Table 1.
Demographics, baseline, and clinical characteristics of the Induction, Maintenance, and Overall Cohorts.
| Characteristic | Induction Cohorta | Maintenance Cohortb | Overall Cohortc | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| < 65 years | ≥ 65 years | < 65 years | ≥ 65 years | < 65 years | ≥ 65 years | |||||||
| Placebo (N = 261) | Tofacitinib 10 mg BID (N = 876) | Placebo (N = 21) | Tofacitinib 10 mg BID (N = 62) | Placebo (N = 180) | Tofacitinib 5 mg BID (N = 185) | Tofacitinib 10 mg BID (N = 179) | Placebo (N = 18) | Tofacitinib 5 mg BID (N = 13) | Tofacitinib 10 mg BID (N = 17) | Tofacitinib All (N = 1080) | Tofacitinib All (N = 77) | |
| Age, years, mean (SD) | 39.1 (12.3) | 39.3 (11.9) | 69.9 (4.4) | 69.3 (4.0) | 40.9 (12.0) | 39.9 (11.8) | 40.3 (11.9) | 68.6 (3.4) | 70.2 (4.5) | 71.1 (4.7) | 39.3 (12.1) | 69.4 (4.0) |
| Males, n (%) | 142 (54.4) | 514 (58.7) | 13 (61.9) | 43 (69.4) | 104 (57.8) | 95 (51.4) | 98 (54.7) | 12 (66.7) | 8 (61.5) | 12 (70.6) | 626 (58.0) | 53 (68.8) |
| Race, n (%) | ||||||||||||
| White | 211 (80.8) | 709 (80.9) | 18 (85.7) | 47 (75.8) | 140 (77.8) | 154 (83.2) | 141 (78.8) | 15 (83.3) | 10 (76.9) | 12 (70.6) | 867 (80.3) | 60 (77.9) |
| Asian | 27 (10.3) | 105 (12.0) | 1 (4.8) | 9 (14.5) | 23 (12.8) | 21 (11.4) | 24 (13.4) | 3 (16.7) | 2 (15.4) | 1 (5.9) | 134 (12.4) | 10 (13.0) |
| Geographic region, n (%) | ||||||||||||
| Asia | 25 (9.6) | 88 (10.0) | 1 (4.8) | 7 (11.3) | 18 (10.0) | 20 (10.8) | 21 (11.7) | 2 (11.1) | 2 (15.4) | 0 (0.0) | 115 (10.6) | 8 (10.4) |
| Eastern Europe | 87 (33.3) | 273 (31.2) | 3 (14.3) | 10 (16.1) | 55 (30.6) | 65 (35.1) | 62 (34.6) | 2 (11.1) | 1 (7.7) | 1 (5.9) | 330 (30.6) | 12 (15.6) |
| Western Europe | 76 (29.1) | 267 (30.5) | 3 (14.3) | 14 (22.6) | 49 (27.2) | 45 (24.3) | 52 (29.1) | 6 (33.3) | 2 (15.4) | 5 (29.4) | 328 (30.4) | 16 (20.8) |
| North America | 44 (16.9) | 166 (18.9) | 9 (42.9) | 21 (33.9) | 40 (22.2) | 34 (18.4) | 35 (19.6) | 5 (27.8) | 5 (38.5) | 9 (52.9) | 212 (19.6) | 29 (37.7) |
| Rest of world | 29 (11.1) | 82 (9.4) | 5 (23.8) | 10 (16.1) | 18 (10.0) | 21 (11.4) | 9 (5.0) | 3 (16.7) | 3 (23.1) | 2 (11.8) | 95 (8.8) | 12 (15.6) |
| Disease duration, years, mean (SD) | 7.8 (6.3) | 8.1 (6.8) | 12.8 (10.6) | 9.8 (9.3) | 8.3 (6.9) | 8.3 (7.3) | 8.3 (6.6) | 13.3 (11.9) | 7.9 (6.3) | 12.7 (10.0) | 8.1 (6.7) | 10.7 (9.5) |
| Total Mayo score, mean (SD)d | 8.8 (1.5) | 9.0 (1.4) | 9.3 (1.6) | 8.7 (1.5) | 3.3 (1.8) | 3.3 (1.8) | 3.4 (1.8) | 3.1 (1.8) | 3.5 (1.9) | 3.5 (1.7) | 8.6 (2.0) | 8.3 (2.0) |
| Baseline CRP, mg/L, median (range)d | 4.9 (0.1–82.5) | 4.5 (0.1–208.4) | 6.7 (0.2–205.1) | 5.2 (0.4–58.1) | 1.0 (0.1–45.0) | 0.7 (0.1–33.7) | 0.8 (0.1–74.3) | 1.7 (0.1–16.3) | 0.3 (0.1–18.9) | 1.0 (0.1–10.0) | 4.4 (0.1–208.4) | 5.1 (0.4–58.1) |
| Prior TNFi treatment, n (%)e | 122 (56.0) | 452 (53.6) | 8 (50.0) | 36 (59.0) | 80 (44.4) | 85 (45.9) | 91 (50.8) | 12 (66.7) | 5 (38.5) | 9 (52.9) | 568 (54.2) | 44 (57.9) |
