AB0700 GOLIMUMAB PERSISTENCE IN BIOLOGIC NAÏVE AND NON-NAÏVE PATIENTS WITH AXIAL SPONDYLOARTHRITIS: RESULTS OF THE GO-PRACTICE STUDY
Authors: Philippe Bertin, Philippe Goupille, Florence Tubach, Jean Ouaniche, Eric Lespessailles, Najat Gouyette, Naoual Harid, Jean-Marie Fayette, Bruno Fautrel, René-Marc Flipo
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Golimumab (<b>GLM</b>) was the latest anti-TNFα therapy to be indicated in the treatment of chronic inflammatory rheumatic diseases. The pivotal GO-AFTER study <b>[1]</b> and the ongoing observational GO-BEYOND study investigate GLM efficacy in rheumatoid arthritis (<b>RA</b>) patients who previously received biologics. However, clinical studies of GLM in axial spondyloarthritis (<b>AS</b>) are lacking. Using data from the GO-PRACTICE study, we examined GLM persistence in patients with aS. <h3>Objectives:</h3> Primary objective was to estimate GLM persistence at 2 years from initial prescription, as a first line of treatment (in biologic naïve patients:<b>BN</b>) and as a second or further line of treatment (in biologic pretreated patients:<b>BP</b>). Persistence was estimated with the Kaplan-Meier method. Secondary outcomes included assessing disease activity (<b>ASDAS</b>) evolution and patient-reported evaluations of disease activity (<b>BASDAI</b>), pain (<b>VAS</b>), functional ability (<b>HAQ</b>) and quality of life (<b>EQ-5D</b> and <b>SF-12</b>). <h3>Methods:</h3> Observational, prospective, multicenter French study, that recruited adult patients with RA, psoriatic arthritis or aS, who were newly prescribed GLM. Patients were followed-up over 2 years; data were collected at baseline (<b>BL</b>), 1 year and 2 years. This abstract presents results from the aS cohort of GO-PRACTICE. <h3>Results:</h3> 478 patients with aS (constituting 63% of the total cohort) from 134 sites were included from January 2015 to March 2016. Mean age was 43 years, 55% were female; 61% were BN (n=291) and 39% (n=187) were BP. Mean duration of aS was 5.5 and 10.7 years in BN and BP patients, respectively (<i>P</i>&lt;.001). At BL most were prescribed 50 mg GLM monthly (97%). Co-treatments were disease-modifying anti-rheumatic drugs (34%), corticosteroids (17%) and NSAIDs/analgesics (90%). GLM persistence over 2 years was significantly higher in BN than BP patients (59.2% vs 45.1%,<i> p</i>&lt;.01). For those still on GLM at 2 years, disease activity (Table1) and patient assessments showed significant improvements for both, BN and BP patients, with improvements being greater in BN patients. GLM was well tolerated in aS patients (n=478), with 46 (9.6%) discontinuing due to intolerance. Among BN patients, 18 (6.2%) discontinued GLM due to primary treatment failure, compared to 28 BP patients (15%). GLM was re-prescribed for 213 (88%) of the 241 patients persisting on GLM at 2-years. Post-hoc multivariate analysis showed that being female was a risk factor for GLM discontinuation in aS patients (HR1.9, IC95% 1.4-2.6). <h3>Conclusion:</h3> GLM is associated with clinical improvements and good persistence in aS patients, especially those who are biologic naïve. <h3>References</h3> [1] Smolen JS, et al; arthritis research &amp; therapy2015,17:14 <h3>Disclosure of interests:</h3> 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, 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, 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, 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, jean-marie Fayette Consultant for: Contract Research Organisation - ClinSearch, 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, René-Marc Flipo Consultant for: Honoraria from Novartis as steering committe of this survey