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. 2024 Jun;11(3):633-648.
doi: 10.1007/s40744-024-00657-2. Epub 2024 Mar 18.

Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 2 Randomized Clinical Trial

Andrew Östör  1   2   3 , Filip Van den Bosch  4   5 , Kim Papp  6   7 , Cecilia Asnal  8 , Ricardo Blanco  9 , Jacob Aelion  10 , Kyle Carter  11 , Vassilis Stakias  11 , Ralph Lippe  11 , Leonidas Drogaris  11 , Ahmed M Soliman  11 , Michael M Chen  11 , Byron Padilla  11 , Alan Kivitz  12
Affiliations

Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the KEEPsAKE 2 Randomized Clinical Trial

Andrew Östör et al. Rheumatol Ther. 2024 Jun.

Abstract

Introduction: Long-term therapeutic options providing durable response and tolerability are needed for psoriatic arthritis (PsA). The ongoing KEEPsAKE 2 trial is evaluating risankizumab treatment in patients with active PsA who previously had inadequate response/intolerance to ≥ 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and/or 1-2 biologic DMARDs (bDMARD-IR). Herein, we report results through 100 weeks of treatment.

Methods: KEEPsAKE 2 is a global phase 3 trial. Patients with active PsA were randomized 1:1 to double-blind subcutaneous risankizumab 150 mg or placebo (weeks 0, 4, and 16). At week 24, all patients received open-label risankizumab every 12 weeks until end of study. Efficacy endpoints included achieving ≥ 20% improvement in PsA symptoms using American College of Rheumatology criteria (ACR20), attaining minimal disease activity (MDA; meeting ≥ 5/7 criteria of low disease activity and extent), and improving in other measures.

Results: At the cutoff date, 345/443 (77.9%) patients were ongoing in the study. ACR20 was achieved in 57.1% and 52.5% of the continuous risankizumab and placebo/risankizumab cohorts, respectively, at week 100 and in 60.0% and 55.8%, respectively, at week 52. In week 52 responders, maintenance of ACR20 at week 100 was achieved in 74.8% (continuous risankizumab) and 78.7% (placebo/risankizumab) of patients. In the continuous risankizumab and placebo/risankizumab cohorts, respectively, MDA was achieved by 33.0% and 33.3% of patients at week 100 and by 27.2% and 33.8% at week 52. Among MDA responders at week 52, maintenance of MDA response was achieved by 83.6% and 73.0% of the continuous risankizumab and placebo/risankizumab cohorts, respectively. Risankizumab was well tolerated through week 100.

Conclusions: Risankizumab demonstrated durable efficacy and tolerability through 100 weeks; most patients who achieved ACR20 and MDA responses at week 52 maintained this achievement through week 100. There were no new safety signals in patients who had csDMARD-IR and bDMARD-IR.

Trial registration: ClinicalTrials.gov NCT03671148.

Keywords: IL-23; KEEPsAKE 2; Long-term treatment; Psoriatic arthritis; Risankizumab; bDMARD-IR; csDMARD-IR.

Plain language summary

Risankizumab, a biologic disease-modifying antirheumatic drug, helps control the body’s immune system to reduce symptoms of psoriatic arthritis (a disease that inflames the joints of people who have the skin condition psoriasis). The ongoing KEEPsAKE 2 study is evaluating how well risankizumab works and how safe it is for treating adult patients with active psoriatic arthritis who previously experienced inadequate response to one or more specific types of disease-modifying anti-arthritis drugs. Patients were randomly assigned to receive either risankizumab or an inactive drug; after 24 weeks, all patients received risankizumab. At study week 100, 57% of patients who were assigned to receive continuous risankizumab since the start of the study experienced a 20% or more improvement in a measure of psoriatic arthritis symptoms using criteria established by the American College of Rheumatology (ACR20); a similar proportion of patients achieved a 20% improvement at both weeks 24 and 52. Similarly, 56% and 53% of patients who switched from inactive drug to risankizumab achieved ACR20 at weeks 52 and 100 (more than before switching to risankizumab at week 24). Minimal disease activity (MDA) was evaluated by assessing joint and skin symptoms, affected body surface area, pain, and physical function. At week 100, 33% of patients achieved MDA (both groups), which was similar to week 52. Most patients who achieved ACR20 or MDA at week 52 maintained responses at week 100. Improvements with risankizumab were seen in several other measures of treatment outcomes through week 100. Risankizumab was generally safe through 100 weeks.

