Orladeyo Reduces Swelling Rates in Patients Who Switched Therapies

Data presented shows effects of therapy that suppresses production of bradykinin

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A person looks at two different medicine choices, one an injection, the other a pill, in each hand.

People with hereditary angioedema (HAE) who switched to Orladeyo (berotralstat) from other preventive treatments generally experience a reduction in swelling attacks.

That is according to real-world data presented by BioCryst Pharmaceuticals, Orladeyo’s developer, during the 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), this month in Kentucky. The poster was titled “Consistently Low Hereditary Angioedema Attack Rates Observed with Berotralstat Regardless of Previous Prophylaxis: Real-World Outcomes.”

“This real-world evidence suggests that people living with HAE can maintain or improve control of their disease on Orladeyo, regardless of prior treatment history,” Ryan Arnold, chief medical officer of BioCryst, said in a press release.

Orladeyo is an oral prophylactic medicine approved in the U.S. to prevent swelling attacks in HAE patients ages 12 and older. It works by suppressing the production of bradykinin, the signaling molecule that drives swelling attacks in HAE.

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Switching to Oral Orladeyo Boosts Quality of Life for Trial Patients

Here, researchers reported the outcomes of 129 HAE patients who switched to Orladeyo (110 or 150 mg) from another HAE prophylactic medication. Specifically, 53 previously had been on Takhzyro (lanadelumab), 15 on Danocrine (danazol), 31 on Haegarda, 21 on intravenous C1-inhibitor products, and nine on a combination of several therapies.

Regardless of prior treatment, median swelling attack rates decreased from 1.67 attacks per month to 0.33 in the first three months of treatment with Orladeyo. This rate was maintained through a year of treatment.

“These data are particularly exciting because, consistent with our long-term clinical program data, they show that patients on Orladeyo sustain, and even improve, attack control the longer they are on therapy,” Arnold said.

Swelling attack rates dropped by 77% for patients switching from Takzyro to Orladeyo. For those switching from Danocrine to Orladeyo, the decrease was of 70%. Those switching from Haegarda or intravenous C1 inhibitor products experienced a reduction in attack rates of 64% and 72%, respectively.

“Every HAE patient has a unique experience with their therapy, and these data demonstrate that Orladeyo can be a very effective treatment option for patients regardless of their reported prior attack rates or prophylactic therapy history,” said William Lumry, MD, clinical professor of internal medicine at the University of Texas Southwestern Medical School.

In a separate poster presented at ACAAI, BioCryst shared other real-world data for 128 patients treated with Orladeyo for nearly nine months. The second poster was titled “Rapid and Sustained Reductions in Hereditary Angioedema Attack Rates with Long-term Berotralstat: Real-World Outcomes.”

Results showed the median swelling attack rate decreased by 80% compared to rates seen prior to Orladeyo treatment initiation. These effects were similar regardless of prior attack rate.

The incidence of adverse events in both real-world studies was either lower or similar to that reported in Orladeyo clinical trials.

“The sustained, long-term attack rate reductions we are seeing illustrate the durability of this efficacy for patients who are looking to improve control over their HAE by switching to a therapy with a less burdensome route of administration than subcutaneous or intravenous prophylactic therapies,” Lumry said.