C, Furini, F, Lopez-Longo, F, Martínez-Barrio, J, Sebastiani, M, Manfredi, A, Bachiller-Corral, J, Sifuentes Giraldo, W, Cimmino, M, Cosso, C, Belotti Masserini, A, Cagnotto, G, Codullo, V, Romano, M, Paolazzi, G, Pellerito, R, Saketkoo, L, Ortego-Centeno, N, Quartuccio, L, Batticciotto, A, Bartoloni Bocci, E, Gerli, R, Specker, C, Bravi, E, Selmi, C, Parisi, S, Salaffi, F, Meloni, F, Marchioni, E, Pesci, A, Dei, G, Confalonieri, M, Tomietto, P, Nuno, L, Bonella, F, Pipitone, N, Mera-Valera, A, Perez-Gomez, N, Gerzeli, S, Lopez-Mejias, R, Matos-Costa, C, Pereira da Silva, J, Cifrian, J, Alpini, C, Olivieri, I, Blázquez Cañamero, M, Rodriguez Cambrón, A, Castañeda, S, Cavagna, L, González-Gay, Miguel A, Montecucco, Carlomaurizio, Selva-O'Callaghan, Albert, Trallero-Araguas, Ernesto, Molberg, Ovynd, Andersson, Helena, Rojas-Serrano, Jorge, Perez-Roman, Diana Isabel, Bauhammer, Jutta, Fiehn, Christoph, Neri, Rossella, Barsotti, Simone, Lorenz, Hannes M, Doria, Andrea, Ghirardello, Anna, Iannone, Florenzo, Giannini, Margherita, Franceschini, Franco, Cavazzana, Ilaria, Triantafyllias, Konstantinos, Benucci, Maurizio, Infantino, Maria, Manfredi, Mariangela, Conti, Fabrizio, Schwarting, Andreas, Sebastiani, Giandomenico, Iuliano, Annamaria, Emmi, Giacomo, Silvestri, Elena, Govoni, Marcello, Scirè, Carlo Alberto, Furini, Federica, Lopez-Longo, Francisco Javier, Martínez-Barrio, Julia, Sebastiani, Marco, Manfredi, Andreina, Bachiller-Corral, Javier, Sifuentes Giraldo, Walter Alberto, Cimmino, Marco A, Cosso, Claudio, Belotti Masserini, Alessandro, Cagnotto, Giovanni, Codullo, Veronica, Romano, Mariaeva, Paolazzi, Giuseppe, Pellerito, Raffaele, Saketkoo, Lesley Ann, Ortego-Centeno, Norberto, Quartuccio, Luca, Batticciotto, Alberto, Bartoloni Bocci, Elena, Gerli, Roberto, Specker, Christof, Bravi, Elena, Selmi, Carlo, Parisi, Simone, Salaffi, Fausto, Meloni, Federica, Marchioni, Enrico, Pesci, Alberto, Dei, Giulia, Confalonieri, Marco, Tomietto, Paola, Nuno, Laura, Bonella, Francesco, Pipitone, Nicolò, Mera-Valera, Antonio, Perez-Gomez, Nair, Gerzeli, Simone, Lopez-Mejias, Raquel, Matos-Costa, Carlo Jorge, Pereira da Silva, Jose Antonio, Cifrian, José, Alpini, Claudia, Olivieri, Ignazio, Blázquez Cañamero, María Ángeles, Rodriguez Cambrón, Ana Belén, Castañeda, Santos, Cavagna, Lorenzo, González-Gay, M, Montecucco, C, Selva-O'Callaghan, A, Trallero-Araguas, E, Molberg, O, Andersson, H, Rojas-Serrano, J, Perez-Roman, D, Bauhammer, J, Fiehn, C, Neri, R, Barsotti, S, Lorenz, H, Doria, A, Ghirardello, A, Iannone, F, Giannini, M, Franceschini, F, Cavazzana, I, Triantafyllias, K, Benucci, M, Infantino, M, Manfredi, M, Conti, F, Schwarting, A, Sebastiani, G, Iuliano, A, Emmi, G, Silvestri, E, Govoni, M, Scirè, C, Furini, F, Lopez-Longo, F, Martínez-Barrio, J, Sebastiani, M, Manfredi, A, Bachiller-Corral, J, Sifuentes Giraldo, W, Cimmino, M, Cosso, C, Belotti Masserini, A, Cagnotto, G, Codullo, V, Romano, M, Paolazzi, G, Pellerito, R, Saketkoo, L, Ortego-Centeno, N, Quartuccio, L, Batticciotto, A, Bartoloni Bocci, E, Gerli, R, Specker, C, Bravi, E, Selmi, C, Parisi, S, Salaffi, F, Meloni, F, Marchioni, E, Pesci, A, Dei, G, Confalonieri, M, Tomietto, P, Nuno, L, Bonella, F, Pipitone, N, Mera-Valera, A, Perez-Gomez, N, Gerzeli, S, Lopez-Mejias, R, Matos-Costa, C, Pereira da Silva, J, Cifrian, J, Alpini, C, Olivieri, I, Blázquez Cañamero, M, Rodriguez Cambrón, A, Castañeda, S, Cavagna, L, González-Gay, Miguel A, Montecucco, Carlomaurizio, Selva-O'Callaghan, Albert, Trallero-Araguas, Ernesto, Molberg, Ovynd, Andersson, Helena, Rojas-Serrano, Jorge, Perez-Roman, Diana Isabel, Bauhammer, Jutta, Fiehn, Christoph, Neri, Rossella, Barsotti, Simone, Lorenz, Hannes M, Doria, Andrea, Ghirardello, Anna, Iannone, Florenzo, Giannini, Margherita, Franceschini, Franco, Cavazzana, Ilaria, Triantafyllias, Konstantinos, Benucci, Maurizio, Infantino, Maria, Manfredi, Mariangela, Conti, Fabrizio, Schwarting, Andreas, Sebastiani, Giandomenico, Iuliano, Annamaria, Emmi, Giacomo, Silvestri, Elena, Govoni, Marcello, Scirè, Carlo Alberto, Furini, Federica, Lopez-Longo, Francisco Javier, Martínez-Barrio, Julia, Sebastiani, Marco, Manfredi, Andreina, Bachiller-Corral, Javier, Sifuentes Giraldo, Walter Alberto, Cimmino, Marco A, Cosso, Claudio, Belotti Masserini, Alessandro, Cagnotto, Giovanni, Codullo, Veronica, Romano, Mariaeva, Paolazzi, Giuseppe, Pellerito, Raffaele, Saketkoo, Lesley Ann, Ortego-Centeno, Norberto, Quartuccio, Luca, Batticciotto, Alberto, Bartoloni Bocci, Elena, Gerli, Roberto, Specker, Christof, Bravi, Elena, Selmi, Carlo, Parisi, Simone, Salaffi, Fausto, Meloni, Federica, Marchioni, Enrico, Pesci, Alberto, Dei, Giulia, Confalonieri, Marco, Tomietto, Paola, Nuno, Laura, Bonella, Francesco, Pipitone, Nicolò, Mera-Valera, Antonio, Perez-Gomez, Nair, Gerzeli, Simone, Lopez-Mejias, Raquel, Matos-Costa, Carlo Jorge, Pereira da Silva, Jose Antonio, Cifrian, José, Alpini, Claudia, Olivieri, Ignazio, Blázquez Cañamero, María Ángeles, Rodriguez Cambrón, Ana Belén, Castañeda, Santos, and Cavagna, Lorenzo

