BIOSIMILAR CANDIDATE ABP 501: ADDITIONAL EFFICACY ANALYSES FROM THE PHASE 3 STUDY

Background: ABP 501 is being developed as a biosimilar candidate to adalimumab, a fully human recombinant monoclonal antibody. Evidence from analytical and pharmacokinetic comparisons indicates that ABP 501 is highly similar to adalimumab. Results of efficacy and safety from a phase 3 study comparing ABP 501 with adalimumab in subjects with rheumatoid arthritis (RA) have been previously presented. Objectives: To report descriptive results from additional efficacy analysis based on clinical disease activity index (CDAI) and simplified disease activity index (SDAI) composite indices as well as results for the ACR individual components. These analyses provide information on alternate methods for disease management. Methods: This was a randomized, double-blind, active-controlled study in adult subjects with moderate to severe RA who had an inadequate response to methotrexate. Subjects were randomized in a 1:1 ratio (ABP 501: n=264; adalimumab: n=262) to receive either ABP 501 or adalimumab 40 mg subcutaneously every 2 weeks. Details of the study design have been previously reported. For these analyses descriptive summaries of CDAI, SDAI and individual American College of Rheumatology response criteria (ACR) components were generated. Results: Baseline characteristics were well balanced between groups. At week 24, the mean (SD) CDAI improvement from baseline was 25.94 (12.62) for ABP 501 and 25.06 (12.02) for adalimumab. At week 24, the mean (SD) SDAI improvement from baseline was 26.57 (12.97) for ABP 501 and 25.64 (12.31) for adalimumab. Results for CDAI, SDAI and individual ACR components at baseline and week 24 are shown in the Table. The overall safety and immunogenicity profile of ABP 501 was comparable to that of adalimumab and has been previously reported. Table 1. Results [mean (SD)] for individual ACR components at week 24 ParameterABP 501Adalimumab BaselineWeek 24BaselineWeek 24 CDAI39.1 (12.08)13.3 (11.67)38.7 (11.87)13.5 (11.20) SDAI40.5 (12.54)14.0 (11.95)40.1 (12.28)14.3 (11.55) ACR Component Swollen Joint Count14.7 (9.05)4.0 (7.55)14.1 (7.98)3.7 (5.38) Tender Joint Count24.3 (14.35)7.7 (9.99)23.9 (13.49)8.0 (10.67) Subject's Global Health Assessment6.5 (1.92)3.4 (2.25)6.6 (1.86)3.4 (2.10) Investigator's Global Health Assessment6.8 (1.29)2.4 (1.80)6.7 (1.59)2.5 (1.73) Subject Assessment of Disease-related Pain58.3 (21.82)25.6 (23.25)60.6 (22.37)27.3 (23.50) C-reactive Protein (mg/L)13.88 (20.69)7.30 (9.57)14.68 (19.38)7.48 (10.97) Health Assessment Questionaire – Disability Index (HAQ-DI) Total Score1.48 (0.62)0.97 (0.69)1.50 (0.65)0.95 (0.68) Conclusions: These additional analyses confirm that the of efficacy ABP 501 is comparable to adalimumab in multiple clinical characterisitics providing further evidence that ABP 501 is similar to adalimumab. References: 1. Cohen et al. Presented at: American College of Rheumatology Annual Meeting; November 2015; San Francisco, CA. Abstract 2054. 2. Matsumoto et al. Presented at: American College of Rheumatology Annual Meeting; November 2015; San Francisco, CA. Abstract 2757. Acknowledgement: Monica Ramchandani, PhD for medical writing. Disclosure of Interest: S. Cohen Consultant for: Amgen, N. Zhang Shareholder of: Amgen, Employee of: Amgen, P. Kaur Shareholder of: Amgen, Employee of: Amgen DOI: 10.1136/annrheumdis-2016-eular.3734Citation: Annals of the Rheumatic Diseases, volume 75, supplement 2, year 2016, page 499Session: Rheumatoid arthritis - anti-TNF therapy (Poster Presentations )