Iscalimab, an anti-CD40 monoclonal antibody, showed preliminary efficacy for the treatment of primary Sjögren syndrome (pSS) in a phase II placebo-controlled trial (n = 44). Of the two administration routes tested (intravenous and subcutaneous), only intravenous iscalimab resulted in a significant reduction in the EULAR Sjögren’s syndrome disease activity index (ESSDAI) score after 12 weeks of treatment compared with placebo (95% CI 0.96–9.46; one-sided P = 0.0090). Only two severe adverse events were reported across all groups, neither of which was related to iscalimab.
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Fisher, B. A. et al. Assessment of the anti-CD40 antibody iscalimab in patients with primary Sjögren’s syndrome: a multicentre, randomised, double-blind, placebo-controlled, proof-of-concept study. Lancet Rheumatol. https://doi.org/10.1016/S2665-9913(19)30135-3 (2020)
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Clarke, J. CD40 blockade shows promise in pSS trial. Nat Rev Rheumatol 16, 126 (2020). https://doi.org/10.1038/s41584-020-0380-x
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DOI: https://doi.org/10.1038/s41584-020-0380-x