SAT0087 REAL-LIFE GOLIMUMAB PERSISTENCE IN PATIENTS WITH CHRONIC INFLAMMATORY RHEUMATIC DISEASES: FINAL RESULTS OF THE GO-PRACTICE STUDY

Abstract

Background: Golimumab (GLM) is the fifth, most recent anti-TNFα to be indicated in the treatment of chronic inflammatory rheumatic diseases. GO-PRACTICE aimed to assess GLM use in real-life clinical practice, in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (AS). Objectives: Primary objective was to assess the persistence of GLM over 2 years after initial prescription. Cumulative persistence probabilities were estimated with the Kaplan-Meier method. Secondary objectives included evaluations of: 1) clinical disease activity from inclusion to 2 years (with DAS28 for RA and PsA; ASDAS for AS); 2) change in patient reported evaluations of pain (VAS [0-100]), disease activity (RAPID3 for RA and PsA; BASDAI for AS), functional ability (HAQ) and quality of life (EQ-5D and SF-12); 3) GLM clinical safety. Methods: Observational, prospective, multicenter French study. Patients ≥18 years with RA, PsA and AS were included consecutively, following GLM initiation and were followed-up for 2 years. Data were collected at baseline (BL), year 1 and year 2. Results: 770 patients selected from January 2015 to March 2016 at 134 sites, of which 754 included in the analysis. Mean age was 46 years and 61% were female. Most had AS (63%), followed by RA (23%) and PsA (14%). Mean duration of rheumatic disease was 7.6 years and 37% had previously received biologics; the proportion of patients who received 1, 2, 3 and ≥4 biologics were 18%, 11%, 6% and 2%, respectively. Most patients were prescribed 50mg GLM monthly (97%). Concomitant treatments included disease-modifying anti-rheumatic drugs (38%), corticosteroids (19%) and NSAIDs/analgesics (71%). Persistence of GLM at 2 years was 52.4% (56.5%, 45.1% and 52.6% for RA, PsA and AS respectively), and in the AS group was higher for biologics naive than biologics pretreated patients (59.2% vs. 42.7%, P During the study, 67 (8.9%) patients discontinued GLM due to intolerance or adverse event (AE); reported AEs were consistent with GLM’s known safety profile. Post-hoc multivariate analyses with sociodemographic and medical history variables showed that for GLM discontinuation over the 2 years, gastrointestinal disease was a risk factor in RA patients [HR 3.9, CI95% (2.0-7.6)] and being female was a risk factor in AS patients [HR 1.9, CI95% (1.4-2.6)]. GLM was re-prescribed for 338 (93.4%) of 362 patients who persisted on GLM at 2 years. Conclusion: GLM persistence in real-life is satisfactory at 2 years and accompanied by clinical improvements in RA, PsA and AS patients. Disclosure of Interests: Rene-Marc Flipo Consultant for: Honoraria from Novartis as steering committe of this survey, Florence Tubach Grant/research support from: Financial compensation received from MSD on a pro-rota basis for participation in Scientific Committee meetings and functions for this study, Jean OUANICHE Grant/research support from: Financial compensation received from MSD on a pro-rota basis for active participation in Scientific Committee meetings and functions, Philippe Goupille Grant/research support from: Financial compensation received from MSD on a pro-rota basis for participation in Scientific Committee meetings and functions for this study, Speakers bureau: Abbvie, Biogaran, BMS, Hospira, Janssen, MSD, Pfizer, Sanofi-Genzyme, UCB, Eric Lespessailles Grant/research support from: Grants/research support from Amgen, Eli Lily, MSD, UCB., Consultant for: Consultant for Amgen, Expanscience, Eli Lilly, MSD, UCB., Najat Gouyette Employee of: MSD, France, Naoual HARID Employee of: MSD, France, Saannya Sequeira Consultant for: Contract Research Organization - ClinSearch, Philippe Bertin Grant/research support from: Financial compensation received from MSD on a pro-rota basis for participation in Scientific Committee meetings and functions for this study, Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant for: AbbVie, Biogen, BMS, Celgene, Janssen, Lilly, Medac, MSD, NORDIC Pharma, Novartis, Pfizer, Roche, Sanofi-Aventis, Sanofi Genzyme, SOBI, UCB