TY - JOUR
T1 - Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis
T2 - results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study
AU - Baeten, Dominique
AU - Østergaard, Mikkel
AU - Wei, James Cheng-Chung
AU - Sieper, Joachim
AU - Järvinen, Pentti
AU - Tam, Lai-Shan
AU - Salvarani, Carlo
AU - Kim, Tae-Hwan
AU - Solinger, Alan
AU - Datsenko, Yakov
AU - Pamulapati, Chandrasena
AU - Visvanathan, Sudha
AU - Hall, David B
AU - Aslanyan, Stella
AU - Scholl, Paul
AU - Padula, Steven J
N1 - COPECARE
PY - 2018/9
Y1 - 2018/9
N2 - 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.
AB - 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.
U2 - 10.1136/annrheumdis-2018-213328
DO - 10.1136/annrheumdis-2018-213328
M3 - Journal article
C2 - 29945918
SN - 0003-4967
VL - 77
SP - 1295
EP - 1302
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 9
ER -