The feasibility of promptly administering eptinezumab intravenously during a migraine attack remains to be determined, Dr. Roger Cady of Lundbeck La Jolla Research Center, Inc. in San Diego and colleagues acknowledge. Lundbeck markets eptinezumab in the U.S. as Vyepti and funded the study.
The prevention migraine trials showed that eptinezumab's preventive activity kicks in on the first day following infusion and is sustained over 12 weeks.
The RELIEF study assessed the efficacy and safety of eptinezumab when infused during an active migraine attack in 480 adults with a history of migraine for more than one year and experiencing migraine on four to 15 days per month in the previous three months.
Compared with placebo, eptinezumab administered intravenously during the first six hours of a migraine attack significantly shortened time to freedom from pain and the most bothersome accompanying symptom, according to the JAMA report.
The median time to headache freedom with eptinezumab was four hours versus nine hours with placebo, and median time to absence of most bothersome symptom was two hours with eptinezumab group versus three hours with placebo (both P<0.001).
The authors of an editorial in JAMA say this study shows that new classes of migraine treatments are "blurring the line between acute and preventive treatment of migraine."
"The possibility of an entirely new approach to migraine treatment, whereby acute therapies may have preventive benefit and preventive treatments have immediate effects, is an intriguing step forward for the field," write Dr. Rebecca Burch with Harvard Medical School in Boston and Dr. Melissa Rayhill with SUNY Buffalo in New York.
However, they note that some logistical barriers may make it hard to start eptinezumab acutely as it was used in this trial.
"Eptinezumab is currently only available after insurance approval, which can take several days to obtain, and administration requires access to an infusion center. It is unlikely that these barriers will be traversed within six hours of headache onset," they caution.
A companion paper in JAMA reports results of a comprehensive systematic review and meta-analysis looking at the benefits and harms associated with both drug and non-drug acute migraine therapies in roughly 28,800 migraineurs.
Several acute treatments for migraine were associated with improvements in pain and function and also with increased risk of mostly mild and transient adverse effects, with varying strengths of evidence to support their use, report Dr. Juliana VanderPluym of Mayo Clinic, in Rochester, Minnesota, and colleagues.
In particular, use of triptans, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, dihydroergotamine, oral CGRP receptor antagonists or lamiditan (a 5-HT1F-receptor agonist) was associated with improved pain and function with "relatively robust strength of evidence."
In contrast, the evidence for many other interventions, including opioids, was low or limited.
Among devices, remote electrical neuromodulation and external vagus nerve stimulation had moderate strength of evidence, whereas evidence for external trigeminal nerve stimulation was slightly less robust.
"A clear message from this review is that opioid medications are not an appropriate acute treatment for migraine," Dr. Burch and Dr. Rayhill say.
"Given the evidence-based effectiveness of many other medication classes, the lack of good evidence for effectiveness of opioids as acute treatment for migraine, and overwhelming evidence of harm with frequent opioid use, it is clear that opioids should be used sparingly, if at all, for treatment of migraine," they advise in their editorial.
Taken together, these two reports "communicate a message of optimism. Many effective acute treatment options are available for patients with migraine, and CGRP-targeted medications may transform the approach to migraine treatment," write Dr. Burch and Dr. Rayhill.
"To translate these findings into meaningful improvements in clinical practice and patient care, clinicians need comparative effectiveness and safety studies among different migraine acute treatments, including devices; development of care pathways to simplify acute treatment decision-making; review of the ways that cost and access barriers affect acute treatment success on individual and population levels; and continuous safety monitoring of new treatments as more data from clinical practice become available," the editorialists say.
However, they urge clinicians and researchers not to be complacent with recent breakthroughs because many patients are still left with disabling symptoms.
"Unrelenting and bold research is required to continue development of new acute therapies. Effective, reliable, and safe acute treatment for migraine is within reach, and patients deserve nothing less," they conclude.
The RELIEF study was sponsored and funded by H. Lundbeck A/S, including editorial support for manuscript writing. Several authors have disclosed financial relationships with the company. The systematic review was funded by the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services (HHS).
SOURCE: https://bit.ly/3vxWK1O, https://bit.ly/3pXvWXe and https://bit.ly/3gt0Wvr JAMA, online June 15, 2021.
By Megan Brooks
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