Efficacy, Safety and Immunogenicity of Enerceptan Compared to Enbrel in Rheumatoid Arthritis

Phase 3 Completed 168 enrolled Gema Biotech S.A. QUID Quality in Drugs and Devices Latin American Consulting SRL · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to asses the compared efficacy, safety and immunogenicity of ENERCEPTAN® with ENBREL® in combination with Methotrexate for the treatment of patients with rheumatoid arthritis.

Timeline

Start: 2016-02
Primary completion: 2017-03
Completion: 2017-09

Outcome

Met primary endpoint

paper CONCLUSIONS: Efficacy outcomes for EtaBS were noninferior to original etanercept in patients with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate. PMID 33337815 ↗

paper (difference, -1.2%; 95% confidence interval, -10.1% to 7.6%). PMID 33337815 ↗

Publications

Strusberg I, Mysler E, Citera G, Siri D, de Los Angeles Correa M, Lazaro MA, Pardo Hidalgo R, Spindler A, Tate P, Venarotti H, Velasco Zamora J, Klimovsky E, Federico A, Scheines E, Gonzalez E, Cordeiro L, Lago N. Efficacy, Safety, and Immunogenicity of Biosimilar Etanercept (Enerceptan) Versus Its Original Form in Combination With Methotrexate in Patients With Rheumatoid Arthritis: A Randomized, Multicenter, Evaluator-Blinded, Noninferiority Study. J Clin Rheumatol. 2021 Sep 1;27(6S):S173-S179. doi: 10.1097/RHU.0000000000001616.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etanercept	Protein / enzyme biologic	50 mg	Subcutaneous
Background	Methotrexate	Small molecule	15 mg	—
Background	Methotrexate	Small molecule	25 mg	—