▎WuXi AppTec Content Team Report

Source of screenshot:NMPA Official Website

Prurigo Nodularis is a chronic type 2 inflammatory skin disease that causes intense chronic itching and may lead to thickened skin lesions (nodules) appearing across the body. The disease is one of the most severe inflammatory skin conditions in terms of its negative impact on quality of life, affecting mental health, daily activities, and social interactions. Currently, patients lack effective treatments and often rely on high-dose topical steroids to alleviate symptoms, but long-term use poses safety risks.

Dupilumab (trade name: Dupixent) is a fully humanized monoclonal antibody,Can inhibit the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13) proteinsStudies have shown that IL-4 and IL-13 are key drivers of type 2 inflammation, which plays an important role in inflammatory diseases such as asthma, chronic rhinosinusitis with nasal polyps, and atopic dermatitis. Dupilumab is able toBy innovatively blocking the type 2 inflammatory pathway through the "dual targets" of IL-4 and IL-13, it reduces the pathological response of type 2 inflammation, thereby treating type 2 inflammation-related diseases mechanistically.。

Overseas,Dupilumab has been approved in dozens of countries and regions worldwide for the treatment of one or more indications, including specific atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), prurigo nodularis, and eosinophilic esophagitis (EoE) across different age groups.

In China, dupilumab is one of the urgently needed new drugs from overseas for clinical use.Has been approved in China for the treatment of multiple indications，Moderate to Severe Atopic Dermatitis Covering All Age Groups from Infancy to Adulthood。This timeDegreeDupilumab Approved for New Indication in China, for the Treatment ofAdultPrurigo Nodularis。

DegreeDupilumab TreatmentPositive results have been achieved in two double-blind, placebo-controlled phase 3 trials (PRIME and PRIME2) for the efficacy of adult nodular prurigo, with a total evaluation in 311 patients.DegreeEfficacy and Safety of Priluceptinib. Both trials met the primary and key secondary endpoints, compared with placebo,DegreeDupilumabSignificantly alleviated patients' itching and skin lesions.

• At 12 weeks, 44% and 37% of patients in the dupilumab group in the PRIME trial and PRIME2 trial, respectively,Itchiness Achieves Clinically Meaningful Reduction Compared to Baseline, compared with 16% and 22% in the placebo group, respectively;

• At 24 weeks, Dupilumab groups in both trialsThe proportion of patients who achieved a clinically meaningful reduction in itching compared to baseline (60% and 58%) was approximately three times that of the placebo group (18% and 20%).；

• At 24 weeks, two trialsAchieve smooth or nearly smooth skinThe percentage of patients in the dupilumab group (48% and 45%) was more than twice that of the placebo group (18% and 16%).

The safety results in the trial were generally consistent with the known safety profile of dupilumab in its approved dermatological indications. The most common adverse events (≥2%) observed with dupilumab compared to placebo were nasopharyngitis, conjunctivitis, herpes infections, dizziness, myalgia, and diarrhea.

[2] New Indication for Dupixent, a Targeted Biologic for Atopic Dermatitis, Approved in China for Pediatric Patients Aged 6 Months and Above. Retrieved May 30, 2023, from https://www.prnasia.com/story/405920-1.shtml