TABLE 2.
Mean Baseline Distribution of Each IBDQ Item in the Overall Population and by TNFi Experience (FAS, Observed Case)
| Overall Population | TNFi-naïve | TNFi-experienced | ||||
|---|---|---|---|---|---|---|
| Mean (SD) | Placebo (N = 234) | Tofacitinib 10 mg BID (N = 905) | Placebo (N = 104) | Tofacitinib 10 mg BID (N = 417) | Placebo (N = 130) | Tofacitinib 10 mg BID (N = 488) |
| Bowel symptoms | ||||||
| 1. Bowel movement frequency | 3.4 (1.6)a | 3.4 (1.6)b | 3.4 (1.5)c | 3.4 (1.5)d | 3.5 (1.7) | 3.4 (1.7)e |
| 5. Bowel movements been loose | 2.3 (1.4) | 2.3 (1.3)f | 2.3 (1.5) | 2.3 (1.3)g | 2.2 (1.4) | 2.3 (1.3)h |
| 9. Troubled by cramps | 3.8 (1.5) | 3.9 (1.7)f | 3.8 (1.5) | 3.9 (1.6)g | 3.8 (1.6) | 3.9 (1.7)h |
| 13. Troubled by pain | 3.8 (1.5) | 3.9 (1.6)f | 3.8 (1.4) | 4.0 (1.6)g | 3.8 (1.6) | 3.9 (1.6)h |
| 17. Problems with passing gas | 3.9 (1.6) | 3.8 (1.7)f | 3.9 (1.5) | 3.8 (1.7)g | 3.9 (1.7) | 3.9 (1.7)h |
| 20. Troubled by bloating | 3.9 (1.6) | 3.9 (1.6)f | 4.0 (1.5) | 3.8 (1.6)g | 3.9 (1.6) | 4.0 (1.7)h |
| 22. Problem with rectal bleeding | 2.3 (1.3) | 2.3 (1.3)i | 2.3 (1.3) | 2.3 (1.4)g | 2.2 (1.3) | 2.4 (1.3)j |
| 24. Feeling of having to go | 3.6 (1.5) | 3.5 (1.4)i | 3.4 (1.4) | 3.4 (1.4)g | 3.7 (1.5) | 3.6 (1.4)j |
| 26. Accidental soiling underpants | 4.9 (1.7) | 4.7 (1.6)k | 4.8 (1.7) | 4.8 (1.7)l | 5.0 (1.6) | 4.6 (1.6)m |
| 29. Troubled by nausea | 5.2 (1.6) | 5.2 (1.6)f | 5.3 (1.7) | 5.2 (1.6)g | 5.1 (1.6) | 5.2 (1.5)h |
| Systemic symptoms | ||||||
| 2. Feeling fatigued or tired | 3.2 (1.4) | 3.2 (1.4)f | 3.2 (1.5) | 3.2 (1.4)g | 3.2 (1.3) | 3.2 (1.4)h |
| 6. How much energy have you had | 3.4 (1.2) | 3.4 (1.3)f | 3.4 (1.2) | 3.4 (1.3)g | 3.4 (1.2) | 3.5 (1.2)h |
| 10. Felt generally unwell | 3.4 (1.5) | 3.5 (1.5)i | 3.3 (1.5) | 3.5 (1.5)g | 3.4 (1.5) | 3.5 (1.6)j |
| 14. Getting good night’s sleep | 3.0 (1.7) | 3.1 (1.7)f | 3.1 (1.6) | 3.3 (1.8)g | 2.9 (1.8) | 2.9 (1.6)h |
| 18. Problem maintaining weight | 4.6 (1.9)n | 4.5 (2.0)i | 4.6 (2.0) | 4.4 (2.0)g | 4.6 (1.9)o | 4.6 (2.0)j |
| Emotional function | ||||||
