Erenumab monotherapy active long term in patients with episodic migraine
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Aimovig monotherapy demonstrated sustained efficacy up to 64 weeks among patients with episodic migraine who were unsuccessfully treated with multiple other preventive therapies, according to study findings published in Neurology.
In addition, Aimovig (erenumab; Amgen, Novartis) also exhibited a manageable safety profile that appeared consistent with previous findings, researchers noted.
“Patients who have been unsuccessful on prior preventive treatment failures can be difficult to treat,” Peter J. Goadsby, MBBS, MD, PhD, DSc, FRACP, FRCP, director of the NIHR Clinical Research Facility and professor of neurology at King’s College London, and colleagues wrote. “The LIBERTY Open-Label Extension Phase [OLEP] has demonstrated sustained efficacy of erenumab treatment over 1 year in this patient population. Efficacy of erenumab was sustained throughout 64 weeks in patients with episodic migraine unsuccessful on two to four prior preventive treatment failures in both continuous erenumab and those initiating erenumab treatment arms.”
Goadsby and colleagues sought to assess the safety and efficacy of Aimovig among 240 patients with episodic migraine who previously completed the double-blind treatment phase of the trial, in which they were received Aimovig 140 mg monotherapy every 4 weeks or placebo. For the current open-label extension phase of the LIBERTY study, the researchers randomly assigned patients to once-monthly Aimovig monotherapy dosed at 140 mg for 3 years. Patients from the placebo arm of the double-blind phase were allowed to switch to Aimovig.
Overall, 85% of patients completed treatment through 52 weeks, with 36 patients who discontinued treatment in OLEP before or on week 64. Reasons for treatment discontinuation included lack of efficacy (7.9%), subject/guardian decision (4.6%) and adverse events (1.7%).
Among patients who continued treatment with Aimovig, the 50% responder rate increased from 29.9% in weeks 9 to 12 to 44.3% in weeks 61 to 64. Moreover, the 50% response rate for patients continuing Aimovig in the open-label extension phase increased from 29.9% during weeks 9 to 12 to 41.7% during weeks 21 to 24 and remained stable through weeks 61 to 64 (44.3%).
The researchers observed sustained efficacy among patients who received Aimovig in the double-blind treatment phase, whereas patients starting Aimovig in the open-label extension phase achieved sustained improvement from week 13 and thereafter, researchers noted.
Overall, 80.8% of patients experienced adverse events. No deaths occurred.
Goadby and colleagues noted that, because the study was limited to patients with episodic migraine, the results “should not be generalized” to include patients with chronic migraine, although the number of monthly migraine days “are within the range” for the definition of chronic migraine for certain patients.
“The current study provides Class IV evidence on data from patients with episodic migraine that erenumab is safe and provides sustained efficacy at 52 weeks,” the researchers wrote.
Perspective
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Abby Metzler, MD
Preventative treatment with monoclonal antibodies targeting calcitonin gene-related peptide or its receptor has previously been shown to be effective and safe in patients with episodic or chronic migraine. The LIBERTY study demonstrated the efficacy and safety of Aimovig 140 mg versus placebo over 12 weeks in adults with episodic migraine who did not have benefit from, or did not tolerate, multiple preventative medications.
In this interim analysis of the 3-year open-label treatment phase of the LIBERTY study, Goadsby and colleagues report that Aimovig continued to be effective and safe after 52 weeks, with increasing and sustained benefit in the 50% response rate and reduction of monthly migraine days and headache impact scores. Safety data did not reveal any new concerns.
These data are encouraging. Even longer-term evidence of efficacy and safety will be important, particularly in this clinically relevant patient group: episodic migraine with multiple unsuccessful treatment trials).
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