A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis

Jamshidi, A. and Gharibdoost, F. and Vojdanian, M. and Soroosh, S. G. and Soroush, M. and Ahmadzadeh, A. and Nazarinia, M. A. and Mousavi, M. and Karimzadeh, H. and Shakibi, M. R. and Rezaieyazdi, Z. and Sahebari, M. and Hajiabbasi, A. and Ebrahimi, A. A. and Mahjourian, N. and Rashti, A. M. (2017) A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis. Arthritis Research and Therapy, 19 (1).

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Abstract

Background: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA). Methods: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with active RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA® or Humira® every other week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day) over a period of 24 weeks. Physical examinations, vital sign evaluations, and laboratory tests were conducted in patients at baseline and at 12-week and 24-week visits. The primary endpoint in this study was the proportion of patients achieving moderate and good disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR)-based European League Against Rheumatism (EULAR) response. The secondary endpoints were the proportion of patients achieving American College of Rheumatology (ACR) criteria for 20 (ACR20), 50 (ACR50), and 70 (ACR70) responses along with the disability index of health assessment questionnaire (HAQ), and safety. Results: Patients who were randomized to CinnoRA® or Humira® arms had comparable demographic information, laboratory results, and disease characteristics at baseline. The proportion of patients achieving good and moderate EULAR responses in the CinnoRA® group was non-inferior to the Humira® group at 12 and 24 weeks based on both intention-to-treat (ITT) and per-protocol (PP) populations (all p values >0.05). No significant difference was noted in the proportion of patients attaining ACR20, ACR50, and ACR70 responses in the CinnoRA® and Humira® groups (all p values >0.05). Further, the difference in HAQ scores and safety outcome measures between treatment arms was not statistically significant. Conclusion: CinnoRA® was shown to be non-inferior to Humira® in terms of efficacy at week 24 with a comparable safety profile to the reference product. Trial registration: IRCT.ir, IRCT2015030321315N1. Registered on 5 April 2015. © 2017 The Author(s).

Item Type: Article
Additional Information: Cited By :10 Export Date: 16 February 2020 CODEN: ARTRC Correspondence Address: Jamshidi, A.; Rheumatology Research Center, Tehran University of Medical SciencesIran; email: jamshida@tums.ac.ir
Uncontrolled Keywords: Adalimumab Biosimilar CinnoRA® Rheumatoid arthritis biosimilar agent folic acid methotrexate prednisolone antirheumatic agent abdominal pain adult aged American College of Rheumatology Article backache comparative effectiveness controlled study DAS28 double blind procedure drug efficacy drug response drug safety drug tolerability dyspnea erythrocyte sedimentation rate female flu like syndrome headache Health Assessment Questionnaire human injection site bleeding injection site erythema injection site pain injection site pruritus injection site swelling intention to treat analysis Iran laboratory test major clinical study male nausea outcome assessment phase 3 clinical trial physical examination pre protocol population randomized controlled trial rash respiratory tract infection sinusitis statistical analysis swelling urinary tract infection urticaria vital sign clinical trial middle aged treatment outcome Antirheumatic Agents Arthritis, Rheumatoid Biosimilar Pharmaceuticals Double-Blind Method Humans
Subjects: WE Musculoskeletal system
QV pharmacology
Divisions: Mashhad University of Medical Sciences
Depositing User: mr lib3 lib3
Date Deposited: 03 Mar 2020 10:33
Last Modified: 03 Mar 2020 10:33
URI: http://eprints.mums.ac.ir/id/eprint/16875

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