Advances in pharmacotherapy for the prophylactic treatment of resistant and refractory migraine

References

• Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache. 2021;61:60–68.
   PubMed Web of Science ®Google Scholar
• Deuschl G, Beghi E, Fazekas F, et al. The burden of neurological diseases in Europe: an analysis for the global burden of disease study 2017. Lancet Public Health. 2020;5:e551–e567.
   PubMed Web of Science ®Google Scholar
• Vos T, Abajobir AA, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet. 2017;390:1211–1259.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Stewart WF, Diamond S, et al. Prevalence and burden of migraine in the United States: data from the American migraine study II. Headache. 2001;41:646–657.
   PubMed Web of Science ®Google Scholar
• Lantéri-Minet M, Duru G, Mudge M, et al. Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review. Cephalalgia Int J Headache. 2011;31:837–850.
   PubMed Web of Science ®Google Scholar
• Burch RC, Buse DC, Lipton RB. Migraine: epidemiology, burden, and comorbidity. Neurol Clin. 2019;37:631–649.
   PubMed Web of Science ®Google Scholar
• Blumenfeld AM, Bloudek LM, Becker WJ, et al. Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the Second International burden of migraine study (IBMS-II). Headache J Head Face Pain. 2013;53:644–655.
   PubMed Web of Science ®Google Scholar
• Silberstein SD. Preventive migraine treatment. Contin Lifelong Learn Neurol. 2015;21:973–989.
   Google Scholar
• Pringsheim T, Davenport WJ, Mackie G, et al. Canadian headache society guideline for migraine prophylaxis. Can J Neurol Sci J Can Sci Neurol. 2012;39:S1–59.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Silberstein SD. Migraine prevention. Pract Neurol. 2007;7:383–393.
   PubMedGoogle Scholar
• Bordini CA, da Silva HM, Garbelini RP, et al. Effect of preventive treatment on health–related quality of life in episodic migraine. J Headache Pain. 2005;6:387–391.
   PubMedGoogle Scholar
• D’Amico D, Solari A, Usai S, et al. Improvement in quality of life and activity limitations in migraine patients after prophylaxis. A prospective longitudinal multicentre study. Cephalalgia Int J Headache. 2006;26:691–696.
   PubMed Web of Science ®Google Scholar
• Brandes JL, Saper JR, Diamond M, et al. Topiramate for migraine prevention: a randomized controlled trial. JAMA. 2004;291:965–973.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Lipton RB, Ferrari MD. Migraine–current understanding and treatment. N Engl J Med. 2002;346:257–270.
   PubMed Web of Science ®Google Scholar
• Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults. Neurology. 2012;78:1337–1345.
   PubMed Web of Science ®Google Scholar
• Hepp Z, Dodick DW, Varon SF, et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia Int J Headache. 2015;35:478–488.
   PubMed Web of Science ®Google Scholar
• Ford JH, Jackson J, Milligan G, et al. A real-world analysis of migraine: a cross-sectional study of disease burden and treatment patterns. Headache J Head Face Pain. 2017;57:1532–1544.
   PubMed Web of Science ®Google Scholar
• Irimia P, Palma J-A, Fernandez-Torron R, et al. Refractory migraine in a headache clinic population. BMC Neurol. 2011;11:94.
   PubMed Web of Science ®Google Scholar
• Reisman EE. The use of experimental suppositories in treating refractory migraine. Am Pract Dig Treat. 1952;3:308–310.
   PubMedGoogle Scholar
• Raffaