In Prurigo Nodularis, Dupilumab Achieves Clinically Meaningful Improvement

In prurigo nodularis, dupilumab treatment can deliver clinical improvement, even for patients who were inadequately controlled with prior topical therapies, according to study results presented at the 2023 Annual Meeting of the American Academy of Dermatology (AAD), held from March 17 to 21, 2023, in New Orleans, Louisiana. The presentation shows dupilumab can deliver statistically significant and clinically meaningful improvement in worst itch, skin pain, and sleep, the presenters explained.

Researchers reported pooled results of the phase 3 LIBERTY-PN PRIME and PRIME2 (ClinicalTrials.gov Identifiers: NCT04183335 and NCT04202679) trials regarding the proportion of patients treated with dupilumab or placebo who achieved clinically meaningful improvement in symptoms of prurigo nodularis.

The 2 trials included adult patients with moderate to severe prurigo nodularis inadequately treated with topical prescription therapies or for whom those therapies were not appropriate. The investigators offered patients with prurigo nodularis dupilumab 300 mg every 2 weeks or matched placebo for 24 weeks. Use of low- to moderate-potency topical corticosteroids/topical calcineurin inhibitors or antidepressants was permitted if the participants were on a stable regimen before screening and enrollment and they expected the dose to be consistent throughout.

The endpoint was the proportion of patients who achieved within-patient meaningful improvement in weekly average scores on the Worst Itch Numerical Rating Scale (WI-NRS), Skin Pain-NRS, and Sleep-NRS at week 24. Meaningful improvement was defined as a 4-point improvement or better in WI-NRS and Skin Pain-NRS scores and a 2-point or better improvement in Sleep-NRS score.

A total of 311 patients were randomly assigned to dupilumab (n=153) or placebo (n=158). At baseline, the mean (SD) WI-NRS score was 8.4 (1.1) in the placebo group vs 8.6 (0.9) in the dupilumab group, the mean (SD) Skin Pain-NRS score was 7.2 (2.4) in the placebo group vs 7.2 (2.5) in the dupilumab group, and the mean (SD) Sleep-NRS score was 4.2 (2.4) in the placebo group vs 4.4 (2.4) in the dupilumab group.

For significantly more patients with prurigo nodularis, dupilumab was associated with within-patient meaningful improvement in WI-NRS (58.8% vs 19.0%; P <.0001), Skin Pain-NRS (49.7% vs 20.9%; P <.0001), and Sleep-NRS (42.5% vs 23.4%, P <.0001) scores at week 24 compared with patients administered placebo.

The difference was significant as early as week 2 for WI-NRS and Sleep-NRS scores and week 3 for Skin Pain-NRS score. At week 6, statistical significance was lost for Skin Pain-NRS score, but it was regained at week 7 and sustained throughout the remainder of the study.

The overall safety findings were consistent with the known dupilumab safety profile.

Disclosure: This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.