Patients experience more migraine-free days with Aimovig®, starting at month 11,2
Change From Baseline (~8 Monthly Migraine Days) in Mean MMDs Over Months 4 to 61,2,†
This was a phase 3 randomized, double-blind, placebo-controlled study of adult episodic migraine patients.1,2
Study Information
*Earliest post-baseline prespecified assessment.2
†Least-square means are presented. For Aimovig® 70 mg, the difference from placebo was -1.4 (95% CI: -1.9, -0.9). For Aimovig® 140 mg, the difference from placebo was -1.9 (95% CI: -2.3, -1.4).1,2
In the phase 3 EM active treatment phase
Efficacy was maintained at 1 year of treatment3
Change in MMDs from baseline
Study Information
ATP = active treatment phase; DBTP = double-blind treatment phase; EM = episodic migraine; MMDs = monthly migraine days; Ph = phase.
Aimovig® demonstrated sustained efficacy with results out to 5 years1,2
Change From Baseline in Mean MMDs at Month 3 and Year 51-4
N = total number of patients who enter into OLTP.
n = total number of patients with observed monthly migraine days at each visit.
Consider open-label treatment phase study limitations when interpreting results. The OLTP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Overall, a total of 167 patients (43.6%) discontinued during the study, of which 19 patients (5.0%) discontinued due to adverse events.1
Study Information
*Study included additional dosage arms, which were not included in the FDA-approved labeling.2
DBTP = double-blind treatment phase; EM = episodic migraine; MMDs = monthly migraine days; OLTP = open label treatment phase; Ph = phase.
In a phase 3 EM study
Up to half of Aimovig®-treated patients cut migraine days by at least 50%1,2
Percentage of Patients Achieving at Least a 50% Reduction From Baseline in MMDs1
≥50% response rate was the secondary endpoint in the phase 3, double-blind, randomized study.1,2
*Odds of achieving a ≥50% reduction were significantly higher (2.1x, 95% CI: 1.5, 3.0) for the Aimovig® 70 mg group than for the placebo group (P<0.001).1,2
†Odds of achieving a ≥50% reduction were significantly higher (2.8x, 95% CI: 2.0, 3.9) for the Aimovig® 140 mg group than for the placebo group (P<0.001).1,2
In a phase 2 EM study
~7 out of 10 Aimovig®-treated patients cut migraine days by at least 50%3,4
- 46% of Aimovig® 70 mg patients achieved a ≥50% reduction in MMDs at the 3-month, DBTP portion of this phase 2 EM study vs 30% for placebo4
Consider open-label treatment phase study limitations when interpreting results. The OLTP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Overall, a total of 167 patients (43.6%) discontinued during the study, of which 19 patients (5.0%) discontinued due to adverse events.5
DBTP = double-blind treatment phase; EM = episodic migraine; MMDs = monthly migraine days; OLE = open-label extension; Ph = phase.
In a phase 3 EM study exploratory analysis
~1 in 5 Aimovig®-treated patients cut migraine days by at least 75%1
Percentage of Patients Achieving at Least a 75% Reduction From Baseline in MMDs1
≥75% response rate is an exploratory analysis and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.1
In a phase 2 EM study
~5 out of 10 Aimovig®-treated patients cut migraine days by at least 75%2,3
- 20.7% of Aimovig® 70 mg patients achieved a ≥75% reduction in MMDs at the 3-month, DBTP portion of this phase 2 EM study vs 13.3% for placebo3,4,*
Consider open-label treatment phase study limitations when interpreting results. The OLTP was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Overall, a total of 167 patients (43.6%) discontinued during the study, of which 19 patients (5.0%) discontinued due to adverse events.5
*Represents only patients who entered into open-label treatment phase.4
DBTP = double-blind treatment phase; EM = episodic migraine; MMDs = monthly migraine days; OLE = open label extension; Ph = phase.
In a phase 3 EM study subgroup analysis
Patients had relief with Aimovig®, even when their oral preventives failed1
Change in Mean MMDs Between Baseline (~9 MMDs) and Months 4 to 61-3
Subgroup analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.
Preventive medications had failed due to lack of efficacy or intolerance by self-report.1
EM = episodic migraine; MMDs = monthly migraine days; Ph = phase.
Efficacy was evaluated in patients who failed oral preventives1
efficacy
(64.7%; 262/405)1
tolerability
(50.6%; 205/405)1
- This represents 39% (370/955) of the total population1
- ≥1 preventive medication failure = 38.7% (370/955) of total study population1
- ≥2 preventive medication failure = 16.9% (161/955) of total study population1
- Subgroups were defined based on these prior oral preventive treatment failures1
Prior Treatments Failed1,*
*Categories are not mutually exclusive and patients may contribute to more than one category.
†Atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, and timolol.
‡Venlafaxine, desvenlafaxine, duloxetine, and milnacipran.
MMDs = monthly migraine days; SNRI = serotonin–norepinephrine reuptake inhibitor.
