Table 1

Baseline demographics and disease characteristics of patients enrolled in the LTE studies

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), years54.6 (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), kg64.7 (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), years7.7 (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/day6.3 (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.