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) | |
| Female | 532 (76.7%) |
| Age, years | 56.8 (11.8) |
| Race | |
| White | 594 (85.6%) |
| Black or African American | 33 (4.8%) |
| Asian | 37 (5.3%) |
| Other | 30 (4.3%) |
| Region | |
| Europe | 355 (51.2%) |
| US | 276 (39.8%) |
| Latin America | 25 (3.6%) |
| Rest of the World* | 38 (5.5%) |
| Disease duration, years | 8.8 (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 methotrexate | 178 (25.6%) |
| bDMARD excluding TNFi | 100 (14.4%) |
| TNFi | 208 (30.0%) |
| tsDMARD** | 5 (0.7%) |
| Concomitant drug use | |
| Methotrexate dose, mg/week | 16.7 (3.9) |
| Glucocorticoid use | 260 (37.5%) |
| Glucocorticoid dose, mg/day | 5.7 (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-F | 28.6 (10.9) |
| TJC (28 joints) | 13.7 (6.4) |
| SJC (28 joints) | 9.5 (4.8) |
| Pain VAS | 57.5 (22.5) |
| PtGA VAS | 57.7 (22.9) |
| PGA VAS (N1) | 57.0 (17.5) (693) |
| SF-36v2 summary scores | |
| MCS | 43.1 (11.7) |
| PCS | 32.9 (8.0) |
| EQ-5D (N1) | 0.5 (0.3) (693) |
| CRP, mg/L | 11.1 (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.