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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 analysis

PP 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 value

1.000

1.000

 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 value

0.145

0.134

 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 value

0.217

0.209

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 value

0.499

0.303

 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 value

1.000

1.000

 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 value

0.624

0.608

  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