Abstract
INTRODUCTION: To evaluate the efficacy and safety of secukinumab 150 mg, with or without a loading regimen, using a self-administered prefilled syringe in patients with ankylosing spondylitis (AS) over 104 weeks from the MEASURE 4 study. METHODS: Patients (N = 350) with active AS were randomized (1:1:1) to receive subcutaneous secukinumab 150 mg with loading dose (150 mg), without loading dose (150 mg no load), or placebo. All patients received secukinumab or placebo at baseline, weeks 1, 2, and 3 and every 4 weeks starting at week 4. The primary endpoint was the Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) at week 16. RESULTS: A total of 96.9% of patients (339/350) completed 16 weeks and 82.6% (289/350) completed 104 weeks of treatment. The ASAS20 response rate at week 16 was 59.5% and 61.5% with 150 and 150 mg no load groups, respectively, versus placebo (47%; P = 0.057 and 0.054, respectively); the primary endpoint was not met. Increases in response rates achieved with secukinumab for ASAS20 at week 16 were sustained through week 104. The safety profile of secukinumab 150 mg, with or without a loading regimen, showed no new or unexpected safety signals. CONCLUSIONS: Secukinumab 150 mg, with or without loading regimen, provided rapid and sustained decreases in the signs and symptoms of patients with AS, but the differences were not statistically significant at week 16 due to higher than expected placebo responses. The responses and safety profile were consistent with previous phase 3 studies and sustained through 2 years. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02159053. FUNDING: Novartis Pharma AG, Basel, Switzerland.