FRI0178 Five-year Safety and Efficacy of Golimumab in Methotrexate-Naïve Patients with Rheumatoid Arthritis: Final Study Results of the Phase 3, Randomized, Placebo-Controlled Go-Before Trial

Objectives Final 5yr safety and efficacy results of subcutaneous golimumab (GLM)+/-MTX evaluated in a phase 3 trial (GO-BEFORE) of MTX-naïve pts with rheumatoid arthritis (RA) are reported. Methods Pts were randomized to PBO+MTX, GLM 100mg+PBO, GLM 50mg+MTX, or GLM 100mg+MTX q4w. PBO+MTX pts crossed over to GLM+MTX at wks 28 (blinded early escape) or 52 (pts with ≥1 swollen/tender joint). Pts continued treatment at wk52 (start of long-term extension). After the last pt completed wk52 and unblinding occurred, PBO+MTX pts could switch to GLM 50mg+MTX, MTX and corticosteroid use could be adjusted, and a one-time GLM dose change (50 → 100mg or 100 → 50mg) was permitted at investigator’s discretion. The last GLM injection was at wk252. Observed efficacy results (ACR20/50/70, DAS28-CRP, HAQ-DI, radiographic) by randomized treatment group and cumulative safety data are reported through wks 256 and 268, respectively. Results Of 637 randomized pts, 3 were never treated; 419 continued treatment through wk252, and 215 withdrew (111 for AE, 23 for lack of efficacy, 20 lost to follow-up, 53 for other reasons, 8 deaths). 402 completed the safety follow-up through wk268. Efficacy results are presented in the table. At wk 256, 84.3% of all pts had an ACR20, 93.9% had DAS28-CRP EULAR response, and 80.6% had improvement in HAQ-DI ≥0.25. Mean changes from baseline in total vdH-S score were small and 64% of pts randomized to GLM+MTX had no radiographic progression (ΔvdH-S≤0). The most common AEs were upper respiratory tract infection(29.4%), nausea(19.6%), bronchitis(16.6%), and increased alanine aminotransferase(16.1%); 11.9% of pts had an injection-site reaction. Through wk268, 204/616(33.1%) pts had an SAE; 17.5% of pts discontinued study agent due to AEs. Overall rates of serious infections, malignancies, and death were 12.2%, 3.4%, and 1.9%, resp. Of 595 pts with available samples, 58(9.7%) were positive for antibodies to GLM. Image/graph Conclusions The retention rate was high(66.1%) through 5yrs. GLM+MTX therapy resulted in maintained improvements in signs/symptoms of RA and in physical function, and inhibited structural damage progression long-term. No new safety signals were detected through 5years in MTX-naïve RA pts. Disclosure of Interest P. Emery Grant/research support from: Janssen R&D, LLC, R. Fleischmann Grant/research support from: Janssen R&D, LLC, I. Strusberg Grant/research support from: Janssen R&D, LLC, P. Durez Grant/research support from: Janssen R&D, LLC, P. Nash Grant/research support from: Janssen R&D, LLC, E. Amante Grant/research support from: Janssen R&D, LLC, M. Churchill Grant/research support from: Janssen R&D, LLC, W. Park Grant/research support from: Janssen R&D, LLC, B. Pons-Estel Grant/research support from: Janssen R&D, LLC, C. Han Shareholder of: Johnson & Johnson, Employee of: Janssen Global Services, LLC, T. Gathany Shareholder of: Johnson & Johnson, Employee of: Janssen Global Services, LLC, Y. Zhou Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, S. Xu Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, E. Hsia Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC