This article is part of Pulmonology Advisor‘s coverage of the American Academy of Allergy, Asthma & Immunology, taking place in Orlando, Florida. Our staff will report on medical research related to asthma and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from AAAAI/WAO 2018.
ORLANDO — In patients with hereditary angioedema, lanadelumab reduced attack rates compared with placebo, according to the results of a phase 3 clinical trial presented at the 2018 Joint Congress of the American Academy of Allergy, Asthma & Immunology/World Allergy Organization (AAAAI/WAO) in Orlando, Florida.
Researchers conducted the HELP study (ClinicalTrials.gov Identifier: NCT02586805) to assess the efficacy and safety of lanadelumab for long-term prophylaxis of hereditary angioedema in individuals aged ≥18 years.
A total of 125 patients were stratified by baseline attack rate into 1 of 4 parallel 26-week treatment groups in a 3:2:2:2 ratio (placebo or lanadelumab 150 mg once every 4 weeks, 300 mg once every 4 weeks, and 300 mg once every 2 weeks). Patients went through a 2-week washout period prior to the requirement of ≥1 attack in a 4-week run-in period.
The mean hereditary angioedema attack rates in the lanadelumab groups vs placebo group prior to long-term prophylaxis were compared using the Poisson regression model. Researchers analyzed historical, run-in, and on-study attack rates for all treatment regimens.
Of the 125 patients, 60 previously used C1 esterase inhibitor (C1-INH) only as long-term prophylaxis, 10 used other treatments and combinations, and 60 did not use long-term prophylaxis. The attack rate in patients taking C1-INH only was significantly reduced in all lanadelumab regimens compared with placebo (P <.001).
These patients reported mean monthly attack rates of 4.0, 3.0, 2.7, and 2.6 prior to the study; 4.6, 3.3, 3.7, and 4.6 during the run-in; and 2.9, 0.5, 0.7, and 0.5 during the treatment period for placebo and lanadelumab 150 mg once every 4 weeks, 300 mg once every 4 weeks, and 300 mg once every 2 weeks, respectively.
The reduction was similar in patients who did not receive prior long-term prophylaxis. Therefore, the researchers concluded that all lanadelumab dosing regimens reduced attack rates compared with placebo, regardless of whether patients received prior C1-INH long-term prophylaxis.
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Johnston DT, Anderson JT, Schranz J, et al. Efficacy of lanadelumab in patients switching from long-term prophylaxis with C1-inhibitor (C1-INH): results from the phase 3 HELP study. Presented at: 2018 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress; March 2-5, 2018; Orlando, FL. Abstract 150.