Prurigo nodularis is a chronic skin condition that impacts an estimated 75,000 individuals in the United States (US). This condition is characterized by persistent and intense itching, significantly impacting the quality of life for those affected. Research has shown a higher prevalence of prurigo nodularis among individuals with certain comorbidities, such as mental health, endocrine, cardiovascular, and renal disorders, indicating a potential link between underlying health conditions and the development of this condition, likely due to immune system dysregulation.

In our Guidelines Real Time/What’s Changed Series, we typically focus on the most recent guidelines in the field. Currently, there are no specific guidelines for the treatment of prurigo nodularis in the US, likely due to the recent approval of treatments. However, we have identified a consensus from US experts, which is outlined below. In this article, we will highlight the two most recent medications that have received FDA approval for the treatment of prurigo nodularis. Additionally, we will highlight the expert panel consensus and provide updates on FDA-approved treatments for this condition.

Part 1 – Part 1 – Current Prurigo Nodularis Guidelines

As previously mentioned, there are currently no established guidelines in the United States regarding prurigo nodularis. Therefore, we have included a current consensus document as a point of reference:

  • Practical approaches for diagnosis and management of prurigo nodularis
    • United States Expert Panel Consensus
    • Publication: March 2021
    • Prurigo nodularis (PN) is a chronic disease characterized by intensely pruritic, raised, nodular lesions. Because there are currently no United States Food and Drug Administration-approved therapies specifically for PN, management is highly variable, and no consensus exists on treatment regimens. The objective of this document is to provide practical guidance to help United States dermatologists diagnose and effectively treat patients with PN.
Part 2 – Recent FDA Approvals

Below, are the recent medications and therapies recently approved by the FDA that we anticipate being incorporated into future US guidelines:

  • Nemluvio® (nemolizumab)
    • Galderma
    • FDA approved for prurigo nodularis on August 13, 2024
    • Nemluvio is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, a neuroimmune cytokine that drives multiple disease mechanisms in prurigo nodularis.

  • Dupixent® (dupilumab)
    • Sanofi and Regeneron Pharmaceuticals, Inc.
    • FDA approved for prurigo nodularis on September 28, 2022
    • Dupixent is an interleukin-4 receptor alpha antagonist indicated for the treatment of adult patients with prurigo nodularis (PN).

Thank you for taking the time to review the current prurigo nodularis guidelines/consensus, as well as the recent major changes and FDA approvals that have recently occurred. We value your feedback and would like to hear your suggestions for future topics to be covered in our guideline series. Please feel free to contact us with any ideas or questions you may have.

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