Table 1.
Variable | N | |
---|---|---|
Age [years], mean ± SD | 461 | 41.8 ± 13.8 |
Male, n [%] | 461 | 255 [55.3] |
White, n [%] | 461 | 447 [97.0] |
UC duration [years], mean ± SD | 459 | 7.3 ± 7.0 |
Prior TNF antagonist use, n [%] | 463 | 72 [15.6] |
UC-related concomitant medications,an [%] | ||
Mesalazine | 463 | 304 [65.7] |
Azathioprine | 463 | 168 [36.3] |
Prednisolone | 463 | 122 [26.3] |
Prednisone | 463 | 91 [19.7] |
Methylprednisone | 463 | 70 [15.1] |
Sulphasalazine | 463 | 36 [7.8] |
Mercaptopurine | 463 | 28 [6.0] |
Physician’s Global Assessment [PGA], n [%] | 460 | |
PGA of 2 | 386 [83.9] | |
PGA of 3 | 74 [16.1] | |
SCCAI, mean ± SD | 461 | 7.7 ± 2.4 |
SIBDQ total score, mean ± SD | 460 | 30.9 ± 8.7 |
Bowel | 461 | 9.5 ± 3.1 |
Social | 460 | 6.0 ± 2.5 |
Systemic | 461 | 6.5 ± 2.4 |
Emotional | 461 | 8.9 ± 3.1 |
EQ-5D-5L total score, mean ± SD | 454 | 0.6 ± 0.2 |
EQ-5D-5L VAS, mean ± SD | 451 | 50.9 ± 19.4 |
TSQM, mean ± SD | ||
Effectiveness | 452 | 35.2 ± 18.5 |
Side effects | 449 | 70.3 ± 34.3 |
Convenience | 451 | 68.3 ± 20.4 |
Global satisfaction | 449 | 38.0 ± 20.5 |
WPAI, mean ± SD | ||
Work time missed [%]b | 223 | 20.4 ± 30.1 |
Impairment while working [%]b | 229 | 50.2 ± 24.8 |
Overall work impairment [%]b | 221 | 58.5 ± 26.7 |
Activity impairment [%] | 446 | 59.0 ± 23.5 |
EQ-5D-5L, The European Quality of Life—5 Dimensions—5 Level; PGA, Physician’s Global Assessment; SCCAI, Simple Clinical Colitis Activity Index; SD, standard deviation; SIBDQ, Short Inflammatory Bowel Disease Questionnaire TNF, tumour necrosis factor; TSQM, Treatment Satisfaction Questionnaire for Medication; UC, ulcerative colitis; VAS, visual analogue scale; WPAI, Work Productivity and Activity Impairment.
aConcomitant UC-related medications administered to ≥ 5% of patients. A concomitant medication was defined as any medication that started before the first dose of adalimumab [ADA] and continued after the first dose of study drug or any medication that started on or after the first dose of ADA, but was not started later than 14 days after the last dose of ADA.
bOnly patients who were employed were assessed.