Association Between the Angioedema Control Test and Attack Frequency in Hereditary Angioedema

Area of Science:

• Immunology
• Genetics
• Clinical Trials

Background:

• Hereditary angioedema (HAE) causes unpredictable swelling attacks, impacting quality of life.
• Assessing HAE disease activity and treatment response is challenging in routine care.
• The Angioedema Control Test (AECT) is a patient-reported HAE disease control measure.

Purpose of the Study:

• To evaluate the criterion validity of the AECT.
• To assess the correlation between AECT scores and objective measures of HAE disease control, specifically HAE attack rate.

Main Methods:

• Post-hoc analysis of the Phase 3 OASIS-HAE study (NCT05139810).
• Patients with HAE received donidalorsen or placebo for 24 weeks.
• Correlation between AECT scores and investigator-confirmed HAE attack rates was examined at baseline, week 12, and week 24.

Main Results:

• AECT scores showed moderate to strong correlation with HAE attack rates (ρ = -0.40 to -0.85).
• Significant differences in mean attack rates were observed between patients with poorly controlled (AECT < 10) and well-controlled (AECT ≥ 10) HAE.
• Patients achieving complete disease control (AECT=16) had a 0 or 1 attack rate at week 24.

Conclusions:

• The study supports the criterion validity of the AECT in patients with HAE.
• AECT scores are strongly associated with objective measures of HAE disease control.
• The AECT is a valuable tool for monitoring HAE disease control in clinical practice.