Table 3.
History of Patient Reported Outcome Measurement Information System (PROMIS) scores and Work Productivity Activity and Impairment (WPAI) domains at enrollment for patients with ulcerative colitis.
| Ulcerative colitis therapy groups (at beginning of enrollment visit) | ||||
|---|---|---|---|---|
| Total | 5-ASAsa | BIO/JAKia | Difference (95% CI)b | |
| PROMISc | ||||
| Fatigue | n = 595 | n = 284 | n = 311 | |
| Mean (SD) | 50.1 (11.1) | 48.9 (10.7) | 51.3 (11.4) | −2.4 (−4.2, −0.6) |
| Median (Q1, Q3) | 49.4 (42.0, 57.5) | 49.4 (42.0, 56.3) | 50.9 (44.2, 60.0) | |
| Sleep disturbance | n = 601 | n = 289 | n = 312 | |
| Mean (SD) | 50.1 (8.3) | 49.3 (7.8) | 50.8 (8.6) | −1.6 (−2.9, −−0.3) |
| Median (Q1, Q3) | 50.5 (43.8, 54.3) | 50.5 (43.8, 54.3) | 50.5 (46.2, 56.1) | |
| Pain interference | n = 603 | n = 289 | n = 314 | |
| Mean (SD) | 49.3 (9.4) | 49.4 (9.3) | 49.3 (9.5) | 0.0 (−1.5, 1.5) |
| Median (Q1, Q3) | 41.6 (41.6, 55.6) | 41.6 (41.6, 55.6) | 41.6 (41.6, 55.6) | |
| Depression | n = 602 | n = 289 | n = 313 | |
| Mean (SD) | 46.6 (8.0) | 46.0 (7.7) | 47.1 (8.3)c | −−1.1 (-2.4, 0.1) |
| Median (Q1, Q3) | 41.0 (41.0, 51.8) | 41.0 (41.0, 51.8) | 41.0 (41.0, 51.8) | |
| Anxiety | n = 601 | n = 289 | n = 312 | |
| Mean (SD) | 50.4 (9.7) | 49.6 (9.4) | 51.2 (9.9) | −1.6 (−3.2, −0.1) |
| Median (Q1, Q3) | 51.2 (40.3, 57.7) | 48.0 (40.3, 57.7) | 51.2 (40.3, 59.5) | |
| WPAI | ||||
| Current employment | n = 604 | n = 290 | n = 314 | |
| n (%) | 403 (66.7%) | 181 (62.4%) | 222 (70.7%) | −8.3 (−15.8, −0.8) |
| Absenteeism | n = 368 | n = 162 | n = 206 | |
| Mean (SD) | 5.3 (18.2) | 2.8 (12.0) | 7.3 (21.8) | −4.5 (−8.0, −1.0) |
| Presenteeism | n = 399 | n = 180 | n = 219 | |
| Mean (SD) | 15.5 (24.4) | 13.7 (22.6) | 17.0 (25.6) | −3.3 (−8.1, 1.4) |
| Work productivity loss | n = 367 | n = 162 | n = 205 | |
| Mean (SD) | 17.4 (26.3) | 15.1 (23.6) | 19.2 (28.2) | −4.0 (−9.4, 1.3) |
| Activity impairment | n = 603 | n = 290 | n = 313 | |
| Mean (SD) | 19.8 (27.0) | 17.5 (25.6) | 22.0 (28.0) | −4.6 (−8.9, −0.3) |
Concomitant use of steroids or antibiotics at the time of enrollment is allowed in the UC therapy groups.
Unadjusted mean difference (95% CI) between groups for continuous variables and difference in percentage points (95% CI) between groups for categorical variables.
PROMIS scores: <55 = within normal limits (WNL), 55 ≤ 60 = mild, 60 ≤ 70 = moderate, and ≥70 = severe based on the US general population.