Table 1.
Key efficacy end points at week 24 evaluated in subgroups of patients based on 3 categories of MTX doses at baseline (intent‐to‐treat population, sensitivity analysis)a
| MTX ≤10 mg/week | MTX >10 and ≤15 mg/week | MTX >15 mg/week | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| PBO (n = 164) | CZP 200 mg (n = 326) | CZP 400 mg (n = 305) | PBO (n = 119) | CZP 200 mg (n = 201) | CZP 400 mg (n = 221) | PBO (n = 42) | CZP 200 mg (n = 111) | CZP 400 mg (n = 109) | Interaction P | |
| ACR response, % | ||||||||||
| ACR20 | 10.4 | 59.9 | 59.2 | 10.2 | 58.3 | 63.6 | 21.4 | 53.6 | 52.3 | 0.095 |
| ACR50 | 5.5 | 30.9 | 34.9 | 4.2 | 40.7 | 42.7 | 11.9 | 39.1 | 33.0 | 0.201 |
| ACR70 | 2.4 | 16.0 | 13.2 | 0.8 | 21.6 | 21.4 | 4.8 | 24.5 | 17.4 | 0.518 |
| Change from baseline in DAS28‐ESR, mean ± SD | −0.5 ± 1.2 | −2.2 ± 1.4 | −2.5 ± 1.4 | −0.6 ± 1.1 | −2.5 ± 1.5 | −2.6 ± 1.4 | −1.0 ± 1.4 | −2.5 ± 1.5 | −2.3 ± 1.5 | 0.083 |
| DAS28‐ESR remission, % | 1.2 | 8.0 | 8.9 | 0.9 | 11.6 | 14.7 | 2.4 | 17.1 | 11.0 | 0.902 |
| LDA, % | 1.8 | 15.1 | 18.4 | 1.8 | 22.1 | 27.5 | 7.1 | 29.7 | 19.3 | 0.597 |
| Mean change in radiographic end points | ||||||||||
| SHS, mean ± SD | 1.1 ± 4.0 | 0.3 ± 3.4 | −0.2 ± 2.6 | 1.6 ± 4.2 | 0.2 ± 2.7 | 0.3 ± 4.8 | 1.0 ± 1.9 | 0.1 ± 2.5 | −0.2 ± 2.7 | 0.708 |
| Erosion score, mean ± SD | 0.6 ± 2.5 | 0.0 ± 1.8 | −0.3 ± 1.8 | 0.7 ± 2.3 | 0.0 ± 1.5 | 0.1 ± 2.9 | 0.9 ± 1.8 | 0.2 ± 1.7 | 0.0 ± 0.9 | 0.530 |
| JSN score, mean ± SD | 0.5 ± 2.2 | 0.2 ± 2.3 | 0.0 ± 1.6 | 0.9 ± 2.9 | 0.2 ± 1.9 | 0.2 ± 2.4 | 0.1 ± 1.5 | −0.1 ± 2.1 | −0.1 ± 2.0 | 0.751 |
a
MTX = methotrexate; PBO = placebo; CZP = certolizumab pegol; ACR20/50/70 = American College of Rheumatology criteria for 20%/50%/70% improvement in disease activity; DAS28‐ESR = Disease Activity Score 28‐joint assessment using the erythrocyte sedimentation rate; LDA = low disease activity; SHS = modified Sharp/van der Heijde score; JSN = joint space narrowing.