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Fremanezumab effective for episodic migraine
Clinical Question
Is subcutaneous fremanezumab effective for the treatment of episodic migraine in adults?
Bottom line
Subcutaneous fremanezumab is effective in reducing the mean number of monthly migraine days in adults with episodic migraine. Eligible patients in this study had not previously failed 2 or more medication classes commonly used for migraine prophylaxis. Study follow-up was only 12 weeks and the average cost of treatment is $8500 per year. See the Synopsis for additional information about the use of fremanezumab to treat cluster headaches. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (specialty)
Synopsis
These investigators identified adults, aged 18 to 70 years, meeting standard international diagnostic criteria for episodic migraine headache, including at least 4 migraine days per month. Exclusion criteria included previous treatment failure with 2 or more medications commonly used for migraine prophylaxis and chronic migraine (greater than 14 days/month). Eligible patients (N = 875) randomly received (concealed allocation assignment) monthly dosing of fremanezumab (225 mg injection), a single higher dose of fremanezumab (675 mg injection), or matched placebo injections. Individuals who assessed outcomes remained masked to treatment group assignment. Complete follow-up occurred for 97.1% of patients at 12 weeks. Using intention-to-treat analysis, mean migraine days per month decreased significantly more in both the fremanezumab monthly and single-higher-dose groups compared with the placebo group (-1.5 days and -1.3 days, respectively). The proportion of patients reporting at least a 50% reduction in mean number of monthly migraine days was also significantly higher in both the fremanezumab groups compared with the placebo group (numbers needed to treat = 5.0 [95% CI 3.7 - 8.4] and 6.1 [4.2 - 11.5], respectively). Serious adverse events and adverse events leading to discontinuation were infrequent (< 2%) and occurred similarly in all 3 treatment groups. Please note that this study was of episodic migraines only. The manufacturer recently announced that it will stop the Phase III trial of fremanezumab for chronic cluster headaches after concluding that it is unlikely to be proven effective.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
Another expensive drug trying to justify its exorbitant cost. It doesn't.
The only patients who would be reasonable for this novel and expensive Tx are those who have not responded to usual preventative tx. but these patients were excluded from the study
Until drug coverage is in place for this treatment it is unlikely to be a viable option for my patients.
Good poem
Not sure that this would be cost effective.
Difficult to justify the cost