Patients with axial spondyloarthritis (axSpA) frequently report pain, stiffness, fatigue, and sleep problems, which may lead to impaired physical activity. The majority of reported-on measures evaluating physical activity and sleep disturbance in axSpA are self-reported questionnaires, which can be impacted by patient recall Enhanced digital features To view enhanced digital features for this article go to https://doi.org/10.6084/ m9.figshare.9959021.
Objective To assess the efficacy of secukinumab on axial and peripheral enthesitis in patients with ankylosing spondylitis (AS) using pooled data from randomized controlled phase 3 studies. Methods In this post-hoc analysis, data were pooled from patients originally randomized to secukinumab 150 mg, 300 mg, or placebo from phase 3 MEASURE 1-4 studies (ClinicalTrials.gov identifiers: NCT01358175, NCT01649375, NCT02008916 and NCT02159053). Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) was used for assessments of enthesitis through Week 52. Efficacy outcomes were mean change in MASES score and complete resolution (MASES=0) of enthesitis in patients with baseline MASES>0. Results A total of 693 (71.5%) patients had enthesitis at baseline in secukinumab 300 mg, 150 mg and placebo groups (58 [76.3%], 355 [70.4%] and 280 [72%]), respectively, out of 969 patients pooled in this analysis. At Week 16, mean change from baseline for overall MASES and enthesitis at axial MASES-sites was: secukinumab 300 mg (-2.9 [P<0.01] and -2.9 [P<0.01]); 150 mg (-2.4 [P<0.015] and -2.3 [P<0.05]), and placebo (-1.9 and -1.8), with improvements seen through Week 52. More than a third of secukinumab-treated patients (300 mg, 36.2% and 150 mg, 40.8%) achieved complete resolution of enthesitis at Week 16. Conclusion Secukinumab improved enthesitis at overall MASES and axial sites in patients with ankylosing spondylitis.
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