Table 1.
Efficacy results
| Parameter | Week 24 (Period 1)a |
Week 52 (Period 1 and 2) |
||
|---|---|---|---|---|
| RZB 150 mg | PBO | RZB 150 mg | PBO to RZB 150 mg | |
| n = 483 | n = 481 | n = 483 | n = 481 | |
| ACR20, n (%) (95% CI) | 277 (57.3)***,† | 161 (33.5) | 338 (70.0) | 303 (63.0) |
| (52.9, 61.8) | (29.3, 37.8) | (65.9, 74.1) | (58.7, 67.3) | |
| ACR50, n (%) (95% CI) | 162 (33.4)*** | 54 (11.3) | 209 (43.3) | 180 (37.4) |
| (29.2, 37.7) | (8.4, 14.1) | (38.9, 47.7) | (33.1, 41.7) | |
| ACR70, n (%) (95% CI) | 74 (15.3)*** | 23 (4.7) | 125 (25.9) | 96 (20.0) |
| (12.0, 18.5) | (2.8, 6.7) | (22.0, 29.8) | (16.4, 23.5) | |
| Change in HAQ-DI, mean (95% CI) | −0.31***,† | −0.11 | −0.41 | −0.32 |
| (−0.36, −0.27) | (−0.16, −0.06) | (−0.45, −0.37) | (−0.36, −0.27) | |
| ≥0.35 change in HAQ-DI,bn/n (%) (95% CI) | 208/414 (50.3)*** | 117/419 (27.9) | 238/414 (57.5) | 191/419 (45.6) |
| (45.5, 55.1) | (23.5, 32.2) | (52.7, 62.2) | (40.8, 50.4) | |
| PASI 90,cn/n (%) (95% CI) | 143/273 (52.3)***,† | 27/272 (9.9) | 185/273 (67.8) | 163/272 (59.9) |
| (46.4, 58.3) | (6.4, 13.5) | (62.2, 73.3) | (54.1, 65.8) | |
| Change in mNAPSI,d mean (95% CI) | −9.8***,† | −5.6 | −12.9 | −11.3 |
| (−11.0, −8.6) | (−6.7, −4.4) | (−13.9, −11.9) | (−12.2, −10.3) | |
| Change in PGA-F,d mean (95% CI) | −0.8***,† | −0.4 | −1.2 | −1.1 |
| (−1.0, −0.7) | (−0.5, −0.3) | (−1.3, −1.1) | (−1.2, −1.0) | |
| Resolution of enthesitis,en/n (%) (95% CI) | ||||
| KEEPsAKE 1 | 152/297 (51.2)*** | 108/290 (37.2) | 180/297 (60.6) | 174/290 (60.0) |
| (45.5, 56.9) | (31.7, 42.8) | (55.0, 66.2) | (54.4, 65.6) | |
| Pooledf | 215/444 (48.4)***,† | 156/448 (34.8) | 244/444 (55.0) | 257/448 (57.4) |
| (43.8, 53.1) | (30.4, 39.2) | (50.3, 59.6) | (52.8, 61.9) | |
| Resolution of dactylitis,gn/n (%) (95% CI) | ||||
| KEEPsAKE 1 | 99/148 (66.9)* | 80/147 (54.4) | 116/148 (78.4) | 108/147 (73.5) |
| (59.3, 74.5) | (46.4, 62.5) | (71.7, 85.0) | (66.3, 80.6) | |
| Pooledf | 128/188 (68.1)***,† | 104/204 (51.0) | 143/188 (76.1) | 148/204 (72.5) |
| (61.4, 74.7) | (44.1, 57.8) | (70.0, 82.2) | (66.4, 78.7) | |
| MDA achievement, n (%) (95% CI) | 121/483 (25.0)***,† | 49/481 (10.2) | 183 (37.9) | 132 (27.4) |
| (21.2, 28.9) | (7.5, 12.9) | (33.6, 42.2) | (23.5, 31.4) | |
| Change in SF-36 PCS, mean (95% CI) | 6.5*** | 3.2 | 8.4 | 7.3 |
| (5.8, 7.2) | (2.5, 3.9) | (7.8, 9.1) | (6.7, 8.0) | |
| Change in FACIT-Fatigue, mean (95% CI) | 6.5*** | 3.9 | 7.9 | 6.5 |
| (5.6, 7.3) | (3.1, 4.7) | (7.2, 8.7) | (5.7, 7.3) | |
| Change in PsA-mTSS,h mean (95% CI) | 0.18 | 0.26 | 0.36 | 0.56 |
| (0.05, 0.31) | (0.13, 0.39) | (0.10, 0.63) | (0.30, 0.83) | |
| PsA-mTSS ≤0,hn/n (%) (95% CI) | 402/429 (93.7)* | 384/430 (89.3) | 400/435 (92.0) | 384/430 (89.3) |
| (91.4, 96.0) | (86.4, 92.2) | (89.4, 94.5) | (86.4, 92.2) | |
| PsA-mTSS ≤0.5,hn/n (%) (95% CI) | 409/429 (95.3)** | 391/430 (90.9) | 407/435 (93.6) | 384/430 (89.3) |
| (93.3, 97.3) | (88.2, 93.6) | (91.3, 95.9) | (86.4, 92.2) | |
All changes are least squares mean changes from baseline.
Results based on full analysis set, and NRI-C (week 24) or NRI (as observed with imputation) (week 52) was used for binary endpoints; MMRM was used for continuous endpoints.
Nominal P < 0.001;
nominal P < 0.01;
nominal P < 0.05;
statistically significant under overall type I error control.
Data previously reported, except for the mTSS endpoints [11].
In patients with baseline HAQ-DI ≥0.35.
Among patients with ≥3% body surface area affected by psoriasis.
Among patients with nail psoriasis at baseline (RZB, n = 309; PBO, n = 338).
Defined as Leeds Enthesitis Index = 0 among patients with enthesitis or dactylitis at baseline.
Pooled from KEEPsAKE 1 and KEEPsAKE 2 as a prespecified analysis.
Defined as Leeds Dactylitis Index = 0 among patients with enthesitis or dactylitis at baseline.
Results for PsA-mTSS were recorded from the second reading session and assessed using linear extrapolation. For the PBO to RZB group, all data at week 52 were imputed by linear extrapolation; for patients who switched from PBO to RZB at week 24, the week 24 X-ray was used for extrapolation to impute the data at week 52.
ACR20/50/70: ≥20/50/70% improvement in ACR score; FACIT-Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI: HAQ-Disability Index; MDA: minimal disease activity; MMRM: mixed-effect model for repeated measures; mNAPSI: modified Nail Psoriasis Severity Index; NRI-C: non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19; PASI 90: ≥90% reduction in Psoriasis Area Severity Index; PBO: placebo; PGA-F: Physician Global Assessment of Fingernail Psoriasis; PsA-mTSS: PsA modified Total Sharp Score; RZB: risankizumab; SF-36 PCS: 36 Item Short Form Health Survey Physical Component Summary.