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Treatment of prurigo nodularis patients with dupilumab produced statistically significant improvement in skin lesions and pruritus, according to a review of two clinical trials.

Prurigo nodularis is characterized by chronic inflammation of the skin and the development of intensely pruritic nodules. There is inadequate evidence regarding the safety profile and treatment efficacy of dupilumab in patients with prurigo nodularis. The phase 3 randomized controlled trials LIBERTY-PN PRIME and PRIME2 assessed the safety and efficacy of dupilumab by recruiting adult prurigo nodularis patients with severe itch unresponsive to topical treatments and ≥20 nodules. The study findings are published in the journal Nature Medicine.

Study Characteristics

The PRIME trial included 151 patients, consisting of 76 and 75 patients randomized to placebo and dupilumab groups, respectively. The PRIME2 trial enrolled 160 patients, consisting of 78 and 82 patients randomized to dupilumab and placebo groups, respectively. All the study participants had severe itch, as reflected by a mean baseline Worst Itch Numeric Rating Scale (WI-NRS) score of 8.5 ± 1.0. The mean Dermatological Life Quality Index (DLQI) score at baseline in the PRIME and PRIME2 trials was 16.7 ± 7.2 and 18.2 ± 6.7, respectively.

Dupilumab and Sustained Itch Alleviation Beyond Week 12

The primary endpoint of the clinical trials was clinically significant itch improvement. According to the WI-NRS score, participants from the PRIME2 trial demonstrated continued improvement in itch after week 12. There was a significantly greater ≥4-point reduction in the WI-NRS score in dupilumab group patients compared to the placebo group.

Improving Quality of Life With Dupilumab

In the PRIME and PRIME2 trials, there was a higher proportion of dupilumab group patients versus placebo group patients who achieved ≥ 4-point reduction in the WI-NRS. A significantly greater proportion of dupilumab group patients compared to placebo group patients scored 0 or 1 on the Investor Global Assessment (IGA) PN-S scale in both trials. Dupilumab-treated patients experienced significant improvements in quality of life, skin pain, depression, and anxiety compared to patients administered a placebo.

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Safety Profile of Dupilumab

Compared to the placebo group patients, significantly fewer dupilumab group patients required rescue medication. Dupilumab was well tolerated among patients in both trials, and its safety profile was consistent with the known safety characteristics of the drug. In the PRIME trial, five patients in the dupilumab group and six patients in the placebo group reported treatment-emergent serious adverse events. In the PRIME2 trial, two patients in the dupilumab group and two in the placebo group reported treatment-emergent serious adverse events.


Yosipovitch, G., Mollanazar, N., Ständer, S., Kwatra, S. G., Kim, B., Laws, E., Mannent, L., Amin, N., Akinlade, B., Staudinger, H., Patel, N., Yancopoulos, G. D., Weinreich, D. M., Wang, S., Shi, G., Bansal, A., & O’Malley, J. T. (2023). Dupilumab in patients with prurigo nodularis: two randomized, double-blind, placebo-controlled phase 3 trials. Nature Medicine, 29(5), 1180–1190. https://doi.org/10.1038/s41591-023-02320-9