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Conflict of interest statement

Andrew Östör has received speaker or consulting fees and/or research grants from AbbVie, Bristol Myers Squibb, Janssen, Lilly, Novartis, Pfizer, and UCB. Filip Van den Bosch has received speaker and/or consulting fees from AbbVie, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer and UCB. Kim Papp has received research funds from AbbVie, Aceleryn, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Coherus, Dermavant, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Novartis, Ortho Dermatologics, Pfizer, Sanofi Genzyme, Sun Pharma, and UCB. He is a consultant for AbbVie, Aceleryn, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Coherus, Dermavant, Forward Pharma, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Meiji Seika Pharma, Merck, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sandoz, Sanofi Genzyme, Sun Pharma, Takeda, and UCB. He is a speaker for AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Incyte, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sandoz, Sanofi Genzyme, Sun Pharma, and UCB. He is a committee member for PSOLAR (Psoriasis Longitudinal Assessment and Registry) and PURE (registry of patients with moderate-to-severe chronic plaque psoriasis in Latin America and Canada). Cecilia Asnal has received honoraria or fees for serving on advisory boards or as a speaker, as well as research support from AbbVie, Amgen, Genentech, Janssen, Lilly, Pfizer, Roche, and R-Pharm. Ricardo Blanco has received grants or research support from AbbVie, Merck, and Roche. He has received consultation fees or honoraria for serving as a speaker for AbbVie, Bristol Myers Squibb, Janssen, Lilly, Merck, Pfizer and Roche. Jacob Aelion has received grants or research support from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Galapagos/Gilead, Genentech, GlaxoSmithKline, Lilly, Mallinckrodt, Nektar Therapeutics, Nichi-Iko, Novartis, Pfizer, Regeneron, Roche, Sanofi, Selecta Biosciences, and UCB. Kyle Carter, Vassilis Stakias, Ralph Lippe, Leonidas Drogaris, Ahmed M. Soliman, Michael M. Chen, and Byron Padilla are full-time employees of AbbVie and may hold AbbVie stock or stock options or AbbVie patents. Alan Kivitz has received consulting fees from Horizon, Frescenius Kabi, Pfizer, GlaxoSmithKline, Janssen, Selecta, Genzyme, Gilead, Synact, Takeda, and Grunenthal; has received honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from GlaxoSmithKline, Eli Lilly, Pfizer, AbbVie, Amgen, and UCB; has served on boards or advisory boards for Horizon, Janssen, Chemocentryx, Princeton Biopartners, UCB, and Novartis; and has stock or stock options in Pfizer, GSK, Gilead, Novartis, and Amgen.

Figures

Fig. 1
Fig. 1
ACR responses over time for risankizumab 150 mg and placebo over the 24-week, double-blind treatment period and for open-label continuous risankizumab and placebo/risankizumab cohorts from weeks 24 through 100 for a ACR20, b ACR50, and c ACR70 (full analysis set). Results are based on the full analysis set, and NRI-C (week 24) or NRI-MI (weeks 52 and 100) was used for binary/categorical endpoints. ACR20/50/70 ≥ 20%/≥ 50%/≥ 70% improvement in American College of Rheumatology criteria, CI confidence interval, NRI-C nonresponder imputation incorporating multiple imputation where (1) missing data due to COVID-19 were handled by multiple imputation and (2) patients with data missing because of reasons other than COVID-19 or after intercurrent events (i.e., initiation of rescue medication or concomitant medications that could meaningfully impact efficacy assessment) were imputed as nonresponders and a mixed-effect model for repeated measures considering intercurrent events, NRI-MI nonresponder imputation incorporating multiple imputation for patients with missing data due to COVID-19, PBO placebo, RZB risankizumab
Fig. 2
Fig. 2
PASI 90 response over time in patients with ≥ 3% body surface area affected by psoriasis at baseline receiving risankizumab 150 mg or placebo over the 24-week, double-blind treatment period and receiving open-label risankizumab 150 mg from weeks 24 through 100 (full analysis set). Results are based on the full analysis set, and NRI-C (week 24) or NRI-MI (weeks 52 and 100) was used for binary/categorical endpoints. CI confidence interval, NRI-C nonresponder imputation incorporating multiple imputation where (1) missing data due to COVID-19 were handled by multiple imputation and (2) patients with data missing because of reasons other than COVID-19 or after intercurrent events (i.e., initiation of rescue medication or concomitant medications that could meaningfully impact efficacy assessment) were imputed as nonresponders, and a mixed-effect model for repeated measures considering intercurrent events, NRI-MI nonresponder imputation incorporating multiple imputation for patients with missing data due to COVID-19, PASI 90 ≥ 90% reduction in Psoriasis Area and Severity Index, PBO placebo, RZB risankizumab
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