Treatment patterns of patients with migraine eligible for anti-CGRP pathway monoclonal antibodies.

Introduction: Migraine is a debilitating neurological disorder, with a wide range of symptoms and disease burden, underscoring the heterogeneity of patients' disease characteristics and treatment needs. To characterize the profile of migraine patients in the US who may be eligible for preventive treatment with an anti-CGRP pathway mAb and to better understand treatment patterns and real-world use of acute and preventive medications for migraine, we conducted a retrospective cohort study of adult patients. Methods: These patients were identified as having migraine using diagnosis codes or migraine-specific medication use (first = index) in the IQVIA PharMetrics® Plus database. Patients were required to have ≥ 12 months of continuous enrollment in medical and pharmacy benefits prior to index (baseline) and after index (follow-up). Patients were stratified into chronic migraine (CM) and non-chronic migraine (non-CM) by diagnosis codes. Based on acute migraine-specific medication dispensing data in the follow-up period, non-CM patients were divided into 3 cohorts: highest, middle, and lowest tertile of total units of dispensed acute migraine-specific medication (gepants, ditans, ergot derivatives, and triptans). Migraine medication use was captured in the baseline and follow-up periods. Results: A total of 22,584 CM and 216,807 non-CM patients (72,269 patients in each tertile) were identified and included in the study. Over the follow-up, CM patients had a mean of 70 units of acute migraine-specific medications dispensed, while the highest, middle, and lowest tertile of non-CM patients had a mean of 92, 29, and 10 units, respectively. Anti-calcitonin gene-related peptide pathway mAbs were dispensed for 28.9% of CM patients, and for 6.9%, 4.1%, and 2.9% of non-CM patients in the highest, middle, and lowest tertiles, respectively. Conclusion: A lower proportion of non-CM patients had use of anti-calcitonin gene-related peptide pathway mAbs compared to CM patients, confirming the unmet need with appropriate preventive medication. There appears to be a persistent gap in management of patients without a diagnosis of CM who are dispensed high quantities of acute migraine-specific medications.

Quality of life and work productivity and activity impairment among online survey respondents with migraine across a range of headache frequency.

Objective: This study aimed to describe the migraine burden and healthcare utilization in the context of headache frequency using nationwide claims data linked to online survey data previously collected in Japan. Background: It has been shown that increase in headache frequency can impose greater impact on individuals' daily and social functioning, but migraine burden in those with low-frequency headaches remains largely unknown in Japan. Methods: This post-hoc, observational study reported on 674 respondents who were working individuals and their family members aged 19-74 years, responded to an online questionnaire (response rate: 14.1% [21,704 responded/153,545 kencomⓇ registrants]), and were previously classified as having migraine. Disease burden in terms of Migraine-Specific Quality of Life (MSQ) and Work Productivity and Activity Impairment (WPAI) was compared across 0-3, 4-7, 8-14, and ≥ 15 monthly headache days (MHD). Results: Among 674 respondents, 419 (62.2%), 148 (22.0%), 61 (9.1%), and 46 (6.8%) had 0-3, 4-7, 8-14, and ≥ 15 MHD, respectively. Of those, 55 (13.1%), 31 (20.9%), 19 (31.1%), and 20 (43.5%) respondents consulted physicians for headaches. Moderate-to-severe impairments in daily activities were reported by 298 (71.1%), 110 (74.3%), 46 (75.4%), and 38 (82.6%) respondents. The proportion of the respondents with WPAI >0% generally increased with increasing headache frequency (presenteeism: 41.7 and 67.5% in respondents with 0-3 and ≥ 15 MHD, respectively; overall work impairment: 44.8 and 72.5%, respectively; and activity impairment: 44.9 and 73.9%, respectively), except for absenteeism (12.4 and 22.5%, respectively). The mean MSQ score declined with increasing MHD (Role function-restrictive: 75.1 and 59.5 in those with 0-3 and ≥ 15 MHD, respectively; Role function-preventive: 85.8 and 75.0, respectively; and Emotional function: 81.9 and 63.6, respectively). Conclusion: Based on the Japanese nationwide claims data, quality of life and work productivity decreased with increasing numbers of headache days. Substantial disease burden paired with low levels of healthcare utilization highlights the need for medical or non-medical intervention.

The Effect of OnabotulinumtoxinA on Headache Intensity and Number of Monthly Headache Days in Individuals with Chronic Migraine with Different Levels of Neck Disability.

