Monotherapy*† n=1543 | Combination therapy*‡ n=2631 | Mono→combo switchers*§ n=129 | Combo→mono switchers*¶ n=352 | |||||
Tofacitinib 5 mg twice daily n=496 | Tofacitinib 10 mg twice daily n=1047 | Tofacitinib 5 mg twice daily n=775 | Tofacitinib 10 mg twice daily n=1856 | Tofacitinib 5 mg twice daily n=46 | Tofacitinib 10 mg twice daily n=83 | Tofacitinib 5 mg twice daily n=97 | Tofacitinib 10 mg twice daily n=255 | |
Mean age (range), years | 54.6 (19–82) | 52.4 (19–85) | 53.2 (18–82) | 53.3 (18–86) | 51.2 (20–75) | 51.1 (20–71) | 55.5 (28–77) | 54.7 (20–82) |
Female, n (%) | 422 (85.0) | 841 (80.3) | 633 (81.7) | 1514 (81.6) | 30 (65.2) | 66 (79.5) | 80 (82.5) | 207 (81.2) |
White, n (%) | 228 (46.0) | 779 (74.4) | 374 (48.3) | 1273 (68.6) | 20 (43.5) | 52 (62.7) | 66 (68.0) | 197 (77.3) |
Mean weight (SD), kg | 64.7 (16.6) | 73.7 (19.4) | 67.1 (17.5) | 73.0 (19.4) | 68.0 (17.8) | 71.5 (17.4) | 72.4 (20.0) | 76.9 (21.6) |
Mean BMI (SD), kg/m2 | 25.2 (5.4) | 27.4 (6.4) | 25.8 (6.1) | 27.5 (6.4) | 26.0 (5.7) | 26.8 (6.5) | 27.2 (6.0) | 28.4 (7.1) |
Mean duration of RA (range), years | 7.7 (0.0–38.0) | 6.3 (0.0–55.0) | 8.6 (0.2–50.1) | 8.3 (0.1–49.4) | 6.2 (0.2–21.0) | 5.4 (0.1–33.0) | 9.1 (0.2–39.0) | 9.0 (0.1–41.0) |
DAS28-4(ESR), mean (SD) | 6.3 (1.0) | 6.4 (1.0) | 6.1 (1.0) | 6.3 (1.0) | 6.5 (1.1) | 6.5 (1.0) | 6.2 (0.9) | 6.3 (1.1) |
HAQ-DI, mean (SD) | 1.4 (0.7) | 1.5 (0.6) | 1.3 (0.7) | 1.4 (0.7) | 1.4 (0.8) | 1.6 (0.7) | 1.4 (0.6) | 1.4 (0.7) |
Discontinuations during the LTE,** n (%) | 242 (48.8) | 456 (43.6) | 397 (51.2) | 938 (50.5) | 1 (2.2) | 0 (0.0) | 2 (2.1) | 2 (0.8) |
Concomitant GC use at baseline, n (%) | 278 (56.0) | 436 (41.6) | 388 (50.1) | 975 (52.5) | 23 (50.0) | 46 (55.4) | 50 (51.5) | 129 (50.6) |
Mean GC dose at baseline (SD), mg/day | 6.3 (6.1) | 6.5 (3.9) | 6.5 (3.6) | 6.4 (4.1) | 6.2 (3.1) | 6.1 (2.7) | 5.7 (3.9) | 5.8 (2.6) |
*Data as of January 2016, ongoing at time of analysis, database not locked.
†Patients received monotherapy throughout the LTE studies without concomitant csDMARDs.
‡Patients initiated and remained on background csDMARDs for the duration of their participation in the LTE study or had one break of ≤28 days from csDMARDs.
§Patients permanently stopped csDMARD treatment for >28 days and continued tofacitinib monotherapy for the remaining study period.
¶Patients initiated treatment with monotherapy and had a csDMARD added until the last dose of tofacitinib.
**For patients switching treatment regimens, discontinuations from study within 30 days of treatment switch are reported.
BMI, body mass index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-4(ESR), Disease Activity Score in 28 joints, erythrocyte sedimentation rate; GC, glucocorticoid; HAQ-DI, Health Assessment Questionnaire-Disability Index; LTE, long-term extension; RA, rheumatoid arthritis.