February 27, 2019

Only 1 patient who received lanadelumab 150 mg every 4 weeks reported a treatment-emergent adverse event.

SAN FRANCISCO — Patients with hereditary angioedema did not demonstrate higher cardiovascular risk when treated with lanadelumab compared with placebo, according to research presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting 2019, held February 22-25, 2019, in San Francisco, California.

Researchers sought to examine the effect of lanadelumab in reducing active plasma kallikrein, an important enzyme in regulating blood pressure, in patients with type I or type II hereditary angioedema in an analysis of the phase 3 HELP study (ClinicalTrials.gov Identifier: NCT02586805)

The study sample included 125 patients with hereditary angioedema who were ≥12 years old and who had reported ≥1 hereditary angioedema attacks during a 4-week run-in period. During the course of 26 weeks, the participants received either lanadelumab (n=84) 300 mg every 2 weeks, 300 mg every 4 weeks, or 150 mg every 4 weeks, or placebo (n=41). The patients were not permitted to use angiotensin-converting enzyme inhibitors during the study.

Of the patients who received lanadelumab doses, 78 (92.8%) completed the study, and 35 (85.4%) patients who received placebo completed the study. Twelve (14.3%) patients in the lanadelumab groups had a history of hypertension at baseline vs 6 (14.6%) patients in the placebo group had a history of hypertension. Over 26 weeks, blood pressure remained stable in the lanadelumab group; however, diastolic blood pressure slightly decreased in the placebo group compared with the lanadelumab groups (–3.17 mm Hg vs 1.34 mm Hg; P =.002). Neither group reported increased use of anti-hypertensive medications nor did the investigators observe any significant electrocardiographic abnormalities. Only 1 patient who received lanadelumab 150mg every 4 weeks reported a treatment-emergent adverse event in which the patient’s blood pressure increased to 124/91 mm Hg.

The investigators suggested that lanadelumab used to treat patients with hereditary angioedema was not associated with an increased risk of hypertension or electrocardiographic abnormalities.

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Reference

Sexton DJ, Brown NJ, Lumry WR, et al.  Lanadelumab and cardiovascular risk: findings from the phase 3 HELP Study. Presented at: American Academy of Allergy, Asthma & Immunology Annual Meeting 2019; February 22-25, 2019; San Francisco, CA. Abstract 136.