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Table 2 ACR20, 50, and 70 responses between treatment groups at weeks 12 and 24

From: Comparative evaluation of efficacy, pharmacodynamics, and safety of Hetero’s adalimumab (Mabura®, Hetero Biopharma Ltd.) and reference adalimumab (Humira®, Abbvie Inc.) in patients with active rheumatoid arthritis on concomitant methotrexate therapy

 ITT analysisPP analysis
Test (n = 112)Reference (n = 56)Test (n = 107)Reference (n = 52)
At Week 12
 ACR20 response (%)108 (96.43)54 (96.43)107 (100)52 (100)
 PD (95% CI)0.0 (−6.0, 6.0)0.0 (− 0.03, 0.07)
p value1.0001.000
 ACR50 response (%)27 (24.11)20 (35.71)26 (24.30)19 (36.54)
 PD (95% CI)− 11.6 (− 26.4, 3.2)−12.2 (− 27.6, 3.2)
p value0.1450.134
 ACR70 response (%)6 (5.36)6 (10.71)6 (5.61)6 (11.54)
 PD (95% CI)−5.4 (−14.5, 3.8)−5.9 (− 15.6, 3.8)
p value0.2170.209
At Week 24
 ACR20 response (%)104 (92.86)54 (96.43)99 (96.12)51 (100.00)
 PD (95% CI)−3.6 (−10.4, 3.2)−3.9 (−7.6, 0.2)
p value0.4990.303
 ACR50 response (%)89 (79.46)44 (78.57)86 (83.50)42 (82.35)
 PD (95% CI)0.9 (−12.2, 14.0)1.1 (−11.5, 13.8)
p value1.0001.000
 ACR70 response (%)54 (48.21)30 (53.57)53 (51.46)29 (56.86)
 PD (95% CI)−5.4 (−21.4, 10.7)−5.4 (−22.1, 11.3)
p value0.6240.608
  1. p values were calculated using Fisher’s exact test; ACR20, ACR50 and ACR70 responses: ≥20%, ≥50%, and ≥ 70%, respectively, improvement in swollen joint count, tender joint count, physician’s assessment of disease activity, patient’s assessment of disease activity, pain, and physical function, and levels of an acute-phase reactant (either C-reactive protein [CRP] level or erythrocyte sedimentation rate [ESR]); ACR American College of Rheumatology, CI Confidence interval, ITT Intention-to-treat, PP per-Protocol, PD Proportional difference