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1. Dynamic Contrast-Enhanced MRI Confirms Rapid And Sustained Improvement Of Rheumatoid Arthritis Induced By Tocilizumab Treatment: An Italian Multicentre Study

Author

Cimmino MA, Parodi M, Barbieri F, Bombardieri S, Zampogna G, Iagnocco A, Batticciotto A, Sconfienza LM, Sinigaglia L, De Benedetti F, Atzeni F, and Sarzi-Puttini P

Subjects
tocilizumab, rheumatoid arthritis, wrist, synovitis, low-field mri, dedicated mri, Medicine (General), R5-920
Abstract

Marco A Cimmino,1 Massimiliano Parodi,1 Francesca Barbieri,1 Stefano Bombardieri,2 Giuseppe Zampogna,1 Annamaria Iagnocco,3 Alberto Batticciotto,4 Luca Maria Sconfienza,5,6 Luigi Sinigaglia,7 Fabrizio De Benedetti,8 Fabiola Atzeni,9 Piercarlo Sarzi-Puttini10 1Research Laboratory and Academic Division of Clinical Rheumatology, Department of Internal Medicine, University of Genoa, Genoa, Italy; 2Rheumatology Unit, Santa Chiara Hospital, University of Pisa, Pisa, Italy; 3Academic Rheumatology Centre, Università degli Studi di Torino, Turin, Italy; 4Rheumatology Unit ASST-Settelaghi, Ospedale di Circolo – Fondazione Macchi, Varese, Varese, Italy; 5IRCCS Istituto Ortopedico Galeazzi, Milan, Italy; 6Dipartimento di Scienze Biomediche per la Salute, Università degli Studi di Milano, Milan, Italy; 7Rheumatology Unit, G. Pini Hospital, Milan, Italy; 8Division of Rheumatology, IRCCS, Bambin Gesù Paediatric Hospital, Rome, Italy; 9Rheumatology Unit, University of Messina, Messina, Italy; 10Rheumatology Unit, L. Sacco University Hospital, Milan, ItalyCorrespondence: Piercarlo Sarzi-PuttiniReumatology Department, L. Sacco University Hospital, ASST Fatebenefratelli – Sacco, Via G.B. Grassi, 74, Milan 20157, ItalyTel +39 02 39042208Email piercarlo.sarziputtini@gmail.comObjective: This open-label study evaluated the effects of combined tocilizumab (TCZ) and disease-modifying antirheumatic drugs (DMARDs) on magnetic resonance imaging (MRI) changes in synovial membrane enhancement, bone marrow edema (BME), and erosions in the wrist and hand joints of rheumatoid arthritis (RA) patients inadequately responding to DMARDs alone.Methods: The efficacy of intravenous TCZ 8 mg/kg administered every four weeks for 48 weeks was evaluated on six occasions. The primary endpoints were the changes in the extent and degree of wrist synovitis as measured using the RA MRI Score (RAMRIS) and dynamic, gadolinium-enhanced 0.2T MRI (DCE-MRI). A number of different parameters of DCE-MRI were evaluated.Results: Fifty-eight patients were treated, eight of whom (13.8%) discontinued the study prematurely. The mean RAMRIS significantly decreased after two weeks and the decrease was maintained for up to 48 weeks. By week 4, the mean RAMRIS synovitis score had significantly decreased from baseline (− 0.804± 1.575; p=0.018), but not the mean early enhancement (REE) or relative enhancement (RE). However, there were significant decreases in RE at week 24, in REE and Ntotal (total number of enhancing voxels)*IRE (initial rate of enhancement) at weeks 12, 24 and 48, and in Ntotal*ME (maximal enhancement) at weeks 24 and 48. Mean BME decreased from baseline to week 48, and bone erosions did not progress. The patients’ clinical parameters significantly improved from baseline until week 48.Conclusion: TCZ in combination with DMARDs improved wrist synovitis, BME and clinical parameters, without any progression in bone erosions. The RAMRIS for synovitis rapidly improved from as early as two weeks after the first TCZ infusion. (Funded by F. Hoffmann–La Roche; ACTRACE EudraCT No. 2009 012185-32).Keywords: tocilizumab, rheumatoid arthritis, wrist, synovitis, low-field MRI, dedicated MRI

Published
2020

2. Patients’, physicians’, nurses’, and pharmacists’ preferences on the characteristics of biologic agents used in the treatment of rheumatic diseases

Author

Scalone L, Sarzi-Puttini P, Sinigaglia L, Montecucco C, Giacomelli R, Lapadula G, Olivieri I, Giardino AM, Cortesi PA, Mantovani LG, and Mecchia M

Subjects
preferences, biologic drugs, rheumatic disease, decision-making, Medicine (General), R5-920
Abstract

Luciana Scalone,1 Piercarlo Sarzi-Puttini,2 Luigi Sinigaglia,3 Carlomaurizio Montecucco,4 Roberto Giacomelli,5 Giovanni Lapadula,6 Ignazio Olivieri,7,8,† Angela Maria Giardino,9 Paolo Angelo Cortesi,1 Lorenzo Giovanni Mantovani,1 Monica Mecchia9On behalf of the CARA Study Group1Centre of Research on Public Health, University of Milano-Bicocca, and CHARTA Foundation, Milan, Italy; 2Rheumatology Unit, L. Sacco University Hospital, 3Rheumatology Unit, G. Pini Hospital, Milan, Italy; 4University of Pavia School of Medicine, IRCCS Policlinico San Matteo Foundation, Pavia, Italy; 5Rheumatology Unit School of Medicine, University of L’Aquila, L’Aquila, Italy; 6Rheumatology Unit, University of Bari, Bari, Italy; 7Rheumatology Department of Lucania, San Carlo Hospital of Potenza, Potenza, Italy; 8Madonna delle Grazie Hospital of Matera, Matera, Italy; 9MSD Italy, Rome, Italy†Dr Ignazio Olivieri passed away on July 28, 2017Objective: To estimate preferences in relevant treatment characteristics evaluated by different groups involved in the management of patients with rheumatic diseases.Subjects and methods: We surveyed patients with rheumatic diseases, and rheumatologists, nurses, and pharmacists with experience in treatment with/provision of biologic drugs for these patients. Through a discrete choice experiment, participants evaluated 16 possible scenarios in which pairs of similarly efficacious treatments were described with six characteristics: 1) frequency of administration; 2) mode and place of administration; 3) manner, helpfulness, efficiency, and courtesy of health personnel; 4) frequency of reactions at the site of drug administration; 5) severity of generalized undesired/allergic reactions; and 6) additional cost. The direction and strength of preferences toward each characteristic level and the relative importance of each characteristic were estimated through a random-effects conditional logistic regression model.Results: In total, 513 patients, 110 rheumatologists, 51 nurses, and 46 pharmacists from 30 centers in Italy participated. Characteristics 3, 4, and 6 were the most important for every subgroup; 1 was least important for patients and rheumatologists, 2 was least important for pharmacists, and 2 and 5 were least important for nurses. For characteristic 2, pharmacists preferred subcutaneous self-injection with a syringe; nurses preferred assisted infusion at an infusion center close to the patient’s home; patients and rheumatologists preferred subcutaneous self-injection with a pen.Conclusion: The different preferences for some characteristics shown by the different groups can play an important role, together with purely clinical aspects, in the choice and consequent benefit of treatments, contributing also to a more satisfactory use of resources.Keywords: preferences, biologic drugs, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, decision making

