Research results have shown that the migraine prevention drug erenumab is much more effective than existing drugs. Erenumab is a monoclonal antibody targeting anti-calcitonin gene-related peptide (CGRP).
A research group from the Autonomous University of Barcelona, Spain, published in the Journal of the American Medical Association the results of APPRAISE, a clinical study comparing the effectiveness of erenumab with non-specific oral preventive drugs existing migraine (OMPM). JAMA Neurology).
According to the research results, in cases where existing drugs were replaced with erenumab, the average number of monthly migraine days was reduced by half and no safety concerns arose.
Beta blockers, calcium channel blockers, anticonvulsants, and antidepressants used for nonspecific OMPM lack tolerance and effectiveness, so many patients use multiple medications repeatedly. This is why poor patient compliance and medical cost burden are cited as problems.
APPRAISE was conducted at 84 facilities in 17 countries to determine whether early switching from OMPM to erenumab was effective in preventing migraines.
Subjects were 621 patients (mean age 41.3 ± 11.2 years, 87.8% women) with episodic migraine who were ineffective with 1 or 2 types of OMPM (beta-blockers, calcium channel blocker flunarizine, topiramate, valproic acid, tricyclic antidepressants, etc.). An episode is a prodromal symptom or a symptom that appears before the migraine becomes serious.
The selection criteria are patients over 18 years of age who have suffered from migraine for the last 12 months or more, the average number of migraine days per month in the last 3 months is less than 4-15 days and who have not responded to the preventive treatment 1-2 times in the last 6 months due to lack of efficacy or decreased tolerance.
Subjects were randomly assigned 2:1 into a group that replaced 70 mg or 140 mg of erenumab (413 people in the erenumab group) and a group that continued to administer OMPM at the dose prescribed by their doctor (OMPM group, 208 people) and were treated for 52 weeks. In both groups, only single-drug therapy was administered, and drug substitution was left to the discretion of the treating physician and the patient.
The primary measure was the percentage of patients whose average monthly migraine days had decreased by more than 50% at 12 months compared to the start of the study. Secondary endpoints were the cumulative mean change in the mean number of migraine days per month during the treatment period and the treatment response rate on the Global Impressions Rating Scale (PGIC) at 12 months.
As a result of the analysis of 523 of 621 subjects (84.2%), the rate of reaching key endpoints at 12 months was much higher in the erenumab group (56.2% versus 16.8%).
The percentage of patients who showed a high response to treatment (5 or more points) on the PGIC scale at 12 months was significantly higher in the erenumab group (76.0% versus 18.8%). The cumulative mean change in monthly migraine days was also significantly greater in the erenumab group (-4.32 days versus -2.65 days).
There were very few drug changes in the erenumab group (34.6% versus 2.2%) and there were also few cases of treatment discontinuation due to side effects (23.3% versus 2.9%). No new side effects of erenumab have been identified.
Based on the results of this study, the researchers concluded: “This demonstrates that there is no need to continue nonspecific OMPM if it is ineffective.” He added: “Recently published guidelines from the European Headache Federation support the idea that CGRP antibodies should be considered the first-line drug for migraine patients who require preventative treatment.”
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