Erenumab (Aimovig, Amgen), a novel antibody that targets the calcitonin gene–related peptide (CGRP) receptor, is safe and effective in patients with episodic migraine for whom other therapies have failed, newly published research shows.
"Our results suggest that erenumab might be a new treatment option for patients with difficult-to-treat migraine in whom traditional oral migraine preventive treatments were unsuccessful, not tolerated, or contraindicated," the investigators, led by Uwe Reuter, MD, Department of Neurology, Charité Universitätsmedizin Berlin, Germany, write.
The phase 3 results of the LIBERTY study, which were presented at the annual meeting of the American Headache Society and American Academy of Neurology earlier this year and were reported by Medscape Medical News at that time, were published online October 22 in the Lancet.
The analysis included patients aged 18 to 65 years who were treated at 59 sites in 15 countries. Study participants had to have experienced episodic migraine with or without aura for at least a year, with attacks lasting an average of 4 to 14 days per month.
Participants also had to have been treated unsuccessfully with two to four preventive treatments. In most cases, patients cited a lack of efficacy as the main reason for discontinuation of these therapies.
Investigators randomly assigned these patients to receive erenumab 140 mg (n = 121) or placebo (n = 125) subcutaneously every 4 weeks for 12 weeks. The study was double-blind.
At study conclusion, there was a 50% or greater reduction in the mean number of monthly migraine days for 30% of the patients taking erenumab compared to 14% of the participants taking placebo (odds ratio [OR], 2.7; 95% confidence interval [CI], 1.4 - 5.2; P = .002).
Patients in the erenumab arm had improved scores in the everyday activities domain of the Migraine Physical Function Impact Diary compared to patients taking placebo.
Tolerability and safety were similar in the two groups. The most frequent treatment-emergent adverse event was pain at the injection site, which occurred in 6% of participants in both groups.
"Our study provides the first direct, controlled trial evidence for a novel CGRP-directed therapy, which will allow practitioners to consider the place of these novel therapies in evidence-based treatment algorithms," the authors note.
Publication of the LIBERTY results follows previously released data that led to the US Food and Drug Administration approval of erenumabin May of this year.
This is the first approval of a treatment designed to prevent migraine by blocking the CGRP receptor.
In an accompanying editorial, Andrew Charles, MD, Goldberg Migraine Program, David Geffen School of Medicine, University of California, Los Angeles, notes that the study is important for a number of reasons.
It shows the efficacy of erenumab in a population of patients for whom multiple previous preventive therapies were unsuccessful and who are commonly excluded from clinical trials.
In addition, the treatment was well tolerated, even by patients who had experienced adverse effects from other medications.
"Good tolerance to erenumab, even in patients who had intolerable side-effects with other preventive treatments, was reassuring," Charles writes.
The study was funded by Novartis Pharma. The original article contains disclosures of the authors' relevant financial relationships.
Lancet. Published online October 22, 2018. Abstract, Editorial
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Cite this: Erenumab for Migraine: Results Published - Medscape - Oct 26, 2018.