Johnson & Johnson Announces Phase 3 Clinical Trial Results for Nipocalimab in Rheumatoid Arthritis

Topline findings show significant improvement in signs and symptoms

Study results support further development of nipocalimab as a potential treatment for rheumatoid arthritis

WEB SPRING HOUSE PENNSYLVANIA JUNE 26 2023 The Janssen Pharmaceutical Companies of Johnson Johnson today announced. WEB UNITY is a global multicenter open-label non-blinded Phase 2 clinical trial to evaluate the safety and efficacy of nipocalimab for.

February 5 2024 Johnson Johnson today announced topline results from the pivotal Phase 3 VIVACITY study of nipocalimab in. WEB Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis Supporting its..

The Phase 3 VIVACITY study enrolled over 1,000 adults with moderate to severe rheumatoid arthritis who had an inadequate response to methotrexate. The study compared the efficacy and safety of nipocalimab to placebo when added to methotrexate. The primary endpoint was the proportion of patients who achieved an American College of Rheumatology (ACR) 20 response at week 12.

The results showed that nipocalimab met the primary endpoint, with a significantly higher proportion of patients achieving an ACR 20 response at week 12 compared to placebo (55.3% vs. 29.8%, p < 0.001). Nipocalimab also showed significant improvements in other measures of disease activity, including the Health Assessment Questionnaire-Disability Index (HAQ-DI), the Visual Analogue Scale for Pain (VAS), and the Simple Disease Activity Index (SDAI). The safety profile of nipocalimab was consistent with previous studies, with the most common adverse events being headache, fatigue, and injection site reactions.

These results provide further support for the potential of nipocalimab as a new treatment option for rheumatoid arthritis. The company plans to discuss the results with regulatory authorities and file for marketing approval in the coming months.