Additional secondary efficacy endpoints
Placebo | Upadacitinib 15 mg QD | Upadacitinib 30 mg QD | |
ACR50 response rate at week 12 | |||
N | 212 | 211 | 218 |
n (%) | 10 (4.7) | 67 (31.8) | 82 (37.6) |
Response rate mean difference (95% CI) | 27.0 (20.1 to 33.9) | 32.9 (25.9 to 39.9) | |
Nominal p value | <0.001 | <0.001 | |
ACR70 response rate at week 12 | |||
N | 212 | 211 | 218 |
n (%) | 1 (0.5) | 18 (8.5) | 36 (16.5) |
Response rate mean difference (95% CI) | 8.1 (4.2 to 11.9) | 16.0 (11.0 to 21.1) | |
Nominal p value | <0.001 | <0.001 | |
ACR20 response rate at week 2 | |||
N | 212 | 211 | 218 |
n (%) | 23 (10.8) | 69 (32.7) | 73 (33.5) |
Response rate mean difference (95% CI) | 21.9 (14.3 to 29.4) | 22.6 (15.1 to 30.2) | |
Nominal p value | <0.001 | <0.001 | |
Exploratory endpoints | |||
Resolution of enthesitis at week 12 (defined as LEI=0) | |||
N | 144 | 133 | 152 |
n (%) | 29 (20.1) | 52 (39.1) | 73 (48.0) |
Response rate difference (95% CI) | 19.0 (8.4 to 29.5) | 27.9 (17.6 to 38.2) | |
Nominal p value | <0.001 | <0.001 | |
Resolution of dactylitis at week 12 (defined as LDI=0) | |||
N | 64 | 55 | 50 |
n (%) | 23 (35.9) | 35 (63.6) | 38 (76.0) |
Response rate difference (95% CI) | 27.7 (10.4 to 45.0) | 40.1 (23.4 to 56.7) | |
Nominal p-value | <0.001 | <0.001 |
ACR20/50/70, 20%/50%/70% improvement in American College of Rheumatology criteria; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; QD, once per day.