Background: A comprehensive understanding of the burden of migraine in Canada is needed to inform clinicians, clinical care and policymakers. This study assessed real-world healthcare resource utilization (HCRU) and costs of patients with episodic migraine (EM) and chronic migraine (CM) in Ontario, Canada.Methods: This study utilized administrative databases from the Institute for Clinical Evaluative Sciences (ICES) containing publicly funded health services records for the covered population of Ontario. Patients >= 26 years old with a migraine diagnosis between January 2013 and December 2017 were selected. EM and CM were inferred in eligible patients based on previously studied predictors. Cases were matched with non-migraine controls and followed for two years.Results: 452,431 patients with migraine, 117,655 patients inferred with EM and 24,763 patients inferred with CM were selected and matched to controls. 39.4% of the inferred EM and 69.3% of the inferred CM subpopulations had >= 1 claims of preventive medications. Migraine-specific acute medications were underutilized (EM: 1.0%, CM: 3.3%), and high proportions of patients utilized opioids (EM: 38.8%, CM: 64.9%). Mean all-cause two-year costs per patient for the overall migraine population and inferred EM and CM subpopulations were $7,486 (CAD), $11,908 (CAD) and $24,716 (CAD), respectively. The two-year incremental all-cause cost of migraine to the Ontario public payer was $1.1 billion (CAD).Conclusion: Migraine poses a significant unmet need and burden on the Canadian healthcare system. These results demonstrate a gap between real-world care and recommendations from treatment guidelines, emphasizing the need for improved awareness and expanded access to more effective treatment options. Utilisation et co & ucirc;ts des soins de sant & eacute; en contexte r & eacute;el chez des patients migraineux en Ontario (Canada).Contexte : Une compr & eacute;hension approfondie du fardeau que repr & eacute;sente la migraine au Canada est n & eacute;cessaire pour mieux informer les cliniciens, les soins cliniques et les d & eacute;cideurs. Cette & eacute;tude a donc cherch & eacute; & agrave; & eacute;valuer l'utilisation en Ontario (Canada) des ressources et les co & ucirc;ts des soins de sant & eacute; en contexte r & eacute;el chez des patients souffrant de migraine & eacute;pisodique (ME) et de migraine chronique (MC).M & eacute;thodes : Cette & eacute;tude a utilis & eacute; les bases de donn & eacute;es administratives de l'Institute for Clinical Evaluative Sciences (ICES) contenant les dossiers relatifs & agrave; des services de sant & eacute; financ & eacute;s par la province de l'Ontario pour une population admissible & agrave; une couverture. Des patients & acirc;g & eacute;s de 26 ans ou plus, chez qui on avait diagnostiqu & eacute; une migraine entre janvier 2013 et d & eacute;cembre 2017, ont & eacute;t & eacute; s & eacute;lectionn & eacute;s. Des cas de ME et de MC ont & eacute;t & eacute; d & eacute;duits chez des patients admissibles sur la base de pr & eacute;dicteurs pr & eacute;c & eacute;demment & eacute;tudi & eacute;s. Ces cas ont & eacute;t & eacute; ensuite appari & eacute;s avec des t & eacute;moins non migraineux et suivis pendant deux ans.R & eacute;sultats : Au total, 452 431 patients migraineux, dont 117 655 patients pr & eacute;sum & eacute;s atteints de ME et 24 763 patients pr & eacute;sum & eacute;s atteints de MC, ont & eacute;t & eacute; s & eacute;lectionn & eacute;s et appari & eacute;s & agrave; des t & eacute;moins. & Agrave; noter que 39,4 % des patients chez qui on avait inf & eacute;r & eacute; la ME et 69,3 % de ceux chez qui on avait inf & eacute;r & eacute; la MC avaient fait une demande ou plus de m & eacute;dicaments pr & eacute;ventifs. Les m & eacute;dicaments aigus sp & eacute;cifiques & agrave; la migraine sont demeur & eacute;s sous-utilis & eacute;s (ME : 1,0 % ; MC : 3,3 %) tandis qu'une forte proportion de patients utilisaient des opio & iuml;des (ME : 38,8 % ; MC : 64,9 %). Toutes causes confondues, les co & ucirc;ts moyens par patient sur deux ans, et ce, pour l'ensemble de la population migraineuse et les sous-populations de patients pr & eacute;sum & eacute;s souffrir de ME et de MC, & eacute;taient respectivement de 7 486 $ (CAD), 11 908 $ (CAD) et 24 716 $ (CAD). Les co & ucirc;ts suppl & eacute;mentaires repr & eacute;sent & eacute;s par la migraine en Ontario, toutes causes confondues et sur deux ans, & eacute;tait de 1,1 milliard de dollars canadiens.Conclusion : En somme, la migraine repr & eacute;sente un important besoin non satisfait et un lourd fardeau pour le syst & egrave;me de sant & eacute; canadien. Ces r & eacute;sultats d & eacute;montrent aussi un & eacute;cart entre les soins prodigu & eacute;s en contexte r & eacute;el et les recommandations inclues dans les directives th & eacute;rapeutiques, ce qui met en & eacute;vidence la n & eacute;cessit & eacute; d'une meilleure sensibilisation et d'un acc & egrave;s & eacute;largi & agrave; des options de traitement plus efficaces.

