Luca Iaccarino1, Laura Andreoli2, Elena Bartoloni Bocci3, Alessandra Bortoluzzi4, Fulvia Ceccarelli5, Fabrizio Conti5, Rossella De Angelis6, Ginevra De Marchi7, Salvatore De Vita7, Andrea Di Matteo6, Giacomo Emmi8, Lorenzo Emmi9, Mariele Gatto1, Roberto Gerli3, Maria Gerosa10, Marcello Govoni4, Maddalena Larosa1, Pier Luigi Meroni10, Marta Mosca11, Giulia Pazzola12, Rossella Reggia2, Francesca Saccon1, Carlo Salvarani12, Chiara Tani11, Margherita Zen1, Anna Chiara Frigo13, Angela Tincani2, Andrea Doria14. 1. Division of Rheumatology, Department of Medicine-DIMED, University of Padova, Padova, Italy. 2. Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia, Italy. 3. Rheumatology Unit, Department of Medicine, University of Perugia, Perugia, Italy. 4. Medical Sciences, UOC of Rheumatology, University Hospital S. Anna, Ferrara, Italy. 5. Rheumatology Unit, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy. 6. Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy. 7. Clinic of Rheumatology, Department of Medical and Biological Sciences, University Hospital "Santa Maria della Misericordia", Udine, Italy. 8. Internal Interdisciplinary Medicine, Centre for Rare Cardiovascular and Immunological Diseases, Lupus Clinic, AOU Careggi, Florence, Italy. 9. Department of Surgery and Translational Medicine, University of Florence, Italy. 10. Rheumatology Department, University of Milan, Istituto Ortopedico Gaetano Pini, Milano, Italy. 11. Rheumatology Unit, University of Pisa, Pisa, Italy. 12. Rheumatology Unit, Internal Medicine Department, Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Italy. 13. Biostatistics, Epidemiology and Public Health Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy. 14. Division of Rheumatology, Department of Medicine-DIMED, University of Padova, Padova, Italy. Electronic address: adoria@unipd.it.
Abstract
OBJECTIVE: To investigate efficacy, safety and survival of belimumab and to identify predictors of drug response and drug discontinuation in patients with active SLE in clinical practice. PATIENTS AND METHODS: Data of SLE patients, treated with belimumab, from 11 Italian prospective cohorts were analyzed. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24-h proteinuria, CLASIa (Cutaneous LE Disease Area and Severity Index Activity) were recorded at baseline and every 6 months. SLE Responder Index-4 (SRI-4) was calculated at 12 and 24 months. Demographic and clinical features and comorbidities were included in the univariate and multivariate analysis. Adverse events were recorded at each visit. Statistics was performed using the SPSS software. RESULTS: We studied 188 SLE patients, mean follow-up 17.5 ± 10.6 months. The most frequent manifestations, which required the use of belimumab, were polyarthritis (45.2%) and skin rashes (25.5%). SRI-4 was achieved by 77.0% and 68.7% of patients at 12 and 24-months. Independent predictors of 12-month response were SLEDAI-2K ≥ 10 (OR 40.46, p = 0.001) and polyarthritis (OR 12.64, p = 0.001) and of 24-month response were SLEDAI-2K ≥ 10 (OR 15.97, p = 0.008), polyarthritis (OR 32.36, p = 0.006), and prednisone ≥7.5 mg/day (OR 9.94, p = 0.026). We observed a low rate of severe adverse events. Fifty-eight patients (30.8%) discontinued belimumab after a mean follow-up of 10.4 ± 7.5 months. The drug survival was 86.9%, 76.9%, 69.4%, 67.1%, and 61.9% at 6, 12, 18, 24, and 30 months, respectively. No factors associated with drug discontinuation were found. CONCLUSION: Belimumab is effective and safe when used in clinical practice setting.
OBJECTIVE: To investigate efficacy, safety and survival of belimumab and to identify predictors of drug response and drug discontinuation in patients with active SLE in clinical practice. PATIENTS AND METHODS: Data of SLEpatients, treated with belimumab, from 11 Italian prospective cohorts were analyzed. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24-h proteinuria, CLASIa (Cutaneous LE Disease Area and Severity Index Activity) were recorded at baseline and every 6 months. SLE Responder Index-4 (SRI-4) was calculated at 12 and 24 months. Demographic and clinical features and comorbidities were included in the univariate and multivariate analysis. Adverse events were recorded at each visit. Statistics was performed using the SPSS software. RESULTS: We studied 188 SLEpatients, mean follow-up 17.5 ± 10.6 months. The most frequent manifestations, which required the use of belimumab, were polyarthritis (45.2%) and skin rashes (25.5%). SRI-4 was achieved by 77.0% and 68.7% of patients at 12 and 24-months. Independent predictors of 12-month response were SLEDAI-2K ≥ 10 (OR 40.46, p = 0.001) and polyarthritis (OR 12.64, p = 0.001) and of 24-month response were SLEDAI-2K ≥ 10 (OR 15.97, p = 0.008), polyarthritis (OR 32.36, p = 0.006), and prednisone ≥7.5 mg/day (OR 9.94, p = 0.026). We observed a low rate of severe adverse events. Fifty-eight patients (30.8%) discontinued belimumab after a mean follow-up of 10.4 ± 7.5 months. The drug survival was 86.9%, 76.9%, 69.4%, 67.1%, and 61.9% at 6, 12, 18, 24, and 30 months, respectively. No factors associated with drug discontinuation were found. CONCLUSION: Belimumab is effective and safe when used in clinical practice setting.
Authors: A Doria; W Stohl; A Schwarting; M Okada; M Scheinberg; R van Vollenhoven; A E Hammer; J Groark; D Bass; N L Fox; D Roth; D Gordon Journal: Arthritis Rheumatol Date: 2018-06-15 Impact factor: 10.995
Authors: Khaled Mahmoud; Ahmed S Zayat; Yuzaiful Yusof; Elizabeth Hensor; Philip G Conaghan; Paul Emery; Edward M Vital Journal: Rheumatology (Oxford) Date: 2019-01-03 Impact factor: 7.046