An open-label study to evaluate the long-term safety and efficacy of lanadelumab for prevention of attacks in hereditary angioedema: design of the HELP study extension

Table 2 Safety and efficacy results from Phase 1a and 1b studies with lanadelumab

Study	Population	N	Treatments	TEAEs	Anti-drug antibodies	Efficacy
Phase 1a^a	Healthy subjects	32	Single dose: Placebo 0.1, 0.3, 1.0, or 3.0 mg/kg lanadelumab	Most common TEAE was headache (25% of both placebo- and lanadelumab-treated patients)	None	NA
Phase 1b^b	Patients with HAE	37	Two doses: Placebo 30, 100, 300, or 400 mg lanadelumab	Most common treatment emergent adverse events for lanadelumab versus placebo were angioedema attacks (38 vs 69%), injection site pain (25 vs 23%), and headache (17 vs 23%) Local AEs in 25 vs 23.1% for lanadelumab and placebo, respectively 3 severe related treatment emergent adverse events: injection site pain (1 patient); headache, night sweats (1 patient)	Positive results in 3/92 (3.3%) post-dose samples from 2/23 patients (8.7%) None were neutralizing	Angioedema attack rate decreased by 100% in 300 mg group (P < 0.0001) and by 88% in 400 mg group (P = 0.005)

AE adverse event; HAE hereditary angioedema; NA not applicable; TEAE treatment-emergent adverse event
^aDX-2930-01 (NCT01923207) [6]
^bDX-2930-02 (NCT02093923) [7]

ISSN: 2045-7022