Published
2018

4. Increased COVID-19 mortality in patients with rheumatic diseases: results from the CONTROL-19 study by the Italian Society for Rheumatology

Author

Zanetti, A, Carrara, G, Landolfi, G, Rozza, D, Chighizola, C, Alunno, A, Andreoli, L, Caporali, R, Gerli, R, Sebastiani, G, Valesini, G, Sinigaglia, L, Raffeiner, B, Lomater, C, Caprioli, M, Fredi, M, Romeo, N, Cuomo, G, Vadacca, M, Scire, C, Zanetti A., Carrara G., Landolfi G., Rozza D., Chighizola C. B., Alunno A., Andreoli L., Caporali R., Gerli R., Sebastiani G. D., Valesini G., Sinigaglia L., Raffeiner B., Lomater C., Caprioli M., Fredi M., Romeo N., Cuomo G., Vadacca M., Scire C. A., Zanetti, A, Carrara, G, Landolfi, G, Rozza, D, Chighizola, C, Alunno, A, Andreoli, L, Caporali, R, Gerli, R, Sebastiani, G, Valesini, G, Sinigaglia, L, Raffeiner, B, Lomater, C, Caprioli, M, Fredi, M, Romeo, N, Cuomo, G, Vadacca, M, Scire, C, Zanetti A., Carrara G., Landolfi G., Rozza D., Chighizola C. B., Alunno A., Andreoli L., Caporali R., Gerli R., Sebastiani G. D., Valesini G., Sinigaglia L., Raffeiner B., Lomater C., Caprioli M., Fredi M., Romeo N., Cuomo G., Vadacca M., and Scire C. A.

Abstract

Objective To investigate differences in coronavirus disease 2019 (COVID-19) mortality between patients with rheumatic musculoskeletal diseases (RMD) and the general population in Italy. Methods We analysed the data from the national surveillance study promoted by the Italian Society for Rheumatology (CONTROL-19 database) including patients with RMD and COVID-19 between 26 March 2020 and 29 November 2020, compared with official data from the Italian population (within the same period) adjusted for age, sex and geographic location. The main outcome of the analyses was mortality. The relationship between RMD and mortality was analysed using adjusted logistic models and sensitivity analyses were conducted to support the robustness of our results. Results We included 668 RMD patients (62.7% with inflammatory arthritis, 28.6% with systemic autoimmune diseases), who had a mean age of 58.4 years and of which 66% were female. Compared to the general population, the RMD population showed an increased risk of death (OR 3.10 (95% CI 2.29–4.12)), independently from the differences in age and sex distribution. Even after considering the potential influence of surveillance bias, the OR was 2.08 (95% CI: 1.55–2.73). Such excess of risk was more evident in the subgroup of younger patients, and more consistent in women. Subjects with systemic autoimmune diseases showed a higher risk of death than patients with any other RMDs. Conclusions Patients with RMD and COVID-19 infection evidenced a significant increase in mortality during the first pandemic phases in Italy. These findings support the need for strong SARS-CoV-2 prevention in patients with rheumatic diseases.

Published
2022

7. 854MO Avelumab-cetuximab-radiotherapy (RT) versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Final analysis of randomized phase III GORTEC 2017-01 REACH trial

Author

Tao, Y., Auperin, A., Sun, X., Liem, X., Sire, C., Martin, L., Pointreau, Y., Borel, C., Kaminsky-Forrett, M-C., Miroir, J., Rolland, F., Coutte, A., Clatot, F., Sinigaglia, L., Thariat, J., Even, C., Saada, E.B., Guigay, J., and Bourhis, J.

Published
2024
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9. POS0111 MORE METICULOUSLY FOLLOWING TREAT-TO-TARGET IN RA DOES NOT LEAD TO LESS RADIOGRAPHIC PROGRESSION: A LONGITUDINAL ANALYSIS IN BIODAM

Author

Ramiro, S., primary, Landewé, R. B. M., additional, Van der Heijde, D., additional, Sepriano, A., additional, Fitzgerald, O., additional, Østergaard, M., additional, Homik, J., additional, Elkayam, O., additional, Thorne, C., additional, Larché, M., additional, Ferraccioli, G., additional, Backhaus, M., additional, Boire, G., additional, Combe, B., additional, Schaeverbeke, T., additional, Saraux, A., additional, Dougados, M., additional, Rossini, M., additional, Govoni, M., additional, Sinigaglia, L., additional, Cantagrel, A., additional, Allaart, C., additional, Barnabe, C., additional, Bingham, C., additional, Van Schaardenburg, D., additional, Hammer, H. B., additional, Dadashova, R., additional, Hutchings, E., additional, Paschke, J., additional, and Maksymowych, W. P., additional

Published
2022
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10. Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study

Author

Emery, P, Burmester, GR, Naredo, E, Sinigaglia, L, Lagunes, I, Koenigsbauer, F, and Conaghan, PG

Subjects
musculoskeletal diseases, Adult, Male, Remission Induction, Adalimumab, Rheumatoid Arthritis, DMARDs (biologic), anti-TNF, Middle Aged, Symptom Flare Up, Arthritis, Rheumatoid, Double-Blind Method, Antirheumatic Agents, Humans, Female, skin and connective tissue diseases, disease activity, Aged
Abstract

