Switch to Garadacimab Shows Strong Safety, Zero Hereditary Angioedema Attacks in Interim Study
USA: Switching to garadacimab may provide a safe and effective option for preventing hereditary angioedema (HAE) attacks, according to interim findings from an ongoing Phase 4 clinical study. Patients who transitioned from other approved long-term prophylaxis therapies experienced no HAE attacks after starting garadacimab, and the treatment demonstrated a favorable safety profile.
The findings were published in The Journal of Allergy and Clinical Immunology by Jonathan Bernstein from the University of Cincinnati and the Bernstein Clinical Research Center, Cincinnati, and colleagues.
Hereditary angioedema is a rare genetic condition characterized by recurrent swelling episodes affecting the skin, gastrointestinal tract, and airways. Although treatment guidelines aim to achieve complete disease control and allow patients to live normal lives, some individuals continue to experience attacks despite long-term prophylaxis. Garadacimab, a monoclonal antibody that blocks activated factor XII, has recently been approved in the United States for long-term prevention of HAE attacks in adults and adolescents.
To evaluate outcomes after switching therapies, researchers conducted an ongoing multicenter, single-arm, open-label Phase 4 study involving patients aged 12 years or older with HAE who had been receiving approved long-term prophylaxis for at least three months. Participants transitioned directly to garadacimab without a washout period or overlap with their previous medication.
Patients received a 400 mg subcutaneous loading dose followed by 200 mg administered once monthly using a prefilled autoinjector or pen for up to three months. The primary endpoint was the occurrence of treatment-emergent adverse events. Secondary safety outcomes included serious adverse events and hypersensitivity or anaphylaxis reactions. Researchers also explored changes in HAE attack rates after the switch.
Key Findings:
- At the interim data cutoff of July 31, 2025, six patients were included in the analysis, including three females.
- Before switching, three patients were receiving subcutaneous lanadelumab and three were treated with subcutaneous plasma-derived C1-esterase inhibitor therapy.
- Garadacimab exposure ranged from approximately 0.1 to 2.6 months, with five patients completing at least one month of treatment.
- Only one treatment-emergent adverse event was reported—a mild upper respiratory tract infection that was considered unrelated to garadacimab.
- No treatment discontinuations, deaths, serious adverse events, hypersensitivity reactions, or other adverse events of special interest were reported.
- Before switching therapies, patients experienced between zero and three hereditary angioedema attacks in the three months before study entry.
- No hereditary angioedema attacks were reported during the treatment period after initiating garadacimab.
The researchers concluded that garadacimab showed a favorable safety profile and effective protection against HAE attacks from the first dose after switching from other approved prophylactic therapies. They noted that continued follow-up and larger studies will be important to further confirm these findings.
Reference:
Bernstein, J., Levy, D., Gagnon, R., Keith, P., Chapdelaine, H., Shetty, H., Quazi, K., Pollen, M., Wieman, L., & Hsu, C. (2026). Safety and Efficacy in Patients With Hereditary Angioedema After Switching to Garadacimab: Interim Analysis of a Phase 4, Open-Label Study. Journal of Allergy and Clinical Immunology, 157(2), AB3. https://doi.org/10.1016/j.jaci.2025.12.015
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