VYEPTI for chronic migraine

PROMISE-2 trial design

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.


Endpoints*

Primary endpoint:

Mean change from baseline in MMD (Months 1-3)

Select key secondary endpoints:

  • ≥75% MRR (Month 1)
  • ≥75% MRR (Months 1-3)
  • Percentage of subjects with migraine Day 1 post-dose
  • Mean reduction in 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)


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).4

**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).

Chronic migraine efficacy results icon

Explore VYEPTI clinical trial data in chronic migraine

Shield icon

Review clinical trial adverse event and discontinuation rates

References:
  1. VYEPTI [package insert]. Deerfield, IL: Lundbeck Seattle BioPharmaceuticals, Inc.
  2. Data on file. Deerfield, IL: Lundbeck Seattle BioPharmaceuticals, Inc.
  3. Kudrow D, Lipton R, Silberstein S, et al. Eptinezumab for prevention of chronic migraine: results of 2 Infusions in the phase 3 PROMISE-2 (PRevention Of Migraine via Intravenous Eptinezumab Safety and Efficacy–2) trial. Poster presented at: 71st American Academy of Neurology (AAN) Annual Meeting; May 4-10, 2019; Philadelphia, PA. 10-006.
  4. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629-808.
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 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, and rash, have occurred with VYEPTI in clinical trials. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. 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 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 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, and rash, have occurred with VYEPTI in clinical trials. Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. Serious hypersensitivity reactions may occur. 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 Prescribing Information and Patient Information.