Table 3

Additional secondary efficacy endpoints

PlaceboUpadacitinib 15 mg QDUpadacitinib 30 mg QD
ACR50 response rate at week 12
 N212211218
 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
 N212211218
 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
 N212211218
 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)
 N144133152
 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)
 N645550
 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.