| 3. Felt frustrated/impatient/restless | 3.8 (1.5) | 3.9 (1.5)f | 3.7 (1.5) | 3.8 (1.5)g | 4.0 (1.6) | 4.0 (1.5)h |
| 7. Worry about needing surgery | 4.7 (1.8) | 4.7 (1.8)f | 4.8 (1.9) | 4.7 (1.8)g | 4.6 (1.8) | 4.6 (1.7)h |
| 11. Fear of not finding a washroom | 3.2 (1.7) | 3.3 (1.7)f | 3.2 (1.7) | 3.5 (1.7)g | 3.2 (1.7) | 3.2 (1.7)h |
| 15. Felt depressed/discouraged | 4.1 (1.6) | 4.2 (1.6)f | 3.9 (1.6) | 4.1 (1.6)g | 4.3 (1.6) | 4.2 (1.6)h |
| 19. Felt worried or anxious | 3.8 (1.7) | 3.7 (1.6)f | 3.4 (1.6) | 3.7 (1.7)g | 4.1 (1.7) | 3.7 (1.6)h |
| 21. Felt relaxed/free of tension | 2.8 (1.2) | 2.9 (1.3)i | 2.7 (1.1) | 2.7 (1.3)g | 2.9 (1.2) | 3.0 (1.3)j |
| 23. Felt embarrassed | 3.7 (1.8) | 3.7 (1.7)i | 3.7 (1.8) | 3.6 (1.7)g | 3.7 (1.7) | 3.8 (1.6)j |
| 25. Felt tearful or upset | 4.8 (1.6) | 4.8 (1.6)p | 4.5 (1.7) | 4.7 (1.7)l | 5.0 (1.5) | 5.0 (1.6)j |
| 27. Felt angry | 4.3 (1.7) | 4.3 (1.7)i | 4.4 (1.8) | 4.4 (1.7)g | 4.2 (1.6) | 4.3 (1.7)j |
| 30. Felt irritable | 4.1 (1.6) | 4.2 (1.5)f | 4.2 (1.7) | 4.2 (1.5)g | 4.0 (1.5) | 4.1 (1.5)h |
| 31. Lack of understanding from others | 4.8 (1.7) | 4.9 (1.6)f | 4.8 (1.9) | 4.8 (1.6)g | 4.8 (1.6) | 4.9 (1.6)h |
| 32. Satisfied with personal life | 3.5 (1.3)n | 3.5 (1.3)f | 3.5 (1.3)q | 3.4 (1.3)g | 3.5 (1.4) | 3.6 (1.4)h |
| Social function | ||||||
| 4. Unable to attend school/work | 4.3 (1.9)r | 4.2 (2.0)p | 4.2 (2.0) | 4.3 (1.9)g | 4.4 (1.9)s | 4.2 (2.1)m |
| 8. Delay/cancel social engagements | 4.1 (1.8) | 4.1 (1.8)i | 4.0 (1.7) | 4.1 (1.8)l | 4.1 (1.8) | 4.0 (1.8)h |
| 12. Difficulty doing leisure/sports | 3.0 (1.6) | 3.1 (1.7)f | 3.1 (1.6) | 3.1 (1.7)g | 2.9 (1.6) | 3.1 (1.6)h |
| 16. Avoid attending events | 3.9 (2.1) | 3.8 (2.1)i | 4.0 (2.0) | 3.9 (2.1)l | 3.8 (2.2) | 3.7 (2.0)h |
| 28. Limited sexual activity | 3.9 (2.2)t | 3.8 (2.1)u | 4.1 (2.2)q | 3.7 (2.1)v | 3.8 (2.2)s | 3.8 (2.1)w |
aN = 229; bN = 884; cN = 99; dN = 400; eN = 484; fN = 902; gN = 415; hN = 487; iN = 901; jN = 486; kN = 899; lN = 414; mN = 485; nN = 233; oN = 129; pN = 900; qN = 103; rN = 232; sN = 128; tN = 231; uN = 895; vN = 412; wN = 483.
Abbreviations: FAS, full analysis set.