Efficacy, pharmacokinetics and safety of iscalimab (CFZ533) in patients with proliferative lupus nephritis: A randomised, double-blind, placebo-controlled, Phase II study
RMD Open 2025;11:e005557 Doi:10.1136/rmdopen-2025-005557
Shen N et al. report that iscalimab was clinically effective and generally well tolerated; in addition, it was devoid of the thromboembolic risk characteristic of Fc active anti-CD40L therapies.
Authors evaluated efficacy, pharmacokinetics and safety of iscalimab versus placebo as an add-on to SoC therapy in patients with biopsy-proven active proliferative LN after 24 weeks of treatment. Shen et al. found that iscalimab showed a significant improvement in proteinuria (UPCR) in patients with active LN. Iscalimab was generally well tolerated, with the exception of a few severe infections and one case of macrophage-activation syndrome in immunosuppressed and comorbid patients.