Baseline patient-reported outcomes and changes from baseline at month 6 (FAS)
| Baseline, mean (SE) score | LSM changes from baseline (±SE) at month 6 | |||||
| Tofacitinib 5 mg two times per day (n=384) | Tofacitinib 5 mg two times per day+MTX (n=376) | ADA+MTX (n=386) | Tofacitinib 5 mg two times per day (n=384) | Tofacitinib 5 mg two times per day+MTX (n=376) | ADA+MTX (n=386) | |
| PtGA | (n=383) 60.1 (1.09) | (n=376) 61.7 (1.14) | (n=383) 60.2 (1.20) | (n=357) –35.7 (0.98) | (n=346) –38.4 (0.99)* | (n=348) –38.8 (0.98)† |
| Pain | (n=383) 61.2 (1.11) | (n=376) 60.7 (1.15) | (n=383) 60.6 (1.15) | (n=357) –26.6 (1.26) | (n=347) –30.7 (1.26)* | (n=351) –28.1 (1.26) |
| HAQ-DI | (n=383) 1.6 (0.03) | (n=376) 1.6 (0.03) | (n=382) 1.6 (0.03) | (n=356) –0.52 (0.03) | (n=348) –0.58 (0.03) | (n=350) –0.54 (0.03) |
| FACIT-F | (n=383) 27.1 (0.52) | (n=376) 26.2 (0.53) | (n=384) 27.1 (0.52) | (n=357) 7.14 (0.50) | (n=348) 7.59 (0.50)‡ | (n=352) 6.07 (0.50) |
| SF-36 PCS | (n=381) 32.4 (0.38) | (n=375) 31.7 (0.36) | (n=382) 31.7 (0.38) | (n=355) 6.7 (0.44) | (n=346) 7.9 (0.43)* | (n=349) 7.8 (0.43) |
| SF-36 MCS | (n=381) 39.3 (0.59) | (n=375) 38.8 (0.57) | (n=382) 39.8 (0.58) | (n=355) 5.2 (0.52) | (n=346) 5.7 (0.51) | (n=349) 4.4 (0.51) |
*p<0.05 for tofacitinib+MTX versus tofacitinib monotherapy.
†p<0.05 for ADA+MTX versus tofacitinib monotherapy.
‡p<0.05 for tofacitinib+MTX versus ADA+MTX.
ADA, adalimumab; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire-Disability Index; LSM, least squares mean; MCS, mental component summary; MTX, methotrexate; Pain, arthritis pain; PCS, physical component summary; PtGA, Patient Global Assessment of disease activity; SE, standard error; SF-36, 36-Item Short-Form Health Survey.