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Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study

This first-ever clinical study of an FcRn inhibitor in RA showed nipocalimab reduced levels of circulating IgG antibodies, including ACPAs, indicating they may play a key role in driving RA disease activity

Nipocalimab demonstrated improvements in primary and secondary endpoints and participants with higher baseline ACPAs had more than twice the placebo adjusted DAS28-CRP remission compared to the overall study population

Excerpt from the Press Release:

SPRING HOUSE, Pa., Nov. 7, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from the Phase 2a IRIS-RA clinical study for the treatment of adults living with moderate to severe active rheumatoid arthritis (RA) who have tested positive for anti-citrullinated protein antibodies (ACPAs)a and/or rheumatoid factor (RF), and who have had an inadequate response or intolerance to at least one anti-tumor necrosis factor (anti-TNF) therapy. The data from this study establish proof of mechanism for nipocalimab in RA and support its progression into a combination study.1 IRIS-RA is the first clinical study to assess the efficacy and safety of the anti-neonatal Fc (FcRn)-driven MOA for the treatment of RA.2 The study findings, along with an acceptable benefit-risk profile, support the further investigation of nipocalimab in this refractory population.1 A trial investigating the efficacy and safety of nipocalimab in combination with an anti-TNFα treatment in patients living with RA has recently been initiated.3

Treatment with nipocalimab, an anti-FcRn receptor therapy, resulted in numerically greater improvements at Week 12 across primary and secondary efficacy endpoints including Disease Activity Score 28 using C-reactive protein (DAS28-CRP),b American College of Rheumatology (ACR) responses,c DAS28-CRP remission and Health Assessment Questionnaire – Disability Index (HAQ-DI).1,d A numerically greater number of patients in the nipocalimab group achieved ACR50 (n=5/33 nipocalimab versus n=1/20 placebo) and DAS28-CRP remission (n=7/33 nipocalimab versus n=2/20 placebo) compared with the placebo group.1 

By selectively blocking the FcRn receptor, nipocalimab reduced levels of circulating immunoglobin G (IgG) antibodies, including ACPAs, indicating they may play a key role in driving RA disease activity.4

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