A number of Phase 3 trials are ongoing for etanercept biosimilars.1 One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection site reactions and immunogenicity. The RA trials are evaluating ACR20 as the primary endpoint. Secondary endpoints include ACR50, ACR70, DAS28, AEs, serious AEs, safety and immunogenicity.
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Sarilumab (REGN88/SAR153191) an investigational fully human monoclonal antibody against the interleukin 6 receptor (IL-6R) met co-primary efficacy endpoints in a Phase 3, placebo-controlled clinical trial in RA patients.2 The study, known as SARIL-RA-TARGET, evaluated safety and efficacy of two subcutaneous (SubQ) doses of sarilumab compared with placebo. Sarilumab was added to non-biologic disease-modifying antirheumatic drug (DMARD) therapy in RA patients who were intolerant to or had inadequate responders for tumor necrosis factor alpha inhibitors (n = 546). Patients received sarilumab 150 mg, sarilumab 200 mg or placebo injection every other week (Q2W).
ACR20 improvement was 61% in the sarilumab 200 mg Q2W dosed group, compared with 56% improvement in the sarilumab 150 mg group and 34% improvement in placebo-treated patients. Greater improvement in physical function was also noted by the change from baseline in the Health Assessment Questionnaire-Disability Index at Week 12. Sarilumab blocks IL-6 binding, subsequently interrupting cytokine-mediated inflammatory signaling. Adverse effects reported in the SARIL-RA-TARGET study included infections and injection site reactions. Neutrophil count reduction was the only laboratory abnormality noted in 0.6–1% of sarilumab-treated patients and 1% of placebo-treated patients. Serious infections were uncommon, and no unexpected safety findings were seen.
Two additional Phase 3 studies have shown sarilumab meeting its primary endpoints. These studies include a total of 419 patients.2 These studies are named SARIL-RA-EASY and SARIL-RA-ASCERTAIN.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Genetics and Biosimilars Initiative. Clinical trials for etanercept biosimilars. 22 May 2015.
- Regeneron Pharmaceuticals Inc. News Release: Regeneron and Sanofi announce positive topline results from Phase 3 studies with sarilumab in patients with rheumatoid arthritis. 21 May 2015.