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Abstract Details

Long-Term Efficacy and Safety of Fremanezumab in Migraine: Results of a 1-Year Study
Headache
S38 - Headache: Clinical Trials II (1:33 PM-1:44 PM)
004
Migraine preventive treatment is intended to reduce the frequency and severity of attacks, thus reducing disability. Fremanezumab, a fully humanized monoclonal antibody (IgG2?a) that selectively targets calcitonin gene-related peptide (CGRP), is approved for the preventive treatment of migraine.

To assess the long-term efficacy and safety of fremanezumab in adults with migraine.
In this 52-week, multicenter, randomized, double-blind, parallel-group study, adults with chronic migraine (CM) and episodic migraine (EM) who completed placebo-controlled studies, as well as new patients, received subcutaneous fremanezumab either monthly (225 mg monthly; CM: starting dose of 675 mg), or quarterly (675 mg every 3 months). 
Of the 1890 patients enrolled, 1494 (79%) completed 12 months of treatment as of the cutoff (30 May 2018). The mean change in the monthly number of migraine days from baseline to Month 12 in CM patients (n=1110) was –7.2 days for quarterly and –8.1 days for monthly, with ≥50% response rates of 53% and 57% in the quarterly and monthly groups, respectively. Similar decreases were seen for headache days of at least moderate severity (quarterly: –6.4 days; monthly: –6.8 days) and any severity (quarterly: –7.2 days; monthly: –7.8 days). The mean change in the monthly number of migraine days from baseline to Month 12 in EM patients (n=780) was –5.2 for quarterly and –5.1 days for monthly, with ≥50% response rates of 66% and 68% in the quarterly and monthly groups, respectively. Headache days of at least moderate severity (quarterly: –4.4 days; monthly: –4.2 days) and any severity (quarterly: –4.9 days; monthly: –4.8 days) also decreased. The most-common AEs were injection-site reactions (26–33%); most were mild to moderate. Serious AEs occurred in 3% of patients; none were considered related to treatment.
Efficacy and safety of fremanezumab was maintained over 12 months. 
Authors/Disclosures
Peter Goadsby, MD, PhD, FRS (University of California, Los Angeles)
PRESENTER 		Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli-Lilly. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aurene. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva Pharmaceuticals. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Goadsby has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CoolTech LLC. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PureTech Health LLC. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vial. Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon Biopharma. Dr. Goadsby has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Massachusetts Medical Society. The institution of Dr. Goadsby has received research support from NIHR. The institution of Dr. Goadsby has received research support from Kallyope. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has received publishing royalties from a publication relating to health care. Dr. Goadsby has a non-compensated relationship as a Trustee with Migraine Trust that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Trustee with Organisation for Understanding Cluster Headache (UK) that is relevant to AAN interests or activities. Dr. Goadsby has a non-compensated relationship as a Executive roles with American Headache Society that is relevant to AAN interests or activities.
Teshamae Monteith, MD, FAAN (University of Miami) Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for American Headache Society . Dr. Monteith has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for e-Neura. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Monteith has received personal compensation in the range of $0-$499 for serving as a Consultant for Merz. Dr. Monteith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN . Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN . Dr. Monteith has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Cephalalgia. The institution of Dr. Monteith has received research support from AbbVie. The institution of Dr. Monteith has received research support from lilly. The institution of Dr. Monteith has received research support from Ipsen. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a 好色先生 with Medscape. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a 好色先生 with Massachusetts Medical Society . Dr. Monteith has a non-compensated relationship as a President Elect with Florida Society of Neurology that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Editorial Board /Board Member with American Migraine Foundation that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Board Member with International Headache Society that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Pfizer that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Abbvie that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Theranica that is relevant to AAN interests or activities.
Paul P. Yeung, MD, PhD No disclosure on file
Joshua M. Cohen, MD No disclosure on file
No disclosure on file