Patient baseline demographics and disease characteristics
| All tofacitinib doses N=7061 | Average tofacitinib 5 mg BID* N=3066 | Average tofacitinib 10 mg BID* N=3995 | |
|---|---|---|---|
| Age (years), mean (range) | 52.1 (18–86) | 52.2 (18–86) | 52.0 (18–85) |
| Female, n (%) | 5829 (82.6) | 2543 (82.9) | 3286 (82.3) |
| Race, n (%) | |||
| White | 4576 (64.8) | 1823 (59.5) | 2753 (68.9) |
| Black | 219 (3.1) | 88 (2.9) | 131 (3.3) |
| Asian | 1566 (22.2) | 880 (28.7) | 686 (17.2) |
| Other | 700 (9.9) | 275 (9.0) | 425 (10.6) |
| Regions, n (%) | |||
| North America | 1745 (24.7) | 599 (19.5) | 1146 (28.7) |
| Latin America | 1221 (17.3) | 586 (19.1) | 635 (15.9) |
| Europe | 2382 (33.7) | 951 (31.0) | 1431 (35.8) |
| Asia | 1673 (23.7) | 890 (29.0) | 783 (19.6) |
| ROW | 40 (<1.0) | 40 (1.3) | 0 (0) |
| Duration of RA since first diagnosis (years), mean (range) | 8.0 (0.0–65.0) | 8.3 (0.0–50.1) | 7.8 (0.0–65.0) |
| DAS28-4(ESR), mean (SD) | 6.4 (1.0) (n=6238) | 6.4 (1.0) (n=2688) | 6.4 (1.0) (n=3550) |
| Swollen joint count, mean (SD) | 14.9 (8.9) (n=7007) | 14.2 (8.5) (n=3049) | 15.4 (9.1) (n=3958) |
| Tender joint count, mean (SD) | 23.3 (14.5) (n=7007) | 20.4 (13.7) (n=3049) | 25.5 (14.8) (n=3958) |
| HAQ-DI, mean (SD) | 1.5 (0.7) (n=6952) | 1.5 (0.7) (n=3037) | 1.5 (0.7) (n=3915) |
| BMI (kg/m2), mean (SD) | 27.1 (6.4) (n=7056) | 26.7 (6.3) (n=3063) | 27.5 (6.5) (n=3993) |
| Comorbidities, n (%) | |||
| Diabetes mellitus | 562 (8.0) | 276 (9.0) | 286 (7.2) |
| Coronary heart disease | 28 (<1.0) | 11 (<1.0) | 17 (1.0) |
| Myocardial infarction | 84 (1.2) | 3.4 (1.1) | 50 (1.3) |
| Hypertension | 2460 (34.8) | 1046 (34.1) | 1414 (35.4) |
| COPD | 478 (6.8) | 172 (5.6) | 306 (7.7) |
| Positive for latent TB by lab testing (QuantiFERON Gold), n (%) | 236 (3.3) | 73 (2.4) | 163 (4.1) |
| Positive for latent TB by PPD skin test, n (%) | 57 (0.8) | 36 (1.2) | 21 (0.5) |
| Therapy prior to enrolment, n (%) | |||
| MTX | 5758 (81.5) | 2711 (88.4) | 3047 (76.3) |
| csDMARD other than MTX | 3587 (50.8) | 1503 (49.0) | 2084 (52.2) |
| TNFi | 1138 (16.1) | 356 (11.6) | 782 (19.6) |
| Non-TNFi biological DMARDs | 355 (5.0) | 118 (3.8) | 237 (5.9) |
| Concomitant corticosteroids, n (%) | 3972 (56.3) | 1778 (58.3) | 2184 (54.7) |
Data are based on index study baseline assessments. All studies were completed by March 2017, including the LTE study ORAL Sequel (NCT00413699; study database was locked at the time of analysis).
*Average dosing was based on average daily dose: patients receiving <15 mg/day were assigned to the tofacitinib 5 mg BID group; patients receiving ≥15 mg/day were assigned to the tofacitinib 10 mg BID group, except for patients from China and Japan who initiated tofacitinib 5 mg BID per protocol.
BID, twice daily; BMI, body mass index; COPD, chronic obstructive pulmonary disease; csDMARD, conventional synthetic DMARD; DAS28-4(ESR), Disease Activity Score in 28 joints, erythrocyte sedimentation rate; DMARD, disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire-Disability Index; LTE, long-term extension; MTX, methotrexate; N, number of patients in the treatment group; n, number of unique patients with event; PPD, purified protein derivative; RA, rheumatoid arthritis; ROW, rest of world; TB, tuberculosis; TNFi, tumour necrosis factor inhibitor.