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On September 20, 2024, we reported on findings from a study published in JAMA Neurology that assessed the safety and efficacy of erenumab in patients with nonopioid chronic migraine and medication overuse headaches (CM-MOH).
The study
The phase 4 prospective, randomized, double-blind, parallel-group, placebo-controlled trial was conducted between October 7, 2019, and November 2, 2022, across North America, Europe, and Australia. The primary analysis was conducted in January 2023 using data from December 1, 2022, which contains the complete dataset from the study’s double-blind treatment period.
A cohort of 620 adults met the eligibility requirements: age 18 years or older and younger than 65 years and chronic migraine and MOH without remission despite previous treatment with one or more preventive medications. Of this group, 584 comprised the group for primary analysis, ie, had no history of treatment with opioids. Participants were randomly assigned to receive erenumab 70 mg, erenumab 140 mg, or placebo , once monthly for 24 weeks.
The findings
At month 6, researchers reported, 69.1% of participants in the erenumab 140 mg group (odds ratio [OR], 2.01; 95% CI, 1.33 to 3.05; P < .001) and 60.3% in the erenumab 70 mg group (OR, 1.37; 95% CI, 0.92 to 2.05; P = .13) reached MOH remission, compared with 52.6% of participants who received placebo.
Remission was predefined as less than 10 mean monthly acute headache medication days (AHMD) with the measure reduced among both groups receiving erenumab compared with placebo. The investigators found a change from baseline in mean monthly AHMD of:
– 9.4 days in the erenumab 140 mg group (difference from placebo, –2.7; 95% CI, –3.9 to –1.6; P < .001)
– 7.8 days in the erenumab 70 mg group (difference from placebo, –1.2; 95% CI, –2.4 to –0.1; P = .03).
Treatment with erenumab was judged as safe, and the treatment-emergent AEs were consistent with the known safety profile of erenumab.
Authors' comment
"To our knowledge, this study is the first controlled trial to provide American Academy of Neurology class I evidence of beneficial effects of a migraine preventive treatment in patients with CM-MOH (nonopioid)."
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