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Treatment with 300 mg lanadelumab every 2 weeks significantly reduced monthly hereditary angioedema (HAE) attack rates compared with the 3-month historic baseline of patients with and those without prior C1-inhibitor (C1-INH) deficiency long-term prophylaxis use, according to research intended to be presented at the 2020 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
Researchers are conducting an ongoing open-label extension (OLE; ClinicalTrials.gov Identifier: NCT02741596) of the phase 3 HELP study, the results of which demonstrated that lanadelumab may prevent HAE attacks. Given that previous long-term prophylaxis use may indicate greater disease severity in HAE, researchers sought to investigate the efficacy of lanadelumab according to a history of long-term prophylaxis use.
A total of 212 participants aged >12 years with HAE type I/II received 300 mg lanadelumab every 2 weeks. These individuals included both rollover participants from the HELP study (n=109) and newly enrolled nonrollover participants (n=103) who could be given lanadelumab for <3 weeks and continue existing long-term prophylaxis. HAE attack frequency was reported as the monthly attack rate (number of attacks/4 weeks), and this rate was compared with the 3-month historic baseline rate for attacks preceding study enrollment.
Overall, 50.0% (n=106) of participants had received prior C1-INH long-term prophylaxis only, 9.0% (n=19) received other long-term prophylaxis, and 41.0% (n=87) had no prior long-term prophylaxis. Participants with a history of C1-INH long-term prophylaxis only had a mean baseline attack rate of 2.9 per 4 weeks, which was reduced to 0.3 with lanadelumab treatment (mean reduction, 77.1%; median reduction, 97.0%). Participants without a history of long-term prophylaxis use had a mean baseline attack rate of 3.0 per 4 weeks, which reduced to 0.2 with lanadelumab treatment (mean reduction, 91.4%; median reduction, 98.8%). Participants who switched from alternate long-term prophylaxis also experienced reductions in attack rate with lanadelumab. In all subgroups, attack rate reductions were comparable between rollover and nonrollover participants.
The investigators concluded, “Long-term treatment with lanadelumab 300mg [every 2 weeks] significantly reduced monthly HAE attack rates compared with 3-month historical baseline in patients with and without prior C1-INH [long-term prophylaxis] use.”
Disclosure: This clinical trial was supported by Takeda. Please see the original reference for a full list of authors’ disclosures.
Reference
Paes K, Craig T, Bernstein J, et al. Efficacy of lanadelumab in hereditary angioedema patients with and without prior long-term prophylaxis use: Interim results from the HELP open-label extension study. J Allergy Clin Immunol. 2020;145(Suppl 2):AB102.
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