TY - JOUR
T1 - Fremanezumab for preventive treatment of migraine
T2 - Functional status on headache-free days
AU - VanderPluym, Juliana
AU - Dodick, David W.
AU - Lipton, Richard B.
AU - Ma, Yuju
AU - Loupe, Pippa S.
AU - Bigal, Marcelo E.
N1 - Funding Information:
The EM and CM phase 2 studies of fremanezumab described in this report were funded by Global Specialty Research and Development Teva Pharmaceutical Industries Ltd (Netanya Israel).
Funding Information:
J. VanderPluym reports speaking fees for Amgen and Novartis and consulting for Healint. D. Dodick has received compensation from serving on advisory boards and/or consulting from Allergan, Amgen, Novartis, Alder, Arteaus, Pfizer, Colucid, Merck, NuPathe, Eli Lilly and Company, Autonomic Technologies, Ethicon J&J, Zogenix, Supernus, Labrys, Boston Scientific, Medtronic, St Jude, Bristol-Myers Squibb, Lundbeck, Impax, MAP, Electrocore, Tonix, Novartis, Teva, Alcobra, Zosano, Insys, Ipsen, GBS/Nocira, Acorda, eNeura, Charleston Laboratories, Gore, Biohaven, Bioventric, Magellan, Theranica, Xenon, and Dr Reddy’s/Promius Pharma. Dr Dodick owns equity in Epien, GBS/Nocira, Second Opinion, Healint, and Theranica. Dr Dodick has received funding for travel, speaking, editorial activities, or royalty payments from IntraMed, SAGE Publishing, Sun Pharma, Allergan, Oxford University Press, American Academy of Neurology, American Headache Society, West Virginia University Foundation, Canadian Headache Society, Healthlogix, Universal Meeting Management, WebMD, UptoDate, Medscape, Oregon Health Science Center, Albert Einstein University, University of Toronto, Starr Clinical, Decision Resources, Synergy, MedNet LLC, Peer View Institute for Medical Education, Medicom, Chameleon Communications, Academy for Continued Healthcare Learning, Haymarket Medical Education, Global Scientific Communications, HealthLogix, Miller Medical, MeetingLogiX, and Wiley Blackwell. Dr Dodick, through his employer, has consulting use agreements with NeuroAssessment Systems and Myndshft. He holds board of director positions with King-Devick Technologies, and Epien Inc. He holds the following patent: 17189376.1-1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis (no compensation). R. Lipton reports grants and personal fees from Alder, Allergan, CoLucid, Electrocore, and Novartis; personal fees and other from eNeura; personal fees from Ethicon, Merck, Labrys, Autonomic Technologies, Boston Scientific, Bristol-Myers Squibb, Dr Reddy’s Laboratories, Eli Lilly, Endo Pharmaceuticals, Informa, Teva Pharmaceuticals, and Vedanta; and grants from Migraine Research Fund, National Headache Foundation, and NIH. Y. Ma and P. Loupe are employees of the Innovative Research and Development division of Teva Pharmaceutical Industries Ltd. M. Bigal is a former employee of Teva Pharmaceuticals and is now senior vice president and chief medical officer of Purdue Pharma. Go to Neurology.org/N for full disclosures.
Publisher Copyright:
Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.
PY - 2018
Y1 - 2018
N2 - Objective To evaluate the effect of fremanezumab on the functional status on headache-free days in phase 2 episodic migraine (EM) and chronic migraine (CM) studies. Methods Functional status data were collected prospectively via the electronic headache diary on all headache-free days by patients answering questions regarding work/school/household chore performance, speed of work completion, concentration, and feeling of fatigue. Individuals with EM receiving monthly doses of fremanezumab 225 mg (n = 96) or 675 mg (n = 97) or placebo (n = 104) were compared. Individuals with CM receiving fremanezumab 675 mg followed by monthly 225 mg (n = 88) and 900 mg (n = 86) were also independently compared to those receiving placebo (n = 89). Results In patients with EM, compared to patients receiving placebo, those receiving fremanezumab experienced an increased number of headache-free days with normal function in work/school/ household chore performance and concentration/mental fatigue measures compared to their baseline over the entire treatment period (all p < 0.005). An increased number of headache-free days with normal functional performance for some measures was also found in the CM group in those treated with fremanezumab. Conclusion There was an increased number of headache-free days with normal functional performance on all measures for the patients with EM and some measures for patients with CM in the fremanezumab-treated groups. Further research is required to confirm these findings in a prospective study and to clarify the underlying mechanism(s).
AB - Objective To evaluate the effect of fremanezumab on the functional status on headache-free days in phase 2 episodic migraine (EM) and chronic migraine (CM) studies. Methods Functional status data were collected prospectively via the electronic headache diary on all headache-free days by patients answering questions regarding work/school/household chore performance, speed of work completion, concentration, and feeling of fatigue. Individuals with EM receiving monthly doses of fremanezumab 225 mg (n = 96) or 675 mg (n = 97) or placebo (n = 104) were compared. Individuals with CM receiving fremanezumab 675 mg followed by monthly 225 mg (n = 88) and 900 mg (n = 86) were also independently compared to those receiving placebo (n = 89). Results In patients with EM, compared to patients receiving placebo, those receiving fremanezumab experienced an increased number of headache-free days with normal function in work/school/ household chore performance and concentration/mental fatigue measures compared to their baseline over the entire treatment period (all p < 0.005). An increased number of headache-free days with normal functional performance for some measures was also found in the CM group in those treated with fremanezumab. Conclusion There was an increased number of headache-free days with normal functional performance on all measures for the patients with EM and some measures for patients with CM in the fremanezumab-treated groups. Further research is required to confirm these findings in a prospective study and to clarify the underlying mechanism(s).
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U2 - 10.1212/01.wnl.0000544321.19316.40
DO - 10.1212/01.wnl.0000544321.19316.40
M3 - Article
C2 - 30120138
AN - SCOPUS:85054083264
SN - 0028-3878
VL - 91
SP - E1152-E1165
JO - Neurology
JF - Neurology
IS - 12
ER -