Table 2.
Primary and secondary efficacy endpoints
| Parameter | RZB 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.