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Table 3 DAS28-CRP value and HAQ-DI scores 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)
DAS28 CRP value
 Change from baseline at week 12*−2.1 (1.06)− 2.0 (1.36)−2.2 (1.02)− 2.1 (1.24)
 MD (±SE)−0.08 (0.19)−0.04 (0.19)
 95% CI(−0.5, 0.3)(− 0.4, 0.3)
p value0.9680.945
 Change from baseline at week 24*−3.3 (1.58)−3.2 (1.53)−3.5 (1.48)−3.4 (1.32)
 MD (±SE)−0.12 (0.26)−0.09 (0.24)
 95% CI(−0.6, 0.4)(−0.6, 0.4)
p value0.9200.997
HAQ-DI
 Change from baseline at week 12*−1.0 (0.51)−0.9 (0.50)−1.0 (0.51)− 1.0 (0.44)
 MD (±SE)−0.02 (0.08)−0.00 (0.08)
 95% CI(−0.2, 0.1)(−0.2, 0.2)
p value0.6790.588
 Change from baseline at week 24*−1.3 (0.54)−1.3 (0.58)− 1.4 (0.52)−1.3 (0.50)
 MD (±SE)−0.06 (0.09)−0.03 (0.09)
 95% CI(−0.2, 0.1)(−0.2, 0.1)
p value0.6530.449
  1. Data presented as mean ± SD; p values were obtained using paired t-test; *p < 0.001 vs. baseline; CI Confidence interval, DAS28-CRP Disease Activity Score 28–C-Reactive Protein, HAQ-DI Health Assessment Questionnaire–Disability Index, ITT Intention-to-treat, PP Per-protocol, MD Mean difference, SE Standard error