Leonard L. Dragone, MD, PhD, Disease Area Leader in Autoantibody and Rheumatology, Johnson & Johnson Innovative Medicine, discusses positive topline results from a study of nipocalimab in patients with systemic lupus erythematosus (SLE).
SLE is an autoimmune disease characterized by inflammation in the connective tissues, leading to multisystem involvement and potentially significant morbidity and mortality. Genetic, immunological, endocrine, and environmental factors influence the loss of immunological tolerance against self-antigens leading to the formation of pathogenic autoantibodies that cause tissue damage through multiple mechanisms. Common signs and symptoms include severe fatigue, malaise, fever, loss of appetite, weight loss, joint pain and swelling, butterfly rash, and muscle pain and weakness.
Recently, positive topline results from the phase 2b JASMINE clinical trial were announced. JASMINE (NCT04882878) is a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study evaluating nipocalimab in 228 adult patients with active SLE. Nipocalimab is an investigational monoclonal antibody designed to bind with high affinity to block FcRn and reduce levels of circulating IgG antibodies.
The study met its primary endpoint of percentage of patients in the nipocalimab group achieving SLE Responder Index composite response at week 24 with statistical significance compared with the placebo group. It also met key secondary and exploratory endpoints. Its safety and tolerability profile was consistent with previous phase 2 studies, with no new safety concerns identified.
This study marks the first positive study of an FcRn blocker for the treatment of SLE. Based on these results, there are plans to initiate a phase 3 program. Nipocalimab is currently approved to treat another autoimmune disease, myasthenia gravis.
Full results from the JASMINE study are expected to be presented at a future medical congress.
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To learn more about SLE and other rare autoimmune disorders, visit https://checkrare.com/diseases/autoimmune-autoinflammatory-disorders/
