A population-based survey of Americans with frequent migraine and acute medication use: A plain language summary.

WHAT IS THIS SUMMARY ABOUT?: The Harris Poll Migraine Report Card was a survey about people's experiences and challenges with headaches and migraine. The survey was conducted from December 9, 2021, to January 10, 2022, in the United States. The people who took the survey had frequent headaches/migraine attacks (on 8 or more days per month) and used acute headache/migraine medication to relieve head pain and other symptoms (on 10 or more days per month). This summary focuses on the responses of adults with frequent headaches and frequent acute medication use at the time of the survey or within the few months (not specified) before the survey (and not those who previously had frequent headaches and frequent acute medication use at some point in their life prior to the survey). The group of people who took the survey will be called 'respondents'. The term 'headaches' can mean any type of headache including as part of a migraine attack, a tension type headache, or another unknown headache type. All respondents screened positive for having migraine, so many of the headaches they reported on may have been a migraine headache or part of a migraine attack. WHAT WERE THE RESULTS?: Over 50% of respondents said their headaches affected their overall quality of life. Many respondents wished their healthcare provider who was managing their headaches understood more about how headaches affect their mental well-being, how much pain their headaches cause, and why they get headaches. 80% of respondents had concerns about their overall health. Over 60% of respondents said they have experienced anxiety and/or depression. In this survey, although all respondents were eligible to receive a preventive headache/migraine medication because of their headache frequency, only 15% were taking one. WHAT DO THE RESULTS OF THE SURVEY MEAN?: The findings from this survey showed many ways that headaches/migraine care can improve, including talking about mental and emotional well-being, making sure the treatment plan works and does not have side effects that cannot be tolerated, and trying to prevent headaches/migraine from occurring.

Medication "underuse" headache.

BACKGROUND: Many risk factors have been associated with migraine progression, including insufficient and ineffective utilization of migraine medications; however, they have been inadequately explored. This has resulted in suboptimal usage of medications without effective altering of prescribing recommendations for patients, posing a risk for migraine chronification. METHODS: Our aim is to conduct a comprehensive review of the available evidence regarding the underuse of migraine medications, both acute and preventive. The term "underuse" includes, but is not limited to: (1) ineffective use of appropriate and inappropriate medication; (2) underutilization; (3) inappropriate timing of usage; and (4) patient dissatisfaction with medication. RESULTS: The underuse of both acute and preventive medications has been shown to contribute to the progression of migraine. In terms of acute medication, chronification occurs as a result of insufficient drug use, including failure of the prescriber to select the appropriate type based on pain intensity and disability, patients taking medication too late (more than 60 minutes after the onset or after central sensitization has occurred as evidenced by allodynia), and discontinuation because of lack of effect or intolerable side effects. The underlying cause of inadequate effectiveness of acute medication lies in its inability to halt the propagation of peripheral activation to central sensitization in a timely manner. For oral and injectable preventive migraine medications, insufficient efficacy and intolerable side effects have led to poor adherence and discontinuation with subsequent progression of migraine. The underlying pathophysiology here is rooted in the repetitive stimulation of afferent sensory pain fibers, followed by ascending brainstem pain pathways plus dysfunction of the endogenous descending brainstem pain inhibitory pathway. Although anti-calcitonin gene-related peptide (CGRP) medications partially address pain caused by the above factors, including decreased efficacy and tolerability from conventional therapy, some patients do not respond well to this treatment. Research suggests that initiating preventive anti-CGRP treatment at an early stage (during low frequency episodic migraine attacks) is more beneficial than commencing it during high frequency episodic attacks or when chronic migraine has begun. CONCLUSIONS: The term "medication underuse" is underrecognized, but it holds significant importance. Optimal usage of acute care and preventive migraine medications could potentially prevent migraine chronification and improve the treatment of migraine attacks.

Real-world Impact of Fremanezumab on Migraine-Related Health Care Resource Utilization in Patients with Comorbidities, Acute Medication Overuse, and/or Unsatisfactory Prior Migraine Preventive Response.