Objective: To investigate the association between baseline disease activity and the occurrence of flares after adalimumab tapering or withdrawal in patients with rheumatoid arthritis (RA) in sustained remission. Methods: The PREDICTRA phase IV, randomised, double-blind (DB) study (ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels, and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Patients) enrolled patients with RA receiving adalimumab 40 mg every other week who were in sustained remission ≥6 months. After a 4-week, open-label lead-in (OL-LI) period, patients were randomised 5:1 to DB adalimumab taper (every 3 weeks) or withdrawal (placebo) for 36 weeks. The primary endpoint was the association between DB baseline hand and wrist MRI-detected inflammation with flare occurrence. Results: Of 146 patients treated during the OL-LI period, 122 were randomised to taper (n=102) or withdrawal (n=20) arms. Patients had a mean 12.9 years of active disease and had received adalimumab for a mean of 5.4 years (mean 2.2 years in sustained remission). Overall, 37 (36%) and 9 (45%) patients experienced a flare in the taper and withdrawal arms, respectively (time to flare, 18.0 and 13.3 weeks). None of the DB baseline disease characteristics or adalimumab concentration was associated with flare occurrence after adalimumab tapering. Approximately half of the patients who flared regained clinical remission after 16 weeks of open-label rescue adalimumab. The safety profile was consistent with previous studies. Conclusions: Approximately one-third of patients who tapered adalimumab versus half who withdrew adalimumab experienced a flare within 36 weeks. Time to flare was numerically longer in the taper versus withdrawal arm. Baseline MRI inflammation was not associated with flare occurrence. Trial registration number: NCT02198651, EudraCT 2014-001114-26.

Published
2020

11. GENDER AND FIBROMYALGIA SEVERITY: REAL LIFE DATA FROM THE ITALIAN REGISTRY

Author

Batticciotto, A, Campanaro, F, Atzeni, F, Alciati, A, Di Carlo, M, Bazzichi, L, Govoni, M, Biasi, G, Di Franco, M, Mozzani, F, Gremese, E, Dagna, L, Fischetti, F, Giacomelli, R, Guiducci, S, Guggino, G, Bentivegna, M, Gerli, R, Salvarani, C, Bajocchi, G, Ghini, M, Iannone, F, Giorgi, V, Farah, S, Bonazza, S, Barbagli, S, Gioia, C, Capacci, A, Cavalli, G, Carubbi, F, Nacci, F, Ilenia, R, Sinigaglia, L, Cutolo, M, Cappelli, A, Sarzi-Puttini, P, Salaffi, F, Batticciotto, A, Campanaro, F, Atzeni, F, Alciati, A, Di Carlo, M, Bazzichi, L, Govoni, M, Biasi, G, Di Franco, M, Mozzani, F, Gremese, E, Dagna, L, Fischetti, F, Giacomelli, R, Guiducci, S, Guggino, G, Bentivegna, M, Gerli, R, Salvarani, C, Bajocchi, G, Ghini, M, Iannone, F, Giorgi, V, Farah, S, Bonazza, S, Barbagli, S, Gioia, C, Capacci, A, Cavalli, G, Carubbi, F, Nacci, F, Ilenia, R, Sinigaglia, L, Cutolo, M, Cappelli, A, Sarzi-Puttini, P, and Salaffi, F

Subjects
Fibromyalgia, Rheumatology
Abstract

Background: Fibromyalgia (FM) patients report chronic widespread pain, fatigue, cognitive difficulties and sleep disturbances, often associated with anxiety and/or depression (1). FM syndrome more frequently affects women and many papers describe gender-related differences in the perception, description and expression of pain (2), but up to now, the impact of gender on the clinical severity of FM is still a controversial topic. Objectives: The aim of this study was to analyse the data from a web-based registry of FM patients in order to detect a relationship between gender and disease severity. Methods: Adult patients with FM, diagnosed on the basis of the 2010/2011 American College of Rheumatology (ACR) diagnostic criteria (3), were recruited at 19 Italian rheumatology centres between November 2018 and April 2019. Those affected by other conditions that could interfere with the assessment of FM, e.g. psychiatric disorders, were excluded from the study. The severity of the disease was evaluated by validated FM-specific questionnaires: the revised Fibromyalgia Impact Questionnaire (FIQR) (4), the modified Fibromyalgia Assessment Status (ModFAS) questionnaire (5), and the Polysymptomatic Distress Scale (PDS) (6). The data obtained were collected in the Italian Fibromyalgia Registry, an online registry created with the support of the Italian Society of Rheumatology (SIR). Results: We analyse data from 2.381 patients affected by FM, 2.184 females (91.7%) and 197 males. No significant differences in mean age, disease duration, or BMI between the two genders were reported. The women expressed greater disease burden as indicated by higher scores for each completed test: higher mean ModFAS score (25.23 ± 8.83 Vs 23.37 ± 9.22; p = 0.005), mean FIQR score (58.62 ± 23.22 Vs 51.68 ± 23.06; p

Published
2021

12. Il Manifesto delle malattie autoinfiammatorie rare: uno strumento educazionale per promuovere la conoscenza e migliorare la gestione di queste malattie

Author

Bona G, Bergamini L, Calveri P, Cavallaro P, Celano A, Guarisco R, Maggio MC, Manessi C, Manna R, Scopinaro A, Sinigaglia L, Taverna R, Bori B, and Bona G, Bergamini L, Calveri P, Cavallaro P, Celano A, Guarisco R, Maggio MC, Manessi C, Manna R, Scopinaro A, Sinigaglia L, Taverna R, Bori B

Subjects
Settore MED/38 - Pediatria Generale E Specialistica, malattie autoinfiammatorie rare, manifesto, Rare Autoinflammatory Disease Council
Published
2021

13. Erratum: Management of adult-onset Still's disease with interleukin-1 inhibitors: Evidence- And consensus-based statements by a panel of Italian experts (Arthritis Res Ther (2019) 21:275 DOI: 10.1186/s13075-019-2021-9)

Author

Colafrancesco, S., Manara, M., Bortoluzzi, A., Serban, T., Bianchi, G., Cantarini, L., Ciccia, F., Dagna, L., Govoni, M., Montecucco, C., Priori, R., Ravelli, A., Sfriso, P., Sinigaglia, L., Alivernini, S., Baldissera, E., Bartoloni, E., Berti, A., Bugatti, S., Camellino, D., Cammelli, D., Caporali, R., Caso, F., Cavallaro, E., Cavalli, G., Colaci, M., Costa, L., Di Scala, G., Emmi, G., Frassi, M., Gerli, R., Giacomelli, R., Gremese, E., Iannone, F., Lapadula, G., Leveghi, L., Lopalco, G., Manna, R., Marotto, D., Mathieu, A., Neri, R., Patisso, I., Piga, M., Punzi, L., Romano, M., Ruscitti, P., Salvarani, C., Scarpa, R., Scrivo, R., Talarico, R., Verrecchia, E., Viapiana, O., Vitale, A., Vitiello, G., Colafrancesco, S., Manara, M., Bortoluzzi, A., Serban, T., Bianchi, G., Cantarini, L., Ciccia, F., Dagna, L., Govoni, M., Montecucco, C., Priori, R., Ravelli, A., Sfriso, P., Sinigaglia, L., Alivernini, S., Baldissera, E., Bartoloni, E., Berti, A., Bugatti, S., Camellino, D., Cammelli, D., Caporali, R., Caso, F., Cavallaro, E., Cavalli, G., Colaci, M., Costa, L., Di Scala, G., Emmi, G., Frassi, M., Gerli, R., Giacomelli, R., Gremese, E., Iannone, F., Lapadula, G., Leveghi, L., Lopalco, G., Manna, R., Marotto, D., Mathieu, A., Neri, R., Patisso, I., Piga, M., Punzi, L., Romano, M., Ruscitti, P., Salvarani, C., Scarpa, R., Scrivo, R., Talarico, R., Verrecchia, E., Viapiana, O., Vitale, A., and Vitiello, G.

