AB0214 SURVIVAL, EFFICACY AND SAFETY OF GOLIMUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS AND SPONDYLOARTHRITIS: DATA FROM AN ARGENTINEAN COHORT
Authors: C. A. Isnardi, E. E. Civit De Garignani, A. García Ciccarelli, J. Sanchez Alcover, R. Garcia Salinas, S. Magri, E. Albiero, C. Gobbi, E. Velozo, E. Soriano, M. Brom, J. Zacariaz, I. Strusberg, M. Baravalle, S. Castaños, L. Morales, S. Paira, R. Calvo, A. Ortiz, R. Perez Alamino, H. Maldonado Ficco, G. Citera
Journal: Annals of the Rheumatic Diseases (2021)

Background: Golimumab is a human monoclonal antibody directed against TNFα in its soluble and transmembrane forms. It can be used subcutaneously or intravenously and has shown efficacy for use in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Objectives: The aim of this study was to evaluate the efficacy, safety, and cumulative survival of golimumab in patients with RA, PsA and AS from different rheumatology centers in Argentina. Methods: We performed a longitudinal study of consecutive adults with RA (ACR/EULAR 2010 criteria), PsA (CASPAR criteria) and AS (ASAS 2009 criteria), who have started treatment with subcutaneous or intravenous golimumab according to medical indication in each center. Data was obtained by review of medical records. Sociodemographic and clinical data, musculoskeletal manifestations, comorbidities, previous treatments were recorded. In reference to golimumab treatment, start date, route of administration and concomitant treatments were identified. Disease activity was assessed using DAS28 for RA patients, DAPSA and MDA for PsA and BASDAI for AS. The presence of adverse events (AE) was recorded. If golimumab was stopped, date and cause was documented. Patients were followed up until golimumab discontinuation, loss of follow-up, or study completion (November 30, 2020). Statistical analysis: Chi 2 test or Fischer exact test and T test or Mann Whitney and ANOVA or Kruskal Wallis, as appropriate. The incidence of EA was assessed in events every 100 patient/year. Kaplan-Meier curves and log Rank analysis. Cox proportional regression. Results: One hundred eighty two patients were included, 116 with a diagnosis of RA, 30 with PsA and 36 with AS. Most of them (70.9%) were female with a median (m) age of 55 years (IQR 43.8-64) and m disease duration of 7 years (IQR 4-12.7) at treatment initiation. Al least one prior biological DMARD or a small molecule was received by 63 patients (34.6%). The most frequent indication cause was conventional DMARD failure. In 94.8% of the patients Golimumab was administered subcutaneously, and in 80.8% in association with conventional DMARDs, the most frequently used was methotrexate. Total follow-up was 318.1 patients/year. Golimumab treatment showed clinical improvement in all three groups of patients. In RA patients DAS28 significantly decreased during the first 12 months of follow-up, m 5.9 (IQR 4.9-6.6) at baseline, 3.8 (IQR 2.6-4.6) at 6 months and 2.8 (IQR 2.1-3.6) at 12 months, p &lt;0.0001. In PsA, m DAPSA-ESR value was 32.2 (IQR 24.2-47.7), 10.1 (IQR 5.8-18.3) and 11.2 (IQR 3.4-24) at baseline, 6 and 12 months, respectably (p &lt;0.0001). In AS, m BASDAI was 6.2 (IQR 4.8-7.3), 2.8 (IQR 1.7-4.1) and 2.2 (IQR 1.1-3.2), at baseline, 6 and 12 months respectively (p &lt;0.0001). The incidence of adverse events was 6.6 per 100 patients/year, being infections the most frequents ones. During follow-up, 50 patients (27.5%) discontinued golimumab, the most frequent cause was treatment failure (68%), followed by lack of health insurance (16%) and adverse events (10%). Golimumab persistence was 79% and 57.6% at 12 and 24 months, respectively. Treatment survival was 50.2 months (95% CI 44.4-55.9). Patients who had received prior treatment with biological DMARDs or small molecules showed lower survival (Figure 1). In the multivariate analysis, adjusting for age, sex and disease duration, those patients showed twice the risk of suspending treatment (HR 2.01, 95% CI 1.1-3.7). Figure 1. Golimumab survival according to prior b-DMARD o small molecule treatment. Conclusion: Golimumab treatment in real life patients in Argentina has shown good efficacy and safety. Drug survival was over 4 years and almost 80% were still using golimumab after one year. Prior treatment with other b-DMARDs o small molecules was associated with lower treatment survival. Disclosure of Interests: Carolina Ayelen Isnardi Speakers bureau: Bristol Myers Squibb, Janssen, Grant/research support from: Pfizer, Emma Estela Civit De Garignani Speakers bureau: Abbvie, Novartis, Agustín García Ciccarelli Speakers bureau: Janssen, Novartis, Consultant of: Novartis, Grant/research support from: Janssen, Novartis, Jimena Sanchez Alcover: None declared, Rodrigo Garcia Salinas Speakers bureau: Abbvie, AMGEN, Bristol-Myers Squibb, Eli Lilly, GSK, Janssen Cilag, Montpellier-UCB, Novartis, Roche – Genentech, Sanofi, Merck Serono., Sebastian Magri Speakers bureau: Abbvie, AMGEN, Bristol-Myers Squibb, Eli Lilly, GSK, Janssen Cilag, Montpellier-UCB, Novartis, Roche – Genentech, Sanofi, Merck Serono., Eduardo Albiero Consultant of: Janssen, Carla Gobbi Speakers bureau: Pfizer, Consultant of: Pfizer, Janssen, Edson Velozo Speakers bureau: Janssen, Novartis, Pfizer, Consultant of: Abbvie, Janssen, Novartis, Grant/research support from: Janssen, Novartis, Pfizer, Enrique Soriano Speakers bureau: AbbVie, Novartis, Bristol MS, Novartis, Eli Lilly, Genzyme, Pfizer, Amgen, and Roche, Consultant of: Novartis, AbbVie, Pfizer, Eli Lilly, Sanofi, Sandoz, Amgen., Grant/research support from: Roche, Novartis, AbbVie, Glaxo Smith Kline, BMS, Martín Brom: None declared, Johana Zacariaz Grant/research support from: Bristol Myers Squibb, Ingrid Strusberg Speakers bureau: Gema Biotech SAU, BMS, Abbvie, Consultant of: Gema Biotech SAU, Abbvie, Janssen, Grant/research support from: Abbvie, Lilly, Galápagos, Servier, GSK, Merck Serono, Marcos BARAVALLE Speakers bureau: Montepellier, Consultant of: Abbvie, Janssen, Grant/research support from: Abbvie, Lilly, Galápagos, Servier, GSK, Merck Serono, Sol Castaños Speakers bureau: Abbvie, Lilly, Galápagos, Servier, GSK, Merck Serono, Liliana Morales Speakers bureau: Lilly, Consultant of: Janssen, Grant/research support from: Abbvie, Lilly, Galápagos, Servier, GSK, Merck Serono, Sergio Paira: None declared, Romina Calvo: None declared, Alberto Ortiz: None declared, Rodolfo Perez Alamino Speakers bureau: Pfizer, Abbvie, Amgen, Bristol-Myers-Squibb, Lilly, Janssen, Novartis, Hernan Maldonado Ficco Speakers bureau: Pfizer, Abbvie, Jansen, Novartis, Bago, Bristol, Eli Lilly., Consultant of: Pfizer, Abbvie, Novartis, Jansen, Bago, Eli Lilly., Gustavo Citera Speakers bureau: Abbvie, BMS, Lilly, Jansen, Gema, Pfizer, Roche, Grant/research support from: Pfizer