INTRODUCTION: Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is indicated for preventive treatment of migraine in adults. Real-world evidence assessing the effect of fremanezumab on migraine-related medication use, health care resource utilization (HCRU), and costs in patient populations with comorbidities, acute medication overuse (AMO), and/or unsatisfactory prior migraine preventive response (UPMPR) is needed. METHODS: Data for this US, retrospective claims analysis were obtained from the Merative® MarketScan® Commercial and supplemental databases. Eligible adults with migraine initiated fremanezumab between 1 September 2018 and 30 June 2019 (date of earliest fremanezumab claim is the index date), had ≥ 12 months of continuous enrollment prior to initiation (preindex period) and ≥ 6 months of data following initiation (postindex period; variable follow-up after 6 months), and had certain preindex migraine comorbidities (depression, anxiety, and cardiovascular disease), potential AMO, or UPMPR. Changes in migraine-related concomitant acute and preventive medication use, HCRU, and costs were assessed pre- versus postindex. RESULTS: In total, 3193 patients met the eligibility criteria. From pre- to postindex, mean (SD) per patient per month (PPPM) number of migraine-related acute medication and preventive medication claims (excluding fremanezumab), respectively, decreased from 0.97 (0.90) to 0.86 (0.87) (P < 0.001) and 0.94 (0.74) to 0.81 (0.75) (P < 0.001). Migraine-related outpatient and neurologist office visits, emergency department visits, and other outpatient services PPPM decreased pre- versus postindex (P < 0.001 for all), resulting in a reduction in mean (SD) total health care costs PPPM from US$541 (US$858) to US$490 (US$974) (P = 0.003). Patients showed high adherence and persistence rates, with mean (SD) proportion of days covered of 0.71 (0.29), medication possession ratio of 0.74 (0.31), and persistence duration of 160.3 (33.2) days 6 months postindex. CONCLUSIONS: Patients with certain migraine comorbidities, potential AMO, and/or UPMPR in a real-world setting had reduced migraine-related medication use, HCRU, and costs following initiation of fremanezumab. Graphical abstract available for this article.

Monoclonal antibodies targeting the calcitonin gene-related peptide pathway improve the effectiveness of acute medication-a real-world study.

BACKGROUND: One of the aims of migraine prevention is to improve response to acute migraine treatments. The aim of the present study was to assess whether monoclonal antibodies targeting the CGRP pathway (CGRP-mAbs) can improve the perceived efficacy of acute treatments. METHODS: We included and followed up patients with chronic or episodic migraine from the Headache Centers of Avezzano-L'Aquila and Naples treated with CGRP-mAbs from March 2021 to December 2022. All patients filled out the Migraine Treatment Optimization Questionnaire (MTOQ), the Headache Impact Test (HIT-6), and the Migraine Impact and Disability Assessment Scale (MIDAS) at baseline and 3-6 months after the start of treatment with CGRP-mAbs. RESULTS: Sixty-five patients (81.3%) completed the 6-month follow-up. Most patients were female (55, 84.6%), with a median age of 46 years (IQR 39-56). Median MTOQ score increased from 8 (interquartile range [IQR] 4-13) at baseline to 15 (IQR 11-17) at 3 months (p < 0.001) and 16 (IQR 13-17) at the 6-month follow-up (p < 0.001). Median migraine days over 90-day periods decreased from 40 (IQR 24-60) to 24 (IQR 15-30) at 3 months (p < 0.001) and to 20 (IQR 12-24) at 6 months (p < 0.001). Median monthly intake of acute medication decreased from 55 doses (IQR 29-80.5) to 24 doses (IQR 15-40) at 3 months and 18 doses (IQR 11-30) at 6 months (p < 0.001). CONCLUSIONS: We showed that 6 months of preventive treatment with CGRP-mAbs led to a significantly better effectiveness of acute treatments, paralleled by decreased monthly migraine days and acute treatment intake.

Harris Poll Migraine Report Card: population-based examination of high-frequency headache/migraine and acute medication overuse.

