Table 2.
Improvement in patient-reported outcomes with CT-P13 and RP in the per-protocol population
| CT-P13 (3 mg/kg) | RP (3 mg/kg) | |||||
|---|---|---|---|---|---|---|
| Time point | n | Actual result (mean ± SD) | Change from baseline (mean ± SD) | n | Actual result (mean ± SD) | Change from baseline (mean ± SD) |
| VAS score for the patient assessment of pain | ||||||
| Baseline | 248 | 65.7 ± 17.8 | – | 251 | 65.5 ± 17.7 | – |
| Week 14 | 248 | 36.1 ± 21.4 | −29.6 ± 23.3 | 250 | 38.3 ± 22.2 | −27.1 ± 23.1 |
| Week 30 | 248 | 36.2 ± 22.9 | −29.5 ± 25.6 | 250 | 37.7 ± 23.6 | −27.7 ± 24.9 |
| Week 54 | 226 | 35.0 ± 21.2 | −30.2 ± 23.8 | 220 | 37.4 ± 24.7 | −28.4 ± 26.9 |
| VAS score for the patient global assessment of disease activity | ||||||
| Baseline | 248 | 65.1 ± 17.5 | – | 251 | 65.3 ± 17.3 | – |
| Week 14 | 248 | 35.6 ± 21.1 | −29.5 ± 22.1 | 249 | 39.7 ± 22.5 | −25.5 ± 24.4 |
| Week 30 | 247 | 37.0 ± 22.3 | −28.1 ± 25.9 | 250 | 38.4 ± 23.4 | −26.9 ± 25.5 |
| Week 54 | 225 | 34.9 ± 20.7 | −30.3 ± 24.3 | 220 | 38.7 ± 25.3 | −26.6 ± 27.8 |
| HAQ estimate of physical ability | ||||||
| Baseline | 248 | 1.61 ± 0.56 | – | 251 | 1.54 ± 0.58 | – |
| Week 14 | 248 | 1.02 ± 0.62 | −0.59 ± 0.55 | 251 | 1.04 ± 0.64 | −0.50 ± 0.50 |
| Week 30 | 248 | 1.01 ± 0.64 | −0.60 ± 0.60 | 251 | 1.03 ± 0.66 | −0.51 ± 0.56 |
| Week 54 | 226 | 0.99 ± 0.61 | −0.60 ± 0.61 | 220 | 1.02 ± 0.64 | −0.52 ± 0.59 |
| SF-36 score (physical component summary) | ||||||
| Baseline | 247 | 31.4 ± 6.1 | – | 251 | 31.8 ± 7.2 | – |
| Week 14 | 247 | 38.9 ± 7.6 | 7.5 ± 7.1 | 251 | 37.6 ± 7.9 | 5.8 ± 6.8 |
| Week 30 | 248 | 38.6 ± 7.9 | 7.1 ± 7.9 | 250 | 38.3 ± 8.0 | 6.5 ± 7.6 |
| Week 54 | 226 | 39.2 ± 7.5 | 7.6 ± 8.1 | 220 | 38.6 ± 8.7 | 6.6 ± 8.4 |
| SF-36 score (mental component summary) | ||||||
| Baseline | 247 | 36.8 ± 10.4 | – | 251 | 38.4 ± 11.3 | – |
| Week 14 | 247 | 43.4 ± 10.7 | 6.6 ± 10.2 | 251 | 44.9 ± 9.6 | 6.5 ± 10.4 |
| Week 30 | 248 | 44.0 ± 10.2 | 7.1 ± 10.0 | 251 | 45.0 ± 10.3 | 6.6 ± 10.4 |
| Week 54 | 226 | 43.9 ± 9.9 | 7.1 ± 10.1 | 220 | 45.1 ± 10.0 | 6.9 ± 11.2 |
HAQ Health Assessment Questionnaire, RP reference product (i.e., reference infliximab), SD standard deviation, SF-36 Medical Outcomes Study Short Form Health Survey, VAS visual analogue scale (mm)