Abstract

Following publication of the original article [1], it was brought to our attention that the AOSD Consensus Group was incorrectly tagged and therefore not searchable. The publishers apologize for this error.

Published
2020

14. Erratum: Correction to: Management of adult-onset Still's disease with interleukin-1 inhibitors: evidence- and consensus-based statements by a panel of Italian experts (Arthritis research & therapy (2019) 21 1 (275))

Author

Colafrancesco S., Manara M., Bortoluzzi A., Serban T., Bianchi G., Cantarini L., Ciccia F., Dagna L., Govoni M., Montecucco C., Priori R., Ravelli A., Sfriso P., Sinigaglia L., Colafrancesco, S., Manara, M., Bortoluzzi, A., Serban, T., Bianchi, G., Cantarini, L., Ciccia, F., Dagna, L., Govoni, M., Montecucco, C., Priori, R., Ravelli, A., Sfriso, P., and Sinigaglia, L.

Abstract

Following publication of the original article [1], it was brought to our attention that the AOSD Consensus Group was incorrectly tagged and therefore not searchable. The publishers apologize for this error.

Published
2020

15. LBA35 Avelumab-cetuximab-radiotherapy versus standards of care in patients with locally advanced squamous cell carcinoma of head and neck (LA-SCCHN): Randomized phase III GORTEC-REACH trial

Author

Bourhis, J., primary, Tao, Y., additional, Sun, X., additional, Sire, C., additional, Martin, L., additional, Liem, X., additional, Coutte, A., additional, Pointreau, Y., additional, Thariat, J., additional, Miroir, J., additional, Rolland, F., additional, Kaminsky, M-C., additional, Borel, C., additional, Maillard, A., additional, Sinigaglia, L., additional, Guigay, J., additional, Saada-Bouzid, E., additional, Even, C., additional, and Aupérin, A., additional

Published
2021
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17. Long-term methotrexate use in Rheumatoid Arthritis patients: real-world data from the MARTE study

Author

Serban, T., Allara, R., Azzolini, V., Bellintani, C., Belloli, L., Belai Beyene, N., Bucci, R., Caporali, R., Cappelli, A., Corbelli, V., de Gennaro, F., Fusaro, E., Giusti, A., Govoni, M., Magnani, L., Manzo, C., Romano, C., Rossini, M., Santilli, D., Savi Ola, G., Sinigaglia, L., Bianchi, G., Arnoldi, C., Arrigoni, E., Bajocchi, G., Beccaris, A., Brussino, L., Califano, E., Carlino, G., Castellana, P., Del Piano, M., Delvino, P. G., Denotti, A., Diana, P., Epis, O. M., Fava Lli, E., Foti, R., Ghiringhelli, P., Gilardi, A. G., Iagnocco, A., Idolazzi, L., Italiano, G., Lapadula, G., Lomater, C., Longhi, M., Lupo, A., Malav Olta, N., Manara, M., Marchetta, A., Marcialis, M. R., Mathieu, A., Mazzochi, D., Mosca, M., Muratore, M., Naclerio, C., Nallino, G., Nutile, G., Pendolino, M., Piccolo, S., Ricioppo, A., Romeo, N., Rossini, T., Salvatore, S., Sambataro, A., Sangari, D., Santo, L., Selmi, C. F., Semeraro, A., Serafino, L., Tartarelli, G., Tirri, E., Todoerti, M., Traballi, G., Tropea, S., Zizo, G., Zuccaro, C., Serban, Teodora, Allara, Roberto, Azzolini, Valeria, Bellintani, Claudio, Belloli, Laura, Belai Beyene, Nebiat, Bucci, Romano, Caporali, Roberto, Cappelli, Antonella, Corbelli, Vincenzo, DE Gennaro, Fabio, Fusaro, Enrico, Giusti, Andrea, Govoni, Marcello, Magnani, Luca, Manzo, Ciro, Romano, Ciro, Rossini, Maurizio, Santilli, Daniele, Saviola, Gianantonio, Sinigaglia, Luigi, and Bianchi, Gerolamo

Subjects
Male, rheumatoid arthritis, Time Factors, Cross-sectional study, Arthritis, Arthritis, Rheumatoid, 0302 clinical medicine, Methotrexate, Arthritis, rheumatoid, Long-term care, Citizen science, Intramuscular, Smokers, Subcutaneous, marte study, General Medicine, Postmenopause, Italy, 030220 oncology & carcinogenesis, Rheumatoid arthritis, Antirheumatic Agents, 030211 gastroenterology & hepatology, Female, medicine.drug, musculoskeletal diseases, medicine.medical_specialty, rheumatoid, Injections, Subcutaneous, Injections, Intramuscular, methotrexate, Injections, NO, 03 medical and health sciences, Route of administration, Sex Factors, Internal medicine, medicine, Humans, Dosing, Aged, Rheumatoid, Cross-Sectional Studies, Socioeconomic Factors, rheumatoid arthritis, marte study, methotrexate, business.industry, medicine.disease, Rheumatology, Discontinuation, business
Abstract

BACKGROUND The MARTE study investigated the demographic, clinical, and therapeutic characteristics of rheumatoid arthritis (RA) patients ongoing methotrexate (MTX) treatment for longer than 8 years. METHODS This cross-sectional, observational study considered 587 RA patients from 67 Rheumatology Units across Italy. Data collected included demographic, clinical, and therapeutic characteristics, focusing on MTX prescription patterns (route of administration, dosing regimens, treatment duration, and discontinuation). RESULTS As initial therapy, 90.6% of patients received one conventional synthetic Disease Modifying Anti Rheumatic Drug (csDMARD), with treatment started within the first 3 months from diagnosis in half of the patients. MTX was the first csDMARD in 46.2% of patients. The prevalent route of administration at diagnosis was the intramuscular (60.5%), while at study entry (baseline) 57.6% were receiving subcutaneous MTX. Patients who required a higher MTX dose at study entry were those who received a significantly lower starting MTX dose (P