BACKGROUND: Migraine is a disabling neurologic disease that can fluctuate over time in severity, frequency, and acute medication use. Harris Poll Migraine Report Card was a US population-based survey to ascertain quantifiable distinctions amongst individuals with current versus previous high-frequency headache/migraine and acute medication overuse (HFM+AMO). The objective of this report is to compare self-reported experiences in the migraine journey of adults with HFM+AMO to those who previously experienced HFM+AMO but currently have a sustained reduction in headache/migraine frequency and acute medication use. METHODS: An online survey was available to a general population panel of adults (≥18 years) with migraine per the ID Migraine™ screener. Respondents were classified into "current HFM+AMO" (within the last few months had ≥8 headache days/month and ≥10 days/month of acute medication use; n=440) or "previous HFM+AMO" (previously had HFM+AMO, but within the last few months had ≤7 headache days/month and ≤9 days/month of acute medication use; n=110). Survey questions pertained to demographics, diagnosis, living with migraine, healthcare provider (HCP) communication, and treatment. RESULTS: Participants in the current HFM+AMO group had 15.2 monthly headache days and 17.4 days of monthly acute medication use in last few months compared to 4.2 and 4.1 days for the previous HFM+AMO group, respectively. Overall, current preventive pharmacologic treatment use was low (15-16%; P>0.1 for current vs previous) in both groups. Previous HFM+AMO respondents reported better current acute treatment optimization. More respondents with current (80%) than previous HFM+AMO (66%) expressed concern with their current health (P<0.05). More than one-third of both groups wished their HCP better understood their mental/emotional health (current 37%, previous 35%; P>0.1 for current vs previous) and 47% (current) to 54% (previous) of respondents worried about asking their HCP too many questions (P>0.1 for current vs previous). CONCLUSION: Apart from optimization of acute medication, medical interventions did not significantly differentiate between the current and previous HFM+AMO groups. Use of preventive pharmacological medication was low in both groups. Adults with current HFM+AMO more often had health concerns, yet both groups expressed concerns of disease burden. Optimization of acute and preventive medication and addressing mental/emotional health concerns of patients are areas where migraine care may impact outcomes regardless of their disease burden.

Health care resource utilization and costs associated with diagnosed medication overuse headache and potential acute medication overuse in individuals with migraine.

OBJECTIVE: Estimate health care resource utilization and costs associated with medication overuse headache and potential acute medication overuse. METHODS: A retrospective analysis was conducted with Clinformatics Data Mart data (1 January 2019-31 December 2019) that included continuously enrolled commercially insured adults with migraine (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] code G43.xxx). Medication overuse headache was defined as ≥1 inpatient or ≥2 outpatient claims with an ICD-10-CM code G44.41/40 (drug-induced headache). Potential acute medication overuse was defined as possessing sufficient medication for >10 mean treatment days/month for ergots, triptans, opioids, or combination analgesics or >15 mean cumulative days/month for simple prescription analgesics (e.g., acetaminophen, aspirin, other non-opioid analgesics) for >6 consecutive months. All-cause and migraine-related health care resource utilization and costs were compared after adjusting for demographic and clinical characteristics. RESULTS: Among 90,017 individuals with migraine, the frequency of medication overuse headache/potential acute medication overuse was 12.6% (diagnosed medication overuse headache: 0.6%; potential acute medication overuse: 12.1%). Adjusted all-cause total costs ($31,235 vs $21,486; difference: $9,749 [P < 0.001]) and adjusted migraine-related total costs ($9,770 vs $6,207; difference: $3,563 [P < 0.001]) were higher in the medication overuse headache/potential acute medication overuse group versus those without medication overuse headache/potential acute medication overuse. CONCLUSIONS: Individuals with diagnosed medication overuse headache/potential acute medication overuse had higher all-cause and migraine-related health care resource utilization and costs versus individuals without medication overuse headache/potential acute medication overuse, suggesting that improved migraine management is needed to reduce associated costs.

Alterations in DNA methylation associate with reduced migraine and headache days after medication withdrawal treatment in chronic migraine patients: a longitudinal study.

BACKGROUND: Chronic migraine, a highly disabling migraine subtype, affects nearly 2% of the general population. Understanding migraine chronification is vital for developing better treatment and prevention strategies. An important factor in the chronification of migraine is the overuse of acute headache medication. However, the mechanisms behind the transformation of episodic migraine to chronic migraine and vice versa have not yet been elucidated. We performed a longitudinal epigenome-wide association study to identify DNA methylation (DNAm) changes associated with treatment response in patients with chronic migraine and medication overuse as part of the Chronification and Reversibility of Migraine clinical trial. Blood was taken from patients with chronic migraine (n = 98) at baseline and after a 12-week medication withdrawal period. Treatment responders, patients with ≥ 50% reduction in monthly headache days (MHD), were compared with non-responders to identify DNAm changes associated with treatment response. Similarly, patients with ≥ 50% versus < 50% reduction in monthly migraine days (MMD) were compared. RESULTS: At the epigenome-wide significant level (p < 9.42 × 10-8), a longitudinal reduction in DNAm at an intronic CpG site (cg14377273) within the HDAC4 gene was associated with MHD response following the withdrawal of acute medication. HDAC4 is highly expressed in the brain, plays a major role in synaptic plasticity, and modulates the expression and release of several neuroinflammation markers which have been implicated in migraine pathophysiology. Investigating whether baseline DNAm associated with treatment response, we identified lower baseline DNAm at a CpG site (cg15205829) within MARK3 that was significantly associated with MMD response at 12 weeks. CONCLUSIONS: Our findings of a longitudinal reduction in HDAC4 DNAm status associated with treatment response and baseline MARK3 DNAm status as an early biomarker for treatment response, provide support for a role of pathways related to chromatin structure and synaptic plasticity in headache chronification and introduce HDAC4 and MARK3 as novel therapeutic targets.

