Table 2

Clinical outcomes at week 16 per treatment arm

COBRA ClassicCOBRA SlimCOBRA Avant-Gardep ValueΔ between Classic vs Slim (95% CI)Δ between Avant-Garde vs Slim (95% CI)
Number of patients989894
DAS28 (CRP) change2.8±1.22.6±1.22.4±1.30.1400.2 (−0.13 to 0.52)−0.2 (−0.49 to 0.21)
Remission70.4%73.5%68.1%0.713−3.1% (−15.4% to 9.5%)−5.4% (−18.0% to 7.4%)
Low-disease activity84.7%86.7%87.2%0.863−2.0% (−12.0% to 7.9%)0.5% (−9.3% to 10.2%)
Good EULAR response79.6%79.6%76.6%0.8440.0% (−11.3% to 11.3%)−3.0% (−14.7% to 8.7%)
Moderate EULAR response98.0%95.9%93.6%0.3202.1% (−3.6% to 8.2%)−2.3% (−9.6% to 4.6%)
HAQ change0.8±0.60.6±0.60.7±0.60.0810.2 (0.02 to 0.37)0.1 (−0.17 to 0.19)
Clinically meaningful HAQ change84.7%76.5%76.6%0.2718.2% (−3.0% to 19,1%)0.1% (−11.9% to 12.0%)
HAQ=045.9%42.9%48.9%0.7003.0% (−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.