Efficacy of risankizumab across subgroups in patients with active psoriatic arthritis: a post hoc integrated analysis of the phase 3 KEEPsAKE 1 and KEEPsAKE 2 randomized controlled trials

Abstract

In the KEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 (NCT03671148) phase 3 trials, risankizumab demonstrated greater efficacy compared with placebo in patients with active psoriatic arthritis (PsA). This post hoc integrated analysis evaluated achieving the following efficacy outcomes at weeks 24 and 52 by baseline demographics and clinical characteristics: ≥20%/50%/70% improvement in American College of Rheumatology response criteria (ACR20/50/70), ≥90% improvement in Psoriasis Area and Severity Index, minimal disease activity status, Low Disease Activity status (Disease Activity in Psoriatic Arthritis), and minimal clinically important difference in pain. Baseline demographics and clinical characteristics were similar between risankizumab (n = 707) and placebo (n = 700) groups. Numerically higher ACR20 response rates at week 24 (primary endpoint) were observed among the risankizumab (46.3%−60.1%) vs. placebo (15.5%−36.2%) cohorts, regardless of subgroups. At week 52, consistent proportions of patients randomized to risankizumab achieved ACR20 (48.6%−75.8%) while those initially randomized to placebo and switched to risankizumab experienced an improvement from week 24 (43.7%−63.9%), regardless of subgroups. Similar trends were observed for other efficacy measures assessing rigorous skin response criteria, composite measures of overall disease activity, and PsA-related symptoms. Risankizumab treatment was efficacious among patients with varying demographic and psoriatic disease characteristics through 52 weeks.

Keywords:

• Biologics
• interleukin-23
• psoriatic arthritis
• risankizumab

Acknowledgments

AbbVie and authors thank all the trial investigators and the patients who participated in this clinical trial.

Contributions

J. F. Merola, A. Armstrong, S. Khattri, S. Y. Paek, B. Padilla, C. Yue, H. Photowala, B. Kaplan, and L. E. Kristensen contributed to data interpretation, critically reviewed this manuscript, and provided final approval for publication. B. Padilla, C. Yue, H. Photowala, and B. Kaplan contributed to the study concept and design. C. Yue participated in statistical analysis. L. E. Kristensen participated in data acquisition.

Disclosure statement

J. F. Merola reports consultant or investigator work for AbbVie, Amgen, Biogen, BMS, Dermavant, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB.

A. Armstrong has received research grants from AbbVie, BMS, Dermira, Janssen, Kyowa Hakko Kirin, Lilly, Novartis, and UCB; and has received personal fees from AbbVie, BI/Parexel, BMS, Celgene, Dermavant, Genentech, GSK, Janssen, Lilly, Menlo Therapeutics, Merck, Modernizing Medicine, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Science 37, Sun Pharma, and Valeant.

S. Khattri is a speaker for AbbVie, Janssen, Lilly, and UCB; serves as an advisory board member/consultant for AbbVie, Janssen, Lilly, Novartis, and UCB; and has received research grants from AbbVie, BMS, LEO, Novartis, and Pfizer.

S. Y. Paek has received fees for serving as a speaker or consultant from AbbVie, BMS, Janssen, Novartis, Sanofi Genzyme, and UCB. She has received research grants from AbbVie, Amgen, and Incyte.

B. Padilla, C. Yue, H. Photowala, and B. Kaplan are employees of AbbVie, and may hold AbbVie stock and/or stock options.

L. E. Kristensen has received honoraria or fees for serving as a speaker or consultant from AbbVie, Amgen, Biogen, BMS, Gilead, Janssen, Lilly, Merck, Novartis, Pfizer, and UCB. He has received investigator-initiated study grants from AbbVie, Biogen, Janssen, Lilly, Novartis, Pfizer, and UCB.

Ethics statement

The Independent Ethics Committee or Institutional Review Board at each study site approved the study protocol, informed consent forms, and recruitment materials before patient enrollment. The studies were conducted in accordance with the International Conference for Harmonization guidelines, applicable regulations, and the Declaration of Helsinki. All patients provided written informed consent before screening.

Data availability statement

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement. Data requests can be submitted at any time after approval in the United States and Europe and after acceptance of this manuscript for publication. These data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: https://vivli.org/ourmember/abbvie/ then select ‘Home’.

Additional information

Funding

AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Melissa Julyanti, PharmD, of JB Ashtin, and funded by AbbVie.