Treatment pattern and health care resource utilization for Taiwanese patients with migraine: a population-based study.

Objectives: Given the substantial disease burden, appropriate and effective management of migraine is a public health priority. To gain insights into real-world migraine management practices in Taiwan, current treatment patterns, costs, and health care resource use were assessed. Methods: This was a retrospective, longitudinal study using the Taiwan National Health Insurance Research Database. Included patients had an initial diagnosis of migraine (defined using International Classification of Diseases codes) between 1 January 2013 and 31 December 2017. Data analyzed included demographics; the use, number, and type of acute and preventive medications; and drug and medical services costs. Data were stratified according to migraine type (chronic [CM] or episodic [EM] migraine). Results: A total of 312,718 patients were included in the analyses: 53,992 (17.3%) had CM and 258,726 (82.7%) had EM. Most patients (81.7%) had used acute and/or preventive medications; acute medications used more frequently than preventive medications (78.0% vs. 20.2%). Acute medications were used by 81.6 and 77.3% of patients with CM and EM, respectively. Commonly used acute medications were acetaminophen (68.8%), ergots (49.4%), and non-steroidal anti-inflammatory drugs (38.4%); the use of triptans (6.0%), tramadol (3.1%), and other opioids (0.2%) was less common. A total of 28.6 and 18.5% of patients with CM and EM, respectively, used preventive medications. Flunarizine (68.9%), propranolol (40.7%), and topiramate (16.0%) were the most commonly used preventive medications. Most patients had used 1-2 acute or preventive medications, with the use of ≥3 acute or preventive medications more common in patients with CM than EM. Average total medical cost per annum was 4,169 New Taiwan Dollars (NTDs) per CM patient and 2,928 NTDs per EM patient, with CM patients having higher costs associated with medical service utilization and acute medication use. Conclusion: These real-world data suggest unmet needs for Taiwanese patients with migraine, including under-utilization of preventive medications and greater costs and health care resource use for patients with CM versus EM. These findings provide important information on treatment patterns, cost, and health care resource use for patients with migraine in Taiwan.

Long-term efficacy and safety of erenumab in patients with chronic migraine and acute medication overuse: A subgroup analysis.

OBJECTIVE: Assess the long-term efficacy and safety of erenumab in patients with chronic migraine with acute medication overuse. BACKGROUND: Overuse of acute medication in patients with chronic migraine has been linked to greater pain intensity and disability and may diminish the effectiveness of preventive therapies. METHODS: This 52-week open-label extension study followed a 12-week double-blind placebo-controlled study in which patients with chronic migraine were randomized 3:2:2 to placebo or once-monthly erenumab 70 mg or 140 mg. Patients were stratified by region and medication overuse status. Patients received erenumab 70 mg or 140 mg throughout or switched from erenumab 70 to 140 mg (based on protocol amendment to augment safety data at higher dose). Efficacy was assessed in patients with and without medication overuse at parent study baseline. RESULTS: Of 609 patients enrolled in the extension study, 252/609 (41.4%) met the criteria for medication overuse at parent study baseline. At Week 52, the mean change in monthly migraine days from parent study baseline was -9.3 (95% confidence interval: -10.4, -8.1 days) in the medication overuse subgroup versus -9.3 (-10.1, -8.5 days) in the non-medication overuse subgroup (combined erenumab doses); proportion of patients achieving ≥50% reduction in monthly migraine days at Week 52 was 55.9% (90/161; 48.2%, 63.3%) versus 61.3% (136/222; 54.7%, 67.4%), respectively. Among baseline users of acute migraine-specific medication, the mean change in monthly migraine-specific medication days at Week 52 was -7.4 (-8.3, -6.4 days) in the medication overuse subgroup versus -5.4 (-6.1, -4.7 days) in the non-medication overuse subgroup. Most patients (197/298; 66.1%) in the medication overuse subgroup transitioned to non-overuse status by Week 52. Erenumab 140 mg was associated with numerically greater efficacy than erenumab 70 mg across all endpoints. No new safety signals were identified. CONCLUSION: Long-term erenumab treatment demonstrated sustained efficacy and safety in patients with chronic migraine with and without acute medication overuse.