Published
2021

18. Cetuximab, docetaxel, and cisplatin versus platinum, fluorouracil, and cetuximab as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (GORTEC 2014-01 TPExtreme): a multicentre, open-label, randomised, phase 2 trial

Author

Guigay, J, Auperin, A, Fayette, J, Saada-Bouzid, E, Lafond, C, Taberna, M, Geoffrois, L, Martin, L, Capitain, O, Cupissol, D, Castanie, H, Vansteene, D, Schafhausen, P, Johnson, A, Even, C, Sire, C, Duplomb, S, Evrard, C, Delord, JP, Laguerre, B, Zanetta, S, Chevassus-Clement, C, Fraslin, A, Louat, F, Sinigaglia, L, Keilholz, U, Bourhis, J, Mesia, R, Gallego, O, López Pousa A., and Vazquez Fernandez, Silvia

Abstract

Background Results from a phase 2 trial of the TPEx chemotherapy regimen (docetaxel-platinum-cetuximab) showed promising results, with a median overall survival of 14.0 months in first-line recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). We therefore aimed to compare the efficacy and safety of the TPEx regimen with the standard of care EXTREME regimen (platinum-fluorouracil-cetuximab) in this setting. Methods This was a multicentre, open-label, randomised, phase 2 trial, done in 68 centres (cancer centres, university and general hospitals, and private clinics) in France, Spain, and Germany. Eligible patients were aged 18-70 years with histologically confirmed recurrent or metastatic HNSCC unsuitable for curative treatment; had at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1; and had an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less. Participants were randomly assigned (1:1) using the TenAlea website by investigators or delegated clinical research associates to the TPEx regimen or the EXTREME regimen, with minimisation by ECOG performance status, type of disease evolution, previous cetuximab treatment, and country. The TPEx regimen consisted of docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2), both intravenously on day 1, and cetuximab on days 1, 8, and 15 (intravenously 400 mg/m(2) on day 1 of cycle 1 and 250 mg/m(2) weekly subsequently). Four cycles were repeated every 21 days with systematic granulocyte colony-stimulating factor (G-CSF) support at each cycle. In case of disease control after four cycles, intravenous cetuximab 500 mg/m(2) was continued every 2 weeks as maintenance therapy until progression or unacceptable toxicity. The EXTREME regimen consisted of fluorouracil 4000 mg/m(2) on day 1-4, cisplatin 100 mg/m(2) on day 1, and cetuximab on days 1, 8, and 15 (400 mg/m(2) on day 1 of cycle 1 and 250 mg/m(2) weekly subsequently) all delivered intravenously. Six cycles were delivered every 21 days followed by weekly 250 mg/m(2) cetuximab as maintenance therapy in case of disease control. G-CSF support was not mandatory per the protocol in the EXTREME regimen. The primary endpoint was overall survival in the intention-to-treat population; safety was analysed in all patients who received at least one dose of chemotherapy or cetuximab. Enrolment is closed and this is the final analysis. This study is registered at ClinicalTrials.gov, NCT02268695. Findings Between Oct 10, 2014, and Nov 29, 2017, 541 patients were enrolled and randomly assigned to the two treatment regimens (271 to TPEx, 270 to EXTREME). Two patients in the TPEx group had major deviations in consent forms and were not included in the final analysis. Median follow-up was 34.4 months (IQR 26.6-44.8) in the TPEx group and 30.2 months (25.5-45.3) in the EXTREME group. At data cutoff, 209 patients had died in the TPEx group and 218 had died in the EXTREME group. Overall survival did not differ significantly between the groups (median 14.5 months [95% CI 12.5-15.7] in the TPEx group and 13.4 months [12.2-15.4] in the EXTREME group; hazard ratio 0.89 [95% CI 0.74-1.08]; p=0.23). 214 (81%) of 263 patients in the TPEx group versus 246 (93%) of 265 patients in the EXTREME group had grade 3 or worse adverse events during chemotherapy (p

Published
2021

19. Definition of fibromyalgia severity: Findings from a cross-sectional survey of 2339 Italian patients

Author

Salaffi, F., Di Carlo, M., Bazzichi, L., Atzeni, F., Govoni, M., Biasi, G., Di Franco, M., Mozzani, F., Gremese, E., Dagna, L., Batticciotto, A., Fischetti, F., Giacomelli, R., Guiducci, S., Guggino, G., Bentivegna, M., Gerli, R., Salvarani, C., Bajocchi, G., Ghini, M., Iannone, F., Giorgi, V., Farah, S., Cirillo, M., Bonazza, S., Barbagli, S., Gioia, C., Santilli, D., Capacci, A., Cavalli, G., Carubbi, F., Nacci, F., Riccucci, I., Sinigaglia, L., Masullo, M., Polizzi, B. M., Cutolo, M., Sarzi-Puttini, P., Gremese E. (ORCID:0000-0002-2248-1058), Bentivegna M., Santilli D., Cavalli G. (ORCID:0000-0003-1968-8987), Masullo M., Salaffi, F., Di Carlo, M., Bazzichi, L., Atzeni, F., Govoni, M., Biasi, G., Di Franco, M., Mozzani, F., Gremese, E., Dagna, L., Batticciotto, A., Fischetti, F., Giacomelli, R., Guiducci, S., Guggino, G., Bentivegna, M., Gerli, R., Salvarani, C., Bajocchi, G., Ghini, M., Iannone, F., Giorgi, V., Farah, S., Cirillo, M., Bonazza, S., Barbagli, S., Gioia, C., Santilli, D., Capacci, A., Cavalli, G., Carubbi, F., Nacci, F., Riccucci, I., Sinigaglia, L., Masullo, M., Polizzi, B. M., Cutolo, M., Sarzi-Puttini, P., Gremese E. (ORCID:0000-0002-2248-1058), Bentivegna M., Santilli D., Cavalli G. (ORCID:0000-0003-1968-8987), and Masullo M.

