TY - JOUR
T1 - Chronic versus episodic migraine
T2 - The 15-day threshold does not adequately reflect substantial differences in disability across the full spectrum of headache frequency
AU - Ishii, Ryotaro
AU - Schwedt, Todd J.
AU - Dumkrieger, Gina
AU - Lalvani, Nim
AU - Craven, Audrey
AU - Goadsby, Peter J.
AU - Lipton, Richard B.
AU - Olesen, Jes
AU - Silberstein, Stephen D.
AU - Burish, Mark J.
AU - Dodick, David W.
N1 - Funding Information:
Ryotaro Ishii has nothing to disclose. Todd Schwedt has served as a consultant for Alder, Allergan, Amgen, Avanir, Biohaven, Cipla, Click Therapeutics, Dr. Reddy's, Eli Lilly, Equinox, Ipsen Bioscience, Nocira, Novartis, Salvia, Teva, Xoc Pharmaceuticals, and Weber and Weber. He has stock options in Aural Analytics, Nocira, and Second Opinion. He has received research funding from: Amgen, American Migraine Foundation, Arizona State University, Henry Jackson Foundation, National Institutes of Health, Patient‐Centered Outcomes Research Institute, and U.S. Department of Defense. He serves on the Board of Directors for the American Headache Society and the International Headache Society. Gina Dumkrieger has nothing to disclose. Nim Lalvani on behalf of the American Migraine Foundation has served on patient advocacy roundtables for Lundbeck Pharmaceuticals, Allergan‐AbbVie, and Impel NeuroPharma. These roles were not participated in as an individual for personal benefit. Steering committees: CHAMP and IHS‐GPAC. Audrey Craven has nothing to disclose. Peter J. Goadsby reports, over the last 36 months, grants and personal fees from Amgen and Eli Lilly and Company; a grant from Celgene; and personal fees from Alder Biopharmaceuticals, AEON Biopharma, Allergan, Biohaven Pharmaceuticals Inc., Clexio, electroCore Inc., eNeura, Epalex, GlaxoSmithKline, Impel NeuroPharma, Lundbeck, Mundipharma, Novartis, Pfizer, Praxis, Sanofi, Santara Therapeutics, Satsuma, Teva Pharmaceuticals, Trigemina, Inc., WL Gore; and personal fees for advice through Gerson Lehrman Group, LEK, and Guidepoint; fees for educational materials from Massachusetts Medical Society, Medery, Medlink, PrimeEd, UptoDate, and WebMD; and publishing royalties from Oxford University Press and Wolters Kluwer and for medicolegal advice in headache, and a patent magnetic stimulation for headache assigned to eNeura without fee. Richard B. Lipton holds stock options in Biohaven Holdings and Ctrl M Health. He serves as consultant, advisory board member, and has received honoraria from or research support from: AbbVie (Allergan), American Academy of Neurology, American Headache Society, Amgen, Biohaven, BioVision, Boston, Dr. Reddy's (Promius), Electrocore, Eli Lilly, eNeura, Equinox, GlaxoSmithKline, Grifols, Lundbeck (Alder), Merck, Pernix, Pfizer, Teva, Vector, and Vedanta. Jes Olesen has nothing to disclose. Stephen D. Silberstein reports the following conflicts: honoraria as a consultant and/or advisory panel member, from AbbVie; Amgen; AEON Biopharma; Axsome Therapeutics; Biohaven Pharmaceuticals; Cefaly; Curelator, Inc.; Epalex; GlaxoSmithKline Consumer Health Holdings, LLC.; electroCore Medical, LLC; Impel NeuroPharma, Inc.; Lilly USA, LLC; Medscape, LLC; Lundbeck; Nocera; Novartis, Inc.; Revance: Salvia, Bioelectronics; Satsuma Pharmaceuticals; Supernus Pharmaceuticals, Inc.; Teva Pharmaceuticals; Theranica; Thermaquil; and Trillen Medical Inc. Mark Burish reports the following conflicts: consultant for Beckley Psytech Ltd (with a donation to the Will Erwin Headache Research Center in lieu of compensation) and research support from the Will Erwin Headache Research Center. David W. Dodick reports the following conflicts: Personal fees: Amgen, AEON, Association of Translational Medicine, University Health Network, Daniel Edelman Inc., Autonomic Technologies, Axsome, Allergan, Alder BioPharmaceuticals, Biohaven, Charleston Laboratories, Clexio, Dr Reddy's Laboratories/Promius, Electrocore LLC, Eli Lilly, eNeura, Neurolief, Novartis, Ipsen, Impel, Satsuma, Supernus, Sun Pharma (India), Theranica, Teva, Vedanta, WL Gore, Nocira, PSL Group Services, XoC, Zosano, ZP Opco, Foresite Capital, Oppenheimer; Upjohn (Division of Pfizer), Pieris, Revance, Equinox, Salvia, Amzak Health. Speaking fees: Eli Lilly, Novartis Canada, Amgen, Lundbeck. Speakers Bureaus: None. CME fees or royalty payments: HealthLogix, Medicom Worldwide, MedLogix Communications, Mednet, Miller Medical, PeerView, WebMD Health/Medscape, Chameleon, Academy for Continued Healthcare Learning, Universal