Benvitimod is Safe for Palmoplantar Pustulosis, New Study Finds

Image Credit: © Dr Lawrence Meyerson - dermnetnz.org

A recent study successfully evaluated the safety and efficacy of 1% benivitimod cream for treating palmoplantar pustulosis (PPP).¹ Researchers found there was little to no disease progression with few adverse events during the treatment period. The anti-inflammatory, nonsteroid cream (Symbiox) was approved for the treatment of psoriasis in 2019 by the China Food and Drug Administration but has not been previously tested in patients with PPP.

The open-label, uncontrolled, prospective study included 40 patients being treated at 4 hospitals. The participants had a mean age of 45 and 60% were female. The trial took place between March and October of 2021 with 8 weeks of treatment and 4 weeks of safety follow-up. Benvitimod cream (1%) was applied twice a day.

Clinical assessments occurred at baseline and every two weeks thereafter. The researchers utilized the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) and Dermatology Life Quality Index (DLQI) to compare results. Disease relapse was also evaluated at week 12. If complete clearance and remission were achieved, the drug was discontinued for an additional 4 weeks to monitor safety.

At week 0, the mean ± PPPASI and DLQI scores were 9.9 ± 8.73 and 9 ± 5.85, respectively. These numbers continued to significantly decrease throughout the trial. The greatest drop occurred in the first 2 weeks, confirming the rapid action of benivitimod. Clinical images of the hands and feet from before and after the study showed a reduction of crusts, pustules, and erythemas.

By week 8, the mean ± PPPASI was at 3.39 ± 3.86 (p < 0.0001) while the DLQI was at 2.49 ± 3.34 (p < 0.0001). At this point, 70% of patients achieved a PPPASI-50 response. Moreover, 35% achieved a PPPASI-75 response, and 17.5% achieved a PPPASI-90 response.

Relapse occurred in only 3 of the participants. According to the investigators, self-reported compliance was 12.77%. No other limitations were reported.

5 patients experienced common drug-related adverse effects including xerosis cutis and desquamation. Only one patient’s disease advanced during the trial, causing them to discontinue the treatment.

Based on this study, benivitimod has the potential to become a new nonsteroidal management strategy for PPP and similar chronic skin diseases. Existing treatments such as bimekizumab and adalimumab may only provide short-term relief.²

“The burden of palmoplantar psoriasis on patients is substantial and mostly due to functional disability, pain, and visibility of the lesion,” the authors wrote. "Although various therapeutic modalities for the management of PPP exist, it is often challenging and unsatisfactory for refractory PPP treatment.”

Although these findings correlate with benvitimod’s excellent treatment outcomes for other inflammatory skin diseases such as psoriasis and atopic dermatitis, large-scale studies are still needed to confirm the therapy’s long-term efficacy and safety for PPP.³

References

1. Wang G, Zhang S, Yan H, et al. Efficacy and safety of benvitimod in patients with Palmoplantar pustulosis: An open‐label, Multicenter, prospective study. Dermatol Ther. 2024;2024(1). doi:10.1155/2024/8829762

2. Spencer RK, Jin JQ, Elhage KG, et al. Comparative efficacy of biologics and oral agents in palmoplantar psoriasis and palmoplantar pustulosis: A systematic review and network meta-analysis of randomized clinical trials. J Am Acad Dermatol. 2023;89(2):423-425. doi:10.1016/j.jaad.2023.04.043

3. Ehsan M, Rehman AU, Athar F, et al. Benvitimod for the treatment of psoriasis: A systematic review and meta-analysis of randomized controlled trials. Dermatol Ther. 2022;35(12):e15957. doi:10.1111/dth.15957