Risankizumab, an IL-23 inhibitor, for ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, proof-of-concept, dose-finding phase 2 study
| Autor: | Carlo Salvarani, Dominique Baeten, Lai-Shan Tam, David B. Hall, Alan M. Solinger, Steven J. Padula, Tae-Hwan Kim, Chandrasena Pamulapati, Paul Scholl, James Cheng-Chung Wei, Mikkel Østergaard, Joachim Sieper, Pentti Järvinen, Stella Aslanyan, Sudha Visvanathan, Yakov Datsenko |
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| Přispěvatelé: | Clinical Immunology and Rheumatology, AII - Inflammatory diseases |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Adolescent Immunology Arthritis Phases of clinical research DMARDs (biologic) Placebo Proof of Concept Study Severity of Illness Index General Biochemistry Genetics and Molecular Biology 03 medical and health sciences Young Adult 0302 clinical medicine Rheumatology Double-Blind Method Internal medicine Severity of illness ankylosing spondylitis medicine Clinical endpoint Immunology and Allergy Humans Spondylitis Ankylosing Adverse effect Aged 030203 arthritis & rheumatology Ankylosing spondylitis Risankizumab Dose-Response Relationship Drug treatment business.industry Remission Induction Antibodies Monoclonal Clinical and Epidemiological Research Middle Aged medicine.disease 030104 developmental biology Antirheumatic Agents Interleukin-23 Subunit p19 Female business Follow-Up Studies |
| Zdroj: | Annals of the Rheumatic Diseases 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, vol. 77, no. 9, pp. 1295-1302 . https://doi.org/10.1136/annrheumdis-2018-213328 Annals of the rheumatic diseases, 77(9), 1295-1302. BMJ Publishing Group |
| ISSN: | 0003-4967 |
| Popis: | ObjectivesTo 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).MethodsA 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.ResultsAt 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.ConclusionsTreatment 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 numberNCT02047110; Pre-results. |
| Databáze: | OpenAIRE |
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