To compare the baseline characteristics of the Headache Assessment via a Digital platform in United States (HeAD-US) and the American Migraine Prevalence and Prevention (AMPP) studies.

IntroductionAlthough acute and preventive treatments for migraine are commonly given in combination, data on the real-world effectiveness of ubrogepant as an acute treatment when used with an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (with or without onabotulinumtoxinA) are limited. This analysis sought to evaluate the real-world effectiveness, treatment satisfaction, and optimization of ubrogepant for the acute treatment of migraine when used in combination with an anti-CGRP monoclonal antibody, with or without concomitant onabotulinumtoxinA.MethodsThis prospective, multiple-attack, open-label, observational study (COURAGE) assessed meaningful pain relief (MPR), return to normal function (RNF), treatment satisfaction, and acute treatment optimization of ubrogepant (50 or 100 mg) when combined with an anti-CGRP monoclonal antibody, onabotulinumtoxinA, or both in adult users of Migraine Buddy, a migraine tracking application.ResultsIn the ubrogepant and anti-CGRP monoclonal antibody arm (n = 245), following the first ubrogepant-treated attack, 61.6% (151/245) and 80.4% (197/245) of ubrogepant-treated participants achieved MPR at 2 and 4 h post-dose, respectively, and 34.7% (85/245) and 55.5% (136/245) achieved RNF at 2 and 4 h post-dose, respectively. Across up to 10 ubrogepant-treated attacks (N = 1153), MPR was achieved in 51.3% (592/1153) and 73.5% (847/1153) at 2 and 4 h post-dose, respectively. RNF was achieved by 32.2% (371/1153) and 53.2% (613/1153) at 2 and 4 h post-dose. After 30 days, 72.7% (168/231) of participants reported satisfaction (using a 7-point scale) with ubrogepant when used in combination with an anti-CGRP monoclonal antibody, and 79.7% (184/231) of participants achieved acute treatment optimization (defined as moderate-maximum treatment efficacy using the Migraine Treatment Optimization Questionnaire-4).ConclusionReal-world ubrogepant use with an anti-CGRP monoclonal antibody was associated with MPR, RNF, satisfaction, and acute treatment optimization.

Background and ObjectivesMany acute treatment options exist for migraine. However, large-scale, head-to-head comparisons of treatment effectiveness from real-world patient experience reports are lacking.MethodsThis is a retrospective analysis of 10,842,795 migraine attack records extracted from an e-diary smartphone application between June 30, 2014, and July 2, 2020. We analyzed 25 acute medications among 7 classes-acetaminophen, nonsteroid anti-inflammatory drugs (NSAIDs), triptans, combination analgesics, ergots, antiemetics, and opioids. Gepants and ditan were not included in this analysis. Different doses and formulations of each medication, according to the generic names, were combined in this analysis. We used a 2-level nested logistic regression model to analyze the odds ratio (OR) of treatment effectiveness of each medication by adjusting concurrent medications and the covariance within the same user. Subgroup analyses were conducted for users in the United States, the United Kingdom, and Canada.ResultsOur final analysis included 4,777,524 medication-outcome pairs from 3,119,517 migraine attacks among 278,006 users. Triptans (mean OR 4.8), ergots (mean OR 3.02), and antiemetics (mean OR 2.67) were the top 3 classes of medications with the highest effectiveness, followed by opioids (mean OR 2.49), NSAIDs (other than ibuprofen, mean OR 1.94), combination analgesics (acetaminophen/acetylsalicylic acid/caffeine) (OR 1.69, 95% CI 1.67-1.71), others (OR 1.49, 95% CI 1.47-1.50), and acetaminophen (OR 0.83, 95% CI 0.83-0.84), using ibuprofen as the reference. Individual medications with the highest ORs were eletriptan (OR 6.1, 95% CI 6.0-6.3), zolmitriptan (OR 5.7, 95% CI 5.6-5.8), and sumatriptan (OR 5.2, 95% CI 5.2-5.3). The ORs of acetaminophen, NSAIDS, combination analgesics, and opioids were mostly around or less than 1, suggesting similar or lower reported effectiveness compared with ibuprofen. The ORs for 24 medications, except that of acetylsalicylic acid, achieved statistical significance with p < 0.0001, and our nested logistic regression model achieved an area under the curve (AUC) of 0.849. Country-specific subgroup analyses revealed similar ORs of each medication and AUC (United States 0.849, United Kingdom 0.864, and Canada 0.842), demonstrating the robustness of our analysis.DiscussionUsing a big data approach, we analyzed patient-generated real-time records of 10 million migraine attacks and conducted simultaneous head-to-head comparisons of 25 acute migraine medications. Our findings that triptans, ergots, and antiemetics are the most effective classes of medications align with the guideline recommendations and offer generalizable insights to complement clinical practice.Classification of EvidenceThis study provides Class IV evidence that for patients with migraine, selected acute medications (e.g., triptans, ergots, antiemetics) are associated with higher odds of user-rated positive response than ibuprofen.

