Erenumab, a monthly injectable medication, has shown promise in treating medication overuse headache (MOH) in patients with chronic migraine. A recent study published in JAMA Neurology indicates that erenumab can safely and effectively achieve MOH remission within 6 months in individuals with nonopioid chronic migraine. This is particularly significant as MOH can worsen pre-existing headaches and decrease quality of life.
The phase 4, randomized, double-blind, placebo-controlled clinical trial (NCT03971071) evaluated the efficacy and safety of erenumab in adults with chronic migraine, with or without aura, for at least 12 months, who also had a diagnosis of MOH and a history of at least one preventive treatment failure. The primary endpoint of the study was the absence of MOH at month 6.
The study included 482 women and 201 men. At baseline, the mean monthly headache days were 20.8 ± 3.9, and the mean acute headache medication use days were 18.9 ± 4.2. The most common medications overused were triptans, simple analgesics/nonsteroidal anti-inflammatory drugs, and combination analgesics.
Erenumab Efficacy
From months 4 to 6, 69.1% of participants receiving 140 mg erenumab and 60.3% of patients receiving 70 mg erenumab achieved MOH remission, compared with 52.6% of the placebo group (OR, 2.01, 1.37 in each treatment group, respectively). The reduction of acute headache medication use days and rates of sustained MOH remission were higher in the erenumab group compared to the placebo group.
Throughout the double-blind treatment period, MOH remission was sustained in 6.13% and 49.5% of the erenumab patients (140 mg and 70 mg, respectively) vs 37.6% of the placebo group. An ad hoc sensitivity analysis indicated that 53.6% and 45.9% of the 140 mg and 70 mg erenumab groups achieved MOH remission, vs 36.6% of the placebo group. Absence of MOH at month 6 was achieved by 59.3% and 49% of each group, vs 40.2% of the placebo group.
Safety Profile
The incidence rates of adverse events were consistent with the known safety profile of erenumab in migraine. Most adverse events were mild to moderate in severity and included constipation, injection site pain, nasopharyngitis, and insomnia. Six participants reported serious adverse events.
Study Limitations
Limitations of the study include the study design, which was not intended to evaluate erenumab safety and efficacy outside of the context of migraine, limiting the generalizability of the results.
Expert Commentary
According to the investigators, this study provides American Academy of Neurology class I evidence of the beneficial effects of a migraine preventive treatment in patients with chronic migraine and medication overuse headache.