Eptinezumab was associated with early and sustained improvements in patient-reported outcomes for the treatment of comorbid chronic migraine and medication-overuse headache. These are the findings of a study published in the journal Headache.
Patients with chronic migraine often rely on the use of acute medication to mitigate migraine pain. A subset of patients develop medication-overuse headache, which is associated with disability and poor health-related quality of life.
For this post hoc analysis, researchers sourced data from the PROMISE-2 trial (ClinicalTrials.gov Identifier: NCT02974153), which was a phase 3, randomized, double-blind, placebo-controlled parallel-group study conducted at 128 sites in 13 countries. Patients (N=431) with both chronic migraine and medication-overuse headache were randomly assigned in a 1:1:1 ratio to receive up to 2 doses of 100 mg (n=139) or 300 mg (n=147) eptinezumab or placebo (n=145) on day 0 and week 12. In this analysis, changes in 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), and patient-identified most bothersome symptom (PI-MBS) scores were evaluated through week 24. Response to treatment was defined as a ≥6-point decrease in HIT-6 score from baseline.
The low-dose eptinezumab, high-dose eptinezumab, and placebo groups comprised individuals with a mean age, 41.5, 42.1, and 40.7 years; 86.3%, 89.1%, and 86.2% were women; 95.7%, 93.2%, and 91.7% were White; they reported an average of 16.7, 16.7, and 16.7 migraine days per month; and 20.7, 20.6, and 20.7 headache days per month, respectively. The most endorsed PI-MBSs were photophobia or light sensitivity (16.3%-18.7%), non-headache pain (12.9%-15.0%), nausea or vomiting (10.2%-16.5%), headache (12.9%-15.0%), and pain with activity (8.3%-18.0%).
At baseline, the average HIT-6 scores ranged between 65.0-65.2 points in the 3 groups. At week 24, the average change from baseline was -7.7 points for the 100 mg eptinezumab recipients, -9.1 points for the 300 mg eptinezumab recipients, and -4.4 points for the placebo recipients. The proportions of HIT-6 responders at the final follow-up were 48.9%, 59.9%, and 33.1% for the low- and high-dose eptinezumab and placebo groups, respectively.
Eptinezumab was associated with a higher rate of reporting “much improvement” or “very much improvement” compared with placebo according to the PGIC (58.5%-67.4% vs 35.8%) and PI-MBS (57.1%-64.6% vs 29.9%) instruments at week 12 and PGIC (57.4%-64.3% vs 37.4%) and PI-MBS (58.2%-65.0% vs 35.1%) instruments at week 24, respectively.
A potential limitation of this study was the imposed limit on opioid and barbiturate use to fewer than 4 days per month. These findings are likely not generalizable for patients who were unable to follow the imposed limit.
In this post hoc analysis, the subset of patients with comorbid chronic migraine and medication-overuse headache associated with rapid and sustained clinically meaningful improvements in patient-reported outcomes with either 100 mg or 300 mg eptinezumab treatment.
Researchers concluded that “The analysis also suggests that starting preventive treatment with eptinezumab can improve outcomes for patients with CM/MOH [chronic migraine/medication-overuse headache] even without explicit instructions to wean or withdraw acute medication use.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
This article originally appeared on Neurology Advisor
Starling AJ, Cowan RP, Buse DC, et al. Eptinezumab improved patient-reported outcomes in patients with migraine and medication-overuse headache: subgroup analysis of the randomized PROMISE-2 trial. Headache. Published online January 12, 2023. doi:10.1111/head.14434