Clinical outcomes at week 16 per treatment arm
| COBRA Classic | COBRA Slim | COBRA Avant-Garde | p Value | Δ between Classic vs Slim (95% CI) | Δ between Avant-Garde vs Slim (95% CI) | |
|---|---|---|---|---|---|---|
| Number of patients | 98 | 98 | 94 | |||
| DAS28 (CRP) change | 2.8±1.2 | 2.6±1.2 | 2.4±1.3 | 0.140 | 0.2 (−0.13 to 0.52) | −0.2 (−0.49 to 0.21) |
| Remission | 70.4% | 73.5% | 68.1% | 0.713 | −3.1% (−15.4% to 9.5%) | −5.4% (−18.0% to 7.4%) |
| Low-disease activity | 84.7% | 86.7% | 87.2% | 0.863 | −2.0% (−12.0% to 7.9%) | 0.5% (−9.3% to 10.2%) |
| Good EULAR response | 79.6% | 79.6% | 76.6% | 0.844 | 0.0% (−11.3% to 11.3%) | −3.0% (−14.7% to 8.7%) |
| Moderate EULAR response | 98.0% | 95.9% | 93.6% | 0.320 | 2.1% (−3.6% to 8.2%) | −2.3% (−9.6% to 4.6%) |
| HAQ change | 0.8±0.6 | 0.6±0.6 | 0.7±0.6 | 0.081 | 0.2 (0.02 to 0.37) | 0.1 (−0.17 to 0.19) |
| Clinically meaningful HAQ change | 84.7% | 76.5% | 76.6% | 0.271 | 8.2% (−3.0% to 19,1%) | 0.1% (−11.9% to 12.0%) |
| HAQ=0 | 45.9% | 42.9% | 48.9% | 0.700 | 3.0% (−10.7% to 16.6%) | 6.0% (−7.9% to 19.7%) |
Remission was defined as DAS28(CRP) <2.6. Low-disease activity was defined as DAS(CRP) ≤3.2. Good EULAR response was defined as low-disease activity with a DAS28(CRP) change >1.2. Moderate EULAR response was defined as DAS28(CRP) change >1.2 or a DAS28(CRP) ≤5.1 and a DAS28(CRP) changes between 0.6 and 1.2. Clinically meaningful HAQ change was defined as an HAQ change >0.22. Data are presented as mean±SD or as percentages. Statistical analysis was performed by χ2 or Kruskal–Wallis test. A p value <0.05 was considered statistically significant. DAS28(CRP) was imputed in seven out of 98 Classic, two out of 96 Slim and four out of 94 Avant-Garde patients. HAQ was imputed in seven out of 98 Classic, two out of 96 Slim and four out of 94 Avant-Garde patients.
COBRA, combination therapy for early rheumatoid arthritis; CI (calculated by the Newcombe method for differences between proportions); CRP, C-reactive protein; DAS28(CRP), 28 joint disease activity score calculated with C-reactive protein; DAS28(CRP) change, DAS score on baseline minus DAS score on week 16; EULAR, European League Against Rheumatism; HAQ, health assessment questionnaire; HAQ change, baseline HAQ minus week 16 HAQ; Δ, difference.