Delphi Consensus on Attenuated Androgen Use for Long-Term Prophylaxis in Hereditary Angioedema: AURA Project

Area of Science:

• Clinical Immunology
• Endocrinology
• Pharmacology

Background:

• Danazol, an attenuated androgen, has been a long-term prophylaxis (LTP) option for Hereditary Angioedema (HAE).
• Androgenic side effects limit danazol's use, prompting a shift towards second-line therapy with newer agents.
• Evolving HAE treatment guidelines necessitate updated frameworks for danazol management.

Purpose of the Study:

• To establish expert consensus on danazol's role in HAE long-term prophylaxis.
• To develop guidelines for danazol prescription, monitoring, and discontinuation.
• To address the need for standardized danazol management protocols in HAE.

Main Methods:

• A 2-round Delphi methodology was employed.
• A steering committee of specialists defined statements based on evidence.
• A panel of 23 HAE management experts voted to achieve consensus.

Main Results:

• Forty-six recommendations were generated for danazol prescription, monitoring, and discontinuation in HAE LTP.
• Consensus was reached on contraindications, monitoring parameters, and therapy adjustments.
• Seven recommendations specifically address danazol discontinuation strategies for HAE patients.

Conclusions:

• The Delphi study fills a critical gap in clinical guidance for danazol in HAE.
• The consensus document aids in standardizing danazol discontinuation protocols.
• This provides a framework for optimizing patient access to safe and effective HAE treatments.