Abstract

Objective To evaluate if the timing of appearance with respect to disease onset may influence the arthritis presentation pattern in antisynthetase syndrome (ASSD). Methods The patients were selected from a retrospective large international cohort of ASSD patients regularly followed-up in centres referring to AENEAS collaborative group. Patients were eligible if they had an antisynthetase antibody testing positive in at least two determinations along with arthritis occurring either at ASSD onset (Group 1) or during the course of the disease (Group 2). Results 445 (70%; 334 females, 110 males, 1 transsexual) out of the 636 ASSD we collected had arthritis, in the majority of cases (367, 83%) from disease onset (Group 1). Patients belonging to Group 1 with respect to Group 2 had an arthritis more commonly polyarticular and symmetrical (p=0.015), IgM-Rheumatoid factor positive (p=0.035), erosions at hands and feet plain x-rays (p=0.036) and more commonly satisfying the 1987 revised classification criteria for rheumatoid arthritis (RA) (p=0.004). Features such as Raynaud's phenomenon, mechanic's hands and fever (e.g. accompanying findings) were more frequently reported in Group 2 (p=0.005). Conclusion In ASSD, the timing of appearance with respect to disease onset influences arthritis characteristics. In particular, RA features are more common when arthritis occurs from ASSD onset, suggesting an overlap between RA and ASSD in these patients. When arthritis appears during the follow-up, it is very close to a connective tissue disease-related arthritis. Also, the different prevalence of accompanying features between these two groups is in line with this possibility