Treatment with eptinezumab for migraine prevention in people with chronic migraine and medication-overuse headache: a plain language summary.

WHAT IS THIS SUMMARY ABOUT?: This is a summary of three articles describing preventive treatment of migraine in participants with a diagnosis of both chronic migraine and medication-overuse headache in a study called PROMISE-2 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy-2). People living with chronic migraine and medication-overuse headache have one of the most disabling, costly, and difficult-to-treat headache disorders. WHAT WERE THE RESULTS?: After preventive migraine treatment with eptinezumab (trade name Vyepti), participants with chronic migraine and medication-overuse headache experienced fewer migraine days, a reduced severity of migraine attacks, and a reduced use of acute medication. More participants receiving eptinezumab treatment no longer met the definition of either chronic migraine or medication-overuse headache throughout the study when compared with those receiving placebo. WHAT DO THE RESULTS MEAN?: Eptinezumab is beneficial for people who often use acute medication(s) due to frequent headache episodes or migraine attacks.

Efficacy of Kampo medicine Kakkonto as acute medication to treat tension-type headache among musculoskeletal pain patients using regular analgesics.

OBJECTIVES: Tension-type headache (TTH) is the most prevalent type of primary headache disorder. Its acute pharmacotherapy is acetaminophen or non-steroidal anti-inflammatory drugs based on the Japanese Clinical Practice Guideline for Headache Disorders 2021. With Japan's aging population, however, the number of TTH patients with comorbidities that have been treated by analgesics is increasing. Under this context, it is sometimes difficult to select an acute pharmacotherapy for TTH. Kakkonto, Japanese traditional herbal kampo medicine, is empirically used for TTH. We hypothesized that kakkonto has efficacy for TTH with painful comorbidities. MATERIALS AND METHODS: We prospectively collected 10 consecutive TTH patients who had already taken analgesics for comorbidities. We prescribed 2.5 g of kakkonto (TJ-1), and patients took it. A numerical rating scale for pain before and 2 hours after kakkonto intake was evaluated. RESULTS: Eight women and 2 men were included. The mean age was 71.0 ± 13.4 years old. Four patients had lower back pain, 2 had lumbar spinal stenosis, 2 had knee pain, 1 had neck pain, and 1 had shoulder myofasciitis. Celecoxib was used for 4 patients, acetaminophen for 3, loxoprofen for 2, and a combination of tramadol and acetaminophen for 1, as routinely used analgesics. The median numerical rating scale statistically improved from the median of 4 to that of 0. There were no side effects of kakkonto. CONCLUSION: Kakkonto showed efficacy as an acute medication for TTH with comorbidities that have been treated by analgesic.

Oral Cannabinoid Preparations for the Treatment of Chronic Migraine: A Retrospective Study.

OBJECTIVE: To explore the effectiveness and safety of three oral cannabinoid preparations (FM2®, Istituto farmaceutico militare, Firenze, Italy; Bedrocan®, Bedrocan International, Vandaam, Netherlands; and Bediol®, Bedrocan International, Vandaam, Netherlands) in the treatment of chronic migraine. DESIGN: Retrospective, cohort study. SUBJECTS: Patients with chronic migraine who received FM2, Bedrocan, or Bediol daily for the off-label treatment of their headache, for up to 6 months. METHODS: The number of migraine days per month, pain intensity, the number of acute medications taken per month, the number of days per month on which the patient took at least one acute medication, and adverse events were recorded at baseline and at 3 months and 6 months after the start of treatment with oral cannabinoid preparations. RESULTS: The number of migraine days did not change significantly after the third month or the sixth month when compared with baseline (P = 0.1182). The pain intensity (P = 0.0004), the acute medication consumption (P = 0.0006), and the number of days per month in which patients took at least one acute medication significantly decreased when compared with baseline (P = 0.0004). No significant differences were found between patients who were still taking a preventive treatment for chronic migraine and those who were not (all P > 0.05). Different oral cannabinoid preparations displayed similar levels of effectiveness (all P > 0.05). The adverse events were mostly mild and occurred in 43.75% of patients. CONCLUSIONS: Oral cannabinoid preparations may have a role in reducing pain intensity and acute medication intake in patients with chronic migraine, but the magnitude of the effect seems modest; further studies are needed.

Effectiveness of medication in cluster headache.

