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AIMOVIGTM (erenumab-aooe) injection, for subcutaneous use(八)
2018-07-13 06:29:40 来源: 作者: 【 】 浏览:6699次 评论:0
e days per month and was similar between treatment groups.
AIMOVIG treatment demonstrated statistically significant improvements for key efficacy endpoints comparedto placebo, as summarized in Table 4.
Page 9 of 14
Reference ID: 4264882 
 
Table 4: Efficacy Endpoints at Month 3 for Study 2
 AIMOVIG
70 mg Once Monthly
N = 282
Placebo
N = 288
Monthly Migraine Days (MMD)
Change from baseline -2.9 -1.8
Difference from placebo -1.0
p-value < 0.001
≥ 50% MMD responders
% Responders 39.7% 29.5%
Difference from placebo 10.2%
Odds ratio relative to placebo 1.6
p-value 0.010
Monthly acute migraine-specific medication days
Change from baseline -1.2 -0.6
Difference from placebo -0.6
p-value 0.002
Figure 3: Change from Baseline in Monthly Migraine Days in Study 2aaLeast-square means and 95% confidence intervals are presented.
Figure 4 shows the distribution of change from baseline in monthly migraine days at month 3 in bins of 2 daysby treatment group. A treatment benefit over placebo for AIMOVIG is seen across a range of changes from
baseline in monthly migraine days.
Page 10 of 14
Reference ID: 4264882 
Figure 4: Distribution of Change from Baseline in Monthly Migraine Days at Month 3 by TreatmentGroup in Study 2
Figure excludes patients with missing data.
The pre-specified analysis for the MPFID was based on at least a 5-point reduction within-patient responderdefinition. AIMOVIG 70 mg once monthly was not significantly better than placebo for the proportion of
responders for everyday activity [difference from placebo: 4.7%; odds ratio = 1.2; p-value = 0.26] and physicalimpairment [difference from placebo: 5.9%; odds ratio = 1.3; p-value = 0.13]. In an exploratory analysis of the
change from baseline in the mean MPFID scores at month 3, patients treated with AIMOVIG 70 mg, ascompared to placebo, showed nominally greater reductions of physical impairment scores [difference from
placebo: -1.3; p-value = 0.021], but not of everyday activities scores [difference from placebo: -1.1; p-value =0.061].
Chronic Migraine
Study 3 (NCT 02066415) was a randomized, multi-center, 3-month, placebo-controlled, double-blind studyeva luating AIMOVIG as a preventive treatment of chronic migraine. A total of 667 patients with a history of
chronic migraine with or without aura were randomized to receive AIMOVIG 70 mg (N = 191), AIMOVIG140 mg (N = 190), or placebo (N = 286) by subcutaneous injections once monthly for 3 months. Patients were
allowed to use acute headache treatments including migraine-specific medications (i.e., triptans, ergotaminederivatives) and NSAIDs during the study.
The study excluded patients with medication overuse headache caused by opiate overuse and patients withconcurrent use of migraine preventive treatments. Patients with myocardial infarction, stroke, transient ischemic
attacks, unstable angina, coronary artery bypass surgery, or other revascularization procedures within 12 monthsprior to screening were also excluded.
The primary efficacy endpoint was the change from baseline in monthly migraine days at month 3. Secondaryendpoints included the achievement of a ≥ 50% reduction from baseline in monthly migraine days (“≥ 50%
MMD responders”) and change from baseline in monthly ac
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