Nipocalimab bests placebo, ‘justifies further development’ in Sjögren’s disease
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WASHINGTON — A 15 mg/kg dose of the neonatal fragment crystallizable receptor blocker nipocalimab outperformed placebo in improving Sjögren’s disease activity at 24 weeks, according to data presented at ACR Convergence 2024.
“Currently there are no immunomodulatory therapies that target the systemic manifestations of the disease that are approved for Sjögren’s,” Ghaith Noaiseh, MD, of the University of Kansas Medical Center, told attendees.
To assess the efficacy and safety of nipocalimab (Johnson & Johnson) in adults with primary Sjögren's disease, Noaiseh and colleagues conducted DAHLIAS, a phase 2, randomized, placebo-controlled trial.
“DAHLIAS was the first study to assess an FcRn blocker in Sjogren’s,” Noaiseh said. “It specifically blocks the binding of FcRn to IgG.”
Cohorts included 53 patients treated with nipocalimab 5 mg/kg, 54 patients treated with nipocalimab 15 mg/kg, and 56 patients who received placebo. Change from baseline in the EULAR Sjögren’s Syndrome Disease Activity Index (clinESSDAI) score at 24 weeks served as the primary endpoint. The researchers additionally assessed safety at 30 weeks.
Compared with placebo, the 15 mg/kg active therapy arm met the primary endpoint (least squares mean difference, –2.65; P = .002), although the trend did not hold for the 5 mg/kg dose (least squares mean difference, –0.34; P= .681), according to the researchers.
“The primary endpoint was met by the high dose of nipocalimab,” Noaiseh said. “Interestingly, you will see a separation from week 4 all the way through week 24. This could prove promising for the endpoint through the study at week 48.”
Nipocalimab at 15 mg/kg was also associated with improvements vs. placebo in changes from baseline at week 24 in Physicians Global Assessment, ESSDAI score, treatment response via the Sjögren’s Tool for Assessing Response, and disease activity level response, according to the findings.
In addition, numerical improvements were reported for the 15 mg/kg dose compared with placebo for patient-reported outcome measures.
Serious adverse event rates were 7.4% for the nipocalimab 15 mg/kg dose, 7.5% for the 5 mg/kg dose and 5.4% for placebo.
“Nipocalimab was generally felt to be safe throughout the study,” Noaiseh said. “There were no deaths observed. No MACE or opportunistic infections occurred in the treatment group.”
Importantly, dose dependent reductions in IgG and Aab were additionally reported for nipocalimab.
“We can safety conclude that this study justifies further development of nipocalimab in Sjögren’s,” Noaiseh said.
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Noaiseh G. Abstract #2527. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C.
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