Oct 23, 2018 - ... Laria , Micaela Fredi , Francesca Regola , Angela Tincani , Laura Andreoli , ... Paulis , Ginevra De Marchi , Salvatore De Vita , Alessandra ...
ABSTRACT NUMBER: 2650
E cacy, Safety, and Predictor of Response to Belimumab in a Large Nationwide Cohort Study of Patients with Active Systemic Lupus Erythematosus Luca Iaccarino1, Francesca Saccon1, Alessandro Mathieu2, Matteo Piga3, Angela Ceribelli4, Carlo Selmi5, Paolo Cardinaletti6, Armando Gabrielli7, Andrea Di Matteo8, Rossella De Angelis9, Paola Faggioli10, Antonella Laria11, Micaela Fredi12, Francesca Regola13, Angela Tincani12, Laura Andreoli14, Giulia Pazzola15, Carlo Salvarani15, Francesco Puppo16, Ottavia Magnani16, Marcella Prete17, Elisa Gremese18, Maria Gerosa19, Tania Ubiali20, Enrica Bozzolo21, Valentina Canti21, Vito Racanelli17, Fabrizio Conti22, Fulvia Ceccarelli23, Elena Bartoloni24, Roberto Gerli25, Antonio Lobasso26, Amato de Paulis27, Ginevra De Marchi28, Salvatore De Vita29, Alessandra Bortoluzzi30, Marcello Govoni30, Francesco Benvenuti31, Margherita Zen32, Marta Mosca33, Chiara Tani34, Maurizio Rossini35, Giovanni Orsolini35, Salvatore Scarpato36, Ernico Brunetta37, Aurora Zumbo38, Giacomo Tanti39 and Andrea Doria40, 1Department of Medicine-DIMED, University of Padova, Padova, Italy, 2University of Cagliari, Cagliari, Italy, 3Unit and Chair of Rheumatology, University Hospital of Cagliari, Cagliari, Italy, 4Rheumatology and Clinical Immunology, Humanitas Research Hospital, Rozzano (MI), Italy, 5Rheumatology and Clinical Immunology Unit, Humanitas Research Hospital, Rozzano (MI), Italy, 6University of Ancona, Ancona, Italy, 7Univeristy of Ancona, Ancona, Italy, 8Polytechnic University of Marche, Rheumatology Clinic, Jesi, Italy, 9Polytechnic University of Marche, Rheumatology Clinic, jesi, Italy, 10Hospital of Legnano, Legnano, Italy, 11Hospital of Magenta, Magenta, Italy, 12Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia, Italy, 13University of Brescia, Brescia, Italy, 14Department of Clinical and Experimental Sciences, Spedali Civili and University of Brescia, Brescia, Italy, Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia, Italy, 15University of Reggio Emilia, Reggio Emilia, Italy, 16University of Genova, Genova, Italy, 17University of Bari, Bari, Italy, 18Division of Rheumatology, Fondazione Policlinico Universitario A.Gemelli IRCCS, Catholic University of the Sacred Heart, Rome, Italy, 19Istituto Ortopedico Gaetano Pini, University of Milan, Milano, Italy, 20Istituto Gaetano Pini, University of Milano, Milano, Italy, 21Hospital San Ra aele, Milano, Italy, 22Rheumatology Unit, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy, 23UO Complessa Reumatologia, Policlinico Umberto I Università Sapienza di Roma, Rome, Italy, 24Rheumatology Unit, University of Perugia, Perugia, Italy, 25Department of Medicine, Rheumatology Unit, University of Perugia, Perugia, Italy, 26University Federico II of Napoli, Napoli, Italy, 27Department of Translational Medical Sciences and Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy, 28Hospital/University of Udine, Udine, Italy, 29Rheumatology Clinic, Academic Hospital S. M. della Misericordia, Medical Area Department, University of Udine, Italy, Udine, Italy, 30UOC of Rheumatology, University Hospital S. Anna, Cona Ferrara, Italy, 31University of Padova, Padova, Italy, 32Division of Rheumatology, University of Padova, Padova, Italy, 33Rheumatology Unit, University of Pisa, Pisa, Italy, 34Univeristy of Pisa, Pisa, Italy, 35Rheumatology Unit, University of Verona, Verona, Italy, 36Hospital of Salerno, Salerno, Italy, 37Humanitas Hospital, Milano, Italy, 38Humnaitas Hospital, Milano, Italy, 39Catholic University of the sacred hearth, Roma, Italy, 40University and Azienda Ospedaliera of Padova, Padova, Italy Meeting: 2018 ACR/ARHP Annual Meeting Keywords: E ective, Lupus and belimumab
SESSION INFORMATION Date: Tuesday, October 23, 2018
Session Type: ACR Poster Session C
PDFCROWD.COM
Session Title: Systemic Lupus Erythematosus – Clinical Poster III: Treatment
Session Time: 9:00AM-11:00AM
Background/Purpose: To investigate e ectiveness, safety, and predictors of response to belimumab in patients with active SLE in clinical practice setting. Methods: Four hundred and one active SLE patients (ACR criteria) with positive anti-dsDNA antibody and low C3 and/or C4, from 22 Italian Centers, were treated with belimumab (10 mg/kg day 0, 14, 28 and then every 28 days), as add-on therapy. They were 366 (91.27%) females, mean age 43.51±11.20 years; mean disease duration 12.79±8.74 years. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24-hours proteinuria, CLASIa (Cutaneous LE Disease Area and Severity Index Activity), PGA, Fatigue (VAS 0-10) were recorded at baseline and every 6 months. SLICC-DI was evaluated 5-years before belimumab initiation, at baseline and every year after belimumab initiation. Response was evaluated according to SLE Responder Index-4 (SRI-4) at 12, 24, 36 and 48 months. Adverse events (AEs) were subdivided in noninfectious or infectious AE, and infusion reactions. AE was de ned as severe (SAE) when hospitalization was required and/or death and/or life-threatening manifestations occurred. Statistics were performed by pairs T-test, chi-square test and multiple logistic regression analysis using SPSS package (version 22.0). Results: Mean follow-up was 21.07±15.34 months (range 3-60). Active manifestations requiring the use of belimumab were articular in 40.82%, mucocutaneous in 21.84%, renal in 14.56%, hematologic in 16.32% and serositis in 6.24% of cases. SRI-4 was achieved by 68.2%, 73.3%, 74.7% and 68.3% of patients at 12, 24, 36 and 48 months, respectively. The improvement in clinical and serological variables during the follow-up are reported in the Table. We observed a decrease in the mean number of are during belimumab treatment compared with the corresponding period before belimumab initiation (p
