What is the recommended dosing regimen for dupilumab (dupilumab) in the treatment of prurigo nodularis (PN), considering its IL-31 driven pathophysiology?

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From the FDA Drug Label

2.7 Recommended Dosage for Prurigo Nodularis The recommended dosage of DUPIXENT for adult patients is an initial dose of 600 mg (two 300 mg injections) followed by 300 mg given every other week (Q2W).

The recommended dosing regimen for dupilumab in the treatment of prurigo nodularis (PN) is an initial dose of 600 mg followed by 300 mg every other week.

  • Initial dose: 600 mg (two 300 mg injections)
  • Subsequent dosage: 300 mg every other week (Q2W) 1

From the Research

Dupilumab is recommended at an initial dose of 600 mg (two 300 mg injections) followed by 300 mg every two weeks administered subcutaneously for the treatment of prurigo nodularis (PN), considering its IL-31 driven pathophysiology. This dosing regimen is supported by the most recent and highest quality study, which demonstrated significant improvements in itch and skin lesions in patients with PN 2. The study showed that dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13, which indirectly reduces IL-31 levels, a key cytokine driving the intense itch-scratch cycle characteristic of PN.

Key Points

  • Dupilumab works by inhibiting IL-4 and IL-13 signaling, which indirectly reduces IL-31 levels, a key cytokine driving the intense itch-scratch cycle characteristic of PN.
  • The medication should be continued long-term as PN is typically a chronic condition, with clinical improvement in itch often observed within 4-8 weeks and nodule reduction following over subsequent months.
  • Patients should be monitored for common side effects including injection site reactions, conjunctivitis, and rarely, facial redness.
  • The medication is self-administered and should be stored in the refrigerator but brought to room temperature before injection.
  • For optimal outcomes, dupilumab should be used alongside gentle skin care, trigger avoidance, and possibly topical anti-inflammatory agents to manage this IL-31-mediated inflammatory skin condition.

Benefits of Dupilumab

  • Significant improvements in itch and skin lesions in patients with PN, as demonstrated in the LIBERTY-PN PRIME and PRIME2 phase 3 trials 2, 3.
  • Clinically meaningful and statistically significant improvements in itch and skin lesions versus placebo in PN, with a significant proportion of patients achieving clear or almost clear skin 2, 3.
  • Treatment benefits are independent of baseline demographics, and dupilumab shows benefits across demographics 3.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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