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

作者：Giampiero Girolomoni, Steven R. Feldman, Paul Emery, Jeehoon Ghil, Jung Won Keum, Soo Yeon Cheong, E. Hong · 发表于：British Journal of Dermatology · 年份：2017 · DOI：10.1111/bjd.16032 · 被引用次数：32 · 研究领域：Biosimilars and Bioanalytical Methods、Rheumatoid Arthritis Research and Therapies、Statistical Methods in Clinical Trials

Dear Editor, Injection‐site reactions (ISRs) are common adverse reactions to biological drugs, consisting of itching, erythema and induration at the injection site.1 ISRs usually appear within 24–48 h of injection and subside within a few days. They typically occur in the first 2 months of treatment and subsequently decrease in frequency; incidence varies by drug. While ISRs seldom result in discontinuation of treatment, they remain a safety concern when using biological drugs. Etanercept is a recombinant tumour necrosis factor‐α soluble receptor fused to the Fc fragment of human IgG1. We previously reported a therapeutic equivalence of the etanercept (ETN) biosimilar SB4 and reference ETN in patients with moderate‐to‐severe rheumatoid arthritis. The primary end point of efficacy (American College of Rheumatology ACR 20 response) at week 24 was achieved by 78·1% and 80·5% of patients treated with SB4 and ETN, respectively.2 Other efficacy and pharmacokinetic end points were also comparable, but ISRs were observed less frequently with SB4 than with ETN up to week 52: 22 cases of ISRs were reported in 3·7% of patients (11 of 299) with SB4, and 157 cases of ISRs were reported in 17·5% of patients (52 of 297) with ETN. Historically, rates of ISRs to ETN have been reported in the range of 10–49%, and more frequent dosing was associated with higher incidences of ISRs.3,4 With the current 50‐mg once‐weekly treatment regimen, the incidence of ISRs to ETN (17·5%) was similar to that i...