Dr. Gil Yosipovitch suspects that dupilumab will be approved for use in patients with prurigo nodularis based on new data from the LIBERTY-RN PRIME2 trial.
New data on prurigo nodularis found that the biologic dupilumab significantly improved itch and skin lesions in patients affected by the chronic inflammatory skin disease.
Data from the LIBERTY-PN PRIME2 trial presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting provided insights into the future of prurigo nodularis management.
Prurigo nodularis affects approximately 200,000 patients in the United States, with patients suffering from a lack of sleep, disfiguration, and various mental and emotional strains due to persistent itch.
Currently, there are no approved systemic therapies by the Food and Drug Administration (FDA) or European Medicines Agency (EMA).
“It's one of those cases where many dermatologists say, ‘oh my god, what should I do?’, and the fact that now there is a drug targeting this with quite impressive results is really a major game changer for patients,” said Gil Yosipovitch, MD,
The primary endpoint of LIBERTY-PN PRIME2 assessed the 160 adult patients included in the study measured a ≥4-point reduction on the Worst-Itch Numeric Rating Scale (WI-NRS, range: 0-10) from baseline to Week 12.
Key secondary endpoints included proportions of patients with ≥4-point reduction in WI-NRS from baseline to week 24, and Investigator’s Global Assessment PN-Stage (IGA PN-S, range: 0-4] of 0 or 1 at week 24.
By week 12 of the study, 37.2% of dupilumab achieved ≥4-point reduction in WI-NRS (P=0.0216) and 57.7% achieved a ≥4-point reduction at week 24 (P<0.0001).
Furthermore, 44.9% of patients with prurigo nodularis achieved an Investigator’s Global Assessment PN-Stage (IGA PN-S) score of 0 or 1 at week 24 compate to 15.9% of the placebo group (P<0.0001), and the rate of treatment-emergent adverse events was 57.1% and 51.2% for dupilumab vs placebo, respectively.
Yosipovitch believed that dupilumab could provide a better alternative to the typical immunosuppressants prescribed for patients with the disease.
“Previously, I've used drugs (on patients) that are immunosuppressants, and some of them are very strong like,” Yosipovitch said. “They did work, but they come with a bag of side effects that patients could not tolerate, and the safety issue is really the major issue. But now we could do something safe and very targeted, so I do believe that this drug would make it to the market.”
Given the strength of the data,Yosipovitch anticipates an FDA approval in the near future, and suspects that future studies will focus on a variety of factors associated with prurigo nodularis.
“I think more research will be done on assessing other factors including the effect on sleep, the rapid effect of this drug, whether this drug works better on specific populations,” he said. “There's an unmet need in patients with skin of color who have severe prurigo nodularis, but I think with all the studies that will be done we will learn more and more.”