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Anti-CGRP monoclonal antibody therapy for migraine prevention in the real world
Long-term clinical studies and real-world evidence are providing supportive data on the efficacy, tolerability and safety of anti-calcitonin gene-related peptide monoclonal antibody therapy for migraine prevention and are also helping to address unanswered clinical questions, explained experts at EAN 2022.
Real-world evidence can inform and shape best practice guidelines
Real-world studies provide evidence on efficacy and safety for regulatory authorities and for experts writing guidelines
Real-world evidence refers to any data collected outside restricted randomized controlled trials, said Professor Cristina Tassorelli, Pavia, Italy. Sources include diverse and unrestricted electronic health and claims databases, and observational prospective or retrospective studies.
Real-world studies have become increasingly important in providing evidence on efficacy and safety in the real world for regulatory authorities and for experts writing guidelines, and are also helping to address unanswered questions, Professor Tassorelli said.
Real-world data on discontinuing and switching anti-CGRP mAbs
Migraine frequency may increase after withdrawal of an anti-CGRP mAb3
The latest real-world evidence is providing information on unanswered questions about outcomes for patients after cessation of an anti-CGRP mAb2 and after switching to a different anti-CGRP mAb following a failure to respond to a first anti-CGRP mAb,3 said Professor Messoud Ashina, Copenhagen, Denmark, as follows:
- Migraine frequency significantly increased 16 weeks after discontinuation of an anti-CGRP mAb;2 care is therefore required when withdrawing an anti-CGRP mAb
- Switching to a different anti-CGRP mAb resulted in a ≥50% reduction in monthly migraine days from baseline to month 6 in 32% of patients who had previously failed to respond to a first anti-CGRP mAb3
In individuals with an inadequate response to one anti-CGRP mAb, switching to another anti-CGRP mAb may be an option4
Professor Ashina highlighted that the positive real-world finding that switching from one anti-CGRP mAb to another can provide beneficial efficacy contributed to the following 2022 update to the European Headache Federation guidelines, which now states:
- “In individuals with migraine with an inadequate response to one anti-CGRP mAb, there is insufficient evidence on the potential benefits of antibody switch but switching may be an option4”
Latest data on tolerability and safety
Anti-CGRP mAbs are well tolerated and safe
Both long-term clinical studies and real-world studies are demonstrating that anti-CGRP mAbs are well tolerated and safe when used as recommended,5–7 said Professor Hans-Christoph Diener, Duisberg, Germany. Most adverse events (AEs) are mild to moderate in severity and injection site reactions are the most common.
Injection site reactions are the most common adverse event
Because CGRP is abundant in the vasculature,8 Professor Diener suggested that anti-CGRP mAbs should be avoided in patients with cardio- or cerebrovascular disease.9 Anti-CGRP mAbs should also be avoided during pregnancy.9
Support for this satellite symposium was provided by Teva.
Our correspondent’s highlights from the symposium are meant as a fair representation of the scientific content presented. The views and opinions expressed on this page do not necessarily reflect those of Lundbeck.
References
- Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35(11):1763–74.
- Raffaelli B, Terhart M, Overeem LH, et al. Migraine evolution after the cessation of CGRP(-receptor) antibody prophylaxis: a prospective, longitudinal cohort study. Cephalalgia. 2022;42(4–5):326–34.
- Schankin CJ, Broessner G, Gaul C, et al. Response to fremanezumab in migraine patients with and without prior anti-CGRP mAbs – preliminary data from the FINESSE study. Nervenheilkunde 2022;41(05):353.
- Sacco S, Amin FM, Ashina M, et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention - 2022 update. J Headache Pain. 2022;23(1):67.
- Goadsby PJ, Silberstein SD, Yeung PP, et al. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology. 2020;95(18):e2487–99.
- Kudrow D, Cady RK, Allan B, et al. Long-term safety and tolerability of eptinezumab in patients with chronic migraine: a 2-year, open-label, phase 3 trial. BMC Neurol. 2021;21(1):126.
- Barbanti P, Egeo G, Aurilia C, et al. FRIEND-Study Group. Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain. 2022;23(1):46.
- Deen M, Correnti E, Kamm K, et al; European Headache Federation School of Advanced Studies (EHF-SAS). Blocking CGRP in migraine patients – a review of pros and cons. J Headache Pain. 2017;18(1):96.
- Sacco S, Bendtsen L, Ashina M, et al. European Headache Federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. J Headache Pain. 2019;20(1):6.