De granskade artiklarna som ligger till grund för detta litteraturarbete hämtades från databasen Pubmed, flera artiklar skulle möjligen kunna hittas genom sökningar i andra databaser. Artiklarna som inkluderades skulle ha liknande studiedesign och
ufallsvariabler för att kunna jämföras mot varandra, det är möjligt att det finns fler artiklar än de utvalda som skulle passa in på kriterierna. Det blev inte en jämn
fördelning av antal artiklar per substans, tre studier handlar om fremanezumab, 2 studier om erenumab, 2 studier om galcanezumab och endast en studie om eptinezumab. Flera av artiklarna visade sig ha samma författare; Peter J Goadsby är medförfattare till studie I (35), III (37) och VIII (41), Stephen Silberstein är medförfattare till studie I (35), II (36), IV (29) och V (38), David W Dodick är medförfattare till studie I (35), IV (29), V (38), vilket skulle kunna ge viss bias.
Slutsats
Denna litteraturstudie har undersökt hur effektiv behandling med de monoklonala antikropparna erenumab, fremanezumab, galcanezumab och eptinezumab riktade mot CGRP eller CGRP-receptorn är som profylax mot episodisk och kronisk migrän jämfört mot placebo. De åtta studiernas resultat visar att behandling med erenumab,
fremanezumab, galcanezumab eller eptinezumab hos patienter med kronisk och episodisk migrän minskar minska antalet migrändagar per månad signifikant jämfört mot placebo. Behandlingarna har tolererats väl och det har varit relativt få biverkningar som har varit jämförbara med placebo. Dock behöver det göras fler långtidsstudier för att upptäcka eventuella biverkningar på längre sikt. För den enskilda patienten betyder resultatet att det vid svårbehandlad kronisk eller episodisk migrän kan vara värt att prova behandling med någon av dessa monoklonala antikroppar.
TACK
Ett stort tack vill jag rikta till min handledare Sven Tågerud för all hjälp och vägledning under arbetets gång. Jag vill även tacka mina kurskamrater Elena Andersson och Riim Adel för ett fint stöd och samarbete under dessa tre års studier.
Sollentuna 2020-03-16 Jenny Gröhn
REFERENSER
1. Edvinsson L, Haanes KA, Warfvinge K. Does inflammation have a role in migraine? Nature reviews Neurology. 2019;15(8):483-90.
2. Edvinsson L. Kalcitoningenrelaterad peptid och migrän. Lakartidningen.
2010;107(50):3208-11.
3. Dodick DW. Migraine. Lancet (London, England).
2018;391(10127):1315-30.
4. Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia.
2018;38(1):1-211.
5. Hasselström J, Jägervall M, Waldenlind E. läkemedelsboken -huvudvärk [updated 2015/08/27; cited 2020 Jan 7]. Available from:
https://lakemedelsboken.se/kapitel/neurologi/huvudvark.html#r2_20.
6. Moriarty M, Mallick-Searle T, Barch CA, Oas K. Monoclonal Antibodies to CGRP or Its Receptor for Migraine Prevention.(Report). Journal for Nurse
Practitioners. 2019;15(10):717.
7. Torres-Ferrús M, Quintana M, Fernandez-Morales J, Alvarez-Sabin J, Pozo-Rosich P. When does chronic migraine strike? A clinical comparison of migraine according to the headache days suffered per month. Cephalalgia. 2017;37(2):104-13.
8. Schwedt TJ. Chronic migraine. Bmj. 2014;348:g1416.
9. Göbel CH, Karstedt SC, Münte TF, Göbel H, Wolfrum S, Lebedeva ER, et al. ICHD-3 is significantly more specific than ICHD-3 beta for diagnosis of migraine with aura and with typical aura. J Headache Pain. 2020;21(1):2.
10. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33(9):629-808.
11. Edvinsson L. Both neurogenic and vascular causes of primary headache.
Lakartidningen. 2001;98(39):4176.
12. Edvinsson L, Villalón CM, Maassenvandenbrink A. Basic mechanisms of migraine and its acute treatment. Pharmacology and Therapeutics. 2012;136(3):319-33.
13. Haanes K, Edvinsson L. Pathophysiological Mechanisms in Migraine and the Identification of New Therapeutic Targets. CNS Drugs. 2019;33(6):525-37.
14. Edvinsson L, Haanes KA, Warfvinge K, Krause DN. CGRP as the target of new migraine therapies - successful translation from bench to clinic. Nature reviews Neurology. 2018;14(6):338-50.
15. Ong JJY, De Felice M. Migraine Treatment: Current Acute Medications and Their Potential Mechanisms of Action. Neurotherapeutics. 2018;15(2):274-90.
16. Raffaelli B, Reuter U. The Biology of Monoclonal Antibodies: Focus on Calcitonin Gene-Related Peptide for Prophylactic Migraine Therapy. Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics.
2018;15(2):324-35.
17. Ong JJY, De Felice M. Migraine Treatment: Current Acute Medications and Their Potential Mechanisms of Action. Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics. 2018;15(2):274-90.
18. Della Pietra A, Mikhailov N, Giniatullin R. The Emerging Role of Mechanosensitive Piezo Channels in Migraine Pain. International journal of molecular sciences. 2020;21(3):E696.
