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Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study.


ABSTRACT: OBJECTIVES:To evaluate the efficacy and safety of risankizumab, a humanised monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), in patients with active ankylosing spondylitis (AS). METHODS:A total of 159 patients with biological-naïve AS, with active disease (Bath Ankylosing Spondylitis Disease Activity Index score of ?4), were randomised (1:1:1:1) to risankizumab (18?mg single dose, 90?mg or 180?mg at day 1 and weeks 8, 16 and 24) or placebo over a 24-week blinded period. The primary outcome was a 40% improvement in Assessment in Spondylo Arthritis International Society (ASAS40) at week 12. Safety was assessed in patients who received at least one dose of study drug. RESULTS:At week 12, ASAS40 response rates were 25.5%, 20.5% and 15.0% in the 18?mg, 90?mg and 180?mg risankizumab groups, respectively, compared with 17.5% in the placebo group. The estimated difference in proportion between the 180?mg risankizumab and placebo groups (primary endpoint) was -2.5% (95% CI -21.8 to 17.0; p=0.42). Rates of adverse events were similar in all treatment groups. CONCLUSIONS:Treatment with risankizumab did not meet the study primary endpoint and showed no evidence of clinically meaningful improvements compared with placebo in patients with active AS, suggesting that IL-23 may not be a relevant driver of disease pathogenesis and symptoms in AS. TRIAL REGISTRATION NUMBER:NCT02047110; Pre-results.

SUBMITTER: Baeten D 

PROVIDER: S-EPMC6104676 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study.

Baeten Dominique D   Østergaard Mikkel M   Wei James Cheng-Chung JC   Sieper Joachim J   Järvinen Pentti P   Tam Lai-Shan LS   Salvarani Carlo C   Kim Tae-Hwan TH   Solinger Alan A   Datsenko Yakov Y   Pamulapati Chandrasena C   Visvanathan Sudha S   Hall David B DB   Aslanyan Stella S   Scholl Paul P   Padula Steven J SJ  

Annals of the rheumatic diseases 20180626 9


<h4>Objectives</h4>To evaluate the efficacy and safety of risankizumab, a humanised monoclonal antibody targeting the p19 subunit of interleukin-23 (IL-23), in patients with active ankylosing spondylitis (AS).<h4>Methods</h4>A total of 159 patients with biological-naïve AS, with active disease (Bath Ankylosing Spondylitis Disease Activity Index score of ≥4), were randomised (1:1:1:1) to risankizumab (18 mg single dose, 90 mg or 180 mg at day 1 and weeks 8, 16 and 24) or placebo over a 24-week bl  ...[more]

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