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Inventi Impact: Biosimilars & Biopharmaceuticals

Articles

  • Inventi:pbs/24782/17
    A Phase III, Randomized, Two-Armed, Double-Blind, Parallel, Active Controlled, and Non-Inferiority\nClinical Trial to Compare Efficacy and Safety of Biosimilar Adalimumab (CinnoRA®) to the Reference\nProduct (Humira®) in Patients with Active Rheumatoid Arthritis
    01-Jan-1970 Research 2018 : January - March
    Ahmadreza Jamshidi, Farhad Gharibdoost, Mahdi Vojdanian, Soosan G Soroosh, Mohsen Soroush, Arman Ahmadzadeh, Mohammad Ali Nazarinia, Mohammad Mousavi, Hadi Karimzadeh, Mohammad Reza Shakibi, Zahra Rezaieyazdi, Maryam Sahebari, Asghar Hajiabbasi, Ali Asghar Ebrahimi, Najmeh Mahjourian, Amin Mohammadinejad Rashti

    Background: This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA�®, CinnaGen, Iran) to\nthe innovator product (Humira�®, AbbVie, USA) in adult patients with active rheumatoid arthritis (RA).\nMethods: In this randomized, double-blind, active-controlled, non-inferiority trial, a total of 136 patients with\nactive RA were randomized to receive 40 mg subcutaneous injections of either CinnoRA�® or Humira�® every\nother week, while receiving methotrexate (15 mg/week), folic acid (1 mg/day), and prednisolone (7.5 mg/day)\nover a period of 24 weeks. Physical examinations, vital sign evaluations, and laboratory tests were conducted\nin patients at baseline and at 12-week and 24-week visits. The primary endpoint in this study was the\nproportion of patients achieving moderate and good disease activity score in 28 joints-erythrocyte\nsedimentation rate (DAS28-ESR)-based European League Against Rheumatism (EULAR) response. The secondary\nendpoints were the proportion of patients achieving American College of Rheumatology (ACR) criteria for\n20% (ACR20), 50% (ACR50), and 70% (ACR70) responses along with the disability index of health assessment\nquestionnaire (HAQ), and safety. Results: Patients who were randomized to CinnoRA�® or Humira�® arms had comparable demographic information,\nlaboratory results, and disease characteristics at baseline. The proportion of patients achieving good and moderate\nEULAR responses in the CinnoRA�® group was non-inferior to the Humira�® group at 12 and 24 weeks based on both\nintention-to-treat (ITT) and per-protocol (PP) populations (all p values >0.05). No significant difference was noted in\nthe proportion of patients attaining ACR20, ACR50, and ACR70 responses in the CinnoRA�® and Humira�® groups\n(all p values >0.05). Further, the difference in HAQ scores and safety outcome measures between treatment\narms was not statistically significant.\nConclusion: CinnoRA�® was shown to be non-inferior to Humira�® in terms of efficacy at week 24 with a\ncomparable safety profile to the reference product.

    How to Cite this Article
    CC Compliant Citation: Jamshidi, Ahmadreza, et al. \"A phase III,\nrandomized, two-armed, double-blind, parallel, active controlled,\nand non-inferiority clinical trial to compare efficacy and safety of\nbiosimilar adalimumab (CinnoRA®) to the reference product\n(Humira®) in patients with active rheumatoid arthritis.\"\nArthritis research & therapy 19.1 (2017): 168, DOI 10.1186/\ns13075-017-1371-4, https://creativecommons.org/licenses/\nby/4.0/.
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