AL STUDIES
The efficacy of EMGALITY was eva luated as a preventive treatment of episodic or chronic migraine in three multicenter,randomized, double-blind, placebo-controlled studies: two 6-month studies in patients with episodic migraine (Studies 1and 2) and one 3-month study in patients with chronic migraine (Study 3).
Episodic Migraine
Study 1 (NCT02614183) and Study 2 (NCT02614196) included adults with a history of episodic migraine (4 to 14 migrainedays per month). All patients were randomized in a 1:1:2 ratio to receive once-monthly subcutaneous injections ofEMGALITY 120 mg, EMGALITY 240 mg, or placebo. All patients in the 120 mg EMGALITY group received an initial240 mg loading dose. Patients were allowed to use acute headache treatments, including migraine-specific medications(i.e., triptans, ergotamine derivatives), NSAIDs, and acetaminophen during the study.
The studies excluded patients on any other migraine preventive treatment, patients with medication overuse headache,patients with ECG abnormalities compatible with an acute cardiovascular event and patients with a history of stroke,myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep veinthrombosis, or pulmonary embolism within 6 months of screening.
The primary efficacy endpoint for Studies 1 and 2 was the mean change from baseline in the number of monthly migraineheadache days over the 6-month treatment period. Key secondary endpoints included response rates (the meanpercentages of patients reaching at least 50%, 75%, and 100% reduction from baseline in the number of monthly migraineheadache days over the 6-month treatment period), the mean change from baseline in the number of monthly migraineheadache days with use of any acute headache medication during the 6-month treatment period, and the impact ofmigraine on daily activities, as assessed by the mean change from baseline in the average Migraine-Specific Quality ofLife Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive domain score during the last 3 months of treatment(Months 4 to 6). Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.
In Study 1, a total of 858 patients (718 females, 140 males) ranging in age from 18 to 65 years, were randomized. A totalof 703 patients completed the 6-month double-blind phase. In Study 2, a total of 915 patients (781 female, 134 male)ranging in age from 18 to 65 years, were randomized. A total of 785 patients completed the 6-month double-blind phase.
In Study 1 and Study 2, the mean migraine frequency at baseline was approximately 9 migraine days per month, and wassimilar across treatment groups.
EMGALITY 120 mg demonstrated statistically significant improvements for efficacy endpoints compared to placebo over
the 6-month period, as summarized in Table 2. EMGALITY treatment with the 240 mg once-monthly dose showed no
additional benefit over the EMGALITY 120 mg once-monthly dose.
Table 2: Efficacy Endpoints in Studies 1 and 2
Study 1 Study 2
EMGALITY
120 mg
N = 210
Placebo
N = 425
EMGALITY
120 mg
N = 226
Placebo
N = 450
Monthly Migraine Headache Days (over Months 1 to 6)
Baseline migraine headache days 9.2 9.1 9.1 9.2
Mean change from baseline -4.7 -2.8 -4.3 -2.3
Difference from placebo* -1.9 -2.0
≥50% Migraine Headache Days Responders (over Months 1 to 6)
% Responders* 62% 39% 59% 36%
≥75 |
