Hereditary angioedema attacks fall by 80% with lanadelumab
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Key takeaways:
- Participants were aged 12 years and older.
- None of the 129 treatment-related adverse events were considered serious.
- Six of these events were considered related to lanadelumab.
WASHINGTON — Patients with hereditary angioedema experienced reductions in the monthly rate of attacks with lanadelumab, according to a poster presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.
“After 3 years, it was an 80% reduction in HAE attack rates from baseline,” Salomé Juethner, MSN, senior medical director, head of rare genetics, Takeda Pharmaceuticals USA Inc., told Healio.
The full analysis set of the phase 4 EMPOWER study involved 113 patients (mean age, 40.6 years; 65.5% female; 93.8% white) aged 12 years and older with HAE.
Users who had already received four or more doses of lanadelumab (Takhzyro, Takeda) at enrollment were considered prevalent users (n = 93). All others (n = 20) were considered new users.
Treatment included 898.3 ± 470.97 days for prevalent users and 771.7 ± 379.3 days for new users.
Rates of HAE attacks per month fell from 1.57 (95% CI, 0.88-2.81) before treatment to 0.28 (95% CI, 0.15-0.53) during the cumulative period for new users. The prevalent users had a rate of 0.47 (95% CI, 0.25-0.7) HAE attacks per month during 36 months of follow-up.
“From a safety perspective, there were no new signals,” Juethner said.
Among 116 patients who received one or more doses in the safety analysis set (mean, age 40.1 years; 65.5% female; 94% white), with 95 prevalent users and 21 new users, 48 reported 129 treatment-emergent adverse events.
These treatment-emergent adverse events primarily were infections and infestations (28.7%), with 96.1% considered nonserious and 94.6% considered mild or moderate. No treatment-emergent adverse events were considered serious. One treatment-emergent adverse event that was not related to lanadelumab resulted in study discontinuation.
Six treatment-emergent adverse events , experienced by two patients, were considered related to lanadelumab. They included fatigue (n = 2), worsening fatigue (n = 1), tachycardia (n = 1), worsening tachycardia (n = 1) and papular pruritic rash bilateral (n = 1).
“This data is consistent with data that has been reported out from the HELP and HELP OLE study phase 3 trials for lanadelumab,” Juethner said.