Table 2.
Ulcerative Colitis (UC) Past Medications and Patient-Reported Outcomes (PROs) at Enrollment Visit, Stratified by Change in Physician-Reported Fecal Urgency From Time of Enrollment Visit to 6-Mo Follow-Up Visit
| No persistent Urgency (NPU)a N = 175 |
Urgency to none (UN)a< N = 86 |
None to urgency (NU)a< N = 56 |
Persistent Urgency (PU)a N = 83 |
Difference (95% CI)b UN vs NPU< | Difference (95% CI)b NU vs NPU< | Difference (95% CI)b PU vs NPU< | |
|---|---|---|---|---|---|---|---|
| Past medications | |||||||
| Biologic experienced, n (%) | 30/175 (17.1%) | 18/86 (20.9%) | 10/56 (17.9%) | 21/83 (25.3%) | 3.8 (−6.5, 14.0) | 0.7 (−10.8, 12.2) | 8.2 (−2.7, 19.1) |
| Number of prior biologics/JAKi | |||||||
| 0 | 145/175 (82.9%) | 68/86 (79.1%) | 46/56 (82.1%) | 62/83 (74.7%) | −3.8 (−14.0, 6.5) | −0.7 (−12.2, 10.8) | −8.2 (−19.1, 2.7) |
| 1 | 19/175 (10.9%) | 15/86 (17.4%) | 5/56 (8.9%) | 14/83 (16.9%) | 6.6 (−2.7, 15.8) | −1.9 (−10.7, 6.8) | 6.0 (−3.3, 15.3) |
| 2+ | 11/175 (6.3%) | 3/86 (3.5%) | 5/56 (8.9%) | 7/83 (8.4%) | −2.8 (−8.1, 2.5) | 2.6 (−5.7, 10.9) | 2.1 (−4.8, 9.1) |
| TNFi experienced, n (%) | 153/175 (87.4%) | 71/86 (82.6%) | 51/56 (91.1%) | 66/83 (79.5%) | −4.9 (−14.3, 4.5) | 3.6 (−5.3, 12.6) | −7.9 (−17.9, 2.1) |
| Integrin α4 β7 experienced, n (%) | 31/175 (17.7%) | 14/86 (16.3%) | 12/56 (21.4%) | 18/83 (21.7%) | −1.4 (−11.1, 8.2) | 3.7 (−8.4, 15.9) | 4 (−6.5, 14.5) |
| IST experienced, n (%) | 51/175 (29.1%) | 17/86 (19.8%) | 12/56 (21.4%) | 24/83 (28.9%) | −9.4 (−20.1, 1.4) | −7.7 (−20.4, 5.0) | −0.2 (−12.1, 11.6) |
| 5-ASA experienced, n (%) | 143/175 (81.7%) | 71/86 (82.6%) | 48/56 (85.7%) | 67/83 (80.7%) | 0.9 (−9.0, 10.7) | 4.0 (−6.8, 14.8) | −1.0 (−11.2, 9.2) |
| Corticosteroid experienced, n (%) | 104/175 (59.4%) | 55/86 (64.0%) | 40/56 (71.4%) | 55/83 (66.3%) | 4.5 (−8.0, 17.0) | 12.0 (−1.9, 25.9) | 6.8 (−5.7, 19.3) |
| Antibiotic experienced, n (%) | 24/175 (13.7%) | 23/86 (26.7%) | 8/56 (14.3%) | 15/83 (18.1%) | 13.0 (2.4, 23.7) | 0.6 (−9.9, 11.1) | 4.4 (−5.4, 14.1) |
| Patient-reported outcomes (PROs) | |||||||
| Patient-reported outcomes measurement information system (PROMIS) | |||||||
| Fatigue, mean (SD) | 46.1 (10.1) | 52.9 (9.9) | 51.3 (9.8) | 55.4 (9.4) | 6.9 (4.2, 9.5) | 5.2 (2.2, 8.2) | 9.3 (6.8, 11.9) |
