Johnson & Johnson (J&J) has reported promising results from the Phase II DAHLIAS study of nipocalimab, a neonatal crystallisable fragment receptor (FcRn) blocker in treating moderate-to-severe Sjögren’s disease (SjD).
The placebo-controlled, multicentre, double-blind trial assessed the effects of nipocalimab in adults with primary SjD.
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It involved 163 participants aged between 18 and 75 years, who received nipocalimab or placebo alongside standard care.
The trial met its primary endpoint, a change in the baseline ClinESSDAIᵃ score at week 24.
Specifically, individuals with higher levels of anti-Ro and anti-La autoantibodies at baseline reported the greatest improvements in ClinESSDAI, accompanied by a significant decrease of 77% in IgG and total IgG autoantibodies.
Secondary endpoints were also met, showing benefits across various organ systems and physician assessments.
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By GlobalDataThe study revealed that patients receiving a 15mg/kg dose of nipocalimab every two weeks experienced a notable reduction in IgG, including autoantibody levels supporting its proposed mechanism of action through its interaction with FcRn.
J&J Innovative Medicine global medical affairs lead and rheumatology director Federico Zazzetti said: “No advanced therapies have been approved for SjD to date. A clear need exists for new immunoselective treatments with demonstrated safety profiles that can provide sustained relief from the heavy burden of the overall disease for patients living with SjD.
“Johnson & Johnson is committed to continued research to help address this unmet need, and the data presented at ACR demonstrate the potential of nipocalimab in a disease where patients have very few options.”
SjD symptoms, which can severely impact daily life, were also alleviated according to patient reports.
In terms of symptom relief, patients experienced a decrease in mouth dryness, eye dryness, vaginal dryness, fatigue, and joint pain.
Notably, objective salivary flow improvements were observed in more than twice as many patients in the high-dose nipocalimab arm compared to the placebo arm at week 24.
The US Food and Drug Administration (FDA) granted breakthrough status to the therapy for the treatment of adults with moderate-to-severe SjD, based on the outcomes of the DAHLIAS study.
In June, the company reported Phase II DAHLIAS dose-ranging study findings of nipocalimab offering improvements in SjD activity in the subjects.
