Effect of Secukinumab on Patient-Reported Outcomes in Patients With Active Ankylosing Spondylitis A Phase III Randomized Trial (MEASURE 1)

Objective. To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). Methods. In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV -> 150 mg group), or SC secukinumab 75 mg every 4 weeks (IV -> 75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Work Productivity and Activity Impairment-General Health questionnaire (WPAI-GH). Results. At week 16, secukinumab IV -> 150 mg or IV -> 75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (-2.3 for both regimens versus -0.6; P <0.0001 and P <0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P <0.0001 and P <0.001, respectively), and ASQoL (-3.6 for both regimens versus -1.0; P <0.0001 and P <0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. Conclusion. Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related