Published
2018

49. Switch or swap strategy in rheumatoid arthritis patients failing TNF inhibitors? Results of a modified Italian Expert Consensus

Author

Todoerti, Monica, Favalli, Ennio Giulio, Iannone, Florenzo, Olivieri, Ignazio, Benucci, Maurizio, Cauli, Alberto, Mathieu, Alessandro, Santo, Leonardo, Minisola, Giovanni, Lapadula, Giovanni, Bucci, Romano, Gremese, Elisa, Caporali, Roberto, Gremese, Elisa (ORCID:0000-0002-2248-1058), Todoerti, Monica, Favalli, Ennio Giulio, Iannone, Florenzo, Olivieri, Ignazio, Benucci, Maurizio, Cauli, Alberto, Mathieu, Alessandro, Santo, Leonardo, Minisola, Giovanni, Lapadula, Giovanni, Bucci, Romano, Gremese, Elisa, Caporali, Roberto, and Gremese, Elisa (ORCID:0000-0002-2248-1058)

Abstract

Objective: To establish evidence-based and experts' opinion filtered statements on the optimal treatment choice between cycling (switch) and changing mode of action strategies (swap) in RA patients failing TNF inhibitors (TNFis).Methods: The relevant question (switch vs swap) was rephrased into a research question according to the population, intervention, comparison and outcome (PICO) strategy, considering all the available scientific evidence published from the 2013 EULAR set of recommendations up to mid-January 2016. Final statements derived from the retrieved scientific evidence and experts' consensus, with eventual rephrasing through a Delphi method during a national consensus of Italian rheumatologists.Results: From a total of 365 records, 12 studies were finally included. The final statements argued that, until head-to-head comparison data are available, switch and swap can be still considered suitable strategies in RA patients failing first TNFi, even though some data seem to lend more support to a different mode of action-targeted strategy.Conclusion: After failure of first TNFi course, switch and swap can be currently considered as alternative suitable approaches in RA patients.

Published
2018

50. Focus on biosimilar etanercept – bioequivalence and interchangeability

Author

Cantini,Fabrizio, Benucci,Maurizio, Cantini,Fabrizio, and Benucci,Maurizio

Abstract

Fabrizio Cantini,1 Maurizio Benucci2 1Department of Rheumatology, Hospital of Prato, Prato, Italy; 2Rheumatology Unit, Hospital S. Giovanni di Dio, Florence, Italy Background: The recent approval of reference etanercept (re-ETN) biosimilars SB4, GP2015, and HD203 produced relevant changes in the management of rheumatoid arthritis (RA), psoriatic arthritis, and ankylosing spondylitis due to the considerably lower cost of these products and the consequent savings.Aims: To review the pharmacodynamics, pharmacokinetics, efficacy, and safety of ETN biosimilars when employed as first-line therapy or after transition from re-ETN. Patients’ acceptability was also addressed.Evidence review: The available literature was reviewed through a search of PubMed database, and abstract books of the American College for Rheumatology and European League Against Rheumatism annual meetings. SB4, GP2015, and HD203 were licensed by the US, European and South Korea regulatory agencies after the bioequivalence to re-ETN was demonstrated through pharmacodynamic and pharmacokinetic studies, and randomized, head to head, controlled trials. Based on the evidence of efficacy and safety of SB4 and HD203 in RA, and of GP2015 in psoriasis, by the extrapolation principle, the three biosimilars were approved for all indications licensed for re-ETN, and the regulatory agencies introduced the interchangeability from the originator to the biosimilar. Extrapolation of indications, and particularly interchangeability raised relevant concerns among the rheumatologists due to the low level of evidence supporting the switching strategy (or transition). Rheumatologists’ concerns are oriented toward the relevant number of biosimilar discontinuations after the transition ranging from 7%–17% over a short-term follow-up period. As resulted from two studies, at least 20%–30% of the patients claimed more exhaustive information on the switching procedure.Conclusion: Based on th

Published
2018

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