A randomized clinical trial of bermekimab treatment for clinical improvement of systemic sclerosis

• Published in: iScience 2023-09, Vol.26 (9), p.107670-107670, Article 107670
• Main Authors: Solomonidi, Nicky, Vlachoyiannopoulos, Panayiotis G., Pappa, Maria, Liantinioti, Georgia, Ktena, Sofia, Theotikos, Evangelos, Elezoglou, Antonia, Netea, Mihai G., Giamarellos-Bourboulis, Evangelos J.
• Format: Article
• Language: English
• Subjects: Health sciences; Medicine; Neurology; Pharmacology
• ISSN: 2589-0042; 2589-0042
• DOI: 10.1016/j.isci.2023.107670

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. [Display omitted] •Bermekimab is a monoclonal antibody blocking the activity of IL-1α•12-week treatment provides global improvement in systemic sclerosis•Decrease of inflamed joints and improvement of lung function prevail•Production of IL-1α and TNF by circulating monocytes is decreased Health sciences; Medicine; Neurology; Pharmacology