Table 1

Baseline patient-reported outcomes and changes from baseline at month 6 (FAS)

Baseline, mean (SE) scoreLSM 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.