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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

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Baeten, D, Østergaard, M, Wei, JC-C, Sieper, J, Järvinen, P, Tam, L-S, Salvarani, C, Kim, T-H, Solinger, A, Datsenko, Y, Pamulapati, C, Visvanathan, S, Hall, DB, Aslanyan, S, Scholl, P & Padula, SJ 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, bind 77, nr. 9, s. 1295-1302. https://doi.org/10.1136/annrheumdis-2018-213328

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CBE

Baeten D, Østergaard M, Wei JC-C, Sieper J, Järvinen P, Tam L-S, Salvarani C, Kim T-H, Solinger A, Datsenko Y, Pamulapati C, Visvanathan S, Hall DB, Aslanyan S, Scholl P, Padula SJ. 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

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Author

Baeten, Dominique ; Østergaard, Mikkel ; Wei, James Cheng-Chung ; Sieper, Joachim ; Järvinen, Pentti ; Tam, Lai-Shan ; Salvarani, Carlo ; Kim, Tae-Hwan ; Solinger, Alan ; Datsenko, Yakov ; Pamulapati, Chandrasena ; Visvanathan, Sudha ; Hall, David B ; Aslanyan, Stella ; Scholl, Paul ; Padula, Steven J. / Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis : results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study. I: Annals of the Rheumatic Diseases. 2018 ; Bind 77, Nr. 9. s. 1295-1302.

Bibtex

@article{24d507e90e57418c94f92cf29150d553,
title = "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-na{\"i}ve 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.",
author = "Dominique Baeten and Mikkel {\O}stergaard and Wei, {James Cheng-Chung} and Joachim Sieper and Pentti J{\"a}rvinen and Lai-Shan Tam and Carlo Salvarani and Tae-Hwan Kim and Alan Solinger and Yakov Datsenko and Chandrasena Pamulapati and Sudha Visvanathan and Hall, {David B} and Stella Aslanyan and Paul Scholl and Padula, {Steven J}",
note = "COPECARE",
year = "2018",
month = "9",
doi = "10.1136/annrheumdis-2018-213328",
language = "English",
volume = "77",
pages = "1295--1302",
journal = "Annals of the Rheumatic Diseases",
issn = "0003-4967",
publisher = "B M J Group",
number = "9",

}

RIS

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

VL - 77

SP - 1295

EP - 1302

JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

IS - 9

ER -

ID: 56069106