TABLE 3.
Mean Change From Baseline for Each IBDQ Item in the Overall Population (FAS, Observed Case)
| Week 4 | Week 8 | |||
|---|---|---|---|---|
| Placebo (N = 234) | Tofacitinib 10 mg BID (N = 905) | Placebo (N = 234) | Tofacitinib 10 mg BID (N = 905) | |
| Bowel symptoms | ||||
| 1. Bowel movement frequency, LSM (SE) | 1.1 (0.1)a | 2.1 (0.1)b | 1.3 (0.1)c | 2.2 (0.1)d |
| Difference vs placebo (95% CI); P value | 1.0 (0.7, 1.3); P < 0.0001 | 0.9 (0.6, 1.2); P < 0.0001 | ||
| 5. Bowel movements been loose, LSM (SE) | 0.7 (0.1)e | 1.8 (0.1)f | 1.0 (0.1)g | 2.1 (0.1)h |
| Difference vs placebo (95% CI); P value | 1.1 (0.8, 1.3); P < 0.0001 | 1.1 (0.9, 1.4); P < 0.0001 | ||
| 9. Troubled by cramps, LSM (SE) | 0.6 (0.1)e | 1.3 (0.0)f | 0.8 (0.1)g | 1.4 (0.1)h |
| Difference vs placebo (95% CI); P value | 0.7 (0.5, 0.9); P < 0.0001 | 0.6 (0.4, 0.8); P < 0.0001 | ||
| 13. Troubled by pain, LSM (SE) | 0.6 (0.1)e | 1.3 (0.0)f | 0.7 (0.1)g | 1.4 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.6 (0.4, 0.8); P < 0.0001 | 0.7 (0.5, 0.9); P < 0.0001 | ||
| 17. Problems with passing gas, LSM (SE) | 0.5 (0.1)e | 0.9 (0.1)f | 0.7 (0.1)g | 1.1 (0.1)h |
| Difference vs placebo (95% CI); P value | 0.3 (0.1, 0.5); P = 0.0014 | 0.4 (0.2, 0.6); P = 0.0001 | ||
| 20. Troubled by bloating, LSM (SE) | 0.6 (0.1)e | 0.9 (0.0)f | 0.6 (0.1)g | 1.0 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.3 (0.1, 0.4); P = 0.0095 | 0.4 (0.2, 0.6); P < 0.0001 | ||
| 22. Problem with rectal bleeding, LSM (SE) | 1.3 (0.1)e | 2.3 (0.1)i | 1.6 (0.1)g | 2.7 (0.1)j |
| Difference vs placebo (95% CI); P value | 1.0 (0.7, 1.3); P < 0.0001 | 1.1 (0.9, 1.4); P < 0.0001 | ||
| 24. Feeling of having to go, LSM (SE) | 0.9 (0.1)e | 1.5 (0.1)i | 1.1 (0.1)g | 1.7 (0.1)j |
| Difference vs placebo (95% CI); P value | 0.5 (0.3, 0.7); P < 0.0001 | 0.7 (0.5, 0.9); P < 0.0001 | ||
| 26. Accidental soiling underpants, LSM (SE) | 0.6 (0.1)e | 1.1 (0.0)k | 0.6 (0.1)g | 1.1 (0.0)l |
| Difference vs placebo (95% CI); P value | 0.4 (0.2, 0.6); P < 0.0001 | 0.5 (0.4, 0.7); P < 0.0001 | ||
| 29. Troubled by nausea, LSM (SE) | 0.4 (0.1)e | 0.7 (0.0)f | 0.5 (0.1)g | 0.7 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.3 (0.1, 0.5); P = 0.0004 | 0.3 (0.1, 0.4); P = 0.0012 | ||
| Systemic symptoms | ||||
| 2. Feeling fatigued or tired, LSM (SE) | 0.7 (0.1)e | 1.1 (0.1)f | 0.8 (0.1)g | 1.4 (0.1)h |
| Difference vs placebo (95% CI); P value | 0.5 (0.3, 0.7); P < 0.0001 | 0.6 (0.4, 0.8); P < 0.0001 | ||
| 6. How much energy have you had, LSM (SE) | 0.4 (0.1)e | 0.9 (0.0)f | 0.5 (0.1)m | 1.0 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.4 (0.3, 0.6); P < 0.0001 | 0.5 (0.4, 0.7); P < 0.0001 | ||
| 10. Felt generally unwell, LSM (SE) | 0.9 (0.1)e | 1.4 (0.1)n | 1.0 (0.1)g | 1.6 (0.1)j |
| Difference vs placebo (95% CI); P value | 0.5 (0.3, 0.7); P < 0.0001 | 0.6 (0.4, 0.8); P < 0.0001 | ||
| 14. Getting good night’s sleep, LSM (SE) | 0.7 (0.1)e | 1.5 (0.1)f | 0.8 (0.1)g | 1.7 (0.1)h |
| Difference vs placebo (95% CI); P value | 0.8 (0.6, 1.0); P < 0.0001 | 0.9 (0.7, 1.1); P < 0.0001 | ||
| 18. Problem maintaining weight, LSM (SE) | 0.3 (0.1)o | 0.6 (0.1)n | 0.4 (0.1)m | 0.7 (0.1)j |
| Difference vs placebo (95% CI); P value | 0.3 (0.1, 0.5); P = 0.0071 | 0.3 (0.0, 0.5); P = 0.0215 | ||
| Emotional function | ||||
| 3. Felt frustrated/impatient/restless, LSM (SE) | 0.5 (0.1)e | 0.9 (0.0)f | 0.5 (0.1)g | 1.0 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.4 (0.2, 0.6); P = 0.0002 | 0.4 (0.2, 0.6); P < 0.0001 | ||
