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Abstract Details

Consistent efficacy and safety of erenumab over time in patients with episodic migraine who completed a 5-year, open-label extension study
Headache
Headache Posters (7:00 AM-5:00 PM)
001

Erenumab demonstrated significant reduction in migraine frequency in short-term studies; however, long-term data are not available.

Evaluate long-term efficacy and safety of erenumab in patients with episodic migraine who completed a 5-year open-label treatment phase (OLTP; NCT01952574).

Following a 12-week placebo-controlled, double-blind treatment period (DBTP), 383 patients continued in the OLTP, receiving erenumab 70mg every 4 weeks, and increasing to 140mg after a protocol amendment (after ~2 years in OLTP). A separate protocol amendment was implemented to resume efficacy data collection in years 4–5. 215 patients completed the 5-year OLTP; 137 had efficacy data at week 268 (end of 5-year OLTP) and were included in this analysis.

Mean (SD) change in monthly migraine days (MMD) from DBTP baseline of 8.5(2.5) days was –4.8(3.9) at week 64 (mean of last 4 weeks of 1-year OLTP; N=129), and –5.3(3.9) at week 268 (mean of last 4 weeks of 5-year OLTP). The percentage of patients achieving MMD response at week 64/268 was 62%/69% for achievement of ≥50% reduction; 41%/48% for ≥75% reduction; and 26%/36% for 100% reduction. Among acute migraine-specific medication (AMSM) users at baseline (6.1[2.7] treatment days/month), mean(SD) change in AMSM days was –3.2(3.5) at week 64 and –4.4(3.3) at week 268. Clinically meaningful improvements were observed in HIT-6TM: 68%/72% of patients achieved ≥5-point reduction from baseline at weeks 64/268. Exposure-adjusted patient incidence of AEs and serious AEs during OLTP were 92.3 and 2.6 per 100 subject-years, respectively; this was lower than that observed for placebo during DBTP. One fatality (“death unattended”) occurred during safety follow-up period when no erenumab was administered and was considered unrelated to study drug by the investigator.

Patients receiving erenumab through 5 years of treatment demonstrated consistent and sustained response. Safety was comparable to that observed in the full population during the randomized phase of the trial.

Authors/Disclosures
Messoud Ashina, MD, PhD (Dept. of Neurology)
PRESENTER
Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AbbVie. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Ashina has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pfizer.
Peter Goadsby, MD, PhD, FRS (University of California, Los Angeles) Dr. Goadsby has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. 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 Tremeau. 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 Celgene. 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. Dr. Goadsby has a non-compensated relationship as a Director with American Migraine Foundation that is relevant to AAN interests or activities.
Uwe Reuter Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Allergan. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TEVA. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Liily Deutschland. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TEVA. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Allergan. Uwe Reuter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape . Uwe Reuter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Uwe Reuter has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for StreaMEdUp. Uwe Reuter has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. The institution of Uwe Reuter has received research support from Novartis.
Stephen D. Silberstein, MD, FAAN (Jefferson Headache Center) Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alergan. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Abbvie. Dr. Silberstein has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Silberstein has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Davies McFarland & Carroll, LLC. Dr. Silberstein has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for SHEEHEY FURLONG & BEHM P.C.. The institution of Dr. Silberstein has received research support from Lundbeck. The institution of Dr. Silberstein has received research support from abbvie. The institution of Dr. Silberstein has received research support from lundbeck. Dr. Silberstein has received publishing royalties from a publication relating to health care.
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 Education 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 American Academy of Neurology 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.
Feng *Use 393271 Zhang Feng Zhang has received personal compensation for serving as an employee of Amgen Inc.
Fei Xue Fei Xue has received personal compensation for serving as an employee of Amgen Inc.
Sunfa Cheng Sunfa Cheng has received personal compensation for serving as an employee of Amgen. Sunfa Cheng has received stock or an ownership interest from Amgen.
Denise *USE ID 162782 Chou Denise Chou has received personal compensation for serving as an employee of Amgen. Denise Chou has received stock or an ownership interest from Amgen.
Gabriel Paiva da Silva Lima Gabriel Paiva da Silva Lima has received personal compensation for serving as an employee of Amgen Inc. Gabriel Paiva da Silva Lima has received stock or an ownership interest from Amgen Inc.