Significant reduction in attack rate compared with placebo seen for three dose regimens of lanadelumab
WEDNESDAY, Nov. 28, 2018 (HealthDay News) — For patients with hereditary angioedema type I or II, lanadelumab, a fully human monoclonal antibody that selectively inhibits active plasma kallikrein, reduces the attack rate compared with placebo, according to a study published in the Nov. 27 issue of the Journal of the American Medical Association.
Aleena Banerji, M.D., from Massachusetts General Hospital in Boston, and colleagues conducted a phase 3 trial at 41 sites involving patients with hereditary angioedema attacks. Patients were randomly assigned in a two-to-one ratio to receive lanadelumab or placebo; those assigned to the lanadelumab group were further randomly assigned to one of three dose regimens. Forty-one patients who had at least one attack during a four-week run-in period were randomly assigned to receive placebo, and 28, 29, and 27 patients were randomly assigned to receive 26-week treatment with subcutaneous lanadelumab 150 mg every four weeks, 300 mg every four weeks, and 300 mg every two weeks, respectively.
The researchers found that during the run-in period, the mean number of hereditary angioedema attacks was four per month in the placebo group and 3.2, 3.7, and 3.5 in the every-four-week 150-mg group, every-four-week 300-mg group, and every-two-week 300-mg group, respectively. During the treatment period, the mean number of attacks per month was 1.97 for placebo and 0.48, 0.53, and 0.26 for the lanadelumab groups, respectively. The mean differences in the attack rate per month compared with placebo were −1.49, −1.44, and −1.71, respectively.
“All three lanadelumab treatment regimens produced statistically significant reductions in the mean hereditary angioedema attack rate compared with placebo,” the authors write.
The study was funded by Dyax Corp., now Shire Human Genetic Therapies, the manufacturer of lanadelumab.
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