Table 2a.
Secondary efficacy endpoints in the main study (week 0–52) in Crohn’s disease, per-protocol set
| Baseline (week 0) | 52 weeks | Difference at 52 weeks (95% CI) | |||
|---|---|---|---|---|---|
| CT-P13 (n = 63) |
Infliximab originator (n = 66) |
CT-P13 (n = 63) |
Infliximab originator (n = 66) |
||
| Change variables | |||||
| Harvey-Bradshaw Index* | 2.62 (2.39) | 2.58 (2.4) | 3.13 (3.69) | 2.83 (3.14) | 0.28 (−0.52 to 1.08) |
| Physician’s global assessment of disease activity | 1.3 (1.25) | 1.27 (1.26) | 1.85 (1.79) | 1.52 (1.98) | 0.29 (−0.26 to 0.84) |
| Patient’s global assessment of disease activity | 1.79 (2.02) | 1.66 (1.58) | 2.58 (2.39) | 1.92 (1.89) | 0.60 (−0.05 to 1.25) |
| C-reactive protein (mg/L), log10 | 0.50 (0.3) | 0.52 (0.32) | 0.58 (0.39) | 0.56 (0.34) | 0.04 (−0.05 to 0.13) |
| Faecal calprotectin (mg/kg), log10 | 1.97 (0.7) | 1.87 (0.53) | 2.17 (0.62) | 1.98 (0.6) | 0.05 (−0.13 to 0.24) |
| Patient-reported outcome measures | |||||
| SF-36 physical functioning | 91.76 (13.81) | 92.63 (9.21) | 91.69 (15.88) | 90.47 (15.13) | 1.86 (−1.42 to 5.15) |
| SF-36 role limitation physical | 69.76 (38.98) | 70.56 (36.64) | 64.83 (43.83) | 67.21 (41.22) | −2.72 (−14.18 to 8.74) |
| SF-36 pain | 77.78 (22.68) | 78.03 (20.34) | 76.44 (21.86) | 75.78 (26.37) | 0.53 (−5.86 to 6.93) |
| SF-36 general health | 61.83 (22.69) | 61.21 (23.27) | 57.46 (24.08) | 61.23 (25.7) | −4.69 (−9.78 to 0.41) |
| SF-36 emotional well-being | 81.14 (15.2) | 73.88 (19.45) | 77.63 (18.15) | 71.41 (21.1) | −0.74 (−5.34 to 3.86) |
| SF-36 role limitation emotional | 85.19 (30.4) | 73.23 (36.15) | 71.19 (40.8) | 73.22 (36.93) | −10.83 (−21.82 to 0.15) |
| SF-36 social functioning | 83.73 (21.02) | 83.33 (21.74) | 81.57 (24.93) | 81.97 (25.87) | −2.38 (−8.66 to 3.91) |
| SF-36 energy fatigue | 51.83 (20.68) | 54.72 (21.48) | 51.95 (26.59) | 49.92 (27.82) | 4.47 (−1.51 to 10.45) |
| SF-36 physical component summary score | 48.46 (9.67) | 50.55 (6.62) | 48.8 (8.36) | 49.63 (9.02) | 0.63 (−1.44 to 2.7) |
| SF-36 mental component summary score | 49.28 (9.21) | 45.57 (12.79) | 46.22 (12.89) | 44.68 (13.41) | −2.17 (−5.22 to 0.89) |
| EQ-5D index | 0.84 (0.15) | 0.83 (0.18) | 0.82 (0.18) | 0.80 (0.24) | 0 (−0.06 to 0.06) |
| WPAI percentage work missed due to specified problem (absenteeism) | 0.08 (0.24) | 0.04 (0.11) | 0.09 (0.21) | 0.04 (0.13) | 0.03 (−0.06 to 0.12) |
| WPAI percentage impairment while working due to specified problem (presenteeism) | 0.12 (0.18) | 0.16 (0.21) | 0.21 (0.25) | 0.16 (0.23) | 0.10 (0 to 0.19) |
| WPAI percentage overall work impairment due to specified problem | 0.15 (0.22) | 0.18 (0.23) | 0.27 (0.28) | 0.16 (0.22) | 0.14 (0.02 to 0.25) |
| WPAI percentage activity impairment due to specified problem | 0.22 (0.26) | 0.21 (0.25) | 0.26 (0.28) | 0.22 (0.27) | 0.04 (−0.03 to 0.12) |
| IBDQ total score | 184.20 (26.30) | 187.50 (23.10) | 184 (31.90) | 182.10 (31.50) | 3.50 (−2.75 to 9.70) |
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]