BACKGROUND: The aim of this work is to analyze the reports on cluster headache attacks collected online in the citizen science project CLUE with respect to the effectiveness of drugs taken during the attacks. The collection of data within the framework of citizen science projects opens up the possibility of investigating the effectiveness of acute medication on the basis of a large number of individual attacks instead of a simple survey of patients. METHODS: Data from 8369 cluster headache attacks, containing information about acute medication taken and the assessment of its effect, were collected from 133 participants using an online platform and a smartphone app. Chi-square tests were used to investigate whether the effect of the three recommended acute drugs differs when distinguishing between participants with chronic or episodic cluster headache. Furthermore, it was investigated whether there are differences between smokers and non-smokers in the assessment of the effect of the acute medication. RESULTS: Our participants rated the effectiveness of sumatriptan 6 mg s.c. as significantly better than oxygen and zolmitriptan nasal spray. Oxygen is considered to be significantly better in episodic versus chronic cluster headache, and sumatriptan is considered to be significantly better in chronic versus episodic cluster headache. Smokers rate the effect of oxygen as significantly better than non-smokers. CONCLUSIONS: Despite some methodological limitations, web-based data collection is able to support findings from clinical trials in a real world setting about effectiveness of acute cluster headache treatment in several situations.

Treatment Outcomes in Patients Treated With Galcanezumab vs Placebo: Post Hoc Analyses From a Phase 3 Randomized Study in Patients With Episodic Cluster Headache.

BACKGROUND: Cluster headache (CH) is a highly disabling primary headache disorder. To date, characterization of outcomes in the preventive treatment of episodic CH, including precise definitions of clinically meaningful attack frequency reduction and impact on acute treatment management, is lacking. METHODS: This was a Phase 3, randomized, double-blind, placebo-controlled study in patients (men or women aged 18-65 years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders-3 beta criteria. In this post hoc analysis, we evaluated the median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attack frequency, and impact on acute medication use. An anchor-based assessment of clinically relevant attack frequency reduction using the Patient Global Impression of Improvement (PGI-I) scores at Week 4 was also assessed. RESULTS: The median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attacks was consistently shorter (9-10 days sooner) with galcanezumab vs placebo (median [95% confidence interval, 95% CI]: ≥50%, 5 days [4.0 to 7.0] vs 14 days [6.0 to 19.0]; ≥75%, 11 days [7.0 to 16.0] vs 21 days [13.0 to 26.0]; 100%, 22 days [16.0 to 37.0] vs 32 days [23.0 to 34.0]). Mean reduction from baseline in the overall frequency of weekly pooled acute medication use across Weeks 1-3 was significantly greater with galcanezumab vs placebo (11.0 vs 5.5; odds ratio, OR [95% CI]: 5.52 [1.02, 10.01]; P value = .017). Patients reporting "much better" on the PGI-I experienced a median weekly CH attack reduction of approximately 43% from baseline across Weeks 1-3. The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]). CONCLUSIONS: Faster median time-to-first occurrence of response rates, lower frequency of pooled acute medications use, and a greater proportion of patients achieving a response anchored by patient-reported improvement were observed for galcanezumab vs placebo.

Migraine treatment and healthcare costs: retrospective analysis of the China Health Insurance Research Association (CHIRA) database.

BACKGROUND: Adult migraine remains underdiagnosed and undertreated, despite significant negative effects on physical and emotional functioning. Information on prescribing patterns and treatment costs of migraine in China is limited. METHODS: This retrospective analysis of the China Health Insurance Research Association (CHIRA) medical insurance claims database in 2016 to 2017 evaluated treatment patterns, direct medical costs, and healthcare resource utilization among adults with migraine in mainland China. RESULTS: Of 108,375 patients with headache-related outpatient visits, 10,652 were adults with migraine (mean age 51.4 years, 55.4% female). Common comorbidities were major depressive disorder (4.1%), insomnia (3.8%), and anxiety (2.3%). Migraine patients were prescribed acute medication (26.4%), preventive medication (15.0%), and Chinese patent and herbal medicines (24.5% and 11.7%, respectively). Of patients prescribed acute medication, 68.8% received non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs), 7.1% received opioids, while only 3.3% received triptans. Mean annual outpatient costs per patient were 46.5 United States dollars (USD), with mean (standard deviation) 1.8 (2.0) outpatient visits per year. Medication costs for traditional Chinese medicine (22.4 USD per patient) were higher than for Western medicine (13.5 USD). CONCLUSION: Among migraine patients in China, NSAIDs were commonly prescribed as acute medication, while utilization of migraine-specific triptans and preventive medications was low.

Care Among Migraine Patients in a Commercially Insured Population.