ABSTRACT: Background: PREDICT was a Canadian, multicenter, prospective, observational study in adults naïve to onabotulinumtoxinA treatment for chronic migraine (CM). We descriptively assess health resource utilization, work productivity, and acute medication use. Methods: OnabotulinumtoxinA (155–195 U) was administered every 12 weeks over 2 years (≤7 treatment cycles). Participants completed a 4-item health resource utilization questionnaire and 6-item Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0. Acute medication use was recorded in daily headache diaries. Treatment-emergent adverse events were recorded throughout the study. Results: A total of 197 participants were enrolled, and 184 received ≥1 treatment with onabotulinumtoxinA and were included in the analysis. Between baseline and the final visit, there were decreases in the percentage of participants who reported headache-related healthcare professional visit(s) (96.2% to 76.8%) and those who received headache-related diagnostic testing (37.5% to 9.9%). Reductions from baseline were also observed in the mean number of headache-related visits to an emergency room/urgent care clinic (2.5 to 1.4) and median headache-related hospital admissions (4.0 to 1.0). OnabotulinumtoxinA improved work productivity and reduced the mean (standard deviation) number of hours missed from work over a 7-day period (6.1 [9.7] to 3.0 [6.8]). Mean (standard deviation) acute medication use decreased from baseline (15.2 [7.6] to 9.1 [6.5] days). No new safety signals were identified. Conclusions: Real-world evidence from PREDICT demonstrates that onabotulinumtoxinA treatment for CM in the Canadian population reduces health resource utilization and acute medication use and improves workplace productivity, supporting the long-term benefits of using onabotulinumtoxinA for CM.

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Objective: Evaluate the safety of atogepant in PROGRESS trial participants with chronic migraine (CM) and cardiovascular risk factors (CV-RFs). Background: Migraine is associated with cardiovascular disease (CVD) and CV-RFs. Design/Methods: A 12-week, international, randomized, double-blind, placebo-controlled phase 3 trial (PROGRESS; NCT03855137) enrolled participants (18–80 years) with ≥1-year CM (≥15 monthly headache days [MHDs] for 3 months before screening; ≥15 headache days [≥8 migraine days] during the 4-week screening period). Participants treated with atogepant 30mg twice-daily, 60mg daily, or placebo were stratified by 0, 1, or ≥2 baseline CV-RFs. CV-RFs included age (men: ≥45; women: ≥55), smoking, body mass index (BMI) ≥25kg/m2, hypertension, diabetes, dyslipidemia, sleep apnea, concomitant CVD or diabetes medicines, and history of stroke, myocardial infarction, transient ischemic attack, or peripheral arterial disease. CV treatment-emergent adverse events (TEAEs) were assessed. Results: Of 773 participants, 518 (1 missing data) comprised the pooled atogepant group (0 CV-RFs: 110[21.2%]; 1 CV-RF: 146[28.2%]; ≥2 CV-RFs: 261[50.4%]) and 255 comprised the placebo group (0 CV-RFs: 47[18.4%]; 1 CV-RF: 92[36.1%]; ≥2 CV-RFs: 116[45.5%]). Among all participants, the majority had ≥2 CV-RFs compared to 0 or 1 CV-RFs. At baseline, participants with ≥2 CV-RFs had higher mean age, BMI, and MHDs versus those with 0 or 1 CV-RFs. Most common CV-RFs were dyslipidemia (47.6%), BMI ≥25kg/m2 (43.1%), and hypertension (40.9%). CV-TEAEs occurred at low frequencies among participants with ≥2 CV-RFs (placebo: 3/116[2.6%]; pooled atogepant: 9/261[3.4%]), and none were serious. Treatment-related CV-TEAEs included palpitations (n=2) and increased blood pressure (n=1) in the pooled atogepant group (all 30mg twice-daily) and flushing (n=1) in the placebo group. Palpitations led to 1 discontinuation (assessed as not treatment-related) in the pooled atogepant group. Conclusions: This post hoc analysis demonstrates that CV-TEAEs occurred at low frequencies among atogepant-treated participants with CM and CV-RFs. All CV-TEAEs were nonserious, most were not treatment-related, and only 1 led to discontinuation. Disclosure: