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Discussing New Phase 3 Results on Dupilumab for Prurigo Nodularis, With Shawn Kwatra, MD
Shawn Kwatra, MD, highlights his team’s findings presented at EADV on the efficacy of dupilumab in treating prurigo nodularis.
New phase 3 data, pooled from the LIBERTY-PN PRIME and PRIME2 trials, suggest dupilumab is efficacious among patients both above and below the age of 65 years who live with prurigo nodularis.1,2
These data were highlighted in a recent interview with Shawn Kwatra, MD, during the 2025 European Academy of Dermatology and Venereology (EADV) Congress. Kwatra is a renowned leader in the dermatology space, currently serving as a professor and chairman of dermatology at the University of Maryland School of Medicine.
“Prurigo nodularis is one of those diseases that robs people of their dignity. The Itching is relentless,” Kwatra explained. “The scratching is constant, and for many patients, especially our older patients with other medical conditions, it becomes a daily battle. So the question has always been, can we deliver a therapy that is both safe and powerfully effective across patient groups? In particular age groups, it is very important for us to know, since many of our prurigo nodularis patients actually start in middle age. But many are older adults.”
Adult patients with moderate to severe prurigo nodularis had been assessed in the LIBERTY-PN PRIME/PRIME2 studies (NCT04183335/NCT04202679).1 These subjects specifically had disease that was inadequately controlled via topical drugs or for whom those medications were shown to be inadvisable.
Kwatra and colleagues randomized these individuals to 300-mg dupilumab on an every-2-week basis (n = 153) or into the matched placebo cohort (n = 158) for a total of 24 weeks. At Week 24, the investigatorsa evaluated the proportion of individuals younger or older than 65 years who attained a ≥4-point Worst Itch Numerical Rating Scale (WI-NRS) score reduction or Investigator’s Global Assessment for PN-Stage (IGA PN-S) score 0/1.
“In the pooled analysis…dupilumab showed robust efficacy in prurigo nodularis,” Kwatra said. “This was a game changer. I've been studying prurigo nodularis for my career, and we didn't know if we'd ever have an FDA-approved therapy for prurigo nodularis. But the biology happened fast. The trials happened quickly, and we got that approval. Dupilumab led the way here with that first FDA-approved therapy for prurigo nodularis. At 24 weeks, what we found here is that both in PRIME and PRIME2, over 60% of patients, both over and under age 65, had at least a four-point reduction in their itch. That's significant.”
Kwatra highlighted the data in this analysis, noting that those given the treatment compared to those on placebo saw significantly greater proportion of patients aged <65 years (63.5% versus 23.1%; P < .0001) and ≥65 years (63.2% versus 25.0%; P = .0142) attaining a reduction of WI-NRS scores by ≥4 points from baseline.1
The investigators also found that a significantly greater proportion of dupilumab-treated individuals aged <65 years (44.4% versus 19.4%; P = .0023) and ≥65 years (52.6% versus 4.2%; P < .0001) were successful in attaining an IGA PN-S score 0/1 at the 24-week mark.1 Safety was also shown by Kwatra and coauthors to be similar between these age cohorts. It was also noted to have been generally consistent with the established safety profile of dupilumab.
Kwatra's disclosures included the following: AbbVie, Arcutis Biotherapeutics, ASLAN Pharmaceuticals, Celldex Therapeutics, Galderma, Genzada Pharmaceuticals, Incyte, Johnson & Johnson, Novartis, Pfizer, Regeneron Pharmaceuticals Inc., Sanofi – advisory board member/consultant; Galderma, Incyte, Pfizer, Sanofi – investigator.
References
Kwatra S, Ständer S, Wiggins S, et al. Dupilumab Is Efficacious in Patients Above and Below 65 Years Old With Prurigo Nodularis: Pooled Results From Two Phase 3 Trials (LIBERTY-PN PRIME and PRIME2). Presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, Sept 17-20, 2025.
Yosipovitch G, Kim BS, Kwatra SG, et al. Dupilumab improves pruritus and skin lesions in patients with prurigo nodularis: Pooled results from 2 phase 3 trials (LIBERTY-PN PRIME and PRIME2). JAAD Int. 2024 Apr 10;16:163-174. doi: 10.1016/j.jdin.2024.03.025. PMID: 39006917; PMCID: PMC11246003.
