Lanadelumab is more effective than intravenous plasma-derived C1-esterase inhibitor (pdC1-INH IV) in reducing the frequency of hereditary angioedema (HAE) attacks, according to a study published in Allergy.
The current mainstay treatments for HAE are on-demand therapy and short- and long-term prophylaxis. The goal of these therapeutics is to help patients achieve meaningful disease control.
Lanadelumab and pdC1-INH IV have both been authorized by the European Medicines Agency as long-term prophylaxis in HAE care. International guidelines recommend them as first-line use. The authors of the study sought to further analyze the effectiveness of these medications by comparing them against each other.
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The research team relied on data from the HELP trial (for lanadelumab) and the CHANGE trial (for pdC1-INH IV). Both trials were phase 1, randomized, double-blinded, and placebo-controlled. The HELP trial assessed the merits of lanadelumab and treated 212 patients, whereas the CHANGE trial assessed the merits of pdC1-INH IV and had 146 participants.
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The research team analyzed the data of patients who were 12 years of age and above with a diagnosis of type 1 or 2 HAE. Patients who were pregnant or lactating or had a narcotic addiction were excluded. Based on these inclusion and exclusion criteria, the researchers selected 231 patients; 111 patients received 300 mg of lanadelumab every 2 weeks for up to 182 days, and 120 patients received 1 unit of pdC1-INH IV every 3 to 7 days.
The researchers studied parameters of drug efficacy in a HAE context, such as the frequency and severity of HAE attacks, laryngeal HAE attacks, and monthly attack rates. They also evaluated drug safety.
They reported that the monthly HAE attack rate among patients prescribed lanadelumab was nearly half of those who received pdC1-INH IV. In addition, the lanadelumab cohort had a monthly rate that was 5 times lower in laryngeal attacks compared with the pdC1-INH IV cohort. The frequency of severe adverse effects among individuals who received lanadelumab was also lower compared with those who received pdC1-INH IV (2.7% vs 11.7%).
“Since non-randomized approaches are associated with distinct inherent uncertainties and current standard of care in HAE are highly efficacious, the evidence generation for future drugs should consider a direct comparison with the standard of care to demonstrate their non-inferiority or their equivalence, respectively, and to ensure better comparability of efficacy and safety,” the authors concluded.
Reference
Magerl M, Schiffhorst G, Fanter L, et al. Patient-level indirect treatment comparison of lanadelumab versus pdC1-INH i.v. in hereditary angioedema patients: PATCH study. Allergy. Published online August 29, 2023. doi:10.1111/all.15861