Objective: To simultaneously compare patient-reported treatment effectiveness of 25 acute migraine medications using a big-data approach. Background: Many acute treatment options exist for migraine. However, large-scale, head-to-head comparisons of treatment effectiveness from real-world patient experience reports are lacking. Design/Methods: This is a cross-sectional analysis of 10,842,795 migraine attack records extracted from an e-diary smartphone application between June 30, 2014, and July 2, 2020. We analyzed 25 acute medications among seven classes-acetaminophen, NSAIDs, triptans, combination analgesics, ergots, anti-emetics, and opioids. Gepants and ditan were not included due to relatively lower numbers of usage when data was extracted. We employed a two-level nested logistic regression model to analyze the odds ratio(OR) of treatment effectiveness of each medication by adjusting concurrent medications and the covariance within the same user. Subgroup analyses were conducted for users in the United States(US), the United Kingdom(UK), and Canada(CA). Results: Our final analysis included 4,777,524 medication-outcome pairs from 3,119,517 migraine attacks among 278,006 users. Triptans(mean OR 4.8), ergots(mean OR 3.02), and anti-emetics(mean OR 2.67) were the top three classes of medications with the highest effectiveness, followed by opioids(mean OR 2.49), NSAIDs(mean OR 1.94), acetaminophen/acetylsalicylic acid/caffeine(OR 1.69), others(OR 1.49), and acetaminophen(OR 0.83), using ibuprofen as the reference. Individual medications with the highest ORs were eletriptan(OR 6.1), zolmitriptan(OR 5.7), and sumatriptan(OR 5.2). The ORs for 24 medications, except that of acetylsalicylic acid, achieved statistical significance, and our nested logistic regression model achieved an AUC of 0.849. Country-specific subgroup analyses revealed similar ORs of each medication and AUCs(US 0.849, UK 0.864, and CA 0.842). Conclusions: We analyzed patient-generated real-time records of 10 million migraine attacks and conducted simultaneous head-to-head comparisons of 25 acute migraine medications. Our findings that triptans, ergots and anti-emetics are the most effective classes of medications align with the guideline recommendations and offer generalizable insights to complement clinical practice. Disclosure: Dr. Chiang has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Satsuma Pharmaceutical. Dr. Fang has nothing to disclose. Mr. Horvath has nothing to disclose. Mr. Cadiou has received personal compensation for serving as an employee of Healint. Dr. Urani has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Healint. Dr. Poh has received personal compensation for serving as an employee of Healint. Dr. Poh has received stock or an ownership interest from PathoVax, LLC. Prof. NARIMATSU has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol-Myers Squibb Company. Prof. NARIMATSU has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Chugai Pharma. Prof. NARIMATSU has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Horizon Therapeutics. The institution of Dr. Cheng has received research support from NSF. The institution of Dr. Cheng has received research support from NIH. 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 $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. 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.

To evaluate real-world treatment satisfaction and acute treatment optimization in participants using ubrogepant in combination with an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) preventive.

To examine real-world effectiveness of ubrogepant for the acute treatment of migraine in patients who switched to ubrogepant due to the lack of efficacy of their prior acute treatment.

Background The nature of COVID-19 pandemic measures has altered the clinical management of migraine, and has also created barriers to evaluate the impact of such measures of migraine patients. Using the Migraine Buddy smartphone application, we assessed the impact of the COVID-19 pandemic on migraine in users residing in the United States. Methods Migraine Buddy is a smartphone application by individuals to record their migraine headache episodes, characteristics, and coping mechanisms. For this study, anonymized self-reported data from 163,176 adult Migraine Buddy users in the United States between January 2020 and May 2020, were analyzed for migraines associated with stress. A stress-related migraine is defined as one in which stress or anxiety was reported as a trigger or symptom. A questionnaire on the impact of COVID-19 on migraine and its management was also completed by 923 users from the United States in the app between April 2020 and May 2020. Results 88% of the Migraine Buddy database extract and 84% of the respondents are female, with a mean age of 36.2 years. The proportion of stress-related migraine attacks peaked at 53% on March 21 to 23, although the number of migraine attacks decreased. This followed the declaration of the COVID-19 national emergency on March 13 and a spike in the number of COVID-19 cases in the United States. Questionnaire respondents felt that the following added more stress: social isolation (22.6%), information overdose (21.2%), access to essentials (food, medication, etc.) (18.7%), and financial concerns (17.8%). To help manage migraine during COVID-19, respondents suggested stress and diet coaching programs and resources (medical articles, etc.) (34.0%), having the option for home delivery of medication (30.6%) and tele-consulting (25.5%). Conclusion Here, we report the change in the proportion of self-reported stress-related migraine in relation to evolution of the COVID-19 pandemic, as well as its impact of migraine management. Our data will help increase the understanding of patients’ needs and help with planning and execution of mitigating strategies.

