Berotralstat Reduces Real-World Attack Rates in Hereditary Angioedema

In the first 90 days of oral berotralstat treatment, the median monthly HAE attack rate was reduced from 1.7 to 0.3 attacks per month.

Berotralstat is associated with a decrease in real-world attack rates of hereditary angioedema (HAE) within 90 days of treatment initiation, according to study results presented at the American College of Allergy, Asthma & Immunology (ACAAI) 2022 Annual Scientific Meeting, held from November 10 to 14, 2022, in Louisville, Kentucky.

Researchers presented preliminary efficacy data of patients who received berotralstat, an oral once-daily prophylactic treatment for HAE, in a real-world clinical setting. The participants had confirmed HAE type I/II according to laboratory tests and actively received berotralstat 110 or 150 mg for more than 270 days. Baseline attack rates were reported for the 90 days before initiation of berotralstat.

These data show that berotralstat provided a rapid and sustained reduction in HAE attack rates within the first months of starting therapy, making oral berotralstat an effective treatment option for patients with HAE.

The median number of attacks per month during treatment was calculated in 90-day periods by averaging each participant’s monthly reported attack rate. Among 128 patients who actively received berotralstat for more than 270 days, the median baseline attack rate was 1.7 attacks/month. A rapid decrease in median monthly attack rates occurred after initiation of berotralstat. The median monthly attack rate was reduced in the first 90 days of treatment to 0.3 (0, 1.50) attacks/month; from days 91 to 180 to 0.5 (0, 1.00) attacks/month; from days 181 to 270 to 0.3 (0, 1.25) attacks/month, and from days 271 to 360 to 0.3 (0, 1.25) attacks/month.

Adverse events were consistent with previous clinical trials.

“These data show that berotralstat provided a rapid and sustained reduction in HAE attack rates within the first months of starting therapy, making oral berotralstat an effective treatment option for patients with HAE,” the study authors concluded.

This article originally appeared on Pulmonology Advisor.

References:

Lumry W, Desai B, Tilley A, et al. Rapid and sustained reductions in hereditary angioedema attack rates with long-term berotralstat: real-world outcomes. Ann Allergy Asthma Immunol. 2022;129(5):S10. doi:10.1016/j.anai.2022.08.535