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

Dominique Baeten, Mikkel Østergaard, James Cheng Chung Wei, Joachim Sieper, Pentti Järvinen, Lai Shan Tam, Carlo Salvarani, Tae Hwan Kim, Alan Solinger, Yakov Datsenko, Chandrasena Pamulapati, Sudha Visvanathan, David B. Hall, Stella Aslanyan, Paul Scholl, Steven J. Padula

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76 Scopus citations

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.

Original languageEnglish
Pages (from-to)1295-1302
Number of pages8
JournalAnnals of the Rheumatic Diseases
Volume77
Issue number9
DOIs
StatePublished - 2018 Sep 1

Keywords

  • DMARDs (biologic)
  • ankylosing spondylitis
  • treatment

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    Baeten, D., Østergaard, M., Wei, J. C. C., Sieper, J., Järvinen, P., Tam, L. S., Salvarani, C., Kim, T. H., Solinger, A., Datsenko, Y., Pamulapati, C., Visvanathan, S., Hall, D. B., Aslanyan, S., Scholl, P., & Padula, S. J. (2018). Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: Results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study. Annals of the Rheumatic Diseases, 77(9), 1295-1302. https://doi.org/10.1136/annrheumdis-2018-213328