Abstract Details

Title Efficacy of Fremanezumab in Migraine Patients 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 13-011

Objective To assess the efficacy of fremanezumab in migraine patients 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), has been shown to be effective in the prevention of chronic migraine (CM) and episodic migraine (EM).

Design/Methods In two Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trials, patients with CM or EM (confirmed during a 28-day pre-treatment baseline period) received subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at Weeks 4 and 8), monthly (CM: 675 mg at baseline and 225 mg at Weeks 4 and 8; EM: 225 mg at baseline and Weeks 4 and 8), or placebo (at baseline and Weeks 4 and 8). Mean changes from baseline in the monthly average number of headache days of at least moderate severity or the monthly average number of migraine days during the 12-week treatment period were assessed in patients who failed at least one prior migraine preventive medication due to lack of efficacy or intolerability.

Results

In CM patients, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly [least-squares mean change]: –4.0, P<0.0001; monthly: –4.5, P<0.0001) compared with placebo (–1.8). There were similar reductions in the number of migraine days (quarterly: –4.1, P=0.0027; monthly: –4.8, P<0.0001) compared with placebo (–2.3). In EM patients, fremanezumab yielded greater reductions in the number of headache days of at least moderate severity (quarterly: –3.1, P<0.0001; monthly: –3.2, P<0.0001) compared with placebo (–0.8). There were similar reductions in the number of migraine days (quarterly: –3.3, P=0.0015; monthly: –3.7, P<0.0001) compared with placebo (–1.3).

Conclusions

Fremanezumab was efficacious in migraine patients who failed prior migraine preventive medication, with effect sizes greater than those in the overall trial population.

Authors/Disclosures
Peter J. McAllister, MD, FAAN (New England Inst for Neurology and Headache) PRESENTER	Dr. McAllister has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for pfizer. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for lilly. Dr. McAllister has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for abbvie. Dr. McAllister has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for lundbeck.
David W. Dodick, MD, FAAN (Atria Institute)	Dr. Dodick has received personal compensation for serving as an employee of Mayo Clinic. Dr. Dodick has received personal compensation for serving as an employee of Atria Health. Dr. Dodick has received personal compensation for serving as an employee of Thomas Jefferson University . Dr. Dodick has received personal compensation for serving as an employee of Norwegian University of Science and Technology. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Dodick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Allergan. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biopharm Communications. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Inside Practice Australia. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clinical ��ɫ�� Alliance. Dr. Dodick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Headache Cooperative of the Pacific . Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medica Communications. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MJ Healthcare. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nocira. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Praxis. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Revance . Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communications. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vector Psychometrics. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as a Consultant for Ayya Biosciences. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as a Consultant for Theranica. Dr. Dodick has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Atria. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for WebMD. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Thomas Jefferson University. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medforce. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Precision HEOR. Dr. Dodick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Canadian Headache Society. Dr. Dodick has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Headache Cooperative of New England. Dr. Dodick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen Japan. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for KingDevick Technologies. Dr. Dodick has received personal compensation in the range of $1,000,000+ for serving as an officer or member of the Board of Directors for Precon Health. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Ontologics. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Matterhorn. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Axon Therapeutics. Dr. Dodick has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Cephalgia Group. Dr. Dodick has stock in Healint. Dr. Dodick has stock in Theranica. Dr. Dodick has stock in Aural Analytics . Dr. Dodick has stock in Epien. Dr. Dodick has stock in Matterhorn. Dr. Dodick has stock in Ontologics. Dr. Dodick has stock in Precon Health. Dr. Dodick has stock in King Devick Technologies. Dr. Dodick has stock in Nocira. Dr. Dodick has stock in Exsano. Dr. Dodick has stock in Palion. Dr. Dodick has stock in AYYA Biosciences. Dr. Dodick has stock in Perfood. Dr. Dodick has stock in Cephalgia Group. Dr. Dodick has stock in Atria Health. Dr. Dodick has stock in Man and Science. Dr. Dodick has stock in Eigenlyfe. An immediate family member of Dr. Dodick has stock in ScotiaLyfe. Dr. Dodick has stock in Axon Therapeutics. The institution of Dr. Dodick has received research support from Department of Defense. The institution of Dr. Dodick has received research support from Patient Centered Outcomes Research Institute. The institution of Dr. Dodick has received research support from Henry Jackson Foundation. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received intellectual property interests from a discovery or technology relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has received publishing royalties from a publication relating to health care. Dr. Dodick has a non-compensated relationship as a Chair with American Brain Foundation that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Committee member/Course Director with ��ɫ�� that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Chair/Immediate Past Chair with American Migraine Foundation that is relevant to AAN interests or activities. Dr. Dodick has a non-compensated relationship as a Chair Global Patient Advocacy Coalition with International 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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