Table 4.
Baseline demographics and disease characteristics by sustained clinical response status and treatment group.
| Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Placebo | ||||
|---|---|---|---|---|---|---|
| Sustained clinical response at weeks 24 and 52 | Yes N = 97 | No N = 72 | Yes N = 117 | No N = 45 | Yes N = 38 | No N = 120 |
| Age (years), mean (SD)a | 42.9 (14.2) | 40.0 (12.5) | 44.8 (14.4) | 37.3 (12.5) | 44.3 (13.1) | 43.9 (14.2) |
| Age (<65 years), n (%)a | 90 (92.8) | 69 (95.8) | 106 (90.6) | 44 (97.8) | 35 (92.1) | 108 (90.0) |
| Male, n (%)a | 53 (54.6) | 36 (50.0) | 65 (55.6) | 29 (64.4) | 22 (57.9) | 74 (61.7) |
| CRP (mg/L) at baseline of OCTAVE Induction 1 and 2, mean (SD)b | 9.2 (19.3)c | 8.9 (13.5) | 8.8 (16.2)d | 8.1 (12.9)e | 11.3 (19.4) | 10.0 (14.0) |
| CRP (mg/L) at baseline of OCTAVE Sustain, mean (SD)a | 1.8 (2.6) | 2.1 (3.5) | 2.6 (5.6) | 4.0 (7.0) | 2.5 (3.2) | 3.2 (6.5) |
| Albumin (g/dL), mean (SD)b | 4.3 (0.4) | 4.1 (0.4) | 4.2 (0.4) | 4.2 (0.3) | 4.2 (0.4) | 4.2 (0.4) |
| Total Mayo score, mean (SD)b | 8.6 (1.4) | 8.8 (1.4) | 8.8 (1.5) | 9.0 (1.5) | 9.0 (1.3) | 8.8 (1.3) |
| Total Mayo score of <3, n (%)a | 43 (44.3) | 20 (27.8) | 43 (36.8) | 11 (24.4) | 12 (31.6) | 50 (41.7) |
| PMS <2, n (%)a | 54 (55.7) | 25 (34.7) | 61 (52.1) | 15 (33.3) | 17 (44.7) | 51 (42.5) |
| EIMs at baseline of OCTAVE Induction 1 and 2, n (%)b | 22 (22.7) | 23 (31.9) | 27 (23.1) | 9 (20.9)f | 8 (21.1) | 42 (35.0) |
| EIMs at baseline of OCTAVE Sustain, n (%)a | 4 (4.1) | 9 (12.5) | 6 (5.1) | 3 (6.8)g | 3 (7.9) | 17 (14.2) |
| Prior TNFi exposure, n (%)b | 40 (41.2) | 34 (47.2) | 57 (48.7) | 27 (60.0) | 13 (34.2) | 57 (47.5) |
| Prior TNFi failure, n (%)b | 35 (36.1) | 32 (44.4) | 54 (46.2) | 25 (55.6) | 12 (31.6) | 55 (45.8) |
| Oral corticosteroid use, n (%)a | 40 (41.2) | 48 (66.7) | 37 (31.6) | 27 (60.0) | 16 (42.1) | 56 (46.7) |
Sustained clinical response was defined as clinical response at weeks 24 and 52 of OCTAVE Sustain. Clinical response was defined as a decrease from induction study baseline total Mayo score of ≥3 points and ≥30%, plus a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of 0 or 1. 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 = 96.
N = 115.
N = 42.
N = 43.
N = 44.