Medication Overuse Headache Treatment: Is Erenumab Safe and Effective?

Monthly injections of erenumab are safe and effective as a medication overuse headache treatment and can help patients achieve remission within 6 months, according to study findings published in JAMA Neurology.

Researchers conducted a phase 4, randomized, double-blind, parallel-group, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT03971071) at 67 centers in North America, Europe, and Australia between October 2019 and November 2022 to examine the efficacy and safety of erenumab in patients with nonopioid chronic migraine and medication overuse headache. Adults aged 18 to 65 with chronic migraine with or without aura for a minimum of 1 year who had a concomitant diagnosis of medication overuse headache and a history of at least 1 preventative treatment failure were eligible for inclusion. Based on their opioid medication use at baseline, eligible patients were stratified into a nonopioid- and opioid-treated cohort. Individuals in the nonopioid-treated cohort were randomly assigned 1:1:1 to receive 140 mg erenumab, 70 mg erenumab, or placebo once monthly for 24 weeks. The primary outcome was medication overuse headache remission at 6 months. A generalized linear mixed model was used in statistical analyses.

A total of 584 participants (mean age, 44; women, 82.5%; White, 91.8%; mean body mass index [BMI], 25.4 kg/m²) were stratified in the nonopioid-treated cohort and comprised the primary analysis. At baseline, the mean monthly medication headache days and mean monthly acute headache medication days were 20.8 and 18.9 days, respectively.

Compared with 52.6% of patients in the placebo group, 69.1% of patients in the 140 mg erenumab (odds ratio [OR], 2.01; 95% CI, 1.33-3.05; P <.001) and 60.3% of patients in the 70 mg erenumab (OR, 1.37; 95% CI, 0.92-2.05; P =.13) groups had achieved medication overuse headache remission at month 6.

The reduction in mean monthly acute headache medication days was also greater in the erenumab groups vs placebo group. The least squares mean estimate of change from baseline in average monthly acute headache medication days in the 140 erenumab, 70 mg, erenumab, and placebo groups was -9.4 days (difference from placebo, -2.7; 95% CI, -3.9 to -1.6; P <.001), -7.8 days (difference from placebo, -1.2; 95% CI, -2.4 to -0.1; P =.03), and-6.6 days, respectively.

In the double-blind treatment period, medication overuse headache remission was maintained in 61.3% of 140 mg erenumab (OR, 2.63; 95% CI, 1.75-3.96; P <.001) and 49.5% of the 70 mg erenumab (OR, 1.62; 95% CI, 1.08-2.43; P =.02) groups vs 37.6% of participants in the placebo group.

The most common adverse events (AEs) reported in the erenumab groups included constipation (15.2%), COVID-19 infection (13.9%), injection site pain (5.2%), and nasopharyngitis (5.2%). Serious AEs were reported in 1.5% of participants in the combined erenumab groups and 4.1% of participants receiving placebo.

Study limitations include the inability to evaluate the safety and efficacy of erenumab outside the context of migraine, potential selection bias, and reduced generalizability of results to more racially and ethnically diverse patient samples.

“The study findings demonstrate that erenumab treatment can yield and sustain high rates of MOH [medication overuse headache] remission, reduce acute medication consumption and improve participants’ functionality over a 6-month observation period,” the study authors concluded.

Disclosure: This research was supported by Amgen. Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.