Abstract

Objective: To establish optimal cut-off values for the scores of the revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromialgia Assessment Scale (FAS 2019mod), and the Polysymptomatic Distress Scale (PDS) in order to distinguish five levels of FM disease severity. Methods: Consecutive FM patients were evaluated with the three clinimetric indices, and each patient was required to answer the anchor question: 'In general, would you say your health is 1 = very good, 2 = good, 3 = fair, 4 = poor, or 5 = very poor?'-which represented the external criterion. Cut-off points were established through the interquartile reconciliation approach. Results: The study sample consisted of 2181 women (93.2%) and 158 men (6.8%), with a mean age of 51.9 (11.5) years, and mean disease duration was 7.3 (6.9) years. The overall median FIQR, FAS 2019 mod and PDS scores (25th-75th percentiles) were respectively 61.16 (41.16-77.00), 27.00 (19.00-32.00) and 19.0 (13.00-24.00). Reconciliation of the mean 75th and 25th percentiles of adjacent categories defined the severity states for FIQR: 0-23 for remission, 24-40 for mild disease, 41-63 for moderate disease, 64-82 for severe disease and >83 for very severe disease; FAS 2019 mod: 0-12 for remission, 13-20 for mild disease, 21-28 for moderate disease, 29-33 for severe disease and >33 for very severe disease; PDS: 0-5 for remission, 6-15 for mild disease, 16-20 for moderate disease, 21-25 for severe disease and >25 for very severe disease. Conclusions: Disease severity cut-offs can represent an important improvement in interpreting FM.

Published
2021

23. Management of adult-onset Still's disease with interleukin-1 inhibitors: Evidence- And consensus-based statements by a panel of Italian experts

Author

Colafrancesco, S., Manara, M., Bortoluzzi, A., Serban, T., Bianchi, G., Cantarini, L., Ciccia, F., Dagna, L., Govoni, M., Montecucco, C., Priori, R., Ravelli, A., Sfriso, P., AOSD Consensus Group: Aliverini S, Sinigaglia L., Baldissera, E, Bartoloni, E, Colafrancesco, S., Manara, M., Bortoluzzi, A., Serban, T., Bianchi, G., Cantarini, L., Ciccia, F., Dagna, L., Govoni, M., Montecucco, C., Priori, R., Ravelli, A., Sfriso, P., and Sinigaglia, L.

Subjects
Adult, Male, medicine.medical_specialty, lcsh:Diseases of the musculoskeletal system, Consensus, Delphi Technique, Canakinumab, Delphi method, MEDLINE, Disease, Adult-onset Still's disease, NO, 03 medical and health sciences, 0302 clinical medicine, Systemic juvenile idiopathic arthritis, Internal medicine, Still's disease, medicine, Humans, 030212 general & internal medicine, Intensive care medicine, Rilonacept, Adult-onset Still’s disease, 030203 arthritis & rheumatology, Anakinra, business.industry, Still’s disease, Correction, Rash, Rheumatology, Clinical trial, Interleukin-1, Antirheumatic Agents, Female, medicine.symptom, lcsh:RC925-935, business, Still's Disease, Adult-Onset, Research Article, medicine.drug
Abstract

BackgroundAdult-onset Still’s disease (AOSD) is a rare inflammatory condition characterized by fever, rash, and arthritis. Because of its rarity, clinical trials are inherently small and often uncontrolled. Our objective was to develop recommendations for the use of interleukin (IL)-1 inhibitors in the management of patients with AOSD, based on the best evidence and expert opinion.MethodsA panel of 10 experts (9 rheumatologists and 1 pediatrician) was established. The first step was dedicated to a comprehensive literature review and development of statements. Two separate literature searches were performed on the MEDLINE (Pubmed), EMBASE, and BIOSIS databases through April 2018 to identify (1) differences and similarities between AOSD and pediatric Still’s disease (systemic juvenile idiopathic arthritis [SJIA]) and (2) the efficacy and safety of IL-1 inhibitors in AOSD treatment. In the second step, the statements were submitted in a Delphi process to a panel of 67 rheumatologists. Consensus threshold was set at 66%: positive, > 66% of voters selected scores 3 to 5; negative, > 66% of voters selected scores 1 or 2. In the third step, the voting results were analyzed, and the statements were finalized.ResultsEleven statements were developed. Forty-six of 67 rheumatologists (72%) participated in the Delphi process. A positive consensus was reached after the first round of voting and was full (> 95%) on the majority of statements. A large consensus was achieved in considering AOSD and SJIA as the same disease. The use of anti-IL-1 therapies in refractory patients was considered quite safe and effective both as the first and as a subsequent line of biologic treatment, especially in systemic patients. Because of the lack of head-to-head comparisons, a different profile of efficacy among IL-1 inhibitors could not be established. There was a large consensus that failure of the first IL-1 inhibitor does not preclude response to another one. The lack of studies comparing early versus late treatment did not allow to draw conclusions; however, data from SJIA suggest a better response in early treatment.ConclusionsThe Delphi method was used to develop recommendations that we hope will help clinicians in the management of patients with AOSD refractory to conventional therapies.

Published
2019

25. AB0716 FIBROMYALGIA SYNDROME SEVERITY ACCORDING TO AGE CATEGORIES: RESULTS FROM A NATIONAL REGISTER

Author

Di Carlo, M., primary, Farah, S., additional, Bazzichi, L., additional, Atzeni, F., additional, Govoni, M., additional, Biasi, G., additional, DI Franco, M., additional, Mozzani, F., additional, Gremese, E., additional, Dagna, L., additional, Batticciotto, A., additional, Fischetti, F., additional, Giacomelli, R., additional, Guiducci, S., additional, Guggino, G., additional, Bentivegna, M., additional, Gerli, R., additional, Salvarani, C., additional, Bajocchi, G., additional, Ghini, M., additional, Iannone, F., additional, Giorgi, V., additional, Cirillo, M., additional, Bonazza, S., additional, Barbagli, S., additional, Gioia, C., additional, Marino, N. G., additional, Capacci, A., additional, Cavalli, G., additional, Cappelli, A., additional, Carubbi, F., additional, Nacci, F., additional, Ilenia, R., additional, Cutolo, M., additional, Sinigaglia, L., additional, Sarzi-Puttini, P., additional, and Salaffi, F., additional

Published
2021
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26. OP0310 GENDER AND FIBROMYALGIA SEVERITY: REAL LIFE DATA FROM THE ITALIAN REGISTRY

Author

Batticciotto, A., primary, Campanaro, F., additional, Atzeni, F., additional, Alciati, A., additional, DI Carlo, M., additional, Bazzichi, L., additional, Govoni, M., additional, Biasi, G., additional, DI Franco, M., additional, Mozzani, F., additional, Gremese, E., additional, Dagna, L., additional, Fischetti, F., additional, Giacomelli, R., additional, Guiducci, S., additional, Guggino, G., additional, Bentivegna, M., additional, Gerli, R., additional, Salvarani, C., additional, Bajocchi, G., additional, Ghini, M., additional, Iannone, F., additional, Giorgi, V., additional, Farah, S., additional, Bonazza, S., additional, Barbagli, S., additional, Gioia, C., additional, Capacci, A., additional, Cavalli, G., additional, Carubbi, F., additional, Nacci, F., additional, Ilenia, R., additional, Sinigaglia, L., additional, Cutolo, M., additional, Cappelli, A., additional, Sarzi-Puttini, P., additional, and Salaffi, F., additional

