TABLE 2.
Demographics and Baseline Characteristics of the Induction, Maintenance, and Overall Cohorts
| Induction Cohort (phase 3) | Maintenance Cohort (phase 3) | Overall Cohort (phase 3/open-label, long-term extension) | ||||
|---|---|---|---|---|---|---|
| Placebo(N = 234) | Tofacitinib10 mg twice daily (N = 905) | Placebo(N = 198) | Tofacitinib5 mg twice daily (N = 198) | Tofacitinib10 mg twice daily (N = 196) | Tofacitinib All (N = 1124)a | |
| Total PY of exposure | 38.2 | 151.2 | 100.4 | 146.2 | 154.3 | 2576.4 |
| Age (years), mean (SD) | 41.1 (14.4) | 41.2 (13.8) | 43.4 (14.0) | 41.9 (13.7) | 43.0 (14.4) | 41.2 (13.9) |
| Male, n (%) | 132 (56.4) | 536 (59.2) | 116 (58.6) | 103 (52.0) | 110 (56.1) | 658 (58.5) |
| Race, n (%) | ||||||
| White | 186 (79.5) | 726 (80.2) | 155 (78.3) | 164 (82.8) | 153 (78.1) | 897 (79.8) |
| Asian | 28 (12.0) | 114 (12.6) | 26 (13.1) | 23 (11.6) | 25 (12.8) | 144 (12.8) |
| Geographical region, n (%) | ||||||
| Asia | 26 (11.1) | 95 (10.5) | 20 (10.1) | 22 (11.1) | 21 (10.7) | 123 (10.9) |
| Eastern Europe | 67 (28.6) | 260 (28.7) | 57 (28.8) | 66 (33.3) | 63 (32.1) | 319 (28.4) |
| North America | 53 (22.6) | 187 (20.7) | 45 (22.7) | 39 (19.7) | 44 (22.4) | 241 (21.4) |
| Western Europe | 68 (29.1) | 274 (30.3) | 55 (27.8) | 47 (23.7) | 57 (29.1) | 337 (30.0) |
| Rest of the world | 20 (8.5) | 89 (9.8) | 21 (10.6) | 24 (12.1) | 11 (5.6) | 104 (9.3) |
| Extent of disease, n (%)b,c | ||||||
| Proctosigmoiditis | 35 (15.0)d | 132 (14.6)d | 21 (10.6)d | 28 (14.3)d | 33 (16.9)d | 163 (14.5)d |
| Left-sided colitis | 76 (32.6)d | 307 (34.0)d | 68 (34.3)d | 66 (33.7)d | 60 (30.8)d | 380 (33.9)d |
| Pancolitis | 122 (52.4)d | 463 (51.3)d | 108 (54.5)d | 102 (52.0)d | 102 (52.3)d | 577 (51.5)d |
| Duration of UC (years), mean (SD) | 8.1 (7.0) | 8.1 (7.0) | 8.8 (7.5) | 8.3 (7.2) | 8.7 (7.0) | 8.2 (7.0) |
| Mean total Mayo score (SD) | 9.0 (1.5)e | 9.0 (1.4)e | 3.3 (1.8) | 3.3 (1.8) | 3.4 (1.8) | 8.6 (2.0)e |
| Median C-reactive protein, mg/L | 4.7f | 4.6f | 1.0 | 0.7 | 0.9 | 4.5f |
| Prior TNFi treatment, n (%)c | 130 (55.6) | 488 (53.9) | 92 (46.5) | 90 (45.5) | 100 (51.0) | 612 (54.4) |
| Prior TNFi failure, n (%)c | 124 (53.0) | 465 (51.4) | 89 (44.9) | 83 (41.9) | 92 (46.9) | 583 (51.9) |
| Prior thiopurine treatment, n (%)c | 160 (68.4) | 683 (75.5) | 134 (67.7) | 149 (75.3) | 144 (73.5) | 838 (74.6) |
| Oral corticosteroid use at baseline, n (%)g | 113 (48.3) | 412 (45.5) | 100 (50.5) | 101 (51.0) | 86 (43.9) | 505 (44.9) |
| Mean oral corticosteroid daily dose at baseline –prednisone equivalent, mg/day (SD)g | 16.5 (6.0) | 16.1 (6.4) | 15.9 (6.2) | 14.9 (6.2) | 14.5 (5.9) | 16.0 (6.3) |
| Smoker status, n (%) | ||||||
| Current smoker | 9 (3.8) | 47 (5.2) | 12 (6.1) | 7 (3.5) | 6 (3.1) | 58 (5.2) |
| Never smoked | 161 (68.8) | 569 (62.9) | 113 (57.1) | 142 (71.7) | 127 (64.8) | 716 (63.7) |
| Ex-smoker | 64 (27.4) | 289 (31.9) | 73 (36.9) | 49 (24.7) | 63 (32.1) | 350 (31.1) |
Abbreviations: N, number of patients in the treatment group; n, number of unique patients with characteristic; PY, patient-years; SD, standard deviation; TNFi, tumor necrosis factor inhibitor; UC, ulcerative colitis.
aAll patients who received tofacitinib 5 or 10 mg twice daily in phase 3 trials (OCTAVE Induction 1 and 2, OCTAVE Sustain, and OCTAVE Open).
bOne patient with proctitis who received tofacitinib in OCTAVE Induction and placebo in OCTAVE Sustain, and was enrolled as a protocol deviation.
cData were collected at the start of the phase 3 induction studies.
dInduction cohort: placebo, N = 233, tofacitinib 10 mg twice daily, N = 903. Maintenance cohort: placebo, N = 198, tofacitinib 5 mg twice daily, N = 196, tofacitinib 10 mg twice daily, N = 195. Overall cohort: N = 1121.
eInduction cohort: placebo, N = 233, tofacitinib 10 mg twice daily, N = 903. Overall cohort: N = 1122.
fInduction cohort: placebo, N = 233, tofacitinib 10 mg twice daily, N = 891. Overall cohort: N = 1110.
gBased on prednisone-equivalent total daily dose and excludes medications such as budesonide and beclomethasone.