An immediate family member of Dr. Best has stock in Sorrento Therapeutics. The institution of an immediate family member of Dr. Best has received research support from Sorrento Therapeutics. The institution of an immediate family member of Dr. Best has received research support from Bristol Myers. An immediate family member of Dr. Best has received intellectual property interests from a discovery or technology relating to health care. Dr. Harriott has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for Headache Cooperative of New England. The institution of Dr. Harriott has received research support from Electrocore. Dr. Harriott has a non-compensated relationship as a Author agreement with Abbvie that is relevant to AAN interests or activities. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel . Dr. Monteith has received personal compensation in the range of $0-$499 for serving as a Consultant for Abbvie. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LinPharma. Dr. Monteith has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HMP Global . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for American Headache Society . Dr. Monteith has received personal compensation in the range of $0-$499 for serving as a Consultant for American Academy of Neurology . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alder. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alder. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN . The institution of Dr. Monteith has received research support from AbbVie. The institution of Dr. Monteith has received research support from Amgen. The institution of Dr. Monteith has received research support from Teva. The institution of Dr. Monteith has received research support from Electrocore. The institution of Dr. Monteith has received research support from Novartis . The institution of Dr. Monteith has received research support from Amgen. The institution of Dr. Monteith has received research support from lilly. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Education with Medscape. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Education with Massachusetts Medical Society . Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Education with Academic CME. Dr. Monteith has received personal compensation in the range of $10,000-$49,999 for serving as a Education with Rockpointe. Dr. Monteith has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Neuodiem. Dr. Monteith has a non-compensated relationship as a President Elect with Florida Society of Neurology that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Editorial Board with American Migraine Foundation that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a Board Member with International Headache Society that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Pfizer that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Abbvie that is relevant to AAN interests or activities. Dr. Monteith has a non-compensated relationship as a author with Theranica that is relevant to AAN interests or activities. Cristina Tassorelli has nothing to disclose. Dr. Nahas has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for AbbVie. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BioDelivery Sciences. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axsome. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Learning Network. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Springer. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Jackson & Campbell. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a expert/talent for CME event with Medscape/WebMD. Dr. Liu has nothing to disclose. Dr. Dabruzzo has received personal compensation for serving as an employee of AbbVie. Dr. Dabruzzo has stock in AbbVie. Dr. De Abreu Ferreira has received personal compensation for serving as an employee of AbbVie. Dr. De Abreu Ferreira has stock in AbbVie. Dr. Smith has received personal compensation for serving as an employee of AbbVie. Dr. Smith has stock in AbbVie. Dr. Smith has received publishing royalties from a publication relating to health care.

