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Published on: June 2, 2014
A Real-World Study of CGRP Monoclonal Antibodies for Migraine: Long-Term Effectiveness and Treatment Adherence
Keisuke Suzuki1, Shiho Suzuki1, Saro Kobayashi1
1Department of Neurology, Dokkyo Medical University, Mibu, Japan.
Insights
Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) demonstrate long-term effectiveness in reducing monthly migraine days and improving responder rates for migraine prophylaxis. Real-world data show sustained efficacy and favorable tolerability over 24 months.
Area of Science:
- Neurology
- Pharmacology
- Clinical Medicine
Background:
- Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are established treatments for migraine prevention.
- Limited real-world data exist on the long-term effectiveness and patient outcomes of CGRP mAbs beyond one year.
Purpose of the Study:
- To evaluate the long-term effectiveness and tolerability of CGRP mAbs in a real-world setting.
- To analyze treatment persistence and identify factors influencing response over 24 months.
Main Methods:
- A retrospective observational cohort study of 307 Japanese migraine patients treated with CGRP mAbs (erenumab, galcanezumab, fremanezumab) for at least 3 months.
- Outcomes assessed included monthly migraine days (MMDs), ≥50% responder rates, adverse events (AEs), and treatment persistence.
- Patients were categorized into early, late, and ultralate responders based on the timing of achieving a ≥50% reduction in MMDs.
Main Results:
- Significant reductions in MMDs were observed throughout the 24-month study period, with ≥50% response rates increasing from 45.9% at 3 months to 71.0% at 24 months.
- Adverse events were infrequent (12.6%) and mild. Early responders had lower baseline MMDs and disability scores compared to late and ultralate responders.
- Treatment continuation rates were 68.3% at 12 months, decreasing to 50.6% at 24 months, with effectiveness appearing similar across different CGRP mAbs.
Conclusions:
- CGRP mAbs provide sustained long-term reduction in migraine frequency and demonstrate favorable tolerability in a real-world clinical setting.
- Understanding responder phenotypes can inform treatment strategies and patient selection for CGRP mAb therapy.
Background:
Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are effective for migraine prophylaxis; however, real-world evidence beyond 1 year remains limited.
Methods:
This single-center, retrospective observational cohort study in Japan included 307 migraine patients who received CGRP mAbs (erenumab, galcanezumab, or fremanezumab) for ≥ 3 months between April 2022 and February 2025 for an effectiveness analysis. Outcomes included monthly migraine days (MMDs), ≥ 50% responder rates, adverse events (AEs), and treatment persistence. Patients were categorized as nonresponders or responders: early (≥ 50% MMD reduction by Month 3), late (Months 4-5), and ultralate (after Month 6).
Results:
Significant MMD reductions were observed across 24 months. The ≥ 50% response rates were 45.9%, 57.0%, 63.6%, and 71.0% at 3, 6, 12, and 24 months, respectively. AEs occurred in 12.6% and were mild. Early responders had the lowest baseline MMDs and Migraine Disability Assessment (MIDAS) scores; nonresponders had the highest baseline MMDs and MIDAS scores and the highest rates of comorbid medication overuse headache (MOH) and psychiatric disorders. Compared with early responders, late and ultralate responders had higher baseline MMDs, higher MIDAS scores, higher rates of MOH, and more prior preventive failures. Additionally, ultralate responders presented the highest rates of photophobia and pulsatile headache and the fewest psychiatric comorbidities. Effectiveness appeared similar among the three CGRP mAbs. Treatment continuation rates were 68.3%, 58.0%, and 50.6% at 12, 18, and 24 months, respectively.
Conclusion:
CGRP mAbs were associated with a long-term reduction in migraine frequency and favorable tolerability.
