Subcutaneous Lanadelumab Treatment Reduces Attack Rate in Patients with Hereditary Angioedema

Subcutaneous administration of lanadelumab, an investigational monoclonal antibody intended for the prevention of attacks in patients with type I or II hereditary angioedema (HAE), significantly reduced the mean number of attacks compared to placebo treatment. Patients enrolled at 41 sites in Canada, Europe, the U.S. and Jordan were randomly assigned to 26-week treatment with subcutaneous lanadelumab at dosages of 150 mg every four weeks (n=28), 300 mg every four weeks (n=29), 300 mg every two weeks (n=27) or placebo (n=41). All patients received injections every two weeks, with those in the every-four-week groups receiving placebo between active treatments.

During the treatment period, the mean number of attacks per month for the placebo group was 1.97; for the lanadelumab group, the mean numbers of attacks per month were 0.48 (every-four-week 150 mg group), 0.53 (every-four-week 300 mg group) and 0.26 (every-two-week 300 mg group). Patients receiving 300 mg of lanadelumab every two weeks experienced 83 percent fewer moderate to severe HAE attacks than placebo group patients, and 87 percent fewer attacks that required on-demand treatment. A post hoc sensitivity analysis showed 77 percent (20/26) of patients receiving 300 mg of lanadelumab every two weeks were attack-free during steady-state (day 70-182) versus 3 percent (1/37) of patients on placebo treatment.

The most commonly occurring adverse events with greater frequency in the lanadelumab treatment groups were injection site reactions (34.1 percent placebo, 52.4 percent lanadelumab) and dizziness (0 percent placebo, 6.0 percent lanadelumab). “These findings support the use of lanadelumab as a prophylactic therapy for hereditary angioedema,” the authors concluded.