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PROMISE-1 trial design3

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.

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

 

FDA-approved label analyses:

Percentage of subjects with a migraine from Day –1 (day prior to infusion) to Day 7‡

Select other secondary endpoints:

  • Reduction in average daily migraine prevalence from baseline to Week 4
  • 100% MRR (Month 1)
  • MRR for time periods other than Months 1-3
  • Mean change from baseline in MMD (Months 4-6)
     

Post Hoc Analyses: 

  • Average daily migraine prevalence and reduction in migraine prevalence by 1-week interval
  • 100% MRR (Months 1-3) 
  • 100% MRR (Months 4-6)

*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.

PROMISE-1 evaluated reduction in mean monthly migraine days.

Baseline characteristics and demographics2

The study included:

  • Patients using concurrent acute migraine or headache medications, including migraine-specific medications (eg, triptans, ergotamine derivatives)

The study excluded patients with a history of:

  • Cardiovascular disease (hypertension, ischemic heart disease)
  • Neurological disease
  • Cerebrovascular disease

§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.

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VYEPTI SAFETY PROFILE

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CHRONIC MIGRAINE RESULTS
VYEPTI CONNECT SUPPORT
DOSING AND ADMINISTRATION
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:
  1. VYEPTI (eptinezumab-jjmr) [package insert]. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  2. Data on file. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.
  3. Ashina M, Saper J, Cady R, et al. Eptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia. 2020;40(3):241-254.

© 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-100032v15

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