Eptinezumab Demonstrated Migraine Preventive Efficacy on Day 1 After Dosing: Closed Testing Analysis from PROMISE-1 and PROMISE-2

David W Dodick

AHSAM 2020 - Oral session
Published on September 3, 2020

3 minute listen

7 minute read

Key messages

  • Patients seek preventative treatments that deliver a rapid onset of clinical benefit.
  • Eptinezumab provides rapid and sustained preventative migraine relief for patients who experience both episodic and chronic migraine.
  • Eptinezumab prevents the occurrence of migraine from day one following intravenous administration and is sustained for up to 12 weeks in the majority of patients.
  • Background

    What do we already know about this topic?
  • Findings

    What does this study add?
  • Perspectives

    How does this study impact clinical practice?
  • Expert commentary

    by Jessica Ailani, MD, FAHS, FAAN

Key messages

  • Patients seek preventative treatments that deliver a rapid onset of clinical benefit.
  • Eptinezumab provides rapid and sustained preventative migraine relief for patients who experience both episodic and chronic migraine.
  • Eptinezumab prevents the occurrence of migraine from day one following intravenous administration and is sustained for up to 12 weeks in the majority of patients.

Background

What do we already know about this topic?

  • A preventative treatment that delivers rapid clinical benefit remains an unmet need in migraine.
  • Eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody (anti-CRGP mAb) demonstrated efficacy and a rapid onset of action in two Phase III, double-blind, randomized, placebo-controlled trials (PROMISE-1 and PROMISE-2) that evaluated eptinezumab for migraine prevention.1,2
  • A post-hoc analysis was carried out to confirm whether the percentage of patients with a migraine on Day 1 after eptinezumab administration measured onset of full preventive effect

How was this study conducted?

  • PROMISE-1 and PROMISE-2 were Phase III, double-blind, randomized, placebo-controlled clinical trials evaluating eptinezumab 100 mg, 300 mg, or placebo for migraine prevention in patients with episodic (n=888) and chronic (n=1072) patients.1,2
  • A post-hoc closed testing procedure analyzing the proportion of patients experiencing a migraine was used on progressively smaller time intervals from Weeks 1 to 12, Days 1 to 84.
  • For each interval that demonstrated statistical significance (p≤0.05), the interval was reduced by 1 day and treatment effect was tested again.
  • The procedure was stopped at the time point where statistical significance was not achieved, and the onset of preventive efficacy was declared as the end day of the prior interval.

Findings

What does this study add?

  • In both studies, patients on eptinezumab 100 mg and 300 mg achieved a significant mean reduction in monthly migraine days (p< 0.05) from Day 84 to Day 1 across all tests, indicating that eptinezumab was effective from Day 1 after dosing.
  • The response was sustained for 12 weeks following the initial dose.

Perspectives

How does this study impact clinical practice?

  • Eptinezumab provides rapid and sustained migraine relief for patients who experience both episodic and chronic migraine.
  • Eptinezumab prevents the occurrence of migraine from day one following intravenous administration and is sustained for up to 12 weeks in the majority of patients.

 

Perspectives

How does this study impact clinical practice?

  • Eptinezumab provides rapid and sustained migraine relief for patients who experience both episodic and chronic migraine.
  • Eptinezumab prevents the occurrence of migraine from day one following intravenous administration and is sustained for up to 12 weeks in the majority of patients.

 

This is a highlights summary of an oral session given at the AHSAM 2020 Virtual Annual Scientific Meeting and presented by:

David W Dodick

The content is produced by Infomedica, the official reporting partner of ASHAM 2020 Virtual Annual Scientific Meeting. The summary text was drafted by Goldcrest Medical Writing, reviewed by Marco Vercellino, MD, an independent external expert, and approved by Jessica Ailani, MD, FAHS and Mark J. Burish, MD, PhD, the scientific editors of the program.

The presenting authors of the original session had no part in the creation of this conference highlights summary.

In addition, an expert commentary on the topic has been provided by:

Jessica Ailani, MD, FAHS, FAAN
Director, Medstar Georgetown Headache Center
Vice Co-Chair Strategic Planning Medstar Neurology
Professor of Clinical Neurology
Medstar Georgetown University Hospital, Washington D.C. USA

Jessica Ailani, MD
Director Medstar Georgetown Headache Center, Associate Professor Neurology
Department of Neurology, Georgetown University Hospital
Washington D.C., District of Columbia

Jessica Ailani is a Professor of Clinical Neurology, Director of the Georgetown Headache Center, and Vice Co-Chair of Strategic planning Neurology at MedStar Georgetown University Hospital in Washington, DC. Dr. Ailani is a fellow of the American headache society and the American Academy of Neurology. She holds a position on the board as a member at large, is the co-chair of the Practice management group and is on the scientific and Scottsdale program planning committees . She is section editor of Unusual Headache Syndromes for Current Pain and Headache Reports and a reviewer for several professional journals. Dr. Ailani has presented nationally on topics surrounding headache medicine. 

1. Ashina M, Saper J, Cady R, et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia 2020;40:241-254. 

2. Lipton RB, Goadsby PJ, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology 2020;94:e1365-e1377.



Headache
Migraine


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