Johnson & Johnson announced findings from the Phase II DAHLIAS dose-ranging study where its monoclonal antibody nipocalimab offered significant improvements in SjD activity in patients.
DAHLIAS is a randomised, multicentre, placebo-controlled, double-blind dose-ranging study that evaluated the effects of nipocalimab in adults with primary SjD, a chronic and debilitating autoantibody disease.
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This study included a Phase II dose-ranging trial for adults with moderately-to-severely active primary SjD who were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies.
It enrolled 163 adult patients aged 18–75 years and randomised into a 1:1:1 ratio to receive intravenous nipocalimab at either five or 15mg/kg or a placebo every two weeks through week 22.
Additionally, all the patients received protocol-permitted standard of care.
In the trial, nipocalimab was found to offer a statistically significant and clinically meaningful improvement in the ClinESSDAI score compared with placebo at 24 weeks from baseline, meeting the trial’s primary endpoint.
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By GlobalDataThe 15mg/kg nipocalimab treatment group showed clinically meaningful improvements in secondary endpoints at week 24.
They included multiple organ assessments (DALc), physician assessments (PhGAd), and composite tools for clinical trial endpoints (STARe, CRESSf).
There were also observed trends in the improvement of key SjD symptoms such as mouth, eye and vaginal dryness.
The safety and tolerability profile of nipocalimab in the DAHLIAS study was consistent with previous clinical studies.
Johnson & Johnson Innovative Medicine Rheumatology, Immunology Disease area leader and vice-president Terence Rooney said: “A clear need exists for patients living with Sjögren’s disease to have advanced therapies that target the underlying cause and systemic nature of this disease, as none have been approved to date.
“Johnson & Johnson is committed to delivering innovative and transformational approaches for autoantibody-mediated diseases like SjD, and the data presented at EULAR demonstrate the potential of nipocalimab in a disease where patients have very few options.”
In May this year, the company reported that Tremfya (guselkumab) was superior to its Stelara (ustekinumab) medication in all endoscopic endpoints in a Phase II/III Crohn’s disease trial.
