University of Ioannina Study Evaluates Safety, Efficacy, and Tolerability of Sarilumab for Moderate to Severe RA

University of Ioannina Study Evaluates Safety, Efficacy and Tolerability of Sarilumab for Moderate to Severe RA TrialsiteN

Clinical investigators from Greece’s University of Ioannina Medical School evaluated the safety, efficacy, and tolerability of sarilumab in the treatment of moderate to severe rheumatoid arthritis (RA). The Greek investigators concluded beyond any doubt that sarilumab is a molecule that can be added to clinicians’ armamentarium for the treatment of patients with moderate to severe RA with good safety and efficacy profile.


Sarilumab (Kevzara) is a human monoclonal antibody against the interleukin-6 receptor. Regeneron Pharmaceuticals and Sanofi developed the drug for the treatment of rheumatoid arthritis (RA). The FDA approved the drug for RA on 22, May 2017 and European Medicines Agency approved it on June 23, 2017. Other indications were stalled, such as ankylosing spondylitis, after the drug failed to show benefit over methotrexate in a Phase II clinical trial.

New studies are underway, reports the Greek investigators in Dovepress, including polymyalgia rheumatica, giant cell arteritis, juvenile idiopathic arthritis, and indolent systemic mastocytosis.

Safety, Efficacy and Tolerability Proven in Three Pivotal Trials

The molecule has been scrutinized in three pivotal clinical trials: they established sarilumab as one of the safe and efficacious choices for the treatment of RA (mobility, target, and monarch trials).

Adverse Events

Infections and neutropenia are two of the most common adverse events. The MONARCH trial suggested a significantly higher incidence of neutropenia in patients receiving 200mg sarilumab every two weeks, compared to patients being treated with adalimumab (13.6% vs. 0.5%). However, infection rates were similar between both groups (28.8% vs. 27.7%). Some other common side effects occurring in 1% to 10% of patients included thrombocytopenia (low platelet count), infections of the upper respiratory tract and the urinary tract, oral herpes, hyperlipidaemia, and reactions at the injection site.

Lead Research/Investigators

Alexandros A. Drosos, Rheumatology Clinic, Department of Internal Medicine, Medical School, University of Ioannina

Paraskevi V. Voulgari

Eleftherios Pelechas

Call to Action: Interested in learning more about the study results? Contact Alexandros A. Drosos here.