Published
2021
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30. Erratum. management of adult-onset still's disease with interleukin-1 inhibitors. evidence- and consensus-based statements by a panel of Italian experts

Author

Colafrancesco, S., Manara, M., Bortoluzzi, A., Serban, T., Bianchi, G., Cantarini, L., Ciccia, F., Dagna, L., Govoni, M., Montecucco, C., Priori, R., Ravelli, A., Sfriso, P., Sinigaglia, L., Alivernini, S., Baldissera, E., Bartoloni, E., Berti, A., Bugatti, S., Camellino, D., Cammelli, D., Caporali, R., Caso, F., Cavallaro, E., Cavalli, G., Colaci, M., Costa, L., Di Scala, G., Emmi, G., Frassi, M., Gerli, R., Giacomelli, R., Gremese, E., Iannone, F., Lapadula, G., Leveghi, L., Lopalco, G., Manna, R., Marotto, D., Mathieu, A., Neri, R., Patisso, I., Piga, M., Punzi, L., Romano, M., Ruscitti, P., Salvarani, C., Scarpa, R., Scrivo, R., Talarico, R., Verrecchia, E., Viapiana, O., Vitale, A., and Vitiello, G.

Subjects
030203 arthritis & rheumatology, 0301 basic medicine, medicine.medical_specialty, Pediatrics, Adult-onset Still's disease, lcsh:Diseases of the musculoskeletal system, business.industry, Published Erratum, MEDLINE, Interleukin, Rheumatology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Internal medicine, medicine, lcsh:RC925-935, business
Abstract

Following publication of the original article [1], it was brought to our attention that the AOSD Consensus Group was incorrectly tagged and therefore not searchable. The publishers apologize for this error.

Published
2020

33. COVID-19 in rheumatic diseases in Italy: first results from the Italian registry of the Italian Society for Rheumatology (CONTROL-19)

Author

Scire, C, Carrara, G, Zanetti, A, Landolfi, G, Chighizola, C, Alunno, A, Andreoli, L, Caporali, R, Gerli, R, Sebastiani, G, Valesini, G, Sinigaglia, L, Scire, CA, Sebastiani, GD, Scire, C, Carrara, G, Zanetti, A, Landolfi, G, Chighizola, C, Alunno, A, Andreoli, L, Caporali, R, Gerli, R, Sebastiani, G, Valesini, G, Sinigaglia, L, Scire, CA, and Sebastiani, GD

Abstract

BackgroundItaly was one of the first countries significantly affected by the coronavirus disease 2019 (COVID-19) epidemic. The Italian Society for Rheumatology promptly launched a retrospective and anonymised data collection to monitor COVID-19 in patients with rheumatic and musculoskeletal diseases (RMDs), the CONTROL-19 surveillance database, which is part of the COVID-19 Global Rheumatology Alliance.MethodsCONTROL-19 includes patients with RMDs and proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) updated until May 3rd 2020. In this analysis, only molecular diagnoses were included. The data collection covered demographic data, medical history (general and RMD-related), treatments and COVID-19 related features, treatments, and outcome. In this paper,we report the first descriptive data from the CONTROL-19 registry.ResultsThe population of the first 232 patients (36% males) consisted mainly of elderly patients (mean age 62.2 years), who used corticosteroids (51.7%), and suffered from multi-morbidity (median comorbidities 2). Rheumatoid arthritis was the most frequent disease (34.1%), followed by spondyloarthritis (26.3%), connective tissue disease (21.1%) and vasculitis (11.2%). Most cases had an active disease (69.4%). Clinicalpresentationof COVID-19 was typical, with systemic symptoms (fever and asthenia)and respiratorysymptoms. The overall outcome was severe, with high frequencies of hospitalisation (69.8%), respiratorysupport oxygen (55.7%), non-invasive ventilation (20.9%) or mechanical ventilation (7.5%), and 19% of deaths. Male patients typically manifested a worse prognosis. Immunomodulatory treatments were not significantlyassociatedwith an increasedrisk of intensive care unit admission/mechanicalventilation! death.ConclusionAlthough the reportmainly includes the most severe cases, its temporal and spatial trend supports the validity of the nationalsurveillance system. More complete data are being acquired in order to both test the hypoth

Published
2020

37. Definition of a population-specific DXA reference standard in Italian women: the Densitometric Italian Normative Study (DINS)

Author

Pedrazzoni, M., Girasole, G., Bertoldo, F., Bianchi, G., Cepollaro, C., Del Puente, A., Giannini, S., Gonnelli, S., Maggio, D., Marcocci, C., Minisola, S., Palummeri, E., Rossini, M., Sartori, L., and Sinigaglia, L.

Subjects
Bone densitometry -- Usage, Italians -- Health aspects, Osteoporosis -- Diagnosis, Bones -- Density, Bones -- Measurement, Health
Abstract

