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Table 5 Incidence of ADAs at weeks 12 and 24, AEs, and TEAEs between treatment groups

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

 Test (n = 112)Reference (n = 56)
Immunogenicity assessment
 Incidence of ADAs at week 12, n (%)53 (61.63)23 (60.53)
 PD (95% CI)1.1 (−17.5, 19.7)
p value1.000
 Incidence of ADAs at week 24, n (%)51 (61.45)24 (63.16)
 PD (95% CI)−1.7 (−20.3, 16.9)
p value1.000
Safety assessments
 Patients with at least one AE, n (%)34 (30.4)20 (35.7)
p value0.4889
 Number of TEAEs, n (%)60 (53.6)28 (50.0)
p value0.7436
  1. p values were obtained using paired t-test; ADAs Antidrug antibodies, AE Adverse event, TEAE Treatment-emergent adverse event, PD Proportional difference, CI Confidence interval