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2024 AAAAI HAE Conference Coverage

CE / CME

Key Updates on Hereditary Angioedema: CCO Independent Conference Coverage of the 2024 AAAAI Annual Meeting

Physician Assistants/Physician Associates: 0.50 AAPA Category 1 CME credit

Nurses: 0.50 Nursing contact hour

Physicians: maximum of 0.50 AMA PRA Category 1 Credit™

Released: March 22, 2024

Expiration: March 21, 2025

CME/CE Information

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CHAPTER-1: Oral Bradykinin B2 Receptor Antagonist Deucrictibant in Prophylaxis of HAE

Clinical research in HAE continues to evolve, examining novel therapies that may be more effective, safer, and more tolerable to either prevent or treat attacks when they occur.

I begin with discussing deucrictibant—an oral bradykinin B2 receptor antagonist—that is being studied both for on-demand and long-term prophylactic therapy (NCT04618211, NCT05396105, NCT05047185).1

At AAAAI 2024, data from the CHAPTER-1 study were presented. This 2-part phase II study looked at efficacy and safety of deucrictibant for long-term prophylactic treatment for HAE.

This study enrolled adults (aged 18-75 years) with type I or II HAE. These patients were not receiving prophylactic therapy at the time of enrollment and had ≥3 attacks within 3 months prior to screening or ≥2 attacks during the screening period (8 weeks). Once enrolled (N = 34), these patients were randomized to one of 3 different arms: placebo (n = 11), deucrictibant 20 mg/day (n = 11), and deucrictibant 40 mg/day (n = 12). This was a parallel group–designed study that ran for 12 weeks. During the second part of the study, patients were permitted to enroll on an OLE, where they received deucrictibant 40 mg/day.

The primary endpoint was the time-normalized number of investigator-confirmed HAE attacks. Several secondary endpoints were also evaluated, including the number of investigator-confirmed moderate or severe attacks, use of on-demand treatment for attacks, days free from attacks, and safety (NCT05047185).2

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CHAPTER-1: Outcomes

Deucrictibant significantly reduced overall monthly attack rates in both treatment arms vs placebo. Deucrictibant 40 mg/day resulted in an 84.5% reduction (P = .0008) and the 20-mg/day dose resulted in a 79.3% reduction (P = .0009) compared with placebo.

Considering 2 secondary endpoints, deucrictibant significantly reduced both moderate to severe HAE attacks and need for on-demand therapy during the study period. For example, the highest dose (40 mg/day) of deucrictibant resulted in a 92.3% reduction (P = .0067) in moderate to severe attacks and 92.6% reduction (P = .0040) in on-demand treatment attacks compared with placebo. Therefore, this study met its primary and secondary outcomes for efficacy.2

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CHAPTER-1: Deucrictibant Safety

Evaluating safety of novel agents is very important. In CHAPTER-1, there were a few reported AEs. Of note, there were no serious or severe TEAEs, nor did any treatment-related TEAE lead to treatment discontinuation, study withdrawal, or death.

Looking at the data, there were fewer TEAEs among patients in either treatment group vs placebo. Three patients reported treatment-related TEAEs, including nausea, dizziness, or an increase in γ-glutamyltransferase while receiving treatment.2

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CHAPTER-1: Summary

Overall, deucrictibant improved HAE outcomes compared with placebo. Both the 20-mg/day and 40-mg/day doses reduced HAE attack rates, number of moderate to severe attacks, and need for on-demand treatment. Deucrictibant was well tolerated, with only a few mild TEAEs observed. This treatment looks promising for preventing attacks in patients with HAE, but additional data are needed from a larger phase III trial to further solidify these results.2

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