This article is part of Pulmonology Advisor‘s coverage of the ACAAI 2018 meeting, taking place in Seattle, Washington. Our staff will report on medical research related to allergy, asthma, and more conducted by experts in the field. Check back regularly for more news from ACCAI 2018.
SEATTLE — Patients aged ≥12 years with type I or II hereditary angioedema (HAE) who received lanadelumab exhibited little hypersensitivity and had low immunogenicity, according to the results of the phase 3 HELP study (ClinicalTrials.gov Identifier: NCT02586805) presented at the Annual Scientific Meeting of the American College of Allergy, Asthma, & Immunology, held November 15 to 19, 2018, in Seattle.
Treatment-emergent adverse events were recorded from patients aged ≥12 years with type I or II HAE and ≥1 attack during a 4-week run-in who received either subcutaneous lanadelumab at 3 dose ranges (300 mg every 2 weeks, 300 mg every 4 weeks, 150 mg every 4 weeks) or placebo over 26 weeks. Lanadelumab is a fully human monoclonal antibody targeting plasma kallikrein and has previously shown efficacy in patients with HAE.
Of the 125 participants enrolled in the study who received ≥1 dose of medication, 84 received lanadelumab and 41 received placebo. Of those, 92.8% of patients in the lanadelumab group and 85.4% of patients in the placebo group completed the study. A total of 90.5% of patients receiving lanadelumab and 75.6% of patients receiving placebo reported ≥1 treatment-emergent adverse event; there were 685 total events reported. However, none of these were serious or life-threatening.
Injection site reactions were the most commonly reported non-HAE attack treatment-emergent adverse events, with 52.4% of lanadelumab-treated patients experiencing 398 reactions vs 34.1% of placebo-treated patients experiencing 85 events. Injection site pain was the most frequently occurring related treatment-emergent adverse event.
A single lanadelumab-treated participant had 2 related hypersensitivity events, and 10 lanadelumab-treated participants and 2 placebo-treated participants exhibited immunogenicity.
The researchers wrote, “Together with its efficacy in preventing HAE attacks, lanadelumab may offer patients a novel and well tolerated therapeutic option for HAE prophylaxis.”
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Johnston D, Banerji A, Riedl M, et al. Lanadelumab safety and immunogenicity: results from the phase 3 HELP study. Presented at: the Annual Scientific Meeting of the American College of Asthma, Allergy, and Immunology; November 15-19, 2018; Seattle, WA. Poster P166.