| Fatigue–Categorical | |||||||
| Within normal limits (< 55) | 140/172 (81.4%) | 41/84 (48.8%) | 32/56 (57.1%) | 39/82 (47.6%) | −32.6 (−44.8, −20.4) | −24.3 (−38.5, −10.1) | −33.8 (−46.1, −21.6) |
| Mild (55–60) | 14/172 (8.1%) | 20/84 (23.8%) | 10/56 (17.9%) | 14/83 (17.1%) | 15.7 (5.7, 25.7) | 9.7 (−1.1, 20.6) | 8.9 (−0.2, 18.0) |
| Moderate/Severe (≥ 60) | 18/172 (10.5%) | 23/84 (27.4%) | 14/56 (25.0%) | 29/83 (35.4%) | 16.9 (6.3, 27.5) | 14.5 (2.3, 26.8) | 24.9 (13.6, 36.2) |
| Sleep disturbance, mean (SD) | 47.9 (7.6) | 50.7 (8.0) | 49.5 (8.9) | 55.0 (7.7) | 2.8 (0.8, 4.9) | 1.6 (−1.1, 4.2) | 7.1 (5.1, 9.1) |
| Sleep disturbance–Categorical | |||||||
| Within normal limits (< 55) | 153/174 (87.9%) | 62/85 (72.9%) | 42/56 (75.0%) | 48/83 (57.8%) | −15 (−25.6, −4.4) | −12.9 (−25.3, −0.6) | −30.1 (−41.8, −18.4) |
| Mild (55–60) | 16/174 (9.2%) | 14/85 (16.5%) | 10/56 (17.9%) | 15/83 (18.1%) | 7.3 (−1.7, 16.2) | 8.7 (−2.3, 19.6) | 8.9 (−0.5, 18.2) |
| Moderate/Severe (≥ 60) | 5/174 (2.9%) | 9/85 (10.6%) | 4/56 (7.1%) | 20/83 (24.1%) | 7.7 (0.7, 14.7) | 4.3 (−2.9, 11.5) | 21.2 (11.7, 30.8) |
| Pain interference, mean (SD) | 46.1 (7.4) | 52.3 (9.6) | 49.1 (8.3) | 55.1 (9.4) | 6.2 (3.8, 8.5) | 3.0 (0.5, 5.5) | 9.0 (6.7, 11.3) |
| Pain interference–Categorical | |||||||
| Within normal limits (< 55) | 143/175 (81.7%) | 42/85 (49.4%) | 37/56 (66.1%) | 32/82 (39.0%) | −32.3 (−44.4, −20.2) | −15.6 (−29.3, −2) | −42.7 (−54.7, −30.7) |
| Mild (55–60) | 22/175 (12.6%) | 17/85 (20.0%) | 10/56 (17.9%) | 19/82 (23.2%) | 7.4 (−2.4, 17.3) | 5.3 (−5.9, 16.5) | 10.6 (0.2, 21.0) |
| Moderate/Severe (≥ 60) | 10 (5.7%) | 26 (30.6%) | 9 (16.1%) | 31 (37.8%) | 24.9 (14.5, 35.3) | 10.4 (0.1, 20.6) | 32.1 (21.0, 43.1) |
| Depression, mean (SD) | 44.7 (6.9) | 45.8 (7.0) | 48.2 (9.5) | 50.2 (9.0) | 8.2 (0.5, 15.9) | 7.9 (−1.3, 17.1) | 8.7 (0.8, 16.6) |
| Depression–Categorical | |||||||
| Within normal limits (< 55) | 151/175 (86.3%) | 70/85 (82.4%) | 39/56 (69.6%) | 53/83 (63.9%) | −3.9 (−13.5, 5.6) | −16.7 (−29.7, −3.6) | −22.4 (−34, −10.9) |
| Mild (55–60) | 16/175 (9.1%) | 10/86 (11.8%) | 9/56 (16.1%) | 16/83 (19.3%) | 2.6 (−5.5, 10.7) | 6.9 (−3.6, 17.5) | 10.1 (0.6, 19.6) |