| Prior immunosuppressant treatment, n (%)e | 147 (67.4) | 640 (75.8) | 13 (81.3) | 43 (70.5) | 120 (66.7) | 142 (76.8) | 133 (74.3) | 14 (77.8) | 7 (53.8) | 11 (64.7) | 783 (74.7) | 55 (72.4) |
| Immunosuppressant treatment within 8 weeks prior to baseline, n (%)e | 53 (24.3) | 248 (29.4) | 3 (18.8) | 11 (18.0) | 41 (22.8) | 43 (23.2) | 52 (29.1) | 3 (16.7) | 2 (15.4) | 4 (23.5) | 299 (28.5) | 14 (18.4) |
| Oral corticosteroid use at baseline, n (%)d,f | 117 (44.8) | 399 (45.5) | 10 (47.6) | 31 (50.0) | 89 (49.4) | 94 (50.8) | 77 (43.0) | 11 (61.1) | 7 (53.8) | 9 (52.9) | 486 (45.0) | 37 (48.1) |
| Oral corticosteroid daily dose at baseline, prednisone equivalent, mg/day, mean (SD) d,f | 17.2 (6.3) | 16.2 (6.3) | 12.8 (4.4) | 13.6 (6.9) | 16.5 (6.1) | 14.9 (6.1) | 14.5 (5.8) | 11.6 (5.6) | 15.0 (7.6) | 14.4 (7.2) | 16.2 (6.3) | 12.9 (6.6) |
| Extent of disease, n (%)e | ||||||||||||
| Proctosigmoiditis | 35 (16.1) | 118 (14.0) | 0 (0.0) | 14 (23.3) | 17 (9.4) | 27 (14.7) | 31 (17.3) | 4 (22.2) | 1 (8.3) | 2 (12.5) | 148 (14.1) | 15 (20.3) |
| Left-sided colitis | 68 (31.2) | 284 (33.7) | 8 (53.3) | 23 (38.3) | 62 (34.4) | 59 (32.1) | 54 (30.2) | 6 (33.3) | 7 (58.3) | 6 (37.5) | 350 (33.4) | 30 (40.5) |
| Extensive/pancolitis | 115 (52.8) | 440 (52.2) | 7 (46.7) | 23 (38.3) | 100 (55.6) | 98 (53.3) | 94 (52.5) | 8 (44.4) | 4 (33.3) | 8 (50.0) | 548 (52.3) | 29 (39.2) |
| Proctitis | 0 (0.0) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 1 (0.6) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.1) | 0 (0.0) |
| Smoking status, n (%)e | ||||||||||||
| Current smoker | 10 (3.8) | 47 (5.4) | 1 (4.8) | 1 (1.6) | 11 (6.1) | 7 (3.8) | 6 (3.4) | 1 (5.6) | 0 (0.0) | 0 (0.0) | 57 (5.3) | 2 (2.6) |
| Exsmoker | 65 (24.9) | 257 (29.3) | 11 (52.4) | 39 (62.9) | 58 (32.2) | 42 (22.7) | 52 (29.1) | 15 (83.3) | 7 (53.8) | 11 (64.7) | 310 (28.7) | 47 (61.0) |
| Never smoked | 186 (71.3) | 572 (65.3) | 9 (42.9) | 21 (33.9) | 111 (61.7) | 136 (73.5) | 121 (67.6) | 2 (11.1) | 6 (46.2) | 6 (35.3) | 713 (66.0) | 27 (35.1) |
Induction Cohort: placebo, N = 282; and tofacitinib 10 mg BID, N = 938.
Maintenance Cohort: placebo, N = 198; tofacitinib 5 mg BID, N = 198; tofacitinib 10 mg BID, N = 196; and Tofacitinib All, N = 364.
Overall Cohort: tofacitinib 5 mg BID, N = 198; tofacitinib 10 mg BID, N = 959; and Tofacitinib All, N = 1157.
Induction Cohort: parameters based on baseline of the induction trials (phase 2 induction, OCTAVE Induction 1, and OCTAVE Induction 2); Maintenance Cohort: parameters based on baseline of the maintenance trial; Overall Cohort: parameters based on day 1, start of active tofacitinib treatment in the UC program.
Induction, Maintenance, and Overall Cohorts: parameters based on baseline of the induction trials.
Based on prednisone-equivalent total daily doses, and excludes medications like budesonide and beclometasone.
Abbreviations: BID, twice daily; CRP, C-reactive protein; N, total number of patients in the treatment group; n, number of patients in the specified category; SD, standard deviation; TNFi, tumor necrosis factor inhibitor; UC, ulcerative colitis.