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Analysis of Prophylactic Treatment Patterns and Estimation of Disease Burden in Migraine

초록/요약

Migraine is a neurological disorder that affects one billion individuals worldwide and imposes a substantial social and economic burden. Before the introduction of migraine-specific prophylactic therapies, preventive therapies primarily relied on antidepressants, anticonvulsants, and beta-blockers. Anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP mAbs), which directly target CGRP – a key pathway involved in migraine pathology- offer improved tolerability and safety with favorable efficacy profiles. As the use of these agents increases in clinical practice, understanding their real-world utilization has become increasingly important. This study aimed to evaluate prophylactic treatment patterns and the disease burden among migraine patients initiating anti-CGRP monoclonal antibodies in South Korea using nationwide HIRA claims data. This study used HIRA claims data from January 2020 to April 2024, with the study period restricted to September 2021 through April 2024. The study population included patients who initiated galcanezumab or fremanezumab for the first time, defined as mutually exclusive cohorts. The index date was the first prescription date of the anti-CGRP mAb. A 12-month pre-index period was applied for baseline assessment. Follow-up continued until 30 days after the last anti-CGRP mAb prescription or the data cut-off date, whichever occurred first. Baseline characteristics, prophylactic and acute migraine treatment patterns, and migraine- related healthcare resource utilization (HCRU) and costs were evaluated. 80% of anti-CGRP mAb users were women, and the peak age group was 50-54 years. Topiramate and sumatriptan were the most frequently used prophylactic and acute treatment, respectively, both before and after anti-CGRP mAb initiation. Patients visited outpatient clinics approximately once per month on average, and about 30% experienced at least one hospitalization during follow-up. Medication costs accounted for more than 80% of migraine-related medical expenditures and increased with longer follow-up durations. These findings highlight the high treatment burden among anti-CGRP mAb users in South Korea and underscore the need for effective management strategies, particularly for women who represent the majority of treated patients. Given the substantial contribution of medication costs to overall migraine-related expenditures, targeted policies to optimize cost management may be warranted. Keywords: migraine, prophylaxis, anti-CGRP mAb, HIRA claims data, disease burden

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목차

I Study Background 1
A. Definition and Classification of Migraine 1
B. Pathology of Migraine 2
C. Epidemiology and Disease Burden of Migraine 3
D. Overview of Migraine Treatment 4
E. Anti-Calcitonin Gene Related Peptide Monoclonal Antibodies 6
F. Current Status of Migraine Preventive Treatment in South Korea 8
G. Significance of Study 9
II Study Objective 10
III Methods 11
A. Study Design and Database 11
B. Study Population 12
C. Definitions of Drug Exposure Variables 14
D. Definitions of Clinical and Demographic Variables 15
E. Anti-CGRP mAb Prescribing Patterns 17
F. Prophylactic and Acute Treatment Patterns 18
1. Conventional prophylactic drug use 18
2. Triptan use 18
G. Migraine-related Healthcare Resources Utilization 19
H. Migraine-related Healthcare Costs 20
I. Statistical Analysis 21
IV Results 22
A. Patient Sample and Baseline Characteristics 22
B. Anti-CGRP mAb prescribing patterns 26
C. Prophylactic Treatment Patterns in the Pre-Index Period 27
1. Types and Frequency of prior prophylactic medication use 27
2. Number and combination of prior prophylactic medications 28
D. Prophylactic Treatment Patterns in the Follow-up Period 29
E. Triptan Use of Anti-CGRP mAb Users 30
1. Number of triptan users before and after anti-CGRP mAb initiation 30
2. Factors associated with concomitant triptan use 32
F. Migraine-related Healthcare Resources Utilization 34
G. Migraine-related Healthcare Costs 36
H. Subgroup Analysis 38
1. 90-day cohort HCRU 38
2. 90-day cohort healthcare costs 40
3. 180-day cohort HCRU 42
4. 180-day cohort healthcare costs 44
5. Comparison of HCRU and healthcare costs across cohorts 46
V. Discussion 49
A. Key Findings 49
1. Patient characteristics 49
2. Prophylactic treatment patterns 50
3. Triptan use patterns 51
4. Healthcare resources utilization and costs 52
B. Significance of Findings 54
C. Limitations 55
VI Conclusion 57
References 58
Supplementary Materials 65
국문요약 68

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