Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2

Abstract

Background: Secukinumab treatment has previously been shown to significantly improve the signs and symptoms of active ankylosing spondylitis (AS), with responses sustained through 2 years. Here, we report the long-term (3 years) efficacy and safety of secukinumab in the MEASURE 2 study.

Methods: MEASURE 2 (NCT01649375) is a 5-year phase III, randomised, double-blind, double-dummy, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of subcutaneous loading and maintenance dosing of secukinumab in adult subjects with active AS. Subjects were randomised to receive subcutaneous secukinumab 150 mg, 75 mg or placebo at baseline, weeks 1, 2 and 3 and every 4 weeks from week 4. At week 16, placebo-treated subjects were rerandomised to receive secukinumab 150/75 mg.

Results: Retention rates were high during weeks 16-156 and were 86% and 76% for secukinumab 150 and 75 mg, respectively. Secukinumab 150 mg provided sustained improvements in the Assessment of Spondyloarthritis International Society ASAS 20/40 response rates at week 156 (70.1%/60.9%) compared with week 52 (74.2%/57.0%); however, there was a slight decrease for secukinumab 75 mg (54.3%/37.0% vs 62.5%/43.2%, respectively). Sustained improvements were observed in all other end points, including Bath Ankylosing Spondylitis Disease Activity Index, AS Disease Activity Score with C reactive protein inactive disease, ASAS 5/6, Short Form-36 Physical Component Summary and ASAS partial remission. Clinical benefits were observed regardless of prior exposure to anti-tumour necrosis factor agents. The safety profile remained favourable and was consistent with previous reports.

Conclusions: This study showed sustained improvement through 3 years in signs, symptoms and physical function in subjects with AS. Retention rates were high and secukinumab was well tolerated, with a favourable safety profile.

Keywords: ankylosing spondylitis; cytokines; dmards (biologic); spondyloarthritis.

Figure 1

Subject disposition through week 156 of treatment. ^aIncludes placebo switchers, who were rerandomised at week 16; ^bIncludes patients who up-titrated from secukinumab 75 to 150 mg at week 140.

Figure 2

ASAS 20/40 response rates, and mean change from baseline in BASDAI through week 156* of treatment. *For patients who discontinued, the end of treatment visit (ie, final assessment 4 weeks after last study treatment) was considered as week 156. Data are shown as observed through week 156. ASAS 20/40, Assessment of Spondyloarthritis International Society criteria for 20%/40% improvement; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; n, number of subjects in the treatment group with evaluation at each time point.

Figure 3

ASAS 20/40 responses in anti-TNF-naïve and anti-TNF-IR subjects at weeks 52, 104 and 156. Data are shown as observed through week 156. ASAS 20/40, Assessment of Spondyloarthritis International Society criteria for 20%/40% improvement; IR, inadequate response; n, number of evaluable subjects; TNF, tumour necrosis factor.