PT - JOURNAL ARTICLE AU - Josef S Smolen AU - Jung-Yoon Choe AU - Michael E Weinblatt AU - Paul Emery AU - Edward Keystone AU - Mark C Genovese AU - Gihyun Myung AU - Evelyn Hong AU - Inyoung Baek AU - Jeehoon Ghil TI - Pooled analysis of TNF inhibitor biosimilar studies comparing radiographic progression by disease activity states in rheumatoid arthritis AID - 10.1136/rmdopen-2019-001096 DP - 2020 Jan 01 TA - RMD Open PG - e001096 VI - 6 IP - 1 4099 - http://rmdopen.bmj.com/content/6/1/e001096.short 4100 - http://rmdopen.bmj.com/content/6/1/e001096.full SO - RMD Open2020 Jan 01; 6 AB - Objective To evaluate the relationship between disease activity and radiographic progression in rheumatoid arthritis, three phase III studies of SB4, SB2 and SB5 (biosimilars of etanercept, infliximab and adalimumab) were pooled to assess radiographic progression by disease activity status.Methods Patients from each study with radiographic data were pooled and grouped based on disease activity state (remission, low disease activity (LDA), moderate disease activity (MDA) and high disease activity (HDA)), determined by disease activity score based on 28-joint count (DAS28) per erythrocyte sedimentation rate, Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) at different time points. Mean change in modified Total Sharp Score (mTSS) and the proportion of radiographic non-progressors of higher disease activity groups (LDA, MDA and HDA) in reference to remission were summarised descriptively, with comparison of ORs using logistic models.Results 1265 patients were included. In all treatments combined, the 1 year mean change in mTSS was 0.03, 0.4, 0.3 and 1.3 and proportion of radiographic non-progressors was 79.8%, 78.1%, 74.1% and 58.4% in the week 24/30 DAS28-determined remission, LDA, MDA and HDA groups, respectively. ORs (95% CIs) of the proportion of non-progressors were lowest in the HDA group in reference to remission (0.35 (0.23 to 0.54)), followed by MDA (0.72 (0.50 to 1.05)) and LDA (0.90 (0.55 to 1.48)) groups. Similar trends were observed when disease activity was assessed using SDAI or CDAI.Conclusion A pooled analysis of radiographic assessment data from three biosimilar studies showed that radiographic progression is small overall but increases with worse disease activity.Trial registration numbers NCT01895309, NCT01936181 and NCT02167139