INTRODUCTION: Migraine management is characterized by the poor use of preventive therapy and the overuse of acute medications. An analysis of current treatment patterns in migraineurs is needed to improve care in this patient population. The aim of this study was to describe treatment patterns and healthcare utilization of newly diagnosed migraine patients. METHODS: This was a retrospective observation study of newly diagnosed migraine patients (no indication of migraine in the past year) identified in the IBM MarketScan Commercial Claims and Encounters database from 1 January 2010 to 30 June 2014. The final study population comprised persons aged 18-64 years at index (new diagnosis of migraine) with 12 months of continuous enrollment in an insurance plan with medical and pharmacy benefits pre-index and post-index. Treatment patterns and healthcare resource utilization were assessed during the post-index period (at least 12-months). RESULTS: Of the 1,588,666 migraine patients identified in the database as potentially eligible to participate in the study, 284,719 (17.9%) met the final inclusion criteria. Patients generally used acute and preventive therapies to manage migraine attacks, with most patients using preventive therapy (59.1%). However, 67.9% of those using preventive therapy discontinued the current therapy, with a median time to discontinuation of 5 months. Most of the patients who discontinued preventative therapy also used an acute treatment to manage migraine attacks after discontinuation (77.6%), generally in the year following discontinuation (68.4%). Patients on acute therapies were found to use triptans excessively (1.6%) and other non-migraine-specific acute medications for treatment (7.1%). Acute patients were also at risk of opioid dependence (12.0%) and commonly received opioids or barbiturates as first-line therapy (34.1%). CONCLUSION: Newly diagnosed migraine patients are not being properly treated, as indicated by their excessive use of acute therapies and short time on preventive treatment before discontinuation of that treatment. Further study of the reasons why patients discontinue preventive therapy (adverse events, no response, etc.) and continue to excessively use acute treatments once their treatment regimen has been established is needed.

Predicting initiation of preventive migraine medications: exploratory study in a large U.S. medical claims database.

Objective: Despite guidelines that identify potential patients eligible for preventive migraine medications, their underutilization leaves patients at risk of acute medication overuse, disease progression, and higher healthcare resource utilization and disability. This exploratory, retrospective, observational study aimed to identify which factors predict preventive migraine medication initiation. Demographics and initiation of acute medication use were hypothesized to be predictive of initiation of preventive migraine medication.Methods: The Truven Health Analytics MarketScan1 U.S. Commercial and Medicare Supplemental claims database (2011-2013) was used to identify adults newly diagnosed with migraine. Patients were divided into 2 subgroups: initiated a preventive migraine medication (antidepressants, anti-epileptics, beta-blockers, or neurotoxins) within 1 year of migraine diagnosis and did not initiate a preventive migraine medication. Logistic regression models were constructed to identify factors associated with preventive migraine medication initiation.Results: Study population included 147,923 patients: 43,660 preventive migraine medication initiators and 104,263 non-preventive migraine medication patients. Best-fit model for predicting preventive migraine medication initiation included: female gender (odds ratio = 1.181 [95% CI = 1.144,1.218]; measured at date of first migraine diagnosis); headache diagnosis prior to migraine diagnosis (odds ratio = 1.538 [95% CI = 1.498,1.579]; measured 1-year before first migraine diagnosis); and sleep disorder (odds ratio = 1.206 [95% CI = 1.161,1.252]), headache/migraine-specific Emergency Department (ED) visit (odds ratio = 1.224 [95% CI = 1.168,1.283]), neurologist visit (odds ratio = 1.502 [95% CI = 1.459,1.547]), and acute medication refills with <90-day gap (odds ratio = 1.509 [95% CI = 1.470,1.549]) each measured at 1-year before first preventive migraine medication.Conclusions: In addition to consistent acute medication refills, specific comorbidity diagnoses, headache/migraine-specific ED utilization, and neurologist care are predictive of preventive migraine medication initiation in the 1-year post-incident migraine diagnosis.

Predictors of allodynia in persons with migraine: Results from the Migraine in America Symptoms and Treatment (MAST) study.

