Janssen, a Johnson & Johnson company, has announced positive results from a mid-stage study of its investigational FcRn inhibitor in rheumatoid arthritis (RA).

The phase 2a IRIS-RA trial has been evaluating nipocalimab in adults with moderate-to-severe RA who have tested positive for anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and had an inadequate response or been intolerant to at least one anti-TNF therapy.

Approximately 13 million people worldwide are affected by RA, a chronic inflammatory disease that causes joint pain, swelling and stiffness, and in some cases, permanent damage and deformity in structural joint elements such as cartilage and bone.

The presence of autoantibodies is a distinctive feature of RA, with ACPAs and RF being two autoantibody systems commonly used as aids for diagnosing and classifying the disease.

Results from IRIS-RA showed that nipocalimab reduced levels of circulating IgG antibodies, including ACPAs, indicating they may play a key role in driving RA disease activity.

Nipocalimab also demonstrated improvements in primary and secondary endpoints, and patients with higher baseline ACPAs had more than twice the placebo-adjusted Disease Activity Score 28 using C-reactive protein (DAS28-CRP) remission compared to the overall study population.

Terence Rooney, vice president and rheumatology disease area leader at Janssen, said: “Significant patient need remains for those suffering from rheumatoid arthritis and our research shows autoantibodies like ACPAs may contribute to the development and activity of RA.

“Current treatments, like TNF-inhibitors, may not markedly reduce autoantibodies when used alone so these results are promising for patients who have had inadequate responses to other advanced therapies.”

The data from this study establishes proof of mechanism for nipocalimab in RA and support its progression into a combination study, Janssen said, adding that it recently initiated a trial assessing the efficacy and safety of the candidate alongside an anti-TNFα treatment in RA patients who have had an inadequate response or intolerance to at least one advanced disease-modifying anti-rheumatic drug therapy.

Rooney said: “The combination of nipocalimab with therapies that have a complementary mechanism of action, such as anti-TNFs, will be of interest as we explore alternative avenues of treatment for patients with RA, and we are excited to have initiated the phase 2a DAISY-RA trial to explore this combination.”

https://www.pmlive.com/pharma_news/janssen_reveals_positive_results_for_nipocalimab_in_rheumatoid_arthritis_1503565