Table 1 IBDQ total scores (FAS), IBDQ domain score (FAS), and percentage of patients achieving clinically meaningful IBDQ response and remission (ITT)
Placebo (N = 48) | Tofacitinib BID | ||||
|---|---|---|---|---|---|
0.5 mg (N = 31) | 3 mg (N = 33) | 10 mg (N = 33) | 15 mg (N = 49) | ||
IBDQ total score (SD) | |||||
Baseline, n | 47 | 31 | 30 | 31 | 48 |
Mean | 123.2 (29.5) | 123.8 (34.5) | 132.3 (33.6) | 134.5 (32.5) | 124.0 (34.9) |
Week 8, n | 34 | 18 | 26 | 28 | 43 |
Mean | 151.3 (33.4) | 149.6 (37.7) | 166.6 (42.4) | 160.5 (33.7) | 175.4 (35.3) |
Mean change from baseline | 27.8 (29.8) | 27.7 (33.4) | 30.3 (27.3) | 30.4 (39.8) | 50.7 (35.6)# |
Mean change from baseline in IBDQ domains (SD) | |||||
Week 8, n | 34 | 18 | 24 | 26 | 42 |
Bowel function | 9.15 (10.59) | 11.06 (10.48) | 11.46 (9.65) | 13.19 (14.18) | 18.96 (11.60)# |
Emotional status | 9.49 (11.89) | 6.33 (14.09) | 9.21 (10.60) | 7.88 (14.70) | 16.48 (14.75)# |
Systemic symptoms | 4.44 (5.86) | 4.89 (5.81) | 4.79 (4.62) | 3.85 (6.39) | 7.24 (5.88)# |
Social function | 4.67 (6.49) | 5.44 (7.45) | 4.83 (5.72) | 5.46 (6.96) | 8.04 (7.07)# |
IBDQ response a /remission b | |||||
Week 8, n | 48 | 31 | 33 | 33 | 49 |
Patients with Clinically meaningful IBDQ response, n (%) | 20 (41.7) | 12 (38.7) | 14 (42.4) | 16 (48.5) | 37 (75.5) |
Logistic regression odds ratioa (95% CI) | Referent | 0.84 (0.33–2.13) | 1.05 (0.42–2.60) | 1.27 (0.52–3.11) | 4.18* (1.75–10.02) |
Patients with IBDQ remission, n (%) | 11 (22.9) | 8 (25.8) | 14 (42.4) | 12 (36.4) | 30 (61.2) |
Logistic odds ratioc (95% CI) | Referent | 1.12 (0.39–3.23) | 2.56 (0.96–6.80) | 1.87 (0.70–4.99) | 5.23** (2.14–12.75) |