THU0217 Similar efficacy and safety of sarilumab 150 mg or 200 mg q2w regardless of primary (1°) or secondary (2°) failure with tnf inhibitors

Abstract

Background: Sarilumab (150 or 200 mg subcutaneously [SC] every 2 wks [q2w]) +csDMARDs demonstrated efficacy in adults with moderate‐to‐severely active rheumatoid arthritis (RA) with intolerance or inadequate response to prior TNFi treatment in TARGET (NCT01709578). Patients with an initial refractory response (1° failure) to TNFi may respond differently to subsequent treatment vs those who initially respond but lose TNFi effectiveness (2° failure). Objectives: This post hoc analysis examined efficacy and safety of sarilumab +csDMARDS in patients who had previously demonstrated 1° vs 2° TNFi failure. Methods: TNFi failure (1° vs 2°) was investigator‐determined on enrolment to TARGET. Patients who experienced 1° or 2° failure were randomised to placebo (pbo; n=75 and n=99), sarilumab 150 mg (n=72; n=91), or sarilumab 200 mg q2w (n=64; n=103), respectively. Disease activity, physical function (HAQ‐DI), and safety were assessed at Wk 24. Results: By Wk 24, ACR20/50/70 response rates and improvements in LS mean HAQ‐DI were similar in both sarilumab dose groups and superior to pbo, irrespective of 1° vs 2° TNFi failure (table 1). Odds ratios for the benefit of sarilumab over pbo according to ACR response rates, HAQ‐DI, DAS28‐CRP, CDAI and SDAI (figure 1) showed no differences between patients with 1° vs 2° failures. No significant treatment by subgroup (1° vs 2° failure) interactions were observed. In the 1° failure group, treatment emergent adverse events (TEAEs; table 1) occurred in 59.7%, 65.6% vs 45.3% (sarilumab 150, 200 mg vs pbo, respectively) of patients; and in 73.6% and 63.1% vs 52.5% with sarilumab 150, 200 mg vs pbo, respectively, in the 2° failure group. There was only one TEAE leading to death (pbo group) and one case each of venous thrombosis (200 mg sarilumab q2w, 2°) and pulmonary embolism (150 mg sarilumab q2w, 2°). Conclusions: Key efficacy and safety measures were similar in patients treated with sarilumab +csDMARDs, regardless of previous 1° or 2° failure with TNFis. (Figure Presented).