Efficacy and Safety of Secukinumab 150 mg with and Without Loading Regimen in Ankylosing Spondylitis: 104-week Results from MEASURE 4 Study

Abstract

IntroductionTo 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.MethodsPatients (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.ResultsA 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.ConclusionsSecukinumab 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 registrationClinicalTrials.gov identifier, NCT02159053.FundingNovartis Pharma AG, Basel, Switzerland.Electronic supplementary materialThe online version of this article (10.1007/s40744-018-0123-5) contains supplementary material, which is available to authorized users.

Secukinumab: A Review in Ankylosing Spondylitis

“…In MEASURE 4, the EAIR of MACE was 0.9 per 100 PY when administered with a loading dose and 0.0 per 100 PY when administered without a loading dose [15]. …”

Efficacy and safety of IL-17 inhibitors for the treatment of ankylosing spondylitis: a systematic review and meta-analysis

“…The flowchart of the literature search is shown in figure 1. After manually searching the reference lists, our literature search finally identified five published articles including six clinical trials [25][26][27][28][29] with an overall 1733 patients (777 patients received secukinumab vs. 389 patients received a placebo; and 376 patients received ixekizumab vs. 191 patients received a placebo) that could be used in this meta-analysis. All studies were phase III randomized, double-blind, placebo-controlled trials.…”

“…All studies were phase III randomized, double-blind, placebo-controlled trials. Secukinumab was evaluated in 4 trials of 3 published articles [25][26][27], and ixekizumab was used in two articles in the treatment of ankylosing spondylitis [28,29]. No data concerning brodalumab therapy in ankylosing spondylitis were published through the date of literature retrieval.…”

Efficacy and safety of IL-17 inhibitors for the treatment of ankylosing spondylitis: a meta-analysis of randomized controlled trials

“…Initially, 3051 potentially relevant citations were screened, and 2648 remained after duplicates were removed. After manually searching the reference lists, our literature search finally identified five published articles including six clinical trials [26][27][28][29][30] with an overall 1733 patients (1153 patients received IL-17 inhibitors and 580 patients received a placebo) that could be used in this metaanalysis. The flowchart of the literature search is shown in figure 1.…”

“…All studies were phase III randomized, double-blind, placebo-controlled trials. Secukinumab was evaluated in 4 trials of 3 published articles [26][27][28] , and ixekizumab was used in two articles in the treatment of ankylosing spondylitis. 29 30 No data concerning brodalumab therapy in ankylosing spondylitis were published through the date of literature retrieval.…”