Byline: M. Pedrazzoni (1), G. Girasole (2), F. Bertoldo (3), G. Bianchi (2), C. Cepollaro (4), A. Del Puente (5), S. Giannini (6), S. Gonnelli (4), D. Maggio (7), C. Marcocci (8), S. Minisola (9), E. Palummeri (10), M. Rossini (11), L. Sartori (6), L. Sinigaglia (12) Keywords: Bone densitometry; Diagnosis; DXA; Osteoporosis; Reference values Abstract: Osteoporosis is currently defined on the basis of the T-score by dual-energy X-ray absorptiometry (DXA). Despite its limitations, this definition is applied worldwide. However, the normal values provided by manufacturers may not be fully representative of specific local populations. So far, there are no normative data in the Italian population using Hologic densitometers. The Densitometric Italian Normative Study (DINS) is an ongoing multi-center study that aims to establish reference values for bone densitometry with dual-energy X-ray absorptiometry (DXA) in the male and female Italian population. In this paper we report the results of the lumbar vertebrae (L2--L4) and proximal femur in 1,622 women aged 20--79 years. Bone mineral density (BMD) was determined using dual-energy X-ray absorptiometry (DXA) on Hologic bone densitometers (Hologic, Waltham, Mass.). Most of the subjects were examined with a QDR 4500. The BMD of the lumbar vertebrae was virtually constant between 20 and 49 years (test for trend: P=0.66) the BMD values between 20--45 in premenopausal women (mean 1.036 SD 0.109 g/cm.sup.2) were thus defined as the peak bone mass values, significantly lower compared to the Hologic reference curve (mean 1.079, SD 0.11 g/cm.sup.2). The mean BMD values of the femoral neck were virtually identical to those of the NHANES study in the first 3 decades after the age of 50 the BMD values were slightly greater than those of the NHANES subject. The subject classification according to the WHO criteria was similar using the DINS and NHANES reference values for the femur for the spine, the Hologic reference values classified a larger proportion of women as osteoporotic (21 vs. 16%) or osteopenic (42 vs. 38%) compared to DINS. Author Affiliation: (1) Dipartimento di Medicina Interna e Scienze Biomediche, Universita di Parma, Via Gramsci 14, 43100 , Parma, Italy (2) Divisione di Reumatologia, Dipartimento Apparato Locomotore, ASL 3 Genovese, Genova, Italy (3) Dipartimento di Scienze Biomediche e Chirurgiche, Universita di Verona, Verona, Italy (4) Dipartimento di Medicina Interna, Scienze Endocrino-Metaboliche e Biochimica, Universita di Siena, Siena, Italy (5) Reumatologia, Universita 'Federico II', Napoli, Italy (6) Dipartimento di Scienze Mediche e Chirurgiche, Universita di Padova, Padova, Italy (7) Gerontologia e Geriatria, Universita di Perugia, Perugia, Italy (8) Dipartimento di Endocrinologia e Metabolismo, Universita di Pisa, Pisa, Italy (9) Dipartimento di Scienze Cliniche, Universita di Roma 'La Sapienza', Roma, Italy (10) Dipartimento Interaziendale di Geriatria, ASL 3--Ospedali Galliera, Genova, Italy (11) Centro Osteoporosi, Universita-ASL di Verona, Verona, Italy (12) Servizio Malattie Osteometaboliche, Dipartimento di Reumatologia, Istituto G. Pini, Milano, Italy Article History: Received Date: 14/02/2003 Accepted Date: 05/09/2003 Online Date: 03/10/2003

Published
2003

48. 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

49. Development and First Validation of a Disease Activity Score for Gout

Author

Scire, C, Carrara, G, Viroli, C, Cimmino, M, Taylor, W, Manara, M, Govoni, M, Salaffi, F, Punzi, L, Montecucco, C, Matucci-Cerinic, M, Minisola, G, Ariani, A, Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabro, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, M, Broggini, M, Caprioli, M, Favero, M, Salli, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V, Scire C. A., Carrara G., Viroli C., Cimmino M. A., Taylor W. J., Manara M., Govoni M., Salaffi F., Punzi L., Montecucco C., Matucci-Cerinic M., Minisola G., Ariani A., Galossi A., Lauriti C., Fracassi E., Idolazzi L., Bardelli M., Selvi E., Tirri E., Furini F., Inverardi F., Calabro A., Porta F., Bittelli R., Venturino F., Capsoni F., Prevete I., Sebastiani G., Selmi C., Fabbriciani G., D'Avola G., Botticella G., Serale F., Seminara G., D'Alessandro G., Santo L., Longato L., Zaccara E., Sinigaglia L., Atteritano M., Broggini M., Caprioli M., Favero M., Salli S., Scarati M., Parisi S., Malavolta N., Corvaglia S., Scarpato S., Veneto V., Scire, C, Carrara, G, Viroli, C, Cimmino, M, Taylor, W, Manara, M, Govoni, M, Salaffi, F, Punzi, L, Montecucco, C, Matucci-Cerinic, M, Minisola, G, Ariani, A, Galossi, A, Lauriti, C, Fracassi, E, Idolazzi, L, Bardelli, M, Selvi, E, Tirri, E, Furini, F, Inverardi, F, Calabro, A, Porta, F, Bittelli, R, Venturino, F, Capsoni, F, Prevete, I, Sebastiani, G, Selmi, C, Fabbriciani, G, D'Avola, G, Botticella, G, Serale, F, Seminara, G, D'Alessandro, G, Santo, L, Longato, L, Zaccara, E, Sinigaglia, L, Atteritano, M, Broggini, M, Caprioli, M, Favero, M, Salli, S, Scarati, M, Parisi, S, Malavolta, N, Corvaglia, S, Scarpato, S, Veneto, V, Scire C. A., Carrara G., Viroli C., Cimmino M. A., Taylor W. J., Manara M., Govoni M., Salaffi F., Punzi L., Montecucco C., Matucci-Cerinic M., Minisola G., Ariani A., Galossi A., Lauriti C., Fracassi E., Idolazzi L., Bardelli M., Selvi E., Tirri E., Furini F., Inverardi F., Calabro A., Porta F., Bittelli R., Venturino F., Capsoni F., Prevete I., Sebastiani G., Selmi C., Fabbriciani G., D'Avola G., Botticella G., Serale F., Seminara G., D'Alessandro G., Santo L., Longato L., Zaccara E., Sinigaglia L., Atteritano M., Broggini M., Caprioli M., Favero M., Salli S., Scarati M., Parisi S., Malavolta N., Corvaglia S., Scarpato S., and Veneto V.

Abstract

Objective: To develop a new composite disease activity score for gout and provide its first validation. Methods: Disease activity has been defined as the ongoing presence of urate deposits that lead to acute arthritis and joint damage. Every measure for each Outcome Measures in Rheumatology core domain was considered. A 3-step approach (factor analysis, linear discriminant analysis, and linear regression) was applied to derive the Gout Activity Score (GAS). Decision to change treatment or 6-month flare count were used as the surrogate criteria of high disease activity. Baseline and 12-month followup data of 446 patients included in the Kick-Off of the Italian Network for Gout cohort were used. Construct- and criterion-related validity were tested. External validation on an independent sample is reported. Results: Factor analysis identified 5 factors: patient-reported outcomes, joint examination, flares, tophi, and serum uric acid (sUA). Discriminant function analysis resulted in a correct classification of 79%. Linear regression analysis identified a first candidate GAS including 12-month flare count, sUA, visual analog scale (VAS) of pain, VAS global activity assessment, swollen and tender joint counts, and a cumulative measure of tophi. Alternative scores were also developed. The developed GAS demonstrated a good correlation with functional disability (criterion validity) and discrimination between patient- and physician-reported measures of active disease (construct validity). The results were reproduced in the external sample. Conclusion: This study developed and validated a composite measure of disease activity in gout. Further testing is required to confirm its generalizability, responsiveness, and usefulness in assisting with clinical decisions.

Published
2016

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