Abstract Details

Title Impact of Fremanezumab on Response Rates, Migraine Days, and Acute Medication Use in Patients with Chronic Migraine Who Have Failed at Least One Prior Migraine Preventive Medication

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-004

Objective To assess the effects of fremanezumab on response rates, migraine days and acute headache medication use in patients with chronic migraine (CM) who failed at least one prior preventive migraine medication.

Background Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is efficacious in preventing CM, but its effectiveness in patients who have failed previous preventive medications is unknown.

Design/Methods In this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, CM patients were randomized 1:1:1 to receive subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at Weeks 4 and 8), fremanezumab monthly (675 mg at baseline and 225 mg at Weeks 4 and 8), or placebo (at baseline, Weeks 4 and 8) over a 12-week treatment period. Analyses were performed in patients who failed at least one prior preventive migraine medication (due to lack of efficacy or intolerability). Endpoints included the proportion of patients with a ≥50% reduction in headache days of at least moderate severity, mean change from baseline in the monthly average number of migraine days or days of acute headache medication use during the 12-week treatment period.

Results

More patients who received fremanezumab experienced a ≥50% reduction in headache days of at least moderate severity (quarterly: 28%, P<0.0001; monthly: 39%, P<0.0001) than did those given placebo (7%). Fremanezumab treatment reduced the monthly number of migraine days during the 12-week treatment period ([least-squares mean change]: quarterly, –4.1 days, P=0.0027; monthly, –4.8 days, P<0.0001) compared with placebo (–2.3 days). Fremanezumab also reduced the monthly average number of days of any acute headache medication use (quarterly, –3.4 days; monthly, –4.2 days; both, P<0.0001) compared with placebo (–1.1 days).

Conclusions Fremanezumab was efficacious in CM patients with prior preventive treatment failure, with effect sizes in excess of those seen in the overall trial population.

Authors/Disclosures
Stephen D. Silberstein, MD, FAAN PRESENTER	Dr. Silberstein has received publishing royalties from a publication relating to health care.
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology)	Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to AAN interests or activities.
	No disclosure on file
	No disclosure on file
Paul P. Yeung, MD, PhD	No disclosure on file
	No disclosure on file

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