Real-World Data Supports Dupilumab for Prurigo Nodularis Treatment in China

Image Credit: © Dr Mashihul Hossain - dermnetnz.org

According to new data, dupilumab is confirmed to be safe and effective for Chinese patients with moderate to severe refractory PN.¹ This is the largest multicenter real-world study for dupilumab in China, fulfilling a previously unmet need in this PN patient population.

The multicenter, observational study was held across 10 hospitals in China. All 73 participants (33 female and 40 male) were treated between July 2023 and January 2024. The sample was also further divided into subgroups by age with 12 pediatric patients, 38 adults, and 23 elderly patients (≥ 60 years old). The cohort had a mean age of 45.9 years with a median disease duration of 3 years.

Eligible participants had a mean peak pruritus numeric rating scale (PP-NRS) ≥ 7 with at least 20 PN legions. These patients were also resistant to and dissatisfied with conventional therapies like topical or systemic corticosteroids and immunosuppressants. All patients received an initial 600 mg subcutaneous injection and then 300 mg dosages every 2 or 4 weeks thereafter, depending on weight. The follow-up period lasted at least 16 weeks with disease severity scores being reported every 2 weeks.

Participants were assessed using the PP-NRS, investigator global assessment (IGA) for PN, and dermatology life quality index for adults or children (DLQI/CDLQI). At baseline, the mean PP-NRS score was 7.9 and the average DLQI/CDLQI score was 16.6. All patients had an IGA score of 3 or 4, with the least number of nodules being 20 and the most being ≥ 100.

Nearly 85% of patients saw an improvement of ≥ 4 points in PP-NRS at week 12. Also in week 12, 37% achieved an IGA score of 0/1. This improved to 46.6% at week 6, equating to a response of “clear” or “almost clear” skin with a reduction to ≤ 5 nodules. These positive results mirror what was observed in previous phase 3, single-center clinical trials.

Quality of life outcomes also improved substantially, decreasing from 16.6 at baseline to 7.2 at week 12 and 6.4 at week 16. Furthermore, time-effect relationship results in all categories confirmed the fast-acting nature of dupilumab to relieve itch and improve quality of life.

There were no statistically significant differences between the 3 age groups in terms of achieving IGA 0/1, indicating that the treatment worked well among all ages. Additionally, there was no difference in baseline severity and effectiveness in the 36 participants with atopic PN versus those without. Regarding adverse effects, only 1 patient reported dry eyes after the first injection and found relief with an artificial tear solution. This confirms dupilumab’s favorable safety profile.

Potential selection bias and small sample size of pediatric patients may be considered possible limitations of the study. There was also a limited number of recorded laboratory results with different reference ranges depending on the center, which could impact the analysis.

“There is no ‘one fits all’ therapy, so not all PN patients show an optimal response to dupilumab,” the authors wrote. “Therefore, predictors of response and mechanisms of dupilumab in PN await extensive exploration in the future.”

However, this literature addresses the previous gap in research regarding dupilumab’s safety and effectiveness in Chinese patients. Although dupilumab has been approved for PN, only a small number of Asian patients were included in the phase 3 clinical study.²

“Our results redemonstrate the heavy burden of PN,” the authors concluded. “Despite previous topical and systemic therapies, especially high usage of off-label drugs, the patients had a poor disease control and dissatisfaction for treatment at baseline, which reveals a huge unmet need for treatment of PN in China, indicating a strong need for effective therapy.”