Comparison of injection site reactions between the etanercept biosimilar SB4 and the reference etanercept in patients with rheumatoid arthritis from a Phase III study

Abstract

Injection site reactions (ISRs) are common adverse reactions to biologic drugs, consisting of itching, erythema, and induration at the injection site¹. ISRs usually appear within 24-48 hours after injection and subside within a few days. They typically occur in the first two months of treatment and subsequently decrease in frequency; incidence varies by drug. While ISRs seldom result in discontinuation of treatment, ISRs remain a safety concern when using biologic drugs.

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