Dupilumab leads to clinically relevant improvements in signs and symptoms of prurigo nodularis

Dupilumab improved in a second trial, not only itch but also skin lesions in patients with prurigo nodularis. Significantly changes were seen as soon as week 24.

Prurigo nodularis is what Prof. Gil Yosipovitch (University of Miami, FL, USA) called “one of the most challenging conditions that dermatologists deal with.” Dupilumab might now present a solution for this difficult-to-treat condition. Following the positive results in a prurigo nodularis phase 2 trial, a second phase 2 trial, LIBERTY-PN PRIME (NCT04183335), was performed to assess the efficacy and safety of dupilumab in prurigo nodularis [1]. The primary study endpoint was the proportion of patients with a ≥4-point improvement (reduction) in their worst itch numerical rating scale (WI-NRS) from baseline to week 24. A clear (0) or almost clear (1–5 prurigo nodularis lesions) outcome in the investigator´s global assessment (IGA) at week 24 was a secondary endpoint.

All enrolled participants suffered from severe itch, a high lesion count, and an impaired quality-of-life. Their prurigo nodularis was inadequately controlled by topical therapy and over two thirds had previously used systemic therapy. “Almost all participants were treated before but a lot of them were treated with antihistamines, which is not helpful,” Prof. Yosipovitch commented. The study treatment was completed by 59 participants in the placebo group and 74 in the dupilumab group.

At week 24, a statistically significantly higher percentage of participants in the dupilumab group achieved the primary endpoint (60.0% vs 18.4%; P<0.0001; see Figure). Moreover, a significantly higher percentage of participants treated with dupilumab achieved clear or almost clear skin according to the IGA (48.0% vs 18.4%; P=0.0004). “This is a really robust change, considering that these lesions take time to heal,” Prof. Yosipovitch commented.

Figure: Proportion of patients with ≥4-point improvement in WI-NRS at week 24 and proportion of patients achieving IGA PN-S 0 or 1 at week 24 [1]

WI-NRS, worst itch numeric rating scale; IGA PN-S 0 or 1, Investigator´s global assessment prurigo nodularis 0 or 1 (equalling clear or almost clear prurigo nodularis lesions).

There was no difference regarding the side effects between dupilumab and placebo. “Clearly, we need treatment for prurigo nodularis and this treatment has shown that it leads to a clinical relevant improvement,” Prof. Yosipovitch concluded.

1. Yosipovitch G, et al. Dupilumab significantly improves itch and skin lesions in patients with prurigo nodularis: results from a 2nd phase 3 trial (LIBERTY-PN PRIME). EADV Congress 2022, Milan, Italy, 7–10 September.

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Posted on 5 November 2022