Meeting Management, Haymarket, Global Scientific Communications, Global Life Sciences, Global Access Meetings, Catamount, UpToDate (Elsevier), Oxford University Press, Cambridge University Press, Wolters Kluwer Health; Stock options: PreCon Health, Aural Analytics, Healint, Theranica, Second Opinion/Mobile Health, EPIEN, Nocira, Matterhorn, Ontologics, King‐Devick technologies; Consulting without fee: Aural Analytics, Healint, Second Opinion/Mobile Health, Epien; Board of Directors: PreCon Health, Epien, Matterhorn, Ontologics, King‐Devick technologies. Patent: 17189376.1‐1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis without fee; Research funding: American Migraine Foundation, US Department of Defense, PCORI, Henry Jackson Foundation; Professional society fees or reimbursement for travel: American Academy of Neurology, American Brain Foundation, American Headache Society, American Migraine Foundation, International Headache Society, Canadian Headache Society.
Funding Information:
The authors gratefully acknowledge the American Registry for Migraine Research (ARMR) for the use of registry data to conduct this research. In addition, they would like to thank the patients and clinicians who participated in this registry.
Publisher Copyright:
© 2021 American Headache Society
PY - 2021/7/1
Y1 - 2021/7/1
N2 - Objective: To evaluate whether the 15-day threshold of headache days per month adequately reflects substantial differences in disability across the full spectrum of migraine. Background: The monthly frequency of headache days defines migraine subtypes and has crucial implications for epidemiological and clinical research as well as access to care. Methods: The patients with migraine (N = 836) who participated in the American Registry for Migraine Research, which is a multicenter, longitudinal patient registry, between February 2016 and March 2020, were divided into four groups based on monthly headache frequency: Group 1 (0–7 headache days/month, n = 286), Group 2 (8–14 headache days/month, n = 180), Group 3 (15–23 headache days/month, n = 153), Group 4 (≥24 headache days/month, n = 217). Disability (MIDAS), Pain intensity (NRS), Work Productivity and Activity Impairment (WPAI), Pain Interference (PROMIS-PI), Patient Health Questionnaire-4 (PHQ-4), and General Anxiety Disorder-7 (GAD-7) scores were compared. Results: Mean (standard deviation [SD]) age was 46 (13) years (87.9% [735/836] female). The proportion of patients in each group was as follows: Group 1 (34.2% [286/836]), Group 2 (21.5% [180/836]), Group 3 (18.3% [153/836]), and Group 4 (26.0% [217/836]). There were significant relationships with increasing disability, lost productive time, and pain interference in higher headache frequency categories. There were no significant differences between Group 2 and Group 3 for most measures (NRS, all WPAI scores, PROMIS-PI, GAD-7, and PHQ-4), although MIDAS scores differed (median [interquartile range (IQR)]; 38 [20–58] vs. 55 [30–90], p < 0.001). Patients in Group 1 had significantly lower MIDAS (median [IQR];16 [7–30], p < 0.001), WPAI-% total active impairment (mean (SD): Group 1 [30.9 (26.8)] vs. Group 2 [39.2 (24.5), p = 0.017], vs. Group 3 [45.9 (24.1), p < 0.001], vs. Group 4 [55.3 (23.0), p < 0.001], and PROMIS-PI-T score (Group 1 [60.3 (7.3)] vs. Group 2 [62.6 (6.4), p = 0.008], vs. Group 3 [64.6 (5.6), p < 0.001], vs. Group 4 [66.8 (5.9), p < 0.001]) compared to all other groups. Patients in Group 4 had significantly higher MIDAS (median (IQR): Group 4 [90 (52–138)] vs. Group 1 [16 (7–30), p < 0.001], vs. Group 2 [38 (20–58), p < 0.001], vs. Group 3 [55 (30–90), p < 0.001], WPAI-%Presenteeism (Group 4 [50.4 (24.4)] vs. Group 1 [28.8 (24.9), p < 0.001], vs. Group 2 [34.9 (22.3), p < 0.001], vs. Group 3 [40.9 (22.3), p = 0.048], WPAI-% total work productivity impairment (Group 4 [55.9 (26.1)] vs. Group 1 [32.1 (37.6), p < 0.001], vs. Group 2 [38.3 (24.0), p < 0.001], vs. Group 3 [44.6 (24.4), p = 0.019]), and WPAI-%Total activity impairment (Group 4 [55.3 (23.0)] vs. Group 1 [30.9 (26.8), p < 0.001], vs. Group 2 [39.2 (24.5), p < 0.001], vs. Group 3 [45.9 (24.1), p = 0.025]) scores compared with all other groups. Conclusion: Our data suggest that the use of a 15 headache day/month threshold to distinguish episodic and chronic migraine does not capture the burden of illness nor reflect the treatment needs of patients. These results have important implications for future refinements in the classification of migraine.