One of the treatment methods used in chronic migraine is OnabotulinumtoxinA. The effects of OnabotulinumtoxinA on headache intensity (HI) and number of monthly headache days (NMHD) in chronic migraine (CM) patients classified according to neck disability levels are unknown. Our aim was to investigate the effect of OnabotulinumtoxinA on the HI and the NMHD in individuals with CM with different levels of neck disability. One hundred sixteen patients were enrolled in the study. The OnabotulinumtoxinA protocol was administered as per Follow-the-Pain PREEMPT. The Neck Disability Index was used to evaluate neck disability. Primary outcome measures were headache intensity, assessed with the Visual Analogue Scale, and the number of monthly headache days recorded from patients' diaries. Secondary outcome measures were migraine disability, assessed with the Migraine Disability Assessment Test, and quality-of-life, assessed with the Headache Impact Test-6. All assessments were made at baseline and end of the treatment. The OnabotulinumtoxinA treatment showed a greater improvement effect in the number of monthly headache days (p = 0.000) and migraine disability (p = 0.000) parameters in the severe and complete disability groups. CM patients with complete and severe neck disability received the most benefit in reducing the NMHD at 3 months after OnabotulinumtoxinA treatment, but the HI decreased at a similar level in all neck disability groups.

Abnormal heart rate variability and its application in predicting treatment efficacy in patients with chronic migraine: An exploratory study.

AIM: This study aimed to investigate the extent of autonomic nervous system dysfunction in patients with chronic migraine using heart rate variability analysis. In addition, we explored the potential association between heart rate variability and treatment outcomes in patients receiving preventive treatment. METHODS: In this cross-sectional and prospective study, we compared heart rate variability profiles in 81 preventive-naïve chronic migraine patients and 58 healthy controls. In addition, treatment responses of patients, who received a 12-week treatment with flunarizine, were assessed in relation to baseline heart rate variability. RESULTS: We observed that chronic migraine patients had a reduced heart rate variability, signifying autonomic dysfunction in comparison to healthy controls. Furthermore, patients presenting normal heart rate variability, characterized by a standard deviation exceeding 30 milliseconds in normal-to-normal RR intervals, experienced a superior response to flunarizine treatment. This improvement was exemplified by a significantly larger reduction in monthly headache days for patients with higher heart rate variability compared to those with lower heart rate variability: -9.7 (5.9) vs. -6.2 (6.0) days (p = .026). CONCLUSIONS: Autonomic dysfunction occurs in chronic migraine as evaluated by heart rate variability. A preserved function is associated with a better treatment outcome to flunarizine.Trial registration: Neurologic Signatures of Chronic Pain Disorders, NCT02747940. Registered 22 April 2016, https://clinicaltrials.gov/ct2/show/NCT02747940.

Demographic and clinical characteristics of prevention-eligible patients with migraine in the US: a linked national survey and administrative claims database study.

OBJECTIVE: To characterize burden of migraine in prevention-eligible patients compared with prevention non-eligible patients in the United States (US). Receipt of preventive therapy was also examined among prevention-eligible patients. METHODS: This retrospective study utilized data from the 2017 US National Health and Wellness Survey linked with medical and pharmacy claims. Patients aged ≥18 years who self-reported experiencing migraine and had confirmed evidence of migraine (≥1 medical or pharmacy claim) were included. Prevention eligibility was based on number of headache days in the past 30 days (prevention-eligible: ≥4 and prevention non-eligible: <4). Descriptive statistics summarized study variables; bivariate and multivariable analyses were conducted to examine the association of prevention-eligibility status with outcomes. RESULTS: Analyses included 450 patients, 291 (65%) prevention-eligible, and of these 56 (19%) received preventive therapy. Overall, patients were 42.98 ± 14.51 years old; 84% were female. Prevention-eligible patients reported significantly more migraine headache days in the past 6 months (29.27 ± 37.96 vs. 8.61 ± 7.88), had lower mental component summary scores (35.80 ± 2.73 vs. 37.90 ± 2.96), and more presenteeism (47.30 ± 2.98% vs. 37.90 ± 2.60%), overall work impairment (46.30 ± 2.87% vs. 37.90 ± 2.55%) and activity days missed due to migraine (8.16 ± 3.05 vs. 3.82 ± 1.58) than prevention non-eligible patients (all p<.001). Prevention-eligible patients receiving preventive therapy reported more migraine headache days during the past month (9.21 ± 7.99 vs. 6.06 ± 7.10; p=.002) and activity days lost due to migraine (18.39 ± 28.08 vs. 10.69 ± 21.43, p=.015) than those not receiving preventive therapy. CONCLUSIONS: Prevention-eligible patients experience greater burden due to migraine, including more headache days, worse health-related quality-of-life, and greater work and activity impairment than prevention non-eligible patients.