BACKGROUND: Cutaneous allodynia is a common clinical feature of migraine that has been associated with reduced efficacy of acute migraine treatments and an increased risk of disease progression. OBJECTIVE: Identify factors associated with allodynia in a sample of adults with migraine. METHODS: An online survey panel was used to identify adults with migraine who averaged at least 1 monthly headache day over the previous 3 months. Data on sociodemographics, headache frequency, headache pain intensity, migraine symptom severity, medication use, depression and anxiety, and cutaneous allodynia (via the Allodynia Symptom Checklist) were obtained. Binary logistic modeling predicted the presence of allodynia. Odds ratios and 95% confidence intervals (CI) were calculated. RESULTS: In total, 15,133 individuals with migraine met the eligibility criteria. Mean age was 43.1 years, 73.0% were female, and 81.0% were Caucasian. Allodynia was present in 39.9%. The fully adjusted model, controlling for sociodemographics and headache features, demonstrated that allodynia was significantly associated with a higher migraine symptom severity score (odds ratio 1.17, confidence interval 1.15, 1.19) and more severe pain intensity (odds ratio 1.11, confidence interval 1.08, 1.14); probable depression and/or anxiety (odds ratio 1.83, confidence interval 1.67, 2.00); and overuse of acute medication (odds ratio 1.23, confidence interval 1.09, 1.38). A higher number of monthly headache days increased the likelihood of allodynia, but the effect was attenuated in the fully adjusted model. CONCLUSION: In a representative sample of US adults with migraine, there were significant associations between allodynia and headache frequency and intensity, anxiety and/or depression, symptom severity, and acute medication overuse.

Patient satisfaction, health care resource utilization, and acute headache medication use with galcanezumab: results from a 12-month open-label study in patients with migraine.

BACKGROUND: Effects of galcanezumab, a monoclonal antibody against calcitonin gene-related peptide, on patient satisfaction, health care resource utilization (HCRU), and acute medication use were evaluated in a long-term, open-label study in patients with migraine. METHODS: Patients with episodic (78.9%) or chronic migraine (21.1%) were evaluated in the CGAJ study, an open-label study with 12-month treatment period. Galcanezumab 120 mg (with a loading dose of 240 mg) or 240 mg was administered subcutaneously once a month during treatment period. A self-rated scale, Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M), was used to measure satisfaction levels. Participants reported HCRU for the previous 6 months at baseline and that which occurred since the patient's last study visit during treatment period. Acute headache medication use for migraine or headache for the past month was self-reported by participants at baseline and at each monthly visit during treatment period. RESULTS: At Months 1, 6, and 12, at least 69% of patients treated with galcanezumab responded positively for overall satisfaction, preference over prior treatments, and less impact from side effects. There were within-group reductions from baseline in migraine-specific HCRU (per 100 person-years) with galcanezumab for health care professional visits (173.4 to 59.6), emergency room visits (20.2 to 4.7), and hospital admissions (3.7 to 0.4) during treatment period. Statistically significant reductions in HCRU were observed for some events. There were significant within-group reductions from baseline in mean number of days/month with acute headache medication use for migraine or headache at each monthly visit during treatment period (overall change: -5.1 for galcanezumab 120 mg/240 mg; p<0.001). CONCLUSION: Results from this long-term, open-label study suggest that treatment with galcanezumab is likely to lead to high patient satisfaction with treatment as well as meaningful reductions in migraine-specific HCRU and acute headache medication use in people with migraine.

Factors Associated With Medication-Overuse Headache in Patients Seeking Treatment for Primary Headache.

BACKGROUND: Although risk factors for medication-overuse headache have been identified within the general population, most studies have neglected clinical samples. The present study examined the relative and combined associations of these factors with medication-overuse headache in a sample of US adults seeking treatment for primary headache disorders. METHODS: Treatment-seeking headache patients provided data on demographics, headache variables, psychiatric variables, use of headache medications, and use of other prescription medications and substances. A classification tree selection strategy was utilized within this cross-sectional study to differentiate between those with and without medication-overuse headache, and a final multivariable model assessed their combined utility. RESULTS: Forty-three of 164 participants (26.2%) met diagnostic criteria for medication-overuse headache. Relative to non-medication-overuse headache participants, participants with medication-overuse headache reported greater headache-related disability (odds ratio = 1.09, 95% confidence interval = 1.01-1.18), escape and avoidance responses indicative of fear of pain (odds ratio = 1.07, 95% confidence interval = 1.00-1.15), and use of combination medications for headache (odds ratio = 3.10, 95% confidence interval = 1.51-6.36). The final multivariable model differentiated well between the 2 groups (area under the receiver operating characteristic curve = .78; 95% confidence interval = .71-.86). CONCLUSIONS: Items that assess headache-related disability, use of combination medications, and fear of pain help identify patients who are currently overusing acute headache medications and may serve as indicators of treatment progress. Future studies should apply similar analytic approaches longitudinally to identify headache sufferers at risk for medication-overuse headache prior to headache progression.