THU0210 Secukinumab Efficacy in Anti-Tnf-Naive Patients and Patients Previously Exposed to Anti-Tnf Therapy: Results of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study (Measure 2) in Active Ankylosing Spondylitis

BackgroundCurrent treatment options for ankylosing spondylitis (AS) patients with intolerance or an inadequate response to tumor necrosis factor alpha inhibitors (anti-TNF) are limited. Secukinumab, a human anti–interleukin-17A monoclonal antibody, significantly improved the signs and symptoms of AS in the phase 3 MEASURE 2 study (NCT01649375).1ObjectivesTo evaluate the efficacy and safety of secukinumab by anti-TNF history in the MEASURE 2 study.Methods219 adults with active AS were randomized to receive subcutaneous (s.c.) secukinumab (150 or 75 mg) or PBO at baseline, Wk 1, 2 and 3, and every 4 wks starting at Wk 4. Randomization was stratified according to prior anti-TNF experience: anti-TNF-naive, or inadequate response or intolerance to not more than one anti-TNF biologic agent (anti-TNF-IR). At Wk 16, PBO-treated subjects were re-randomized to secukinumab 150 or 75 mg. Pre-planned subgroup analyses of the primary and secondary endpoints were conducted among anti-TNF-naive and anti-TNF-IR subjects and included: the proportion of subjects achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 response (primary endpoint), ASAS40, high sensitivity C-reactive protein (hsCRP), ASAS 5/6, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Short Form-36 (SF-36), Ankylosing Spondylitis Quality of Life (ASQoL), and ASAS partial remission. Analyses at Wk 16 used non-responder imputation (for binary variables) and mixed-effects repeated measures model (for continuous variables). Wk 52 data are as observed.Results62% of subjects enrolled were anti-TNF-naive and 38% were anti-TNF-IR. At Wk 16, secukinumab 150 mg (but not 75 mg) improved ASAS20 response rates compared with PBO in both anti-TNF-naive (68.2% vs 31.1%, respectively; P