Table 2

Mean (SD) change from baseline* in efficacy outcomes and patient-reported outcomes with tofacitinib modified-release 11 mg once daily plus methotrexate at weeks 12 and 24 of the open-label phase

Tofacitinib modified-release 11 mg once daily plus methotrexate
Week 12Week 24
DAS28-4 (ESR)647618
Change from baseline–2.0 (1.2)–2.7 (1.3)
DAS28-4 (CRP)651610
Change from baseline–1.9 (1.2)–2.6 (1.2)
CDAI652623
Change from baseline–19.6 (12.1)–26.2 (12.6)
SDAI648609
Change from baseline–20.3 (12.5)–27.0 (13.1)
TJC657624
Change from baseline–7.7 (6.1)–10.5 (6.3)
SJC657624
Change from baseline–6.0 (4.7)–7.7 (4.8)
PGA VAS653623
Change from baseline–32.5 (21.2)–42.9 (20.1)
CRP, mg/L665615
Change from baseline–6.0 (17.2)–6.8 (17.7)
HAQ-DI656623
Change from baseline–0.5 (0.5)–0.6 (0.6)
FACIT-F656624
Change from baseline6.9 (9.3)9.3 (10.1)
Pain VAS657624
Change from baseline–26.5 (26.0)–36.1 (27.0)
PtGA VAS656624
Change from baseline–26.8 (27.5)–37.5 (27.1)
SF-36v2 summary scores
MCS657623
Change from baseline4.6 (9.9)5.9 (10.3)
PCS657623
Change from baseline6.6 (8.0)9.1 (8.8)
EQ-5D655621
Change from baseline0.2 (0.3)0.2 (0.3)
  • Data are n or mean (SD).

  • *The value at baseline is defined as the last non-missing measurement on or before the first dosing date in the open-label phase.

  • CDAI, Clinical Disease Activity Index; DAS28-4(CRP), Disease Activity Score in 28 joints, C-reactive protein; DAS28-4(ESR), DAS28 joints, erythrocyte sedimentation rate; EQ-5D, EuroQoL-Five Dimensions Health Questionnaire; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCS, Mental Component Summary; n, number of patients evaluable for each outcome measure; PCS, Physical Component Summary; PGA, Physician Global Assessment; PtGA, Patient Global Assessment of Disease Activity; SDAI, Simplified Disease Activity Index; SF-36v2, Short Form-36 Health Survey (V.2; acute); SJC, swollen joint count; TJC, tender joint count; VAS, Visual Analogue Scale.