Table 3

Efficacy responses at month 6 for bDMARD-naive versus bDMARD-IR in the P2/P3 cohort (FAS, NRI)

bDMARD-naivebDMARD-IR
Parameter, % (95% CI)Tofacitinib 5 mg twice daily
N=975
Tofacitinib 10 mg twice daily
N=997
Tofacitinib 5 mg twice daily
N=250
Tofacitinib 10 mg twice daily
N=245
ACR2051.9 (48.7 to 55.1)53.8 (50.6 to 56.9)45.6 (39.3 to 52.0)53.1 (46.6 to 59.4)
ACR5032.9 (30.0 to 36.0)36.5 (33.5 to 39.6)32.0 (26.3 to 38.2)29.8 (24.1 to 36.0)
ACR7015.0 (12.8 to 17.4)19.2 (16.8 to 21.7)14.8 (10.6 to 19.8)17.6 (13.0 to 22.9)
DAS28-4(ESR) ≤3.2*16.3 (13.9 to 19.0)23.3 (20.5 to 26.2)18.3 (13.5 to 24.0)23.0 (17.6 to 29.1)
DAS28-4(ESR) <2.6†7.2 (5.6 to 9.2)12.6 (10.5 to 15.0)7.1 (4.1 to 11.3)13.1 (8.9 to 18.2)
HAQ-DI improvement ≥0.2254.6 (51.3 to 58.0)58.6 (55.3 to 61.9)47.4 (41.0 to 53.8)51.9 (45.3 to 58.4)
HAQ-DI improvement ≥0.541.7 (38.3 to 45.0)46.7 (43.3 to 50.1)33.5 (27.6 to 39.8)38.8 (32.6 to 45.3)
  • No placebo patients are presented at month 6 as most patients advanced to active treatment at month 3; percentages were based on the number of patients available for each parameter analysis.

  • *Low-disease activity.

  • †Disease remission.

  • ACR 20/50/70, proportion of patients achieving ≥20%, ≥50%, and ≥70% improvement in American College of Rheumatology criteria; bDMARD, biological disease-modifying antirheumatic drug; DAS, disease activity score; ESR, erythrocyte sedimentation rate; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire-Disability Index; IR, inadequate responders; N, number of patients with available ACR data at month 6; month 6 analysis does not include phase II studies that were only 3 months in duration; NRI, non-responder imputation; P2/P3, Phase II/Phase III.