Aimovig Injection Prevented Medication Overuse Headache at 6 Months in Chronic Migraine Study

Once-monthly, subcutaneous treatment with Aimovig (erenumab; Amgen, Thousand Oaks, CA) 140 mg safely and effectively induced medication overuse headache (MOH) remission in participants with chronic migraine according to a study published in JAMA Neurology. According to the study authors, this is the first randomized clinical trial providing American Academy of Neurology (AAN) class I evidence of a nonopioid migraine preventive treatment for people with chronic migraine and MOH (CM-MOH).

The phase 4, randomized, double-blind, parallel-group, placebo-controlled clinical trial (NCT03971071) included 584 nonopioid-treated participants aged 18 to 65 years with chronic migraine who experienced ≥1 preventive treatment failure. Participants were randomized to receive Aimovig 140 mg (n=194), Aimovig 70 mg (n=194), or placebo (n=194) subcutaneously once monthly. The primary endpoint was absence of MOH at month 6 based on mean monthly acute headache medication days (AMHD).

The primary endpoint of absence of MOH at month 6 was achieved by:

• 134 participants (69.1%) in the Aimovig 140 mg group (odds ratio [OR], 2.01; 95% CI, 1.33 to 3.05; P<.001 vs placebo)
• 117 participants (60.3%) in the Aimovig 70 mg group (OR, 1.37; 95% CI, 0.92 to 2.05; P=.13 vs placebo); this was not statistically significant.
• 102 participants (52.6%) in the placebo group

In terms of secondary and safety endpoints:

• Sustained MOH remission during the double-blind treatment period (DBTP) was achieved by 119 (61.3%), 96 (49.5%), and 73 (37.6%) participants in the Aimovig 140 mg, Aimovig 70 mg, and placebo groups, respectively.
• Least squares mean (standard error) change from baseline in average monthly AHMD was -9.4 (0.4) days, -7.8 (0.4) days, and -6.6 (0.4) days for the Aimovig 140 mg, Aimovig 70 mg, and placebo groups, respectively.
• Adverse events (AEs) were consistent with Aimovig’s known safety profile.
• 259 participants (66.8%) experienced treatment-emergent AEs in the combined Aimovig group.
• Constipation (n=59; 15.2%) and COVID-19 (n=54; 13.9%) were the most common treatment-emergent AEs.