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Headache Medicine Connections

Article

Headache Medicine Connections

Year: 2021, Volume: 1, Issue: 2, Pages: 23-30

Review Article

Effects of Anti-CGRP monoclonal antibodies for episodic and chronic migraine on migraine characteristics, disability, impact and quality of life beyond 3 months of treatment: A Systematic review and Meta-analysis

Received Date:16 November 2021, Accepted Date:18 November 2021, Published Date:17 December 2021

Abstract

Objective: At the time of this study, there were no systematic reviews to evaluate phase III RCT`s of CGRP monoclonal antibodies on migraine characteristics, migraine related disability, impact and quality of life after 3 months. This meta-analysis is aimed to systematically review available data on the effect of anti-CGRP monoclonal antibodies on migraine characteristics, migraine related disability, impact and quality of life after 3 months of treatment. Methods: A systematic literature search was performed to identify phase III randomized-controlled trials on anti-GCRP monoclonal antibodies on migraine prevention. The primary outcome was the change in migraine characteristics monthly migraine days, monthly acute migraine specific medication days and 50 % responder rate. Secondary outcome was change in patient functioning and quality of life assessed through Migraine- Specific Quality of Life Questionnaire (MSQ) Migraine Disability Assessment Questionnaire (MIDAS), Headache Impact test (HIT -6) and Migraine Physical Function Impact Diary (MPFID). We calculated the mean difference (MD), standard deviation (SD), and 95 % confidence intervals for the outcomes. Results: Four trials showed effect of anti-CGRP monoclonal antibodies on migraine characteristics and quality of life after 3 months, named EVOLVE 1, EVOLVE 2, STRIVE, HALO_LTS. These trials present data on galcanezumab (120mg, 240 mg, monthly), erenumab (70 mg, 140 mg, monthly) and fremanezumab (225 mg, 675 mg, quarterly, monthly), respectively. The trials included 4625 patients with migraine, 3515 with episodic migraine and 1110 with chronic migraine. Just three of them were included in the meta-analysis because HALO_LTS had no placebo-controlled group. In the included trials, anti-CGRP monoclonal antibodies (galcanezumab and erenumab) were superior to placebo for MMDs, 50% reduction rate, MSQ_RFR and MIDAS beyond a 3-month treatment period. Conclusion: Galcanezumab and erenumab demonstrated improvement in migraine characteristics and quality of life above and beyond those seen with placebo after 3-months of treatment in episodic migraine, providing placebo-controlled evidence. There is a need to perform good RCT`s to evaluate the efficacy of all anti-CGRP monoclonal antibodies on migraine characteristics, impact and quality of life on longer time frame (beyond 12 months) and on different migraine populations such as chronic migraine, medication overuse headache and refractory migraine.

 

 

