Patients with chronic migraine who experience 4 or fewer monthly headache days (MHDs) use acute medication less frequently and report improved outcomes, according to results of a study published in Pain Therapy.
In a post hoc analysis, researchers analyzed pooled data from phase 3 of the PROMISE-2 trial (ClinicalTrials.gov identifier: NCT02974153), which was designed to evaluate the use of eptinezumab for the prevention of chronic migraine and establish concrete treatment targets. In PROMISE-2, a total of 1072 patients received either placebo or a 100- or 300-mg dose of eptinezumab. The researchers combined the results of 2 headache assessment instruments (the Patient Global Impression of Change [PGIC] and the 6-item Headache Impact Test [HIT-6]) with the number of days of acute medication use for all post-baseline assessments. They then determined the association of these data with the frequency of MHDs in the 4 weeks prior to assessment via PGIC and HIT-6.
The researchers found that 40.9% of patient-months with 4 or fewer MHDs were associated with a PGIC rating of “very much improved.” In contrast, only 22.9% of patient-months with 5 to 9 MHDs, 10% of patient-months with 10 to 15 MHDs, and 3% of patient-months with more than 15 MHDs achieved the same PGIC rating.
The rate of patient-months with 10 or more days of acute medication use was closely linked to the rate of MHDs: 1.9% in 4 or less MHDs, 4.9% in 5 to 9 MHDs, 49.5% in 10 to 15 MHDs, and 74.1% in 15 or more MHDs. Further, 37.1% of patient-months with 4 or fewer MHDs achieved a HIT-6 impairment rating of “little to none.” In comparison, 19.9% of patient-months with 5 to 9 MHDs, 10.1% of patient-months with 10 to 15 MHDs, and 3.7% of patient-months with 5 to 9 MHDs achieved a HIT-6 impairment rating of “little to none”.
These findings suggest that 4 MHDs may be a useful therapeutic target for health care providers and chronic migraine patients, the researchers wrote. A single treatment target that is easy to explain, they noted, may help providers better educate and manage patients with chronic headache, especially if the provider is not a headache specialist.
Study limitations include the post hoc design, the use of pooled data across treatment arms, and the inclusion of repeated measurements from individual patients. In addition, because of the limited numbers of participants from certain racial groups in PROMISE-2, the results may not be applicable to all patients with chronic migraine. Finally, this analysis was limited to data collected from a single study.
“Treatment goals should be four or fewer headache days per month rather than 50% reduction in monthly migraine frequency, which for patients with high migraine frequency may still be substantial,” the researchers concluded. They emphasized, “Having clearly articulated treatment goals will help improve communication between patients and health care providers and clarify meaningful treatment outcomes.”
Disclosure: This research was supported by Lundbeck LLC. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Kaniecki RG, Friedman DI, Asher D, Hirman J, Cady R. Improving to four or fewer monthly headache days per month provides a clinically meaningful therapeutic target for patients with chronic migraine. Pain Ther. Published online June 28, 2023. doi:10.1007/s40122-023-00525-x