Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5

Abstract

Background Secukinumab demonstrated sustained efficacy in patients with ankylosing spondylitis (AS) through 5 years in pivotal Phase III studies. Here, we present efficacy and safety results (52-week) of secukinumab in patients with AS from the MEASURE 5 study. Methods MEASURE 5 was a 52-week, Phase III, China-centric study. Eligible patients were randomly assigned (2:1) to receive subcutaneous secukinumab 150 mg or placebo weekly for the first five doses and then once every 4 weeks (q4w). All placebo patients switched to secukinumab 150 mg q4w starting at Week 16. Primary endpoint was Assessments of SpondyloArthritis international Society (ASAS) 20 at Week 16. Randomization was stratified by region (China vs . non-China). Results Of 458 patients (secukinumab 150 mg, N = 305; placebo, N = 153) randomized, 327 (71.4%) were from China and 131 (28.6%) were not from China. Of these, 97.7% and 97.4% patients completed Week 16 and 91.1% and 95.3% (placebo-secukinumab) patients completed Week 52 of treatment. The primary endpoint was met; secukinumab significantly improved ASAS20 response at Week 16 vs. placebo (58.4% vs. 36.6%; P < 0.0001); corresponding rate in the Chinese population was 56.0% vs. 38.5% ( P < 0.01). All secondary efficacy endpoints significantly improved with secukinumab 150 mg in the overall population at Week 16; responses were maintained with a trend toward increased efficacy from Week 16 to 52. No new or unexpected safety signals were reported up to Week 52. Conclusions Secukinumab 150 mg demonstrated rapid and significant improvement in signs and symptoms of AS. Secukinumab was well tolerated and the safety profile was consistent with previous reports. Efficacy and safety results were comparable between the overall and Chinese populations. Trial registration ClinicalTrials.gov, NCT02896127; https://clinicaltrials.gov/ct2/show/NCT02896127?term=NCT02896127&draw=2&rank=1 .

Secukinumab in axial spondyloarthritis: a narrative review of clinical evidence

“… 32 , 65 , 66 In each patient population, secukinumab 150 mg provided sustained improvements in the signs and symptoms of r-axSpA. 32 , 65 , 66 …”

“…Patients who were anti-TNF-naïve or had an inadequate response to or intolerance of previous anti-TNF therapy were enrolled across studies. 23 , 30 – 32 This narrative review will primarily focus on r-axSpA data from MEASURE 2, due to the secukinumab dosing regimen approved by the European Medicines Agency (EMA); key data from MEASURE 1 and 3 are also highlighted where appropriate.…”

“… 64 Analyses of Asian populations have taken place across the MEASURE trials to determine whether secukinumab 150 mg is effective in Taiwanese (MEASURE 1), Japanese (MEASURE 2-J, an open-label phase III study) and Chinese (MEASURE 5) populations of patients with r-axSpA. 32 , 65 , 66 In each patient population, secukinumab 150 mg provided sustained improvements in the signs and symptoms of r-axSpA. 32 , 65 , 66 …”

A Pooled Analysis Reporting the Efficacy and Safety of Secukinumab in Male and Female Patients with Ankylosing Spondylitis

“…Secukinumab, an interleukin (IL)-17A inhibitor, has demonstrated sustained improvement in the signs and symptoms of active AS in the MEASURE clinical trial program [5,6,12,14,15]. The impact of sex on the efficacy of secukinumab has not been thoroughly evaluated and although comparative effectiveness in the real-world setting between TNFi and secukinumab has been previously reported, stratification by sex was not investigated further [16,17].…”

<p>Impact of Secukinumab on Patient-Reported Outcomes in the Treatment of Ankylosing Spondylitis: Current Perspectives</p>

“…This encompasses MEASURE 1-5, including the pivotal studies MEASURE 1 and MEASURE 2, as well as Japan (MEASURE 2J) and China-centric (MEASURE 5) studies (Table 1). [15][16][17][18][19] Several clinical trials are currently ongoing with secukinumab in AS, including a head-tohead trial with a biosimilar of adalimumab, which was submit your manuscript | www.dovepress.com…”