CGRP antibodies in the prophylactic treatment of migraine
Authors:
J. Šípková 1; T. Nežádal 1,2; D. Čtrnáctá 1; M. Bajaček 1; J. Dvořák 1
Authors place of work:
Centrum pro diagnostiku a léčbu bolestí hlavy, Neurologické oddělení, ÚVN Praha
1; Neurochirurgická a neuroonkologická klinika 1. LF UK a ÚVN Praha
2
Published in the journal:
Cesk Slov Neurol N 2022; 85(3): 248-256
Category:
Short Communication
doi:
https://doi.org/10.48095/cccsnn2022248
Summary
Aim: In this study, we retrospectively evaluate our center patients on the biological treatment of migraine with CGRP antibodies used after full reimbursement approval from March to the end of 2020. Only patients receiving erenumab and fremanezumab were enrolled, as galcanezumab was not approved until October 2020. Patients and methods: The sample consists of 130 patients, including 118 women (90.8%) and 12 men (9.2%) with an average age of 46.2 (21–76) years. The primary objective was to evaluate the effect of therapy at 3, 6, 9, and 12 months, the number of non-responders (monthly migraine day [MMD] reduction lower than 50%), reduction of acute medication overuse (MOH) days, relationship to disease duration, number of previous prophylaxes, migraine in family history (FH) and comorbidities. The incidence of adverse events (AE) was monitored. Results: The average number of MMD before treatment was 12.2. After 3 months, the MMD decreased by 60.5% (to 4.7), and in the following months, the effectiveness increased even further to more than 70%; greater effectiveness was achieved in chronic migraine (CM) compared to episodic (EM). After 12 months, the decrease was 69.9% for EM and 75.9% for CM. In contrast, the eff ectiveness of treatment in patients with and without positive FH was practically the same. After 12 months of treatment, the effect was more pronounced in patients with MOH (76.2% decrease) than without MOH. Efficacy was similar in men and women. Fifty-two patients received two prophylactics before starting biological therapy, 45 patients had three prophylactic drugs and 29 patients used four prophylactic drugs. The effectiveness of biological therapy was similar in all three groups (after 12 months, the decrease in MMD was 70.3 vs. 73.2 vs. 70.7%). The efficacy of erenumab and fremanezumab (administered in month or three-month intervals) was not significantly different. Therapy was discontinued due to insufficient effect only in 6 patients. AE occurred in only 10 (7.7%) patients, of whom 9 (8.6%) were treated with erenumab and 1 (4.8%) was treated with fremanezumab. Therapy was discontinued due to AE (constipation) only in 1 patient on erenumab. Conclusion: CGRP (calcitonin generelated peptide) antibodies in the treatment of migraine are significantly effective and well tolerated in our group of patients in accordance with previous randomized and observational trials.
Keywords:
Migraine – prophylactic treatment – CGRP antibodies
Zdroje
1. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the global burden of disease study 2019. Lancet 2020; 396(10258): 1204–1222. doi: 10.1016/ S0140- 6736(20)30925-9.
2. Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol 2018; 17(11): 954–976. doi: 10.1016/ S1474- 4422(18)30322-3.
3. Diamond S, Bigal ME, Silberstein SD et al. A patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention Study. Headache 2007; 47(3): 355−363. doi: 10.1111/ j.1526-4610.2006.00 631.x.
4. Nežádal T, Marková J, Bártková A et al. CGRP monoklonální protilátky v léčbě migrény – indikační kritéria a terapeutická doporučení pro Českou republiku. Cesk Slov Neurol N 2020; 83/ 116(4): 445–451. doi: 10.14735/ amcsnn2020445.
5. American Headache Society. The American Headache Society position statement on integrating new migraine treatments into clinical practise. Headache 2019; 59(1): 1–18. doi: 10.1111/ head.13456.
6. 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. doi: 10.1186/ s10194-018-0955-y.
7. Goadsby PJ, Edvinsson L, Ekman R. Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. Ann Neurol 1990; 28(2): 183–187. doi: 10.1002/ ana.410280213.
8. Iyengar S, Ossipov MH, Johnson KW. The role of calcitonin gene-related peptide in peripheral and central pain mechanisms including migraine. Pain 2017; 158(4): 543–559. doi: 10.1097/ j.pain.0000000000000831.