| 7. Worry about needing surgery, LSM (SE) | 0.6 (0.1)e | 1.0 (0.0)f | 0.5 (0.1)g | 1.0 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.4 (0.2, 0.6); P < 0.0001 | 0.5 (0.3, 0.7); P < 0.0001 | ||
| 11. Fear of not finding a washroom, LSM (SE) | 0.9 (0.1)e | 1.4 (0.1)f | 0.9 (0.1)g | 1.7 (0.1)h |
| Difference vs placebo (95% CI); P value | 0.6 (0.3, 0.8); P < 0.0001 | 0.8 (0.6, 1.0); P < 0.0001 | ||
| 15. Felt depressed/discouraged, LSM (SE) | 0.6 (0.1)e | 1.0 (0.0)f | 0.6 (0.1)g | 1.1 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.5 (0.3, 0.7); P < 0.0001 | 0.5 (0.3, 0.7); P < 0.0001 | ||
| 19. Felt worried or anxious, LSM (SE) | 0.8 (0.1)e | 1.2 (0.1)f | 0.9 (0.1)g | 1.4 (0.1)h |
| Difference vs placebo (95% CI); P value | 0.3 (0.1, 0.5); P = 0.0009 | 0.5 (0.2, 0.7); P < 0.0001 | ||
| 21. Felt relaxed/free of tension, LSM (SE) | 0.6 (0.1)e | 1.0 (0.1)i | 0.7 (0.1)g | 1.2 (0.1)j |
| Difference vs placebo (95% CI); P value | 0.3 (0.1, 0.5); P = 0.0009 | 0.5 (0.3, 0.7); P < 0.0001 | ||
| 23. Felt embarrassed, LSM (SE) | 0.7 (0.1)e | 1.4 (0.1)i | 0.9 (0.1)g | 1.6 (0.1)j |
| Difference vs placebo (95% CI); P value | 0.6 (0.4, 0.9); P < 0.0001 | 0.7 (0.5, 0.9); P < 0.0001 | ||
| 25. Felt tearful or upset, LSM (SE) | 0.5 (0.1)e | 0.8 (0.0)p | 0.5 (0.1)g | 0.8 (0.0)q |
| Difference vs placebo (95% CI); P value | 0.3 (0.1, 0.5); P = 0.0004 | 0.3 (0.1, 0.5); P = 0.0008 | ||
| 27. Felt angry, LSM (SE) | 0.4 (0.1)e | 1.1 (0.0)i | 0.5 (0.1)g | 1.1 (0.1)j |
| Difference vs placebo (95% CI); P value | 0.6 (0.4, 0.8); P < 0.0001 | 0.6 (0.4, 0.8); P < 0.0001 | ||
| 30. Felt irritable, LSM (SE) | 0.4 (0.1)e | 0.8 (0.0)f | 0.6 (0.1)g | 1.0 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.4 (0.2, 0.6); P < 0.0001 | 0.4 (0.2, 0.6); P < 0.0001 | ||
| 31. Lack of understanding from others, LSM (SE) | 0.4 (0.1)e | 0.6 (0.0)f | 0.4 (0.1)g | 0.6 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.2 (0.1, 0.4); P = 0.0098 | 0.2 (0.1, 0.4); P = 0.0099 | ||
| 32. Satisfied with personal life, LSM (SE) | 0.4 (0.1)r | 0.7 (0.0)f | 0.6 (0.1)m | 0.9 (0.0)h |
| Difference vs placebo (95% CI); P value | 0.4 (0.2, 0.5); P < 0.0001 | 0.3 (0.2, 0.5); P = 0.0001 | ||
| Social function | ||||
| 4. Unable to attend school/work, LSM (SE) | 0.7 (0.1)o | 1.1 (0.1)i | 0.7 (0.1)s | 1.4 (0.1)q |
| Difference vs placebo (95% CI); P value | 0.4 (0.2, 0.6); P = 0.0007 | 0.7 (0.5, 0.9); P < 0.0001 | ||
| 8. Delay/cancel social engagements, LSM (SE) | 0.8 (0.1)e | 1.4 (0.1)n | 0.8 (0.1)g | 1.5 (0.1)j |
| Difference vs placebo (95% CI); P value | 0.6 (0.4, 0.8); P < 0.0001 | 0.8 (0.5, 1.0); P < 0.0001 | ||
| 12. Difficulty doing leisure/sports, LSM (SE) | 0.9 (0.1)e | 1.6 (0.1)n | 1.0 (0.1)g | 2.0 (0.1)h |
| Difference vs placebo (95% CI); P value | 0.7 (0.5, 0.9); P < 0.0001 | 1.0 (0.8, 1.2); P < 0.0001 | ||
| 16. Avoid attending events, LSM (SE) | 0.5 (0.1)e | 1.3 (0.1)n | 0.5 (0.1)g | 1.5 (0.1)j |
| Difference vs placebo (95% CI); P value | 0.8 (0.5, 1.0); P < 0.0001 | 1.0 (0.7, 1.2); P < 0.0001 | ||
| 28. Limited sexual activity, LSM (SE) | 0.5 (0.1)t | 1.1 (0.1)u | 0.7 (0.1)v | 1.4 (0.1)w |
| Difference vs placebo (95% CI); P value | 0.7 (0.4, 0.9); P < 0.0001 | 0.7 (0.4, 0.9); P < 0.0001 | ||
aN = 227; bN = 862; cN = 213; dN = 832; eN = 231; fN = 881; gN = 218; hN = 849; iN = 879; jN = 848; kN = 877; lN = 846; mN = 217; nN = 880; oN = 229; pN = 878; qN = 847; rN = 230; sN = 216; tN = 228; uN = 872; vN = 215; wN = 839. Abbreviations: FAS, full analysis set.