AB0366 A PROSPECTIVE OBSERVATIONAL STUDY TO ASSESS THE REAL-WORLD EFFECTIVENESS OF GOLIMUMAB IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS AND PREVIOUSLY TREATED WITH INITIAL TNFα INHIBITORY THERAPY

BackgroundTNF inhibitor (TNFi) treatment is standard for RA patients even though many reasons may lead to TNFi therapy failures such as lack of effectiveness, patient dissatisfaction or limited therapy adherence, or even safety. As a consequence, patients may switch to a different TNFi. The efficacy of golimumab (GLM) in RA patients with inadequate response to TNFi was demonstrated in the Go-AFTER phase III clinical trial.ObjectivesThe objectives of the present Go-BEYOND study were to provide real-world data to evaluate disease activity and treatment persistence with GLM as a second line TNFi therapy in RA patients over a one-year follow-up.MethodsGo-BEYOND is an observational French multicenter prospective cohort study. All consecutive patients over 18 years of age with a diagnosis of active RA were eligible at the time of initial GLM prescription. To be included, patients had to be previously treated with only 1 TNFi (discontinued for any reason) other than GLM. Patients were ineligible if they had been previously treated with other “non-TNFi” biologics or more than one TNFi.The study’s primary outcome was the percentage of RA patients with a Disease Activity Score (DAS28-CRP score) ≤ 3.2 at the 6-month visit (M6 visit). Patients who permanently discontinued their treatment over the 1-year follow-up were considered as non-responders. The secondary outcomes were analyzed descriptively and included (but not limited to) DAS28-CRP score at 12-month visit (M12 visit), EULAR criteria assessment, treatment persistence analysis, HAQ score, RAPID3 score, and patient acceptable symptom state and satisfaction with the injection. The study was approved by a French Ethics Committee in July 2017.ResultsA total of 128 patients (72.7% female, median age 58.2 years, and duration of RA 13.2 ± 11.4 years) met the inclusion criteria. Anti-CPP antibodies and rheumatoid factors were present in 80 (62.5%) and 81 (63.3%) patients, respectively. In the majority, the initial TNFi was etanercept (n=88, 68.8%), then adalimumab (n=25, 19.5%). The reasons for switching to GLM were secondary non-response (i.e., lack of effectiveness after an initial response to the treatment) for 75 (58.6%) patients, then safety (n=22, 17.2%), primary non-response (n=21, 16.4%), and other personal or medical reasons (n=10, 7.8%).At the M6 and M12 visits, a small number of patients, 27 (21.1%) and 48 (37.5%) had respectively permanently discontinued their GLM treatment and were considered as non-responders. At the M6 visit, 48 patients over the 128 included (37.5%) had a DAS28-CRP ≤ 3.2 and 32 (25%) < 2.6. At M12 visit, 41 (32%) patients had a DAS28-CRP ≤ 3.2 and 31 (24.2%) < 2.6. According to EULAR response criteria thresholds, 49 (38.3%) and 45 (35.2%) patients had a good or moderate response to GLM at the M6 and M12 visits.ConclusionThe Go-BEYOND study confirms that in RA, a non-response to a first TNFi does not exclude a response to GLM as a second-line biologic in a substantial proportion of patients in real-life settings.ReferencesNoneAcknowledgementsWe would like to thank the investigators and the entire Go-BEYOND team for their involvement in the study.Disclosure of InterestsCécile Gaujoux-Viala Consultant of: AbbVie; Amgen; Boehringer Ingelheim; Bristol-Myers Squibb; Celgene; Eli Lilly; Galapagos; Gilead Sciences; Janssen; Medac; Merck-Serono; Mylan; Nordic Pharma; Novartis; Pfizer; Roche; Sandoz; Sanofi; UCB, Jérémie SELLAM Consultant of: Abbvie; Biogen; BMS; Fresenius Kabi; Janssen; MSD; Novartis; Pfizer; Roche, Florence Tubach: None declared, Naoual HARID Employee of: MSD France - Medical advisor, Bernard Combe Consultant of: AbbVie; Bristol-Myers Squibb; Celltrion; Eli Lilly; Gilead/Galapagos; Janssen; Merck; Novartis; Pfizer; Roche/Chugai; Sanofi; UCB, René-Marc Flipo Consultant of: Abbvie; BMS; Janssen; MSD; Pfizer; Roche-Chugai