Table 2b.
Secondary efficacy endpoints in the main study (week 0–52) in ulcerative colitis, per-protocol set
| Baseline (week 0) | 52 weeks | Difference at 52 weeks (95% CI) | |||
|---|---|---|---|---|---|
| CT-P13 (n = 42) |
Infliximab originator (n = 33) |
CT-P13 (n = 42) |
Infliximab originator (n = 33) |
||
| Change variables | |||||
| Partial Mayo Score* | 0.62 (1.31) | 0.61 (1.32) | 0.45 (1.06) | 0.66 (1.12) | −0.23 (−0.71 to 0.25) |
| Physician’s global assessment of disease activity | 0.88 (1.56) | 0.70 (1.19) | 0.93 (1.4) | 0.81 (1.45) | 0.08 (−0.53 to 0.70) |
| Patient’s global assessment of disease activity | 1.31 (1.75) | 0.94 (1.60) | 1.43 (1.99) | 1.34 (1.79) | −0.05 (−0.86 to 0.77) |
| C-reactive protein (mg/L), log10 | 0.49 (0.32) | 0.52 (0.35) | 0.53 (0.27) | 0.48 (0.25) | 0.04 (−0.08 to 0.170) |
| Faecal calprotectin (mg/kg), log10 | 1.77 (0.62) | 1.82 (0.66) | 1.76 (0.63) | 1.83 (0.77) | −0.09 (−0.38 to 0.20) |
| Patient-reported outcome measures | |||||
| SF-36 physical functioning | 92.32 (14.41) | 89.24 (17.07) | 92.18 (15.03) | 91.91 (13.17) | −1.03 (−5.01 to 2.96) |
| SF-36 role limitation physical | 78.12 (35.44) | 70.31 (38.85) | 80.92 (32.59) | 84.17 (27.45) | −6.17 (−20.05 to 7.71) |
| SF-36 pain | 86.04 (21.77) | 77.73 (19.99) | 81.09 (22.6) | 84.08 (17.13) | −5.57 (−13.49 to 2.34) |
| SF-36 general health | 70.61 (22.06) | 69.53 (21.15) | 67.88 (25.11) | 69.5 (24.99) | 0.43 (−6.09 to 6.94) |
| SF-36 emotional well-being | 77.85 (15.13) | 82 (12.57) | 79.07 (14.87) | 82 (13.52) | 0.19 (−5.12 to 5.49) |
| SF-36 role limitation emotional | 76.42 (35.94) | 82.29 (33.85) | 78.07 (33.13) | 90 (26.48) | −6.91 (−19.01 to 5.2) |
| SF-36 social functioning | 87.20 (18.22) | 87.50 (19.05) | 87.82 (18.91) | 95.42 (11.6) | −6.86 (−13.48 to −0.24) |
| SF-36 energy fatigue | 56.34 (22.05) | 56.56 (19.36) | 58.59 (25) | 57.17 (23.73) | 4.68 (−3.49 to 12.84) |
| SF-36 physical component summary score | 53.10 (8.21) | 49.18 (8.99) | 52.08 (8.44) | 51.19 (7.4) | −1.30 (−4.03 to 1.43) |
| SF-36 mental component summary score | 46.63 (10.15) | 50.10 (8.97) | 48.29 (9.95) | 51.51 (6.26) | −1.00 (−4.5 to 2.5) |
| EQ-5D index | 0.86 (0.18) | 0.87 (0.12) | 0.85 (0.2) | 0.88 (0.12) | −0.01 (−0.08 to 0.06) |
| WPAI percentage work missed due to specified problem (absenteeism) | 0.08 (0.25) | 0.03 (0.07) | 0.08 (0.2) | 0.04 (0.13) | 0.01 (−0.11 to 0.13) |
| WPAI percentage impairment while working due to specified problem (presenteeism) | 0.12 (0.24) | 0.09 (0.15) | 0.17 (0.24) | 0.12 (0.16) | 0.02 (−0.09 to 0.13) |
| WPAI percentage overall work impairment due to specified problem | 0.17 (0.31) | 0.13 (0.19) | 0.21 (0.3) | 0.13 (0.19) | 0.03 (−0.11 to 0.18) |
| WPAI percentage activity impairment due to specified problem | 0.18 (0.28) | 0.15 (0.24) | 0.21 (0.28) | 0.11 (0.18) | 0.05 (−0.04 to 0.13) |
| IBDQ total score | 191 (22.47) | 193.54 (21.05) | 191.83 (23.32) | 198.08 (18.29) | −3.43 (−10.49 to 3.62) |
Data are mean (SD) at baseline and mean (SD) change from baseline (follow-up minus baseline). Difference is adjusted treatment difference of change from baseline with 95% CI
CI confidence interval, EQ-5D EuroQol questionnaire time trade-off UK weighted, IBDQ Inflammatory Bowel Disease Questionnaire, WPAI Work Productivity and Impairment Questionnaire
*Ref. [19]