Lanadelumab Cuts Monthly HAE Attack Rates in Real-World 3-Year Study

A real-world study showed that taking lanadelumab for 3 years reduced the rate of hereditary angioedema (HAE) attacks per month.1 The proportion of patients with an attack each month dropped from 54% before lanadelumab initiation to 9.8%.

“Prior to starting lanadelumab, patients who were on a previous [long-term prophylaxis] had better outcomes before starting lanadelumab treatment than those who were not,” wrote investigators, led by William R. Lumry, MD, from Allergy and Asthma Research Associates in Dallas, Texas. “Regardless of prior [long-term prophylaxis], patients saw incremental improvement in outcomes over time while receiving lanadelumab.”

The US Food and Drug Administration (FDA) approved lanadelumab, the first monoclonal antibody for the treatment of types 1 and II hereditary angioedema in patients aged ≥ 12 years, on August 23, 2018.2 A 26-week randomized, double-blind, placebo-controlled, parallel-group trial evaluated this plasma kallikrein inhibitor. Participants were divided into 3 dosing arms: 50 mg or 300 mg every 4 weeks, 300 mg every 2 weeks, or placebo. Compared with placebo, a significantly greater proportion of patients were attack-free throughout the 26 weeks.

The FDA may have approved lanadelumab to treat HAE 7 years ago, but there remains a lack of real-world data surrounding the outcome of patients receiving long-term lanadelumab. Investigators sought to describe the real-world outcomes of patients with HAE on lanadelumab for ≥ 3 years consecutively.1

The team collected data from the Adelphi Wave II Disease Specific Programme, a real-world, cross-sectional survey of US physicians and their patients with HAE, between 2023 – 2024. Physicians had reported HAE attack frequency, attack severity, and quality of life before lanadelumab initiation, at 12, 24, and 36 months after initiation, and at the time of the survey for 51 patients.

Before lanadelumab, physicians reported mild and severe HAE attack severity in 49% and 8.2% of patients, respectively. At 36 months, physicians reported 62.5% of patients with mild attacks and none with severe attacks.

Fewer patients experienced ≥ 1 attack per month after lanadelumab, dropping from a mean proportion of 54% patients before lanadelumab initiation to 9.8% at the time of the survey. Investigators also observed numerically lower rates of hospitalization after lanadelumab initiation.

Quality of life also improved; the proportion of patients with good or excellent quality of life increased from 68.6% before lanadelumab to 88.2% at the time of the survey. The reductions in attacks and severity may have also reduced patients’ anxiety about future attacks, improving their quality of life.

“However, the fact that 7.8% of patients were reported to have poor or very poor QoL post 36 months at the time of the survey, while none during years 1 to 3, is unexpected,” investigators noted. “The reasons for this are not clear, and fluctuations in long-term QoL warrant further investigation, however this might be partly attributable to recall or recency bias.”

The team also addressed the limitations of only using physician-reported data. Physicians may not fully capture the patient when it comes to HAE attack frequency or quality of life. Investigators wrote that future research should collect data from the Angioedema Quality of Life questionnaire.

“Long-term real-world research in patients with HAE receiving lanadelumab, along with comparison of the results with those for other [long-term prophylaxis] treatments, will further aid treatment decisions and improve outcomes in patients.

References

1. Lumry WR, Davis-Lorton M, Soteres D, et al. Long-term Real-world Outcomes in Patients with Hereditary Angioedema Receiving Lanadelumab for 3 or More Years. Int Arch Allergy Immunol. Published online July 17, 2025. doi:10.1159/000546987

2. FDA Approves Lanadelumab for Hereditary Angioedema. HCPLive. August 23, 2018. https://www.hcplive.com/view/fda-approves-lanadelumab-for-hereditary-angioedema. Accessed July 22, 2025.