Patient-Identified Most Bothersome Symptom in Patients With Chronic Migraine: An Analysis of PROMISE-2

Objective: To assess patient-identified most bothersome symptoms (MBS) in patients with chronic migraine (CM) enrolled in the PROMISE-2 trial. Background: In addition to headache, persons with migraine experience a variety of autonomic, cognitive, and sensory symptoms. Allowing the patient to self-identify an MBS without limitation can provide a unique patient-centered approach for identifying and measuring migraine-associated symptoms that matter most to an individual patient. Design/Methods: PROMISE-2 (NCT02974153) was a double-blind, randomized, placebo-controlled trial evaluating eptinezumab for the preventive treatment of CM. At screening, patients verbally described the MBS associated with their migraines, which was then categorized into a predefined list of 8 symptoms or an “Other, Specify” option with free-text description by the investigator. Symptoms categorized as “other” were recoded to the predefined list or to new symptom classes. Baseline MBS was pooled across the 3 treatment arms (N=1072). Results: 59% of patients chose a MBS option from the predefined list, while 41% specified their own option. Combining the predefined and recoded “other” options, MBS included light sensitivity (18.7%), nausea/vomiting (together or separately, 15.1%), pain with activity (13.7%), sound sensitivity (7.3%), cognitive disruption (4.1%), fatigue (2.4%), and mood changes (1.5%). Additional items from the “other” list included pain (12.4%) and headache (11.2%), as well as throbbing/pulsation (4.7%), multiple symptoms (2.5%), smell sensitivity (0.9%), vision impact (0.7%), aura (0.7%), and pressure/tightness (0.7%), among others. Conclusions: These results demonstrate that migraine is associated with numerous symptoms that may be most bothersome to patients, beyond the ICHD-3 defining symptoms. Approximately 25% of the MBS identified in PROMISE-2 are not included in the ICHD-3 diagnostic classification for migraine. Future efforts should endeavor to capture a broader range of MBS in people with migraine in order to enhance doctor-patient communication and individualize treatment goals. Disclosure: Dr. Lipton has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Teva Pharmaceuticals. Dr. Lipton has received compensation for serving on the Board of Directors of eNeura and Biohaven. Dr. Lipton holds stock and/or stock options in Biohaven which sponsored research in which Dr. Lipton was involved as an investigator. Dr. Lipton holds stock and/or stock options in Biohaven. Dr. Lipton has received research support from Migraine Research Foundation the National Headache Foundation and Amgen.David W. Dodick, MD, reports the following conflicts: Personal fees: AEON, Alder BioPharmaceuticals, Allergan, Amgen, Amzak Health, Association of Translational Medicine, Autonomic Technologies, Axsome, Biohaven, Charleston Laboratories, Clexio, Daniel Edelman Inc., Dr Reddy’s Laboratories/Promius, electroCore LLC, Eli Lilly, eNeura, Equinox, Foresite Capital, Impel, Ipsen, Neurolief, Nocira, Novartis, Oppenheimer, Pieris, PSL Group Services, Revance, Salvia, Satsuma, Sun Pharma (India), Supernus, Teva, Theranica, University Health Network, Upjohn (Division of Pfizer), Vedanta, WL Gore, XoC, Zosano, and ZP Opco; Speaking fees: Amgen, Eli Lilly, Lundbeck, and Novartis Canada; CME fees or royalty payments: Academy for Continued Healthcare Learning, Cambridge University Press, Catamount, Chameleon, Global Access Meetings, Global Life Sciences, Global Scientific Communications, Haymarket, HealthLogix, Medicom Worldwide, MedLogix Communications, Mednet, Miller Medical, Oxford University Press, PeerView, Universal Meeting Management, UpToDate (Elsevier), WebMD Health/Medscape, and Wolters Kluwer Health; Consulting without fee: Aural Analytics, Epien, Healint, Second Opinion/Mobile Health; Professional society fees or reimbursement for travel: American Academy of Neurology, American Brain Foundation, American Headache Society, American Migraine Foundation, Canadian Headache Society, and International Headache Society. Dr. Dodick has received compensation for serving on the Board of Directors of Epien, King-Devick Technologies, Matterhorn, Ontologics, and Precon Health. Dr. Dodick has received research support from American Migraine Foundation, Henry Jackson Foundation, PCORI, and US Department of Defense.Dr. Ailani has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen, Allergan, Eli Lilly and Company, Biohaven, Lundbeck, Theranica, Impel, Satsuma, Zosano, Revance,and Teva. Dr. Ailani has received personal compensation in an editorial capacity for Current Pain and Headache. Dr. Ailani has received research support from Allergan, Biohaven, Zosano, Eli Likky and Company.Dr. Winner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Amgen, Supernus, Teva, Novartis, Avanir, and Promius..Dr. Hindiyeh has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly, Zosano, and Alder.Dr. Hirman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder BioPharmaceuticals, Inc. Dr. Snapinn has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder Biopharmaceuticals. Dr. Mehta has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Full time employee of Alder Biopharmaceuticals.. Dr. Cady has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Full time employee at Alder BioPharmaceuticals Inc..