% Migraine Headache Days Responders (over Months 1 to 6)
% Responders* 39% 19% 34% 18%
100% Migraine Headache Days Responders (over Months 1 to 6)
% Responders* 16% 6% 12% 6%
Monthly Migraine Headache Days that Acute Medication was Taken (over Months 1 to 6)
Mean change from baseline (days)* -4.0 -2.2 -3.7 -1.9
MSQ Role Function-Restrictive Domain Score (over Months 4 to 6)
Baseline 51.4 52.9 52.5 51.4
Mean change from baselinea 32.4 24.7 28.5 19.7
Difference from placebo* 7.7 8.8
a N = 189 for EMGALITY 120 mg and N = 377 for placebo in Study 1; N = 213 for EMGALITY 120 mg and N = 396 for
placebo in Study 2.
* p<0.001
Figure 1: Change from Baseline in Monthly Migraine Headache Days in Study 1aa Least-square means and 95% confidence intervals are presented.
Figure 2: Change from Baseline in Monthly Migraine Headache Days in Study 2aa Least-square means and 95% confidence intervals are presented.
Figure 3 shows the distribution of change from baseline in the mean number of monthly migraine headache days in bins
of 2 days, by treatment group, in Study 1. A treatment benefit over placebo for EMGALITY is seen across a range of
changes from baseline in monthly migraine headache days.
Figure 3: Distribution of Change from Baseline in Mean Monthly Migraine Headache Days over Months 1 to 6 by
Treatment Group in Study 1
Figure 4 shows the distribution of change from baseline in the mean number of monthly migraine headache days in binsof 2 days, by treatment group, in Study 2. A treatment benefit over placebo for EMGALITY is seen across a range ofchanges from baseline in monthly migraine headache days.
Figure 4: Distribution of Change from Baseline in Mean Monthly Migraine Headache Days over Months 1 to 6 byTreatment Group in Study 2
Chronic Migraine
Study 3 (NCT02614261) included adults with a history of chronic migraine (≥15 headache days per month with≥8 migraine days per month). All patients were randomized in a 1:1:2 ratio to receive once-monthly subcutaneousinjections of EMGALITY 120 mg, EMGALITY 240 mg, or placebo over a 3-month treatment period. All patients in the
120 mg EMGALITY group received an initial 240 mg loading dose.
Patients were allowed to use acute headache treatments including migraine-specific medications (i.e., triptans,ergotamine derivatives), NSAIDs, and acetaminophen. A subset of patients (15%) was allowed to use one concomitantmigraine preventive medication. Patients with medication overuse headache were allowed to enroll.
The study excluded patients with ECG abnormalities compatible with an acute cardiovascular event, and patients with ahistory of stroke, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypassgrafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening.
The primary endpoint was the mean change from baseline in the number of monthly migraine headache days over the 3month treatment period. The secondary endpoints were response rates (the mean percentages of patients reaching atleast 50%, 75% and 100% reduction from baseline in the number of monthly migraine headache days over the 3-monthtreatment period), the mean change from baseline in the number of monthly migraine headache days with use of anyacute headache medication during the 3-month treatment period, and the impact of migraine on daily activities asassessed by the mean change from baseline in the MSQ v2.1 Role Function-Restrictive doma |
