Table 2.
Baseline demographics and disease characteristics by sustained remission status and treatment group.
| Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Placebo | ||||
|---|---|---|---|---|---|---|
| Sustained remission at weeks 24 and 52 | Yes N = 44 | No N = 130 | Yes N = 50 | No N = 119 | Yes N = 10 | No N = 153 |
| Age (years), mean (SD)a | 41.9 (15.8) | 41.9 (12.6) | 44.2 (14.4) | 42.3 (14.3) | 38.0 (8.9) | 44.3 (14.0) |
| Age (<65 years), n (%)a | 40 (90.9) | 124 (95.4) | 46 (92.0) | 110 (92.4) | 10 (100.0) | 138 (90.2) |
| Male, n (%)a | 24 (54.5) | 69 (53.1) | 30 (60.0) | 69 (58.0) | 3 (30.0) | 96 (62.7) |
| CRP (mg/L) at baseline of OCTAVE Induction 1 and 2, mean (SD)b | 7.5 (13.0) | 9.4 (17.9)c | 7.7 (12.7) | 9.5 (16.8)d | 6.2 (8.1) | 10.6 (15.6) |
| CRP (mg/L) at baseline of OCTAVE Sustain, mean (SD)a | 1.7 (2.4) | 2.0 (3.2) | 1.4 (2.5) | 3.7 (6.8) | 3.2 (3.4) | 3.1 (6.0) |
| Albumin (g/dL), mean (SD)b | 4.3 (0.4) | 4.2 (0.4) | 4.2 (0.5) | 4.2 (0.4) | 4.3 (0.3) | 4.2 (0.4) |
| Total Mayo score, mean (SD)b | 8.6 (1.6) | 8.7 (1.3) | 8.5 (1.6) | 9.0 (1.4) | 8.9 (1.4) | 8.9 (1.3) |
| Total Mayo score of <3, n (%)a | 28 (63.6) | 35 (26.9) | 28 (56.0) | 27 (22.7) | 5 (50.0) | 59 (38.6) |
| PMS <2, n (%)a | 31 (70.5) | 48 (36.9) | 36 (72.0) | 42 (35.3) | 5 (50.0) | 65 (42.5) |
| EIMs at baseline of OCTAVE Induction 1 and 2, n (%)c | 9 (20.5) | 37 (28.5) | 10 (20.0) | 30 (25.6)e | 1 (10.0) | 50 (32.7) |
| EIMs at baseline of OCTAVE Sustain, n (%)a | 3 (6.8) | 11 (8.5) | 2 (4.0) | 7 (5.9)f | 0 (0.0) | 20 (13.1) |
| Prior TNFi exposure, n (%)b | 18 (40.9) | 59 (45.4) | 18 (36.0) | 68 (57.1) | 6 (60.0) | 65 (42.5) |
| Prior TNFi failure, n (%)b | 15 (34.1) | 55 (42.3) | 16 (32.0) | 64 (53.8) | 5 (50.0) | 63 (41.2) |
| Oral corticosteroid use, n (%)a | 16 (36.4) | 73 (56.2) | 14 (28.0) | 54 (45.4) | 5 (50.0) | 70 (45.8) |
Sustained remission was defined as remission at weeks 24 and 52 of OCTAVE Sustain. Remission was defined as a total Mayo score of ≤2 with no individual subscore >1, and a rectal bleeding subscore of 0. Abbreviations: BID, twice daily; CRP, C-reactive protein; EIM, extraintestinal manifestation; N, number of patients in the specified category with nonmissing data; n, number of patients with the specified characteristic within the given category; PMS, partial Mayo score; SD, standard deviation; TNFi, tumor necrosis factor inhibitor.
Data at baseline of OCTAVE Sustain (following 8 weeks’ tofacitinib induction therapy).
Data at baseline of OCTAVE Induction 1 and 2.
N = 129.
N = 114.
N = 117.
N = 118.