SAT0087 REAL-LIFE GOLIMUMAB PERSISTENCE IN PATIENTS WITH CHRONIC INFLAMMATORY RHEUMATIC DISEASES: FINAL RESULTS OF THE GO-PRACTICE STUDY
Authors: René-Marc Flipo, Florence Tubach, Jean Ouaniche, Philippe Goupille, Eric Lespessailles, Najat Gouyette, Naoual Harid, Saannya Sequeira, Philippe Bertin, Bruno Fautrel
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Golimumab (<b>GLM</b>) 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 (<b>RA</b>), psoriatic arthritis (<b>PsA</b>), and axial spondyloarthritis (<b>AS</b>). <h3>Objectives:</h3> 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 <b>DAS28</b> for RA and PsA; <b>ASDAS</b> for AS); 2) change in patient reported evaluations of pain (<b>VAS</b> [0-100]), disease activity (<b>RAPID3</b> for RA and PsA; <b>BASDAI</b> for AS), functional ability (<b>HAQ)</b> and quality of life (<b>EQ-5D</b> and <b>SF-12</b>); 3) GLM clinical safety. <h3>Methods:</h3> 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 (<b>BL</b>), year 1 and year 2. <h3>Results:</h3> 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 naïve than biologics pretreated patients (59.2% vs. 42.7%, <i>P</i>&lt;.01). Disease activity showed clinically significant improvements from BL to 2 years in persisting patients. For RA, mean DAS28-CRP from 4.3±1.1 to 2.3±0.8 (<i>P</i>&lt;.0001), mean RAPID3 from 4.5±1.8 to 1.8±1.7 (<i>P</i>&lt;.0001). For PsA, mean DAS28-CRP from 3.9±1.0 to 2.0±0.8 (<i>P</i>&lt;.0001), mean RAPID3 from 5.3±1.4 to 2.8±2.2 (<i>P</i>&lt;.0001). For AS, mean ASDAS-CRP from 3.2±0.8 to 1.7±1.0 (<i>P</i>&lt;.0001), mean BASDAI from 5.5±1.6 to 2.8±1.9, (<i>P</i>&lt;.0001). Pain, HAQ, EQ-5D and SF-12 also improved significantly over 2 years. During the study, 67 (8.9%) patients discontinued GLM due to intolerance or adverse event (<b>AE</b>); 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. <h3>Conclusion:</h3> GLM persistence in real-life is satisfactory at 2 years and accompanied by clinical improvements in RA, PsA and AS patients. <h3>Disclosure of Interests:</h3> René-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