Background : The nature of COVID-19 pandemic measures has altered the clinical management of migraine, and has also created barriers to evaluate the impact of such measures of migraine patients. Using the Migraine Buddy smartphone application, we assessed the impact of the COVID-19 pandemic on migraine in users residing in the United States. Methods : Migraine Buddy is a smartphone application by individuals to record their migraine headache episodes, characteristics, and coping mechanisms. For this study, anonymized self-reported data from 163,176 adult Migraine Buddy users in the United States between January 2020 and May 2020, were analyzed for migraines associated with stress. A stress-related migraine is defined as one in which stress or anxiety was reported as a trigger or symptom. A questionnaire on the impact of COVID-19 on migraine and its management was also completed by 1,322 users in the app between April 2020 and May 2020. Results : 88% of the Migraine Buddy database extract and 83% of the respondents are female, with a mean age of 36.2 years. The proportion of stress-related migraine attacks peaked at 50% on March 17, although the number of migraine attacks decreased. This followed the declaration of the COVID-19 national emergency on March 13 and a spike in the number of COVID-19 cases in the United States. Questionnaire respondents felt that the following added more stress: social isolation (22.6%), information overdose (21.2%), access to essentials (food, medication, etc.) (18.7%), and financial concerns (17.8%). To help manage migraine during COVID-19, respondents suggested stress and diet coaching programs and resources (medical articles, etc.) (34.0%), having the option for home delivery of medication (30.6%) and tele-consulting (25.5%). Conclusion : Here, we report the change in the proportion of self-reported stress-related migraine in relation to evolution of the COVID-19 pandemic, as well as its impact of migraine management. Our data will help increase the understanding of patients' needs and help with planning and execution of mitigating strategies.

ObjectiveTo assess the real-world effectiveness of ubrogepant by evaluating self-reported satisfaction with pain relief, ability to think clearly, and return to normal function in individuals who had used ubrogepant to treat a migraine episode within the preceding 14 days.BackgroundUbrogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the acute treatment of migraine in adults. Few studies have evaluated the real-world effectiveness of ubrogepant.MethodsThe UNIVERSE study was an observational, cross-sectional survey conducted between February 2021 and April 2021 in US adult Migraine Buddy application (app) users currently treated with ubrogepant. Individuals who were 18 years of age or older and reported at least one dose of ubrogepant in the previous 14 days completed a 30-question survey in the app. The survey assessed respondent demographics, migraine history, acute treatment patterns, and treatment satisfaction with ubrogepant. Respondents also reported prior acute medication use and reasons for switching to ubrogepant.ResultsOf the 1303 ubrogepant users contacted, 302 (23.2%; 50 mg, 120 participants; 100 mg, 182 participants) were included in this study. The mean (standard deviation) age was 41.9 (11.2) years, and 90.1% (272/302) were female. Satisfaction with migraine relief at 2, 4, and 24 h post-dose was reported by 75.8% (229/302), 83.4% (252/302), and 78.5% (237/302) of participants, respectively. Satisfaction with the ability to think clearly after taking ubrogepant was reported by 85.1% (257/302) of participants, and 83.8% (253/302) were satisfied with their ability to return to normal function. Furthermore, 90.7% (274/302) of participants reported that they were likely to continue using ubrogepant to treat their migraine. Most participants (n = 264 [87%]) reported switching to ubrogepant due to inadequate treatment response with their previous treatment. In this subgroup, comparable outcomes were observed with respect to satisfaction with migraine relief, ability to think clearly, and return to normal function.ConclusionsUbrogepant demonstrated real-world effectiveness in the acute treatment of migraine, as evidenced by high levels of treatment satisfaction and a strong indication of their intent to continue using the medication. Ubrogepant is approved for the acute treatment of migraine in adults. In this study, adults who had used ubrogepant to treat a migraine attack in the previous 14 days responded to survey questions regarding their satisfaction with pain relief, ability to think clearly, and return to normal function. Results indicated that the majority of participants experienced high levels of satisfaction with ubrogepant because most of them said that these areas of their life improved after treatment.

Migraine is a neurological disease characterized by recurring attacks that can cause severe disabling pain. This study described the burden of migraine as reported by individuals with migraine in the real world using a mobile application.

In this paper, we describe how we used a smartphone app to collect migraine data. The users log their migraine details in the app with the purpose of discovering their migraine triggers. We analyze details of over half a million migraines and we report some novel findings that traditional studies missed because of their rigid clinical setting. We report the most common triggers, symptoms, relief methods, onset locations and drug combination outcomes.