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Year : 2018  |  Volume : 13  |  Issue : 2  |  Page : 84-89

A prospective, randomized, double-blind, comparative clinical study of efficacy and safety of a biosimilar adalimumab with innovator product in patients with active rheumatoid arthritis on a stable dose of methotrexate

1 Medical Affairs Group, Reliance Life Sciences, Navi Mumbai, Maharashtra, India
2 Clinical Research Group, Reliance Life Sciences, Navi Mumbai, Maharashtra, India

Correspondence Address:
Dr. Prasad Apsangikar
Reliance Life Sciences, R-282, TTC Area of MIDC, Thane Belapur Road, Rabale, Mumbai - 400 701, MaharashtraLife Sciences, R.282, TTC
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/injr.injr_107_17

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Objective: The objective of this study was to compare efficacy, safety, and immunogenicity between the biosimilar adalimumab (AdaliRel) and the reference innovator product in moderate-to-severe rheumatoid arthritis (RA) patients on stable dose of methotrexate (MTX). Methods: Patients with moderate-to-severe active RA (n = 106) on a stable dose of MTX were randomized to biosimilar adalimumab (AdaliRel) (study arm) or reference innovator adalimumab (reference arm) 40 mg every 2 weeks. The primary endpoint was proportion of patients who achieve ACR20 response at week 16. The secondary endpoint was proportion of patients who achieve ACR50, ACR70, absolute values, and changes from baseline in the disease activity score 28 joint (DAS28), health assessment questionnaire-disability index (HAQ-DI), C-reactive protein (CRP), and rheumatoid factor (RF) at week 16 and week 24. Safety was assessed through adverse events (AEs) and laboratory evaluations up to week 34. Antidrug antibodies were assessed to determine immunogenicity. Results: Out of 106 randomized, 104 individuals were dosed in the study (one subject from each arm was dropped due to consent withdrawal). The number of patients achieving ACR20 response at week 16 was 90.48% in study arm and 90% in the reference arm. The number of patients ACR70 response at week 16 was 13.1% in the study arm and 15% in the reference arm. There was no statistically significant difference between the two treatment arms in terms of number of responders (P > 0.05). No difference also was observed in DAS28, HAQ-DI scores, RF, and CRP changes from baseline. There were no clinically meaningful differences in AEs. Immunogenicity profile at week 16 did not indicate any clinically significant concerns. Conclusion: Biosimilar adalimumab (AdaliRel) and the reference product showed comparable efficacy and safety in RA patients who were on stable dose of MTX.

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