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Ajovy prevents medication overuse

PHILADELPHIA — Ajovy subcutaneous injections for migraine prevention at doses of either 675 mg quarterly or 225 mg monthly after a first dose of 675 mg also showed efficacy in patients with headache brought on by acute medication overuse, according to data presented at the American Headache Society Annual Scientific Meeting.

“Overuse of acute headache medications, such as triptans, ergot derivatives, opioids and combination analgesics, can cause medication overuse headache," researchers wrote in an abstract.

Medication overuse headache occurs in about 32% of patients with chronic migraine, Dmitri Aleksenko, MD, of Louisiana State University, and Juan Carlos Sánchez-Manso of Hospital Virgen de la Concha, wrote in StatPearls: Migraine Overuse Headache.

James and colleagues found that at month 12 and vs. baseline, Ajovy (fremanezumab-vfrm, Teva) use led to a “sustained reduction” in monthly headache days of at least moderate severity in the 599 patients with acute medication overuse and chronic migraine (quarterly = –7 days; monthly = –7.4 days) and the 100 patients with acute medication overuse and episodic migraine (quarterly = –6.1 days; monthly = –4.6 days).

Other studies presented at the meeting involving fremanezumab-vfrm include:

• A 52-week trial that included 268 patients with chronic migraine taking up to two concomitant medications before and during the study. The treatment led to a mean change of monthly number of headache days of at least moderate severity of –5.9 days in the patients receiving the quarterly dose and –6.1 days in the monthly dose vs. baseline. In the 181 patients with identical concomitant regimens but with episodic migraine, the mean change in the number of headache days per month was –3.9 days in the quarterly cohort and –4 days in the monthly cohort vs. baseline.
• Data from this same cohort also showed that regardless of migraine type, quality of life scores improved (mean change for role function-restrictive = 23.4 in the quarterly dose users, 26 in the monthly dose users; role function-preventive = 16.2 in the quarterly dose users, 21.2 in the monthly dose users; emotional function = 25.5 in the quarterly dose users, 27.4 in the monthly dose users).
• A 52-week trial of 813 patients with chronic migraine receiving either dose resulted in 542 patients’ classification changing to episodic migraine.
• A 3-month trial randomized 838 patients who had failed to respond to as many as four preventive medications in an approximate 1:1:1 ratio to receive either dose of the drug or a placebo. Researchers found that more than one-third of those receiving fremanezumab-vfrm achieved a 50% or greater reduction in migraine days within 4 weeks of the first dose, about 20% of patients experienced sustained reductions of 50% or more in migraine days from 4 weeks through 12 weeks, and higher proportions of patients achieved reductions of 75% or more during this same timeframe.
• Data from the same cohort also showed that regardless of migraine type, reductions from the monthly average number of migraine days over 12 weeks of treatment from baseline were significantly greater with both doses (P < .0001). Researchers also found that adverse events occurred in approximately the same numbers as patients taking the drug vs. those taking placebo. The most common adverse event was skin reddening at the injection site. Neither severe treatment-related adverse events nor safety signals were identified.
• A 12-week trial randomly assigned 1,121 patients with chronic migraine in an approximate 1:1:1 ratio to receive one of the drug’s doses or a placebo. Researchers found that those who received the drug had a “significantly greater maximum number of consecutive days without a headache of at least moderate severity” (quarterly dose users = 18 days; monthly dose users = 17.9 days; placebo 12.8 days).
• Two brief studies consisting of 15 adults and 15 pairs of adult patients and adolescent caregivers concluded that 98% of the adults and 97% of the persons in the pairs found an autoinjector with the drug “easy to use.” In addition, 87% of the adults and 94% of the those in the pairs were “confident” using the autoinjector.
• Among 253 patients who participated in a survey 1 to 24 months after completing a fremanezumab-vfrm study found that regardless of the dose a patient received, 68% indicated a preference for quarterly dosing and 70% preferred the monthly option. In addition, 75% of all survey participants believed having dosing flexibility would help them adhere to their treatment regimen and 77% felt dosing flexibility added to the drug’s value.

“The finding that more than two-thirds of patients expressed a preference for quarterly over monthly fremanezumab dosing is relevant for clinical decision makers involved in treatment selection,” researchers wrote in summarizing the last study. – by Janel Miller

References:

Patient preference for dosing regimen and perception of dosing flexibility with fremanezumab for chronic or episodic migraine: results from a web-based, patient survey following completion of a 1-year extension study. Submission ID: 681564

Simulated use of a fremanezumab autoinjector: use as intended, ease of use, and comfort with using the autoinjector. Submission ID:681559

Goadsby P, et al. Long-term efficacy of fremanezumab in migraine patients with and without concomitant oral preventive medication use: results of a 1-year study category.

Silberstein D, et al. Long-term efficacy of fremanezumab in chronic and episodic migraine patients with acute medication overuse at baseline: results of a 1-year study category.

Spierings E, et al. Clinically meaningful responses to fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine.

Richard R, et al. Long-term efficacy of fremanezumab in patients who reverted from a chronic to an episodic migraine classification.

All presented at: American Headache Society Annual Scientific Meeting; July 11-14, 2019; Philadelphia.

Also: StatPearls: Migraine Overuse Headache. https://www.ncbi.nlm.nih.gov/books/NBK470171/

Disclosures: Healio Primary Care was unable to determine the authors’ relevant financial disclosures prior to publication.