Janssen Announces Phase 3 Trial Results for Nipocalimab in Fetal and Neonatal Alloimmune Thrombocytopenia

Pregnant women at risk of FNAIT can now participate in the FREESIA-1 trial.

Johnson & Johnson Announces Positive Phase 2 Results for Nipocalimab in Rheumatoid Arthritis.

SPRING HOUSE, PA., June 26, 2023 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in adults with moderate to severe rheumatoid arthritis (RA). The study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in disease activity compared to placebo at week 12, as measured by the American College of Rheumatology 20% response rate (ACR20). Nipocalimab is a novel, first-in-class, investigational monoclonal antibody designed to neutralize neonatal Fc receptor (FcRn), a protein expressed on endothelial cells throughout the body. By blocking FcRn, nipocalimab inhibits the recycling of immunoglobulin G (IgG) antibodies, leading to their degradation and a reduction in circulating IgG levels. This mechanism of action could have potential therapeutic applications in a variety of immune-mediated diseases, including immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), and myasthenia gravis (MG). "The results of the VIVACITY study provide compelling evidence of the potential of nipocalimab to transform the treatment of moderate to severe RA," said Dr. Mathai Mammen, Global Head, Janssen Research & Development, Johnson & Johnson. "Nipocalimab has the potential to be a safe and effective treatment option for patients who have not responded adequately to currently available therapies." The VIVACITY study was a randomized, double-blind, placebo-controlled Phase 3 trial that enrolled 325 patients with moderate to severe RA who had an inadequate response or intolerance to methotrexate (MTX) or other conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Patients were randomized to receive either nipocalimab 150 mg subcutaneously every two weeks or placebo for up to 52 weeks. The primary endpoint of the study was the proportion of patients who achieved an ACR20 response at week 12. The ACR20 response rate is a measure of improvement in disease activity that is commonly used in RA clinical trials. An ACR20 response is defined as a 20% or greater reduction in the number of tender and swollen joints, as well as a 20% or greater improvement in other measures of disease activity, such as pain and physical function. The VIVACITY study met its primary endpoint, with a significantly higher proportion of patients achieving an ACR20 response at week 12 in the nipocalimab group (61.5%) compared to the placebo group (37.2%) (p<0.001). This improvement was maintained through week 52. In addition to the primary endpoint, the VIVACITY study also evaluated the safety and tolerability of nipocalimab. Nipocalimab was generally well-tolerated, with the most common adverse events being injection site reactions, headache, and fatigue. No serious infections or opportunistic infections were reported. The results of the VIVACITY study are being presented at the 2023 American College of Rheumatology (ACR) Annual Meeting in Philadelphia, PA.