Table 1.
Demographics and clinical characteristics at baseline in phase II and phase III induction studies and the phase III maintenance study, for patients included in these analyses
| Induction studies (by phase) | Pooled data from the phase II induction study and OCTAVE Induction 1 and 2 | OCTAVE Sustain | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Treatment | Treatment | |||||||||
|
Phase II (N = 194) |
Phase III (N = 1,161) |
Placebo (N = 282) |
0.5 mg b.i.d. (N = 31) |
3 mg b.i.d. (N = 33) |
10 mg b.i.d. (N = 938) |
15 mg b.i.d. (N = 71) |
Placebo (N = 198) |
5 mg b.i.d. (N = 198) |
10 mg b.i.d. (N = 196) |
|
| Female, n (%) | 88 (45.4) | 481 (41.4) | 127 (45.0) | 14 (45.2) | 14 (42.4) | 381 (40.6) | 33 (46.5) | 82 (41.4) | 95 (48.0) | 86 (43.9) |
| Age, years, mean (SD) | 42.5 (13.7) | 41.1 (13.9) | 41.4 (14.4) | 43.8 (13.4) | 42.5 (14.3) | 41.3 (13.8) | 40.3 (13.2) | 43.4 (14.0) | 41.9 (13.7) | 43.0 (14.4) |
| Total Mayo score, central, mean (SD) a | — | 9.0 (1.5) | 9.0 (1.4) b | — | — | 9.0 (1.5) b | 8.9 (1.5) b | 3.3 (1.8) | 3.3 (1.8) | 3.4 (1.8) |
| Total Mayo score, local, mean (SD) | 8.2 (1.6) | 9.0 (1.5) | 8.8 (1.5) | 8.6 (1.6) | 8.3 (1.5) | 9.0 (1.5) | 8.3 (1.5) | 3.0 (1.9) | 3.0 (1.8) | 3.2 (1.9) |
| C‐reactive protein, mean (SD), mg/L | 13.8 (20.9) | 11.6 (18.9) | 11.6 (18.6) | 18.8 (29.4) | 12.6 (13.2) | 11.3 (18.6) | 17.5 (24.4) | 3.31 (6.12) | 2.17 (3.84) | 3.96 (9.31) |
| Serum albumin, mean (SD), g/dL | 4.22 (0.38) | 4.16 (0.39) | 4.17 (0.37) | 4.12 (0.42) | 4.19 (0.38) | 4.17 (0.39) | 4.19 (0.46) | 4.49 (0.28) | 4.48 (0.32) | 4.51 (0.33) |
| Prior TNFi treatment, n (%) | 38 (19.6) | 630 (54.3) | 142 (50.4) | 3 (9.7) | 7 (21.2) | 494 (52.7) | 22 (31.0) | 92 (46.5) | 90 (45.5) | 100 (51.0) |
| Prior TNFi failure, n (%) | 36 (18.6) | 599 (51.6) | 136 (48.2) | 2 (6.5) | 6 (18.2) | 471 (50.2) | 20 (28.2) | 89 (44.9) | 83 (41.9) | 92 (46.9) |
| Prior immunosuppressant use, n (%) | 79 (40.7) | 859 (74.0) | 180 (63.8) | 13 (41.9) | 12 (36.4) | 699 (74.5) | 34 (47.9) | 134 (67.7) | 149 (75.3) | 144 (73.5) |
| Concomitant 5‐ASA use, n (%) | 133 (68.6) | 656 (56.5) | 170 (60.3) | 20 (64.5) | 22 (66.7) | 524 (55.9) | 53 (74.6) | 192 (97.0) | 194 (98.0) | 191 (97.4) |
| Concomitant oral corticosteroid use, n (%) | 56 (28.9) | 488 (42.0) | 113 (40.1) | 9 (29.0) | 8 (24.2) | 392 (41.8) | 22 (31.0) | 95 (48.0) | 94 (47.5) | 78 (39.8) |
Data are from the phase II (NCT00787202) and phase III (NCT01465763, NCT01458951) induction studies, and the phase III maintenance study (NCT01458574).
5‐ASA, 5‐aminosalicylates; N, number of patients in the treatment group; n, number of unique patients; TNFi, tumor necrosis factor inhibitor.
Central reads of endoscopy were not performed in the phase II Induction study.
The number of patients in each treatment group were: placebo, N = 233; tofacitinib 10 mg b.i.d., N = 903; tofacitinib 15 mg b.i.d., N = 22; All, N = 1,158.