Baseline demography data by treatment group for patients enrolled in the tofacitinib clinical programme (phase II and III, and LTE studies)
| Phase II studies | Phase III studies* | LTE studies | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Tofacitinib (all doses) | Placebo | ADA | Tofacitinib | Placebo advanced to tofacitinib† | ADA | Tofacitinib | ||||
| n=1393 | n=273 | n=53 | 5 mg twice daily n=1587 | 10 mg twice daily n=1609 | 5 mg twice daily n=343 | 10 mg twice daily n=338 | n=204 | 5 mg twice daily n=1452 | 10 mg twice daily n=3374 | |
| Mean age (range), years | 52.7 (18–83) | 52.3 (20–78) | 53.5 (18–75) | 52.5 (18–86) | 51.7 (18–85) | 52.8 (18–82) | 52.2 (18–80) | 52.5 (23–77) | 53.1 (18–82) | 53.0 (18–86) |
| Gender, % female | 83.9 | 84.6 | 84.9 | 82.5 | 84.2 | 81.0 | 81.4 | 79.4 | 83.2 | 81.9 |
| Race, % | ||||||||||
| White | 55.3 | 54.2 | 81.1 | 61.5 | 62.5 | 66.8 | 62.1 | 72.5 | 46.6 | 70.5 |
| Black | 2.2 | 2.9 | 1.9 | 3.7 | 2.9 | 2.3 | 4.7 | 1.5 | 1.7 | 3.2 |
| Asian | 32.4 | 31.5 | 7.5 | 24.8 | 23.3 | 23.6 | 25.1 | 14.2 | 43.1 | 16.3 |
| Other | 10.1 | 11.4 | 9.4 | 10.0 | 11.2 | 7.3 | 8.0 | 11.8 | 7.5 | 9.5 |
| Regions, % | ||||||||||
| North America | 20.6 | 16.5 | 24.5 | 21.1 | 21.9 | 25.8 | 16.7 | 14.0 | 28.5 | |
| South America | 20.3 | 19.8 | 17.0 | 16.7 | 17.0 | 14.4 | 53.9 | 17.9 | 14.7 | |
| Europe | 27.2 | 22.7 | 50.9 | 35.0 | 34.5 | 33.8 | 11.8 | 25.1 | 37.5 | |
| Asia and Pacific | 31.9 | 41.0 | 7.5 | 27.2 | 26.5 | 26.0 | 17.6 | 43.0 | 19.3 | |
| No prior exposure to biological DMARD | 89.2 | 89.4 | 90.6 | 83.1 | 84.1 | 75.3 | 90.7 | N/A | N/A | |
*Tofacitinib monotherapy or tofacitinib+MTX or other non-biological DMARD(s).
†Patients randomised to placebo were advanced to tofacitinib at month 3 or month 6.
ADA, adalimumab; DMARD, disease-modifying antirheumatic drug; LTE, long-term extension; MTX, methotrexate; N/A, not available.