TOPLINE:
Iscalimab, a novel anti-CD40 monoclonal antibody, showed efficacy in lupus nephritis (LN) by reducing proteinuria at 24 weeks compared with placebo. The treatment was generally well tolerated, with most adverse events being mild to moderate.
METHODOLOGY:
Researchers conducted a phase 2 randomized study to evaluate the efficacy, pharmacokinetics, and safety of iscalimab vs placebo as an add-on to standard-of-care therapy in patients with biopsy-proven active proliferative LN.
Overall, 57 patients with proliferative LN class III or IV who met four or more American College of Rheumatology criteria for systemic lupus erythematosus with a urinary protein-to-creatinine ratio of ≥ 0.5 mg/mg (56.52 mg/mmol) and sufficient kidney function were included.
Patients were randomly assigned