PROMISE-1: EPISODIC MIGRAINE STUDY DESIGN
4 to 14 headache days per month, of which ≥4 were migraine days.1 One month was defined as 28 consecutive days.2
This study included a VYEPTI 30 mg (n=223) treatment arm, but is not an approved dose. 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.
Primary endpoint:
Mean change from baseline in MMD (Months 1-3)
Select key secondary endpoints:
FDA-approved label analyses:
Percentage of subjects with a migraine from Day –1 (day prior to infusion) to Day 7‡
Select other secondary endpoints:
Post Hoc Analyses:
*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.
The study included:
The study excluded patients with a history of:
§Medications were coded using the World Health Organization (WHO) drug dictionary (September 2012 version); 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, 2nd Edition.
**Days with triptan or ergotamine use as recorded in eDiary averaged over the 28-day screening period.
BMI, body mass index; SD, standard deviation.
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
VYEPTI is indicated for the preventive treatment of migraine in adults.
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.
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.
VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Reactions have included anaphylaxis and angioedema.
VYEPTI is indicated for the preventive treatment of migraine in adults.
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.
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.