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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 analysis

PP 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 value

0.968

0.945

 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 value

0.920

0.997

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 value

0.679

0.588

 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 value

0.653

0.449

  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