9. Tepper J. Anti-calcitonin gene-related peptide (CGRP) therapies: update on a previous review after the American Headache Society 60th Scientifi c meeting, June 2018. Headache 2018; 58(Suppl 3): 276–290. doi: 10.1111/ head.13417.
10. Hargreaves R, Olesen J. Calcitonin gene-related peptide modulators – the history and renaissance of a new migraine drug class. Headache 2019; 59(6): 951–970. doi: 10.1111/ head.13510.
11. Nežádal T. CGRP monoklonální protilátky v profylaktické léčbě migrény. Neurol Praxi 2019; 20(5): 356–360. doi: 10.36290/ neu.2019.141.
12. Goadsby PJ, Dodick DW, Leone M et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med 2019; 381(2): 132–141. doi: 10.1056/ NEJMoa1813440.
13. Ashina M, Goadsby PJ, Reuter U et al. Long-term efficacy and safety of erenumab in migraine prevention: results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol 2021; 28(5): 1716–1725. doi: 10.1111/ ene.14715.
14. Nežádal T, Marková J, Bártková A et al. Mezinárodní klasifikace bolestí hlavy (ICHD-3) – oficiální český překlad. Cesk Slov Neurol N 2020; 83(2): 145–152. doi: 10.14735/ amcsnn2020145.
15. Rajdová A, Vlčková E, Niedermayerová I et al. Bolesti hlavy v graviditě. Cesk Slov Neurol N 2020; 83/ 116(3): 269–276. doi: 10.14735/ amcsnn2020269.
16. Goadsby PJ, Reuter U, Hallström Y et al. A controlled trial of erenumab for episodic migraine. N Engl J Med 2017; 377(22): 2123−2132. doi: 10.1056/ NEJMoa1705848.
17. Tepper S, Ashina M, Reuter U et al. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol 2017; 16(6): 425–434. doi: 10.1016/ S1474-4422(17)30083-2.
18. Silberstein SD, Dodick DW, Bigal ME et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 2017; 377(22): 2113–2122. doi: 10.1056/ NEJMoa1709038.
19. Dodick DW, Silberstein SD, Bigal ME et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA 2018; 319(19): 1999−2008. doi: 10.1001/ jama.2018. 4853.
20. Brandes JL, Kudrow D, Yeung PP et al. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia 2020; 40(5): 470–477. doi: 10.1177/ 0333102419885905.
21. Reuter U, Goadsby PJ, Lanteri-Minet M et al. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet 2018; 392(10161): 2280–2287. doi: 10.1016/ S0140- 6736(18)32534-0.
22. Ferrari MD, Diener HC, Ning X et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet 2019; 394(10203): 1030–1040. doi: 10.1016/ S0140- 6736(19)31946-4.
23. Ornello R, Casalena A, Frattale I et al. Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. J Headache Pain 2020; 21(1): 32. doi: 10.1186/ s10194-020-01102-9.
24. Caronna E, Gallardo VJ, Alpuente A et al. Anti-CGRP monoclonal antibodies in chronic migraine with medication overuse: real-life effectiveness and predictors of response at 6 months. J Headache Pain 2021; 22(1): 120. doi: 10.1186/ s10194-021-01328-1.
25. Straube A, Broessner G, Gaul C et al. FINESSE: fremanezumab for preventive treatment in migraine. Neurology 2022; 98 (18 Suppl): P16-2.001.
26. Ashina M, Amin FM, Kokturk P et al. PEARL study protocol: a real-world study of fremanezumab effectiveness in patients with chronic or episodic migraine. Pain Manag 2021; 11(6): 647–654. doi: 10.2217/ pmt-2021- 0015.
Štítky
Paediatric neurology Neurosurgery NeurologyČlánok vyšiel v časopise
Czech and Slovak Neurology and Neurosurgery
2022 Číslo 3
- Advances in the Treatment of Myasthenia Gravis on the Horizon
- Memantine Eases Daily Life for Patients and Caregivers
- Spasmolytic Effect of Metamizole
Najčítanejšie v tomto čísle
- Neurological symptoms associated with COVID-19 based on a nation-wide online survey
- Effects of electrical stimulation according to Jantsch on spasticity – a pilot study
- Stanovisko Sekce pro diagnostiku a léčbu bolestí hlavy
- Intracerebral haemorrhage in COVID-19