Johnson & Johnson announced that its Phase 2b JASMINE study of nipocalimab in adults with systemic lupus erythematosus (SLE) met the primary endpoint of achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI‑4) at week 24, with a statistically significant difference versus placebo.
The study also met key secondary and exploratory endpoints, including a reduction in steroid use and a safety profile that was consistent with earlier Phase 2 data, with no new safety signals identified.
Based on these topline results, Johnson & Johnson will launch a Phase 3 program for nipocalimab in SLE. Nipocalimab is the first FcRn blocker to demonstrate clinical benefit in this antibody‑driven disease, positioning the company to address a substantial unmet need in a market that currently relies on belimumab and other immunomodulators.
SLE affects an estimated 3 to 5 million people worldwide and 450,000 in the United States. The current standard of care, belimumab, offers modest benefit and is associated with long‑term steroid exposure. Nipocalimab’s novel mechanism—blocking the neonatal Fc receptor to reduce pathogenic IgG—could provide a more targeted and steroid‑sparing therapy, potentially expanding Johnson & Johnson’s immunology portfolio and opening new revenue streams.
Leonard L. Dragone, M.D., Ph.D., Disease Area Leader for Autoantibody and Rheumatology, said, “Systemic lupus erythematosus is a serious autoantibody‑driven disease that can impact multiple organ systems, significantly reducing quality of life for millions of people. Many patients also face complications from long‑term steroid use, underscoring the limitations of current treatments and the critical need for immunoselective therapies that are safe, tolerable, and capable of reducing disease activity while preserving immune function.”
The JASMINE results mark a pivotal moment for Johnson & Johnson’s innovative medicine strategy. As the first FcRn blocker to show benefit in SLE, nipocalimab could not only capture a share of the growing SLE market—projected to reach $6.8 billion by 2035—but also serve as a platform for other IgG‑mediated autoimmune diseases such as generalized myasthenia gravis and Sjögren’s disease.
With the Phase 3 program underway, Johnson & Johnson is positioning nipocalimab to become a cornerstone therapy in a field that has long lacked truly disease‑modifying options. The company’s focus on high‑growth, high‑barrier indications aligns with its broader strategy to strengthen its immunology pipeline and drive long‑term shareholder value.
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