Table 2

Primary and multiplicity-controlled efficacy endpoints

PlaceboUpadacitinib 15 mg QDUpadacitinib 30 mg QD
ACR20 response at week 12
 N212211218
 n (%)51 (24.1)120 (56.9)139 (63.8)
 Response rate mean difference vs placebo (95% CI)32.8 (24.0 to 41.6)39.7 (31.1 to 48.3)
 P value<0.001<0.001
HAQ-DI change from baseline at week 12
 N180199204
 LS mean (95% CI)−0.10 (−0.16 to −0.03)−0.30 (−0.37 to −0.24)−0.41 (−0.47 to −0.35)
 LS mean difference (95% CI)−0.21 (−0.30 to −0.12)−0.31 (−0.40 to −0.22)
 P value<0.001<0.001
FACIT-F score change from baseline at week 12
 N184201206
 LS mean (95% CI)1.3 (0.1 to 2.5)5.0 (3.8 to 6.1)6.1 (4.9 to 7.2)
 LS mean difference (95% CI)3.7 (2.0 to 5.4)4.8 (3.1 to 6.4)
 P value<0.001<0.001
SF-36 PCS score change from baseline at week 12
 N185201206
 LS mean (95% CI)1.6 (0.6 to 2.7)5.2 (4.1 to 6.2)7.1 (6.1 to 8.1)
 LS mean difference (95% CI)3.5 (2.1 to 5.0)5.4 (4.0 to 6.9)
 P value<0.001<0.001
Proportion of patients achieving sIGA of psoriasis score of 0 or 1 and at least a 2-point improvement from baseline at week 16 (for patients with baseline sIGA ≥2)
 N163171164
 n (%)15 (9.2)63 (36.8)66 (40.2)
 Response rate mean difference (95% CI)27.6 (19.2 to 36.1)31.0 (22.3 to 39.8)
 P value<0.001<0.001
PASI75 response at week 16 (for patients with ≥3% BSA-psoriasis at baseline)
 N131130131
 n (%)21 (16.0)68 (52.3)74 (56.5)
 Response rate mean difference (95% CI)36.3 (25.6 to 46.9)40.5 (29.9 to 51.0)
 P value<0.001<0.001
Self-Assessment of Psoriasis Symptoms score change from baseline at week 16
 N182191200
 LS mean (95% CI)−1.5 (−4.7 to 1.8)−24.4 (−27.5 to −21.2)−29.7 (−32.8 to −26.6)
 LS mean difference (95% CI)−22.9 (−27.4 to −18.4)−28.2 (−32.7 to −23.8)
 P value<0.001<0.001
Proportion of patients achieving minimal disease activity at week 24
 N212211218
 n (%)6 (2.8)53 (25.1)63 (28.9)
 Response rate mean difference (95% CI)22.3 (16.0 to 28.6)26.1 (19.7 to 32.5)
 P value<0.001<0.001
  • ACR20, 20% improvement in American College of Rheumatolog criteria; BSA, body surface area; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; LS, least squares; PASI75, 75% improvement in Psoriasis Area and Severity Index ; QD, once per day; SF36-PCS, 36-Item Short Form Health Survey Physical Component Summary score; sIGA, Static Investigator Global Assessment.