- 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.
Following the positive results in prurigo nodularis in another 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. The primary study endpoint was the proportion of patients with an ≥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 used as a secondary endpoint.
All enrolled participants suffered from severe itch, a high lesion count, and an impaired quality-of-life who were inadequately controlled by topical therapy, and over 2-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. Gil Yosipovitch (University of Miami, FL, USA) commented. The study treatment was completed by 59 patients in the placebo group and 74 in the dupilumab group. Remarkably, 60 patients dropped out in the placebo 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). Moreover, a significantly higher percentage of participants treated with dupilumab achieved clear or almost clear skin according to the IGA (48% vs 18.4%; P= 0.0004). “This is a really robust change, considering that these lesions take time to heal,” Prof. Yosipovitch commented.
There was no difference regarding the side effect 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.