Keywords: CGRP, Antibodies, Migraine, Disability

References

  1. Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z. Migraine is first cause of disability in under 50s: will health politicians now take notice? The Journal of Headache and Pain. 2018;19(1). Available from: https://dx.doi.org/10.1186/s10194-018-0846-2
  2. Feigin VL, Abajobir AA, Abate KH, Abd-Allah F, Abdulle AM, Abera SF, et al. Global, regional, and national burden of neurological disorders during 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. The Lancet Neurology. 2017;16(11):877–897. Available from: https://dx.doi.org/10.1016/s1474-4422(17)30299-5
  3. Lipton RB, Pan J. Is Migraine a Progressive Brain Disease? JAMA. 2004;291(4):493.
  4. MacGregor EA, Brandes J, Eikermann A, Giammarco R. Impact of migraine on patients and their families: the Migraine And Zolmitriptan Evaluation (MAZE) survey – Phase III. Current Medical Research and Opinion. 2004;20(7):1143–1150. Available from: https://dx.doi.org/10.1185/030079904125004178
  5. Steiner TJ, Stovner LJ, Katsarava Z, Lainez JM, Lampl C, Lantéri-Minet M, et al. The impact of headache in Europe: principal results of the Eurolight project. The Journal of Headache and Pain. 2014;15(1):31. Available from: https://dx.doi.org/10.1186/1129-2377-15-31
  6. Pradeep R, Nemichandra SC, Harsha S, Radhika K. Migraine Disability, Quality of Life, and Its Predictors. Annals of neurosciences. 2020;27(1):18–23. doi: 10.1177/0972753120929563
  7. Munoz-Ceron J, Marin-Careaga V, Peña L, Mutis J, Ortiz G. Headache at the emergency room: Etiologies, diagnostic usefulness of the ICHD 3 criteria, red and green flags. PLOS ONE. 2019;14(1):e0208728. Available from: https://dx.doi.org/10.1371/journal.pone.0208728
  8. Buse DC, Manack A, Serrano D, Turkel C, Lipton RB. Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. Journal of Neurology, Neurosurgery & Psychiatry. 2010;81(4):428–432. Available from: https://dx.doi.org/10.1136/jnnp.2009.192492
  9. Lai THH, Huang TCC. Update in migraine preventive treatment. Progress in Brain Research. 2020;255:1–27.
  10. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2011;77(21):1905. Available from: https://dx.doi.org/10.1212/01.wnl.0000407977.35054.34
  11. Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine. JAMA Neurology. 2018;75(9):1080. Available from: https://dx.doi.org/10.1001/jamaneurol.2018.1212
  12. Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442–1454. Available from: https://dx.doi.org/10.1177/0333102418779543
  13. Detke HC, Goadsby PJ, Wang S. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211.
  14. Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J, et al. Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1) Cephalalgia. 2020;40(3):241–254. Available from: https://dx.doi.org/10.1177/0333102420905132
  15. Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine. Neurology. 2020;94(13):e1365–e1377. Available from: https://dx.doi.org/10.1212/wnl.0000000000009169
  16. Goadsby PJ, Silberstein SD, Yeung PP, Cohen JM, Ning X, Yang R, et al. Long-term safety, tolerability, and efficacy of fremanezumab in migraine. Neurology. 2020;95(18):e2487–e2499. Available from: https://dx.doi.org/10.1212/wnl.0000000000010600
  17. Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, et al. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38(6):1026–1037. Available from: https://dx.doi.org/10.1177/0333102418759786
  18. Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F, et al. One-year sustained efficacy of erenumab in episodic migraine. Neurology. 2020;95(5):e469–e479. Available from: https://dx.doi.org/10.1212/wnl.0000000000010019
  19. Han L, Liu Y, Xiong H, Hong P. CGRP monoclonal antibody for preventive treatment of chronic migraine: An update of meta-analysis. Brain and Behavior. 2019;9(2):e01215. Available from: https://dx.doi.org/10.1002/brb3.1215
  20. Huang IH, Wu PC, Lin EY, Chen CY, Kang YN. Effects of Anti-Calcitonin Gene-Related Peptide for Migraines: A Systematic Review with Meta-Analysis of Randomized Clinical Trials. International Journal of Molecular Sciences. 2019;20(14):3527. Available from: https://dx.doi.org/10.3390/ijms20143527
  21. Tiseo C, Ornello R, Pistoia F, Sacco S. How to integrate monoclonal antibodies targeting the calcitonin gene-related peptide or its receptor in daily clinical practice. The Journal of Headache and Pain. 2019;20(1). Available from: https://dx.doi.org/10.1186/s10194-019-1000-5
  22. Gklinos P, Mitsikostas DD. Galcanezumab in migraine prevention: a systematic review and meta-analysis of randomized controlled trials. Therapeutic Advances in Neurological Disorders. 2020;13. Available from: https://dx.doi.org/10.1177/1756286420918088
  23. Yang Y, Wang Z, Gao B, Xuan H, Zhu Y, Chen Z, et al. Different doses of galcanezumab versus placebo in patients with migraine and cluster headache: a meta-analysis of randomized controlled trials. The Journal of Headache and Pain. 2020;21(1). Available from: https://dx.doi.org/10.1186/s10194-020-1085-x
  24. Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurology. 2020;20(1).
  25. Martin V, Samaan KH, Aurora S, Pearlman EM, Zhou C, Li X, et al. Efficacy and Safety of Galcanezumab for the Preventive Treatment of Migraine: A Narrative Review. Advances in Therapy. 2020;37(5):2034–2049. Available from: https://dx.doi.org/10.1007/s12325-020-01319-9
  26. Gao B, Sun N, Yang Y, Sun Y, Chen M, Chen Z, et al. Safety and Efficacy of Fremanezumab for the Prevention of Migraine: A Meta-Analysis From Randomized Controlled Trials. Frontiers in Neurology. 2020;11. Available from: https://dx.doi.org/10.3389/fneur.2020.00435
  27. Zhu C, Guan J, Xiao H, Luo W, Tong R. Erenumab safety and efficacy in migraine. Medicine. 2019;98(52):e18483. Available from: https://dx.doi.org/10.1097/md.0000000000018483
  28. Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442–1454. Available from: https://dx.doi.org/10.1177/0333102418779543
  29. Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F, et al. A Controlled Trial of Erenumab for Episodic Migraine. New England Journal of Medicine. 2017;377(22):2123–2132. Available from: https://dx.doi.org/10.1056/nejmoa1705848
  30. Buse DC, Lipton RB, Hallström Y, Reuter U, Tepper SJ, Zhang F, et al. Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. Cephalalgia. 2018;38(10):1622–1631. Available from: https://dx.doi.org/10.1177/0333102418789072
  31. Ford JH, Ayer DW, Zhang Q. Two randomized migraine studies of galcanezumab: Effects on patient functioning and disability. Neurology. 2019;93(5):508–525.

Copyright

© 2021 Published by World Headache Society. This is an open-access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/)

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