A randomized clinical trial of bermekimab treatment for clinical improvement of systemic sclerosis
Nicky Solomonidi,
Panayiotis G. Vlachoyiannopoulos,
Maria Pappa,
Georgia Liantinioti,
Sofia Ktena,
Evangelos Theotikos,
Antonia Elezoglou,
Mihai G. Netea,
Evangelos J. Giamarellos-Bourboulis
Affiliations
Nicky Solomonidi
4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece
Panayiotis G. Vlachoyiannopoulos
Department of Pathophysiology, National and Kapodistrian University of Athens, Medical School, Athens, Greece
Maria Pappa
Department of Pathophysiology, National and Kapodistrian University of Athens, Medical School, Athens, Greece
Georgia Liantinioti
Department of Pathophysiology, National and Kapodistrian University of Athens, Medical School, Athens, Greece
Sofia Ktena
4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece
Evangelos Theotikos
Department of Rheumatology, Asklepieion General Hospital of Voula, Athens, Greece
Antonia Elezoglou
Department of Rheumatology, Asklepieion General Hospital of Voula, Athens, Greece
Mihai G. Netea
Department of Internal Medicine and Center for Infectious Diseases, Radboud University, Nijmegen 6500, the Netherlands; Department of Immunology and Metabolism, Life and Medical Sciences Institute, University of Bonn, Bonn, Germany
Evangelos J. Giamarellos-Bourboulis
4th Department of Internal Medicine, National and Kapodistrian University of Athens, Medical School, Athens, Greece; Corresponding author
Summary: Increased concentrations of interleukin (IL)-1α have been recently described in tissues of patients with systemic sclerosis (SSc) suggesting that IL-1α inhibition may be a target for treatment. We conducted a double-blind, placebo-controlled study to assess the safety and efficacy of the fully humanized IL-1α blocking monoclonal antibody bermekimab in SSc. To evaluate response to treatment, we developed the score of inhibition of progression of SSc which was validated using the CRISS index and the modified CRISS index. The primary endpoint was met in 80% of bermekimab-treated patients vs. 20% of placebo-treated patients (p: 0.023). Most of efficacy was found for increase of carbon monoxide lung diffusion capacity. Production of IL-1α and TNF by circulating mononuclear cells was decreased and the absolute count of CD42/Cd62-platelets was decreased. Results suggest that bermekimab is a promising treatment for SSc.
