A phase 3 clinical trial supports the use of the monoclonal antibody lanadelumab to reduce attacks of hereditary angioedema (HAE).
The new study found that subcutaneous lanadelumab for 26 weeks reduced the rate of attacks in patients with HAE type I or II.
The double-blind, parallel-group, placebo-controlled trial, which was conducted at 41 sites in Canada, Europe, Jordan and the United States, randomised participants 2:1 to subcutaneous lanadelumab or placebo for 26 weeks. Those assigned to lanadelumab were further randomised 1:1:1 to one of three doses - 150 mg (D1) or 300 mg (D2) every four weeks or 300 mg every two weeks (D3).
During the run-in period, the mean number of attacks per month in the placebo group was 4.0 vs 3.2 with lanadelumab D1, 3.7 with D2 and 3.5 with D3.
During the treatment period, the rates were 1.97 with placebo group vs 0.48, 0.53 and 0.26 for the D1, D2 and D3 groups, respectively.
Compared with placebo, the mean differences in the attack rate per month were -1.49 (95% CI -1.90 to -1.08; P<.001 ci to p and for the d1 d2 d3 groups.>
The research is published in JAMA.