19. Dahlöf C, Edvinsson L. Background and treatment of migraine disease.
Lakartidningen. 2007;104(23):1806.
20. Derry CJ, Derry S, Moore RA. Sumatriptan (all routes of administration) for acute migraine attacks in adults - overview of Cochrane reviews. Cochrane Database Syst Rev. 2014;2014(5):Cd009108.
21. Diener HC, Solbach K, Holle D, Gaul C. Integrated care for chronic migraine patients: epidemiology, burden, diagnosis and treatment options. Clin Med (Lond). 2015;15(4):344-50.
22. Dubowchik GM, Conway CM, Xin AW. Blocking the CGRP Pathway for Acute and Preventative Treatment of Migraine - The Evolution of Success. Journal of Medicinal Chemistry. 2020.
23. FDA. Eptinezumab 2020 [cited 2020 Mar 2]. Available from:
https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2020.
24. Kaplon H, Muralidharan M, Schneider Z, Reichert JM. Antibodies to watch in 2020. mAbs. 2020;12(1):1703531-.
25. Edvinsson L. CGRP receptor antagonists and antibodies against CGRP and its receptor in migraine treatment. Br J Clin Pharmacol. 2015;80(2):193-9.
26. Holland PR, Goadsby PJ. Targeted CGRP Small Molecule Antagonists for Acute Migraine Therapy. Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics. 2018;15(2):304-12.
27. Scott LJ. Ubrogepant: First Approval. Drugs. 2020:10.1007/s40265-020-01264-5.
28. Do TP, Guo S, Ashina M. Therapeutic novelties in migraine: new drugs, new hope? The journal of headache and pain. 2019;20(1):37-.
29. Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, et al. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017;377(22):2113-22.
30. Läkemedelsverket. [cited 2020 Jan 7]. Läkemedelsinformation].
Available from:
https://lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20180116000010&typ e=product.
31. Fass. Ajovy 2019 [cited 2020 Mar 2]. Available from:
https://www.fass.se/LIF/product?userType=0&nplId=20180116000010#indication.
32. Lamb YN. Galcanezumab: First Global Approval. Drugs.
2018;78(16):1769-75.
33. Markham A. Erenumab: First Global Approval. Drugs. 2018;78(11):1157-61.
34. Fass. Aimovig 2020 [cited 2020 Mar 2]. Available from:
https://www.fass.se/LIF/product?userType=0&nplId=20170524000047.
35. Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J, et al. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019;39(9):1075-85.
36. Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S, 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):425-34.
37. Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, 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):2280-7.
38. Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ,
Blankenbiller T, et al. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. Jama. 2018;319(19):1999-2008.
39. Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R, 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):1030-40.
40. 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):1442-54.
41. Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK.
Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e21.
42. Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, et al. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019;39(6):687-710.
43. Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology.
2012;78(17):1337-45.
44. Huvudvärkssällskapet. Rekommendationer om CGRP-monoklonala antikroppsbehandlingar: Svenska huvudvärkssällskapet; 2019 [cited 2020 Feb 27].
Available from: http://www.huvudvarkssallskapet.se/upload/fil_42.pdf.
45. Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Current pain and headache reports.
2012;16(1):86-92.
46. Antonaci F, Chimento P, Diener HC, Sances G, Bono G. Lessons from placebo effects in migraine treatment. Journal of Headache and Pain. 2007;8(1):63-6.
47. Schott G, Pachl H, Limbach U, Gundert-Remy U, Ludwig W-D, Lieb K.
The financing of drug trials by pharmaceutical companies and its consequences. Part 1:
a qualitative, systematic review of the literature on possible influences on the findings, protocols, and quality of drug trials. Deutsches Arzteblatt international.
2010;107(16):279-85.
48. Hjalte F, Olofsson S, Persson U, Linde M. Burden and costs of migraine in a Swedish defined patient population - a questionnaire-based study. The journal of headache and pain. 2019;20(1):65-.
49. Läkemedelsförmånsverket T-o. [cited 2020 March 5]. Available from:
https://www.tlv.se/beslut/sok-i-databasen.html?product=ajovy&tab=1.
50. Jackson JL, Kuriyama A, Kuwatsuka Y, Nickoloff S, Storch D, Jackson W, et al. Beta-blockers for the prevention of headache in adults, a systematic review and meta-analysis. PloS one. 2019;14(3):e0212785-e.
51. Silberstein SD. Preventive Migraine Treatment. Continuum (Minneapolis, Minn). 2015;21(4 Headache):973-89.
52. Silberstein SD. Topiramate in Migraine Prevention: A 2016 Perspective.
Headache: The Journal of Head and Face Pain. 2017;57(1):165-78.
53. Herd CP, Tomlinson CL, Rick C, Scotton WJ, Edwards J, Ives N, et al.
Botulinum toxins for the prevention of migraine in adults. The Cochrane database of systematic reviews. 2018;6(6):CD011616-CD.
54. Blumenfeld A, Evans RW. OnabotulinumtoxinA for Chronic Migraine.
Headache: The Journal of Head and Face Pain. 2017;57(10):E10-E6.
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