medwireNews: Monthly injections of erenumab may help individuals with chronic migraine (CM) achieve sustained remission from non-opioid medication overuse headaches (MOH), shows a study published in JAMA Neurology.
The results from the phase 4 trial, conducted in 67 centers in North America, Europe, and Australia between 2019 and 2022, “provide American Academy of Neurology Class I evidence of beneficial effects of a migraine preventive treatment in patients with CM-MOH,” say Stewart Tepper (The New England Institute for Neurology and Headache, Stamford, Connecticut, USA) and colleagues.
MOH is defined as “patients with pre-existing primary headache disorders who have developed a chronic headache pattern (ie, 15 or more headache days per month for more than 3 months) due to sustained medication overuse,” they explain.
The researchers analyzed data on 584 participants (mean age 44 years; 82.5% women) who had CM with or without aura for at least 12 months, a concomitant diagnosis of non-opioid MOH, and had failed at least one preventive migraine treatment.
The participants were randomly assigned to receive monthly injections of the calcitonin gene-related peptide (CGRP) receptor inhibitor erenumab, at doses of 140 mg (n=195) or 70 mg (n=195), or placebo (n=194) for 6 months. Overused medications were not required to be withdrawn as part of the study.
At baseline, the patients were experiencing a mean of 21 headache days a month and were taking medication for acute headaches on a mean of 19 days per month.
By the end of 6 months of treatment, 69.1% of patients given erenumab 140 mg achieved MOH remission, as did 60.3% of those given erenumab 70 mg. This compared with 52.6% of those given placebo. This meant that patients given erenumab 140 mg were a significant twofold more likely to achieve remission than placebo-treated participants, while those given erenumab 70 mg were a nonsignificant 1.37-fold more likely.
MOH remission was defined as fewer than 10 acute headache medication days per month on average, or fewer than 14 days in a 28-day study month during months 4, 5, and 6 of the study.
In addition, significantly more participants in the erenumab 140 mg and 70 mg treatment arms achieved sustained remission, defined as the absence of MOH over all 6 months of the study, than in the placebo group (61.3 and 41.5 vs 37.6%, respectively).
Further benefits with erenumab over placebo at 6 months included a significantly greater reduction in mean monthly acute headache medication days relative to baseline. Among patients in the erenumab 140 mg group, the least squares mean reduction was 9.4 days, which was 2.7 more days compared with placebo (6.6 days). For those in the erenumab 70 mg group, the least squares mean reduction was 7.8 days, giving a 1.2-day difference compared with placebo.
Tepper et al comment that the relatively high response in the placebo group “has been extensively documented in migraine prevention studies and noted to be on the rise over the last 30 years.” They say that, in the case of MOH trials, this may be due to the contextual effects of “participant education and cessation of the offending medication.”
Safety data showed that the rates of treatment-emergent adverse events “were consistent with the known safety profile of erenumab in migraine,” and were mostly mild or moderate. Grade 2 or more severe events occurred in 66.8% of all erenumab-treated patients versus 64.9% of placebo-treated patients. The most common side effects were constipation (15.2 vs 4.6%), COVID-19 infection (13.9 vs 6.2%), injection site pain (5.2 vs 3.1%), nasopharyngitis (5.2 vs 1.5%), and insomnia (4.6 vs 1.5%).
The investigators observe that “[c]onsensus treatment for MOH does not exist,” and suggest that monoclonal antibodies targeting the CGRP pathway may offer “a distinct advantage” in the management of CM-MOH.
“Their enhanced safety and tolerability profile, coupled with evidence of superior efficacy over traditional nonspecific oral standard-of-care migraine prophylactic medications underscore this asset,” they comment.
“This is further substantiated by the pivotal role CGRP in the pathogenesis of MOH.”
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