Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial.
In: Annals of the Rheumatic Diseases, Jg. 81 (2022-03-01), Heft 3, S. 351-366
academicJournal
Zugriff:
Objectives: Risankizumab is an interleukin-23 inhibitor under study for the treatment of patients with psoriatic arthritis (PsA). The phase 3 KEEPsAKE 2 trial investigated the efficacy and safety of risankizumab versus placebo in patients with active PsA who had previous inadequate response or intolerance to ≤2 biological therapies (Bio-IR) and/or ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR). Results through week 24 are reported here. Methods: Adults with PsA who were Bio-IR and/or csDMARD-IR were randomised to receive subcutaneously administered risankizumab 150 mg or placebo at weeks 0, 4 and 16 during a 24-week, double-blind treatment period. The primary endpoint was the proportion of patients who achieved ≥20% improvement in American College of Rheumatology score (ACR20) at week 24. Secondary endpoints assessed key domains of PsA and patient-reported outcomes. Results: A total of 444 patients (median age 53 years, range 23-84 years) were randomised to risankizumab (n=224) or placebo (n=220); 206 patients (46.5%) were Bio-IR. At week 24, a significantly greater proportion of patients receiving risankizumab achieved the primary endpoint of ACR20 (51.3% vs 26.5%, p<0.001) and all secondary endpoints (p<0.05) compared with placebo. Serious adverse events were reported for 4.0% and 5.5% of risankizumab-treated and placebo-treated patients, respectively; serious infections were reported for 0.9% and 2.3%, respectively. Conclusion: Treatment with risankizumab resulted in significant improvements versus placebo in key disease outcomes and was well tolerated in patients with PsA who were Bio-IR and/or csDMARD-IR. Trial Registration Number: NCT03671148. [ABSTRACT FROM AUTHOR]
Copyright of Annals of the Rheumatic Diseases is the property of BMJ Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Titel: |
Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial.
|
---|---|
Autor/in / Beteiligte Person: | Östör, Andrew ; Van den Bosch, Filip ; Papp, Kim ; Asnal, Cecilia ; Blanco, Ricardo ; Aelion, Jacob ; Alperovich, Gabriela ; Lu, Wenjing ; Wang, Zailong ; Soliman, Ahmed M. ; Eldred, Ann ; Barcomb, Lisa ; Kivitz, Alan |
Zeitschrift: | Annals of the Rheumatic Diseases, Jg. 81 (2022-03-01), Heft 3, S. 351-366 |
Veröffentlichung: | 2022 |
Medientyp: | academicJournal |
ISSN: | 0003-4967 (print) |
DOI: | 10.1136/annrheumdis-2021-221048 |
Schlagwort: |
|
Sonstiges: |
|