PROMISE-2: CHRONIC MIGRAINE STUDY DESIGN
≥15 to ≤26 headache days per month, of which ≥8 were migraine days.1 One month was defined as 28 consecutive days.2
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PROMISE-2 trial design2
VYEPTI 100 mg is the recommended dose. Some patients may benefit from the available and approved 300 mg dose. The data presentation for 300 mg is included only within the primary endpoint and safety. For more information on the 300 mg data, please see the Prescribing Information.
PROMISE, PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy.
Endpoints1-3*†
Primary endpoint:
Mean change from baseline in MMD (Months 1-3)
Select key secondary endpoints:
- ≥50% MRR (Months 1-3)
- ≥75% MRR (Month 1)
- ≥75% MRR (Months 1-3)
- Percentage of subjects with a migraine on the day after dosing
- Reduction in average daily migraine prevalence from baseline to Week 4
Select other secondary endpoints:
- 100% MRR (Months 1-3)
- MRR for time periods other than Months 1-3
- Mean change from baseline in MMD (Months 4-6)
- PGIC
FDA-approved label analyses:
Percentage of subjects with a migraine from Day –1 (day prior to infusion) to Day 7‡
*One month was defined as 28 consecutive days.
†Primary and key secondary endpoints are hierarchical.
‡Analysis based upon observed data.
MMD, monthly migraine days; MRR, migraine responder rate; PGIC, Patient Global Impression of Change.
PROMISE-2 evaluated reduction in mean monthly migraine days.
Baseline characteristics and demographics (safety population)3
The study included:
- Patients using an established stable regimen of acute migraine or headache prevention medication (except onabotulinumtoxinA)
- Patients with a dual diagnosis of chronic migraine and medication overuse headache attributable to acute medication overuse (triptans, ergotamine, or combination analgesics >10 days per month)
The study excluded:
- Patients using opioids or butalbital-containing products >4 days per month
- Patients with a history of:
- Cardiovascular disease (hypertension, ischemic heart disease)
- Neurological disease
- Cerebrovascular disease
§Concomitant prophylactic medication use based on clinical review of the coded concomitant medications.
¶Migraine days were defined as any day with a headache that met the migraine definition, as outlined in the International Classification of Headache Disorders, 3rd Edition (beta version).
**Days with triptan or ergotamine use as recorded in eDiary averaged over the 28-day screening period.
BMI, body mass index; SD, standard deviation.
The first migraine trial to confirm medication-overuse headache at entry by diagnosis vs relying on medication history alone.††
††This trial included patients with a dual diagnosis of chronic migraine and medication-overuse headache attributed to acute medication overuse (triptans, ergotamine, or combination analgesics >10 days per month).
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IMPORTANT SAFETY INFORMATION
AND INDICATION
Contraindications
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
INDICATION
VYEPTI is indicated for the preventive treatment of migraine in adults.
Warnings and Precautions
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.
Adverse Reactions
The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.
For more information, please see the Full Prescribing Information and Patient Information.
IMPORTANT SAFETY INFORMATION
AND INDICATION
Contraindications
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
INDICATION
VYEPTI is indicated for the preventive treatment of migraine in adults.
Warnings and Precautions
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, dyspnea, and rash, have occurred with VYEPTI in clinical trials and in the postmarketing setting. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. Cases of anaphylaxis have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy.
Adverse Reactions
The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.
For more information, please see the Full Prescribing Information and Patient Information.
References:
- VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
- Lipton RB, Goadsby PJ, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology. 2020;94(13):e1365-1377.
- Data on file. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
© 2023 Lundbeck. All rights reserved. VYEPTI and VYEPTI GO are registered trademarks, and VYEPTI CONNECT and Migraine Victors Program are trademarks of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-100032v14
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