AB - Objective: To evaluate whether the 15-day threshold of headache days per month adequately reflects substantial differences in disability across the full spectrum of migraine. Background: The monthly frequency of headache days defines migraine subtypes and has crucial implications for epidemiological and clinical research as well as access to care. Methods: The patients with migraine (N = 836) who participated in the American Registry for Migraine Research, which is a multicenter, longitudinal patient registry, between February 2016 and March 2020, were divided into four groups based on monthly headache frequency: Group 1 (0–7 headache days/month, n = 286), Group 2 (8–14 headache days/month, n = 180), Group 3 (15–23 headache days/month, n = 153), Group 4 (≥24 headache days/month, n = 217). Disability (MIDAS), Pain intensity (NRS), Work Productivity and Activity Impairment (WPAI), Pain Interference (PROMIS-PI), Patient Health Questionnaire-4 (PHQ-4), and General Anxiety Disorder-7 (GAD-7) scores were compared. Results: Mean (standard deviation [SD]) age was 46 (13) years (87.9% [735/836] female). The proportion of patients in each group was as follows: Group 1 (34.2% [286/836]), Group 2 (21.5% [180/836]), Group 3 (18.3% [153/836]), and Group 4 (26.0% [217/836]). There were significant relationships with increasing disability, lost productive time, and pain interference in higher headache frequency categories. There were no significant differences between Group 2 and Group 3 for most measures (NRS, all WPAI scores, PROMIS-PI, GAD-7, and PHQ-4), although MIDAS scores differed (median [interquartile range (IQR)]; 38 [20–58] vs. 55 [30–90], p < 0.001). Patients in Group 1 had significantly lower MIDAS (median [IQR];16 [7–30], p < 0.001), WPAI-% total active impairment (mean (SD): Group 1 [30.9 (26.8)] vs. Group 2 [39.2 (24.5), p = 0.017], vs. Group 3 [45.9 (24.1), p < 0.001], vs. Group 4 [55.3 (23.0), p < 0.001], and PROMIS-PI-T score (Group 1 [60.3 (7.3)] vs. Group 2 [62.6 (6.4), p = 0.008], vs. Group 3 [64.6 (5.6), p < 0.001], vs. Group 4 [66.8 (5.9), p < 0.001]) compared to all other groups. Patients in Group 4 had significantly higher MIDAS (median (IQR): Group 4 [90 (52–138)] vs. Group 1 [16 (7–30), p < 0.001], vs. Group 2 [38 (20–58), p < 0.001], vs. Group 3 [55 (30–90), p < 0.001], WPAI-%Presenteeism (Group 4 [50.4 (24.4)] vs. Group 1 [28.8 (24.9), p < 0.001], vs. Group 2 [34.9 (22.3), p < 0.001], vs. Group 3 [40.9 (22.3), p = 0.048], WPAI-% total work productivity impairment (Group 4 [55.9 (26.1)] vs. Group 1 [32.1 (37.6), p < 0.001], vs. Group 2 [38.3 (24.0), p < 0.001], vs. Group 3 [44.6 (24.4), p = 0.019]), and WPAI-%Total activity impairment (Group 4 [55.3 (23.0)] vs. Group 1 [30.9 (26.8), p < 0.001], vs. Group 2 [39.2 (24.5), p < 0.001], vs. Group 3 [45.9 (24.1), p = 0.025]) scores compared with all other groups. Conclusion: Our data suggest that the use of a 15 headache day/month threshold to distinguish episodic and chronic migraine does not capture the burden of illness nor reflect the treatment needs of patients. These results have important implications for future refinements in the classification of migraine.
KW - chronic migraine
KW - diagnostic criteria
KW - disability
KW - headache frequency
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U2 - 10.1111/head.14154
DO - 10.1111/head.14154
M3 - Article
C2 - 34081791
AN - SCOPUS:85107214949
SN - 0017-8748
VL - 61
SP - 992
EP - 1003
JO - Headache
JF - Headache
IS - 7
ER -