Improving Beyond Fewer Headache Days: Redefining Success in Migraine Treatment
Stephanie, Florian, and Beth, real VYEPTI patients
Sponsored by Lundbeck
This article features quotes from Dr. Andrew Blumenfeld and Dr. Wade Cooper, who are paid consultants to Lundbeck, the manufacturer of VYEPTI®(eptinezumab-jjmr). VYEPTI is indicated for the preventive treatment of migraine in adults. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of its excipients. Reactions have included anaphylaxis and angioedema. Please see Important Safety Information below.
Striving for optimal migraine prevention with the use of migraine-specific treatments as part of their treatment plan can give patients more than hope, it can help them manage their migraine disease.
The moment a patient hears, “You have migraine disease,” everything changes. Time slows. Questions multiply. For both clinicians and patients, one thing becomes clear: they want to find a treatment that works for them – and this is where cycling through treatments may begin. 1, 2, 3
Addressing the Unmet Need in Migraine Care
Migraine is more than just a headache; it is a debilitating, progressive neurological disease that impacts many facets of a patient's life.4 The frequency and severity of migraine attacks can significantly reduce functionality and may limit a patient's ability to engage in everyday activities and diminish their overall quality of life.5
“In my clinical experience, the more frequently the brain is exposed to migraine attacks, the more likely it is to become sensitized. This can lead to disease progression with more frequent attacks and increasing disability over time. Given the progressive nature of migraine, in my experience, early intervention is critical,” said Andrew Blumenfeld, M.D., Director of the San Diego Headache Center and The Los Angeles Headache Center San Diego/Los Angeles.
The American Headache Society (AHS)’s latest position statement update recommends CGRP-targeting therapies as a first-line approach for migraine prevention along with previous first-line treatments without a requirement for prior failure of other classes of migraine preventive treatment.6 This represents a paradigm shift: when a patient has migraine, CGRP-targeting therapies should be considered as a first-line option, not the last resort.
The AHS also references the Migraine Disability Assessment (MIDAS) questionnaire as one way to measure how migraine symptoms affect a patient’s daily life over a span of three months. This tool helps guide doctor-patient communication on quality of life and functional impacts of migraine symptoms. The AHS defines a clinically meaningful improvement as a ≥30% reduction in MIDAS score (relative to their baseline score of at least 20) or a meaningful improvement as a ≥5% reduction in MIDAS score (relative to their baseline score of 11-20),6 offering providers a way to determine how their patients are responding to migraine treatment.
“In my clinical practice, I focus on two main factors when selecting preventive treatments. The first factor is a high response rate, which means that preventive treatment can be effective for the majority of my patients,” said Dr. Blumenfeld. A high response rate and reduction in monthly migraine days can mean fewer treatment changes for patients, minimizing the risk of treatment cycling. “The second factor is tolerability, where well tolerated treatment typically leads to better adherence, which is essential for long-term success.”
VYEPTI: A Potential Option for a First-Line Therapy
Despite advancements in migraine care, some patients on preventive CGRP-targeting therapies may still experience suboptimal responses to their migraine treatment.7 VYEPTI is an intravenous CGRP-targeting therapy indicated for the preventive treatment of migraine in adults. VYEPTI is one 30-minute infusion, administered four times a year. VYEPTI 100 mg is the recommended dose. Some patients may benefit from a 300 mg dose four times a year.8 VYEPTI has been proven to reduce average monthly migraine days through month 3 when compared to placebo.9 Significant potential reactions during treatment with VYEPTI include hypersensitivity reactions, hypertension, and Raynaud's phenomenon. See additional Important Safety Information for VYEPTI below.
Increasing Clinical Conviction with VYEPTI
Two phase 3 randomized, double-blind, placebo-controlled trials supported the approval of VYEPTI. PROMISE-1 included 665 patients with episodic migraine, and PROMISE-2 included 1,072 patients with chronic migraine. The primary endpoints in both PROMISE-1 and PROMISE-2 trials were the reduction in monthly migraine days across weeks 1-12 from baseline. In both studies, VYEPTI 100 mg and 300 mg met the primary endpoints, significantly reducing monthly migraine days across weeks 1 to 12 compared with placebo.8,10,11
The PROMISE-2 study evaluated the efficacy and safety of VYEPTI as a preventive treatment for chronic migraine in adults. Patients were randomized and received placebo, VYEPTI 100 mg or 300 mg every 12 weeks for 24 weeks. Patients experienced, on average, 23.1 (VYEPTI 100 mg) and 24.6 (VYEPTI 300 mg) fewer migraine days over weeks 1-12 vs. 16.8 with placebo (baseline ~16.1 mean monthly migraine days; p<0.001 vs placebo).12 Furthermore, 39.3% of patients treated with VYEPTI 100 mg and 43.1% of patients treated with VYEPTI 300 mg experienced, on average, ≥75% fewer migraine days with dose 2. A 75% responder rate was defined as a subject achieving, on average, a ≥75% reduction from baseline in migraine days within each 12-week interval.12 The study also showed a ≥52% reduction in acute headache medication days with VYEPTI 300 mg vs. 35% with placebo*.12
“I have found that I am prescribing VYEPTI sooner to my migraine patients because of its successful results,” said Wade Cooper, D.O., Neurologist at Memorial Healthcare Institute for Neuroscience. “VYEPTI has helped many of my patients experience fewer migraine days.”
VYEPTI was generally well tolerated in clinical trials.
In the PROMISE 1 and 2 clinical trials of over 1,700 patients, the most common adverse reactions (incidence of ≥2% for VYEPTI and ≥2% greater than placebo) included nasopharyngitis (6% for VYEPTI 100 mg, 8% for VYEPTI 300 mg, and 6% for placebo) and hypersensitivity reactions such as hypersensitivity, pruritus, and flushing/hot flush that occurred on the day of dosing (1% for VYEPTI 100 mg, 2% for VYEPTI 300 mg, and 0% for placebo). 1.9% of patients treated with VYEPTI discontinued the study due to AEs.8
To learn more about VYEPTI and how to identify appropriate patients who may benefit from this treatment option, visit https://www.vyeptihcp.com/efficacy-and-patient-outcomes.
*Acute headache medication (AHM) use was a prespecified endpoint for the 300 mg dose in weeks 1-12. All other results were exploratory analyses and not adjusted for multiplicity. An AHM day was a day with any triptan or ergotamine use as recorded in the eDiary. If a patient used multiple medications on the same day, they were counted once.