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Table 4 Comparison of exploratory pharmacodynamic parameter between treatment groups at week 12

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 = 27)Reference (n = 13)Test (n = 27)Reference (n = 11)
Interleukin-6
 Change from baseline at week 12−8.2 (15.97)*−10.8 (19.86)#−8.2 (15.97)*−13.5 (20.44)$
 MD (±SE)2.60 (5.84)5.30 (6.20)
 95% CI(−9.2,14.4)(−7.3, 17.9)
p value0.8780.436
  1. p values were obtained using paired t-test; *p = 0.012 vs. baseline; #p = 0.0727 vs. baseline; $p = 0.0525 vs. baseline
  2. CI Confidence interval, ITT Intention-to-treat, PP, Per protocol, MD Mean difference, SE Standard error