Background: Risankizumab (RZB), a monoclonal antibody that specifically inhibits interleukin 23, is being investigated as a treatment for adults with psoriatic arthritis (PsA).

Objectives: We report the proportion of patients with active PsA treated with RZB vs placebo who achieved ≥20% improvement in American College of Rheumatology criteria (ACR20) by baseline demographics and by concomitant or prior medication use subgroups.

Methods: KEEPsAKE 1 (NCT03675308) and KEEPsAKE 2 (NCT03671148) are ongoing, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies. Patients with active PsA with an inadequate response or intolerance to conventional synthetic disease-modifying, anti-rheumatic drug (csDMARD; KEEPsAKE 1 and 2) and/or biologic therapy (KEEPsAKE 2) received RZB 150 mg or placebo (1:1). The primary endpoint was the proportion of patients achieving ≥20% improvement in ACR criteria (ACR20) at week 24.

Results: In KEEPsAKE 1 (RZB, n=483; placebo, n=481) and KEEPsAKE 2 (RZB, n=224; placebo, n=219), baseline demographics and characteristics were generally balanced between treatment groups. In this integrated analysis, a greater proportion of patients receiving RZB vs placebo achieved ACR20 at week 24, regardless of age (<65 years, ≥65 years, ≥65 to <75 years, ≥75 years), sex, body mass index (<25 kg/m ² , ≥25 to <30 kg/m ² , ≥30 kg/m ² ), race (White, non-White), PsA duration (≤5 years, >5 to ≤10 years, >10 years), baseline hs-CRP (<3 mg/L, ≥3 mg/L), concomitant csDMARD at baseline (any csDMARD, any methotrexate, none), or prior biologics use (yes, no). The proportion of RZB-treated patients who achieved ACR20 was generally similar across most assessed demographic or prior treatment subgroups. No new safety concerns were observed with RZB.

Conclusion: RZB demonstrates efficacy vs placebo for active PsA as shown by greater proportions of patients achieving ACR20 at week 24, regardless of baseline demographics, concomitant csDMARD use at baseline, or prior biologic use.

Acknowledgements: AbbVie Inc. participated in the study design; study research; collection, analysis, and interpretation of data; funded the research for this study. Medical writing assistance, funded by AbbVie, was provided by Alicia Salinero, PhD, of JB Ashtin.

Disclosure of Interests: Joseph F. Merola Consultant of: Amgen, Bristol-Myers Squibb, AbbVie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Sun Pharma, Biogen, Pfizer and Leo Pharma, Kristina Callis-Duffin Consultant of: Amgen/Celgene, AbbVie, Boehringer-Ingelheim, Bristol-Myers Squibb, CorEvitas, Janssen, Lilly, Novartis, and Pfizer, Grant/research support from: Amgen/Celgene, AbbVie, Boehringer-Ingelheim, CorEvitas, Lilly, Janssen, Novartis, Pfizer, Byron Padilla Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Zhenyi Xue Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Huzefa Photowala Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Blair Kaplan Shareholder of: AbbVie Inc., Employee of: AbbVie Inc., Iain McInnes Consultant of: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, AstraZeneca, Boehringer Ingelheim, Bristol Myers, Celgene, Janssen, Leo, Lilly, Novartis, Pfizer, and UCB