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This article is part of MPR’s coverage of the American College of Allergy, Asthma & Immunology 2020 Annual Scientific Meeting, being held virtually from November 13-15, 2020. |
Lanadelumab was effective for reducing hereditary angioedema (HAE) attacks at up to 30 months of treatment, suggesting the monoclonal antibody is associated with sustained long-term efficacy when used as HAE prophylaxis, according to study results presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting , held virtually from November 13 to 15.
The study was an open-label extension that included 109 patients aged 12 years or older with HAE type 1/2 who completed the HELP trial (ClinicalTrials.gov Identifier: NCT02586805). Patients received a single 300mg dose of lanadelumab until first attack and subsequently received 300mg every 2 weeks thereafter. Another group of 103 patients with HAE who did not participate in the HELP study were also enrolled and received 300mg lanadelumab every 2 weeks from baseline.
Approximately 92.5% of the study population completed 12 or more months of treatment, whereas 81.6% completed 30 or more months (median, 33.0 months). Treatment with lanadelumab was associated with a marked reduction in the mean attack rate compared with baseline in the overall population (3.05 vs 0.25; reduction relative to baseline, 87.4%). The majority of patients (96.6%) experienced at least a 50% reduction in HAE attacks during treatment.
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Treatment emergent adverse events (TEAEs) excluding HAE attacks were reported in 97.2% of patients. The most frequently reported TEAE was mild to moderate injection site pain (47.2%). More than half (54.7%) of patients reported treatment-related TEAEs, the most common of which were injection site pain (42.5%) and injection site erythema (16.0%). The majority of injection site reactions resolved within a 1-hour period (70.2%) or a day (92.6%) from onset.
A total of 6 (2.8%) patients discontinued therapy because of a TEAE, including 1 patient because of a treatment-related event (edema, joint pain, and wheals). There were no reported treatment-related serious TEAEs or deaths. In 7 (3.3%) patients, the investigators observed 11 treatment-related TEAEs of special interest. There were anti-lanadelumab antibodies present in 21 (9.9%) patients, with 6 (2.8%) positive for neutralizing antibodies. However, the neutralizing antibodies had “no apparent clinical impact,” according to the investigators.
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Reference
Banerji A, Hao J, Yu M, Bernstein J, Johnston D, Riedl M. Long-term efficacy and safety of lanadelumab: final results from the HELP open-label extension study. Presented at: the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting (Virtual Experience); November 13-15, 2020. Abstract P150.
This article originally appeared on Pulmonology Advisor
