Table 1

Demographics and baseline disease characteristics of patients treated in the open-label phase

Tofacitinib modified-release 11 mg once daily plus methotrexate (N=694)
Female532 (76.7%)
Age, years56.8 (11.8)
Race
 White594 (85.6%)
 Black or African American33 (4.8%)
 Asian37 (5.3%)
 Other30 (4.3%)
Region
 Europe355 (51.2%)
 US276 (39.8%)
 Latin America25 (3.6%)
 Rest of the World*38 (5.5%)
 Disease duration, years8.8 (8.8)
DAS28-4(ESR)-defined disease activity
 Moderate†140 (20.2%)
 High‡554 (79.8%)
 CDAI-defined disease activity
 Moderate§ (N1)110 (15.9%) (693)
 High¶ (N1)583 (84.0%) (693)
Previous drug use
 csDMARD excluding methotrexate178 (25.6%)
 bDMARD excluding TNFi100 (14.4%)
 TNFi208 (30.0%)
 tsDMARD**5 (0.7%)
Concomitant drug use
 Methotrexate dose, mg/week16.7 (3.9)
 Glucocorticoid use260 (37.5%)
 Glucocorticoid dose, mg/day5.7 (2.7)
 DAS28-4(ESR)6.1 (1.0)
 DAS28-4(CRP)5.3 (0.9)
 CDAI (N1)34.7 (11.9) (693)
 SDAI (N1)35.8 (12.2) (693)
 HAQ-DI (N1)1.4 (0.6) (693)
 FACIT-F28.6 (10.9)
 TJC (28 joints)13.7 (6.4)
 SJC (28 joints)9.5 (4.8)
 Pain VAS57.5 (22.5)
 PtGA VAS57.7 (22.9)
 PGA VAS (N1)57.0 (17.5) (693)
SF-36v2 summary scores
 MCS43.1 (11.7)
 PCS32.9 (8.0)
 EQ-5D (N1)0.5 (0.3) (693)
 CRP, mg/L11.1 (17.6)
 Rheumatoid factor positive (N1)437 (63.0%) (693)
 Anti-CCP positive (N1)475 (68.4%) (689)
  • Data are n (%) or mean (SD).

  • *Australia, Philippines, South Korea and South Africa.

  • †DAS28-4(ESR) ≥3.2 to ≤5.1.

  • ‡DAS28-4(ESR) >5.1.

  • §CDAI >10 to ≤22.

  • ¶CDAI >22.

  • **Two patients were enrolled before a protocol amendment excluding previous Janus kinase inhibitors; other patients received fostamatinib, apremilast and a Bruton’s tyrosine kinase inhibitor.

  • bDMARD, biological disease-modifying antirheumatic drug; CCP, cyclic citrullinated peptide; CDAI, Clinical Disease Activity Index; csDMARD, conventional synthetic DMARD; DAS28-4(CRP), Disease Activity Score in 28 joints, C-reactive protein; DAS28-4(ESR), Disease Activity Score in 28 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; N1, number of patients meeting the baseline criteria; N, number of patients who entered the open-label phase and received tofacitinib plus methotrexate; 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; TNFi, tumour necrosis factor inhibitor; tsDMARD, targeted synthetic DMARD; VAS, Visual Analogue Scale.