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

Increased concentrations of interleukin (IL)-1 alpha have been recently described in tissues of patients with systemic sclerosis (SSc) suggesting that IL-1 alpha 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-1 alpha 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-1 alpha 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.

Automated summary

This study found that increased concentrations of IL-1 alpha are present in SSc patients. Treatment with the IL-1 alpha blocking antibody, bermekimab, effectively inhibits disease progression and reduces inflammation.