FRI0199 EFFECTIVENESS AND SAFETY OF BELIMUMAB IN PATIENTSWITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS: RESULTS FROM A LARGE, NATIONWIDE, MULTICENTRIC STUDY
Authors: Luca Iaccarino, Francesca Saccon, Alessandro Mathieu, Matteo Piga, Angela Ceribelli, Carlo Selmi, Paolo Cardinaletti, Armando Gabrielli, Andrea DI Matteo, Rossella De Angelis, Paola Faggioli, Antonella Laria, Micaela Fredi, Francesca Regola, Laura Andreoli, Giulia Pazzola, Carlo Salvarani, Francesco Puppo, Simone Negrini, Marcella Prete, Vito Racanelli, Elisa Gremese, Maria Gerosa, Tania Ubiali, Enrica Bozzolo, Valentina Canti, Fabrizio Conti, Fulvia Ceccarelli, Elena Bartoloni Bocci, Roberto Gerli, Antonio Lobasso, Amato De Paulis, Ginevra De Marchi, Salvatore De Vita, Alessandra Bortoluzzi, Marcello Govoni, Francesco Benvenuti, Margherita Zen, Marta Mosca, Chiara Tani, Maurizio Rossini, Giovanni Orsolini, Mariele Gatto, Salvatore Scarpato, Enrico Brunetta, Aurora Zumbo, Gabriele Valentini, Serena Fasano, Giacomo Emmi, Maria Letizia Urban, Giacomo Tanti, Angela Tincani, Andrea Doria
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Belimumab is the unique biologic therapy available for patients with SLE. <h3>Objectives</h3> To investigate effectiveness and safety of belimumab in SLE patients in clinical practice. <h3>Methods</h3> 458 active SLE patients (ACR criteria) from 24 Italian Centers, mean±SD age 43.5±11.3 years; mean±SD disease duration 12.3±8.7 years, were treated with belimumab (10 mg/kg day 0, 14, 28 and then every 28 days), as add-on therapy. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24H proteinuria, CLASI, PGA, Fatigue (VAS 0-10) were recorded at baseline and every 6 months. Flares were defined according to SFI. Response was evaluated according to SRI-4. Statistics were performed by pairs T-test, chi-square test and multiple logistic regression (SPSS, version 22.0). <h3>Results</h3> Mean±SD follow-up was 21.2±15.3 months (range 3-60). Most common features treated with belimumab were articular in 67%, mucocutaneous in 55%, and renal in 17% of cases. Improvement of clinical and serological variables, including daily prednisone dosage, was observed (Table). SRI-4 is summarized in the Figure. At the end of follow-up 293 patients (66%) were still on belimumab. Most common cause of discontinuation were inadequate response (36%), AEs (31%), and pregnancy (8%). Mean number of flare during belimumab treatment compared with the corresponding period before belimumab initiation decreased (p&lt;0.001). SLEDAI-2K ≥10 was an independent predictor of response by logistic regression at month 12 and 24 (p=0.003 and p=0.025). 9,998 infusions were analyzed. 784 AEs were observed in 330 patients, SAEs were 43 in 36 patients. No severe infusion reactions were observed; 16 patients had infective SAEs, and 22 non infective SAEs. <h3>Conclusion</h3> We confirmed the effectiveness, the steroid sparing effect and good safety profile of belimumab in our cohort. <h3>Disclosure of Interests</h3> Luca Iaccarino: None declared, Francesca Saccon: None declared, Alessandro Mathieu: None declared, Matteo Piga: None declared, Angela Ceribelli: None declared, Carlo Selmi Grant/research support from: Abbvie, Janssen, MSD, Novartis, Pfizer, Consultant for: Abbvie, Alfa-Sigma, Biogen, BMS, Celgene, Eli-Lilly, GSK, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, YCB, Speakers bureau: Abbvie, Alfa-Sigma, Biogen, BMS, Celgene, Eli-Lilly, GSK, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, YCB, Paolo Cardinaletti: None declared, Armando Gabrielli: None declared, Andrea Di Matteo: None declared, Rossella De Angelis: None declared, Paola Faggioli: None declared, Antonella Laria: None declared, Micaela Fredi: None declared, Francesca Regola: None declared, Laura Andreoli: None declared, Giulia Pazzola: None declared, Carlo Salvarani: None declared, Francesco Puppo: None declared, Simone Negrini: None declared, Marcella Prete: None declared, Vito Racanelli: None declared, Elisa Gremese Consultant for: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, and Pfizer, Speakers bureau: BMS, Speakers bureau: Roche, Speakers bureau: AbbVie, BMS, Celgene, Janssen, Lilly, MSD, Novartis, Sanofi, UCB, Roche, and Pfizer, Maria Gerosa: None declared, Tania Ubiali: None declared, Enrica Bozzolo: None declared, Valentina Canti: None declared, Fabrizio Conti: None declared, Fulvia Ceccarelli: None declared, Elena Bartoloni Bocci: None declared, Roberto Gerli: None declared, Antonio Lobasso: None declared, Amato De Paulis: None declared, Ginevra De Marchi: None declared, Salvatore De Vita Grant/research support from: Roche, Pfizer, Abbvie, Novartis, BMS, MSD, Celgene, Janssen, Consultant for: Roche, Alessandra Bortoluzzi: None declared, Marcello Govoni Paid instructor for: Pfizer, Roche, Speakers bureau: Pfizer, Abbvie, MSD, Roche, Eli-Lilly, Celgene, Sanofi, Janssen, Francesco Benvenuti: None declared, Margherita Zen: None declared, Marta Mosca Paid instructor for: GlaxoSmithKline, Lilly, UCB, Chiara Tani: None declared, Maurizio Rossini: None declared, Giovanni Orsolini Speakers bureau: Grunenthal, Mariele Gatto: None declared, Salvatore Scarpato: None declared, Enrico Brunetta: None declared, Aurora Zumbo: None declared, Gabriele Valentini: None declared, SERENA FASANO: None declared, Giacomo Emmi: None declared, Maria Letizia Urban: None declared, Giacomo Tanti: None declared, Angela Tincani Consultant for: UCB, Pfizer, Abbvie, BMS, Sanofi, Roche, GSK, AlphaSigma, Lillly, Jannsen, Cellgene, Novartis, Andrea Doria: None declared