TY - JOUR
T1 - Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. Results of a large, multicentric, nationwide study
AU - Iaccarino, Luca
AU - Andreoli, Laura
AU - Bocci, Elena Bartoloni
AU - Bortoluzzi, Alessandra
AU - Ceccarelli, Fulvia
AU - Conti, Fabrizio
AU - De Angelis, Rossella
AU - De Marchi, Ginevra
AU - De Vita, Salvatore
AU - Di Matteo, Andrea
AU - Emmi, Giacomo
AU - Emmi, Lorenzo
AU - Gatto, Mariele
AU - Gerli, Roberto
AU - Gerosa, Maria
AU - Govoni, Marcello
AU - Larosa, Maddalena
AU - Meroni, Pier Luigi
AU - Mosca, Marta
AU - Pazzola, Giulia
AU - Reggia, Rossella
AU - Saccon, Francesca
AU - Salvarani, Carlo
AU - Tani, Chiara
AU - Zen, Margherita
AU - Frigo, Anna Chiara
AU - Tincani, Angela
AU - Doria, Andrea
PY - 2017
Y1 - 2017
N2 - 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.
AB - 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.
KW - Belimumab
KW - Biologic drugs
KW - Drug survival
KW - Predictors of response
KW - Systemic lupus erythematous
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U2 - 10.1016/j.jaut.2017.09.004
DO - 10.1016/j.jaut.2017.09.004
M3 - Article
AN - SCOPUS:85029510658
JO - Journal of Autoimmunity
JF - Journal of Autoimmunity
SN - 0896-8411
ER -