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ABSTRACT: Introduction: Symptoms of cervical dystonia (CD) can vary in severity and cause significant pain. OnabotulinumtoxinA is an approved treatment for CD. This study assessed health-related quality of life (HRQoL) in patients with CD who received multiple onabotulinumtoxinA treatments. Methods: This prospective, observational standard-of-care study was conducted at multiple neurology centers in Québec, Canada. Patients reported the health impact of CD using the Cervical Dystonia Impact Profile (CDIP)-58, before and after up to eight onabotulinumtoxinA treatments. Other measures included the Cervical Dystonia Severity Rating Scale by physician, employment status using the Work Productivity Questionnaire and pain using the Pain Numeric Rating Scale (PNRS). Adverse events (AEs) were recorded. Results: Sixty-two patients were enrolled (safety population, n = 61; modified efficacy population, n = 58). Participants were mostly females who were employed; most (79.3%) had torticollis. In all, 21/62 patients (33.9%) discontinued the study. At the final visit, there was a statistically significant (p < 0.001) improvement in all eight CDIP-58 subscales, particularly head and neck symptoms (−31.0) and psychosocial functioning (−28.2). Employment increased from baseline (55%) to the end of the study (64%), and there was improvement in work productivity. There was a significant (p < 0.0001) reduction in pain measured by the PNRS, from −0.5 post-treatment 1 to −2.4 at end of study. AEs (neck pain, muscular weakness, dysphagia, nausea) were consistent with onabotulinumtoxinA use. Conclusion: These real-world data indicate that after repeated, long-term use, onabotulinumtoxinA continues to be a safe and effective treatment for CD, improving HRQoL and work productivity.

Objective: PREDICT aimed to assess real-world long-term health-related quality of life (HRQOL) in Canadian patients with chronic migraine (CM) treated with onabotulinumtoxinA. Background: CM can adversely affect HRQOL and daily functioning, resulting in social and economic burden. Design/Methods: Canadian, multicentre, prospective, observational study (NCT02502123) in adults naive to botulinum toxin(s) for CM. OnabotulinumtoxinA was administered ≤7 treatment cycles per the Canadian product monograph. Primary endpoint: mean change in Migraine-Specific Quality of Life (MSQ) at Tx4 vs. baseline. Secondary endpoints: mean change in MSQ at final visit vs. baseline, onabotulinumtoxinA treatment utilization (each session), headache days (daily headache diary), and physician (baseline, Tx4, and final visit)/patient (each session) satisfaction. Unless noted, data presented as mean(SD). Results: 184 participants (average 45 years, predominantly female [84.8%] and Caucasian [94.6%]) received ≥1 treatment with onabotulinumtoxinA. Mean dose of onabotulinumtoxinA per treatment cycle was 171(18) U; treatment interval 13.2(1.8) weeks. At baseline, patients reported 20.9(6.7) headache days/month, which decreased over time (range: −3.5[6.3] at Tx1 to −6.3[7.3] at Tx7; all timepoints versus baseline, p Conclusions: Real-world data from PREDICT demonstrate that onabotulinumtoxinA treatment for CM reduced headache days and improved HRQOL, with high physician and patient satisfaction. These results add to the body of evidence on the safety and effectiveness of onabotulinumtoxinA for CM. Disclosure: Dr. Boudreau has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis, Allergan, Teva, Lilly. Dr. Boudreau has received research support from Lilly.Dr. Finkelstein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Novartis, Teva, Lilly, Aralez, Nuvo. Dr. Graboski has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Aralez, Amgen/Novartis, and Lilly. Dr. Graboski has received research support from Allergan and Amgen/Novartis. Dr. Ong-Lam has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Cannimed and Spectrum Canada. Dr. Christie has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Eli Lilly, Novartis, Allergan, Teva. Dr. Christie has received research support from Novartis. Dr. Sommer has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Allergan. Dr. Sommer holds stock and/or stock options in Katherine Sommer, MRes, PhD, is an employee of Allergan plc and receives stock or stock options. which sponsored research in which Dr. Sommer was involved as an investigator. Dr. Sommer holds stock and/or stock options in Employee of Allergan and receives stock options. Dr. Bhogal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Allergan. Dr. Davidovic has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan. Dr. Becker has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Novartis, Weber and Weber.

April 26, 2018April 10, 2018Free AccessCervical Dystonia Patients Treated with OnabotulinumtoxinA Report Improvements in Health-Related Quality of Life in a Multicentre, Prospective, Observational Study: POSTURe (P5.052)Marc Petitclerc, Martin Cloutier, Meetu Bhogal, and Goran DavidovicAuthors Info & AffiliationsApril 10, 2018 issue90 (15_supplement) Letters to the Editor