Table 2

Primary and secondary efficacy endpoints

ParameterRZB 150 mg
N=483
Placebo
N=481
Difference
(95% CI)
P value
Primary endpoint
ACR20 at week 24, n (%)277 (57.3)161 (33.5)24.0 (18.0 to 30.0)<0.001*
Ranked secondary endpoints
Change in HAQ-DI at week 24, mean (95% CI)−0.31 (−0.36,–0.27)−0.11 (−0.16,–0.06)−0.20 (−0.26 to 0.14)<0.001*
PASI 90 at week 24,† n (%)143 (52.3)27 (9.9)42.5 (35.6 to 49.3)<0.001*
ACR20 at week 16, n (%)272 (56.3)161 (33.4)23.1 (16.8 to 29.4)<0.001*
MDA at week 24, n (%)121 (25.0)49 (10.2)14.8 (10.2 to 19.4)<0.001*
Change in mNAPSI at week 24,‡ mean (95% CI)−9.8 (−11.0, –8.6)−5.6 (−6.7, –4.4)−4.2 (−5.7 to −2.7)<0.001*
Change in PGA-F at week 24,‡ mean (95% CI)−0.8 (−1.0, –0.7)−0.4 (−0.5, –0.3)−0.4 (−0.6 to −0.3)<0.001*
Resolution of enthesitis at week 24,§ n (%)215 (48.4)156 (34.8)13.9 (7.6 to 20.2)<0.001*
Resolution of dactylitis at week 24,¶ n (%)128 (68.1)104 (51.0)16.9 (7.5 to 26.4)<0.001*
Change in PsA-mTSS at week 24, mean (95% CI)0.23 (0.02, 0.44)0.32 (0.11, 0.53)−0.09 (−0.4 to 0.2)0.50
Change in SF-36 PCS at week 24, mean (95% CI)6.5 (5.8, 7.2)3.2 (2.5, 3.9)3.3 (2.4 to 4.2)<0.001
Change in FACIT-Fatigue, at week 24, mean (95% CI)6.5 (5.6, 7.3)3.9 (3.1, 4.7)2.6 (1.5 to 3.7)<0.001
Non-ranked secondary endpoints
ACR50 at week 24, n (%)162 (33.4)54 (11.3)22.2 (17.3 to 27.2)<0.001
ACR70 at week 24, n (%)74 (15.3)23 (4.7)10.5 (6.9 to 14.2)<0.001
  • All changes are from baseline. Results for binary endpoints are based on non-responder imputation incorporating multiple imputation if there were missing data due to COVID-19 or non-responder imputation if there were no missing data due to COVID-19. Results for continuous endpoints are based on mixed models for repeated measures, except for PsA-mTSS, which was based on the analysis of covariance model.

  • *Statistically significant under overall type I error control.

  • †Among patients with ≥3% body surface area affected by psoriasis at baseline (RZB, n=273; PBO, n=272).

  • ‡Among patients with nail psoriasis at baseline (RZB, n=309; PBO, n=338).

  • §Defined as LEI=0 among patients with LEI >0 at baseline. Prespecified analysis of pooled data from the KEEPsAKE 1 and KEEPsAKE 2 trials (RZB, n=444; PBO, n=448).

  • ¶Defined as LDI=0 among patients with LDI>0 at baseline. Prespecified analysis of pooled data from the KEEPsAKE 1 and KEEPsAKE 2 trials (RZB, n=188; PBO, n=204).

  • ACR 20/50/70, ≥20/50/70% improvement in American College of Rheumatology score; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire; HAQ-DI, Health Assessment Questionnaire-Disability Index; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MDA, minimal disease activity; mNAPSI, modified Nail Psoriasis Severity Index; PASI 90, ≥90% reduction in Psoriasis Area and Severity Index; PBO, placebo; PGA-F, Physician’s Global Assessment of Fingernail Psoriasis; PsA-mTSS, psoriatic arthritis-modified Total Sharp Score; RZB, risankizumab; SF-36 PCS, 36-Item Short-Form Health Survey Physical Component Summary.