| Moderate/Severe (≥ 60) | 8/175 (4.6%) | 5/85 (5.9%) | 8/56 (14.3%) | 14/83 (16.9%) | 1.3 (−4.6, 7.2) | 9.7 (0.0, 19.4) | 12.3 (3.7, 20.9) |
| Anxiety, mean (SD) | 47.6 (8.6) | 50.9 (9.4) | 50.1 (10.5) | 55.2 (8.8) | 2.5 (−5.9, 10.9) | −1.4 (−10.1, 7.4) | 13.8 (3.6, 24.1) |
| Anxiety–categorical | |||||||
| Within normal limits (< 55) | 132/174 (75.9%) | 50/85 (58.8%) | 34/56 (60.7%) | 36/83 (43.4%) | −17.0 (−29.3, −4.8) | −15.1 (−29.4, −0.9) | −32.5 (−44.9, −20.1) |
| Mild (55–60) | 26/174 (14.9%) | 17/85 (20.0%) | 8/56 (14.3%) | 22/83 (26.5%) | 5.1 (−5.0, 15.1) | −0.7 (−11.2, 9.9) | 11.6 (0.7, 22.4) |
| Moderate/Severe (≥ 60) | 16/174 (9.2%) | 18/85 (21.2%) | 14/56 (25.0%) | 25/83 (30.1%) | 12.0 (2.3, 21.7) | 15.8 (3.7, 27.9) | 20.9 (10.2, 31.7) |
| Work productivity activity impairment (WPAI) | |||||||
| Current employment, n (%) | 122/175 (69.7%) | 58/85 (68.2%) | 33/56 (58.9%) | 55/83 (66.3%) | −1.5 (−13.5, 10.5) | −10.8 (−25.4, 3.8) | −3.4 (−15.7, 8.8) |
| Work hours missed due to UC, n (%) | 6/109 (5.5%) | 14/57 (24.6%) | 6/33 (18.2%) | 17/52 (32.7%) | 19.1 (7.1, 31.0) | 12.7 (−1.2, 26.5) | 27.2 (13.7, 40.6) |
| Impairment while working due to UC, n (%) | 45/122 (36.9%) | 39/58 (67.2%) | 19/33 (57.6%) | 49/54 (90.7%) | 30.3 (15.5, 45.2) | 20.7 (1.8, 39.6) | 53.8 (42.3, 65.4) |
| Work hours affected by UC, n (%) | 41/109 (37.6%) | 39/57 (68.4%) | 19/33 (57.6%) | 47/51 (92.2%) | 30.8 (15.7, 45.9) | 20.0 (0.8, 39.1) | 54.5 (42.8, 66.3) |
| Daily activities affected by UC, n (%) | 70/174 (40.2%) | 64/85 (75.3%) | 33/56 (58.9%) | 77/83 (92.8%) | 35.1 (23.3, 46.8) | 18.7 (3.9, 33.5) | 52.5 (43.4, 61.7) |
aSCCAI, NPU, n = 163; UN, n = 82; NU, n = 53; PU, n = 83.
JAKi, Janus kinase inhibitors; TNFI, tumor necrosis factor inhibitors; 5-ASAs, 5-aminosalicylic acids; ISTs, immunosuppressant therapies; SD, standard deviation.
a
NPU, no persistent urgency at enrollment or follow-up; UN, reported resolution of urgency after enrollment to follow-up; NU, reported onset of urgency after enrollment to follow-up; PU, reported urgency at both enrollment and follow-up.
b
Unadjusted mean difference (95% CI) between groups for continuous variables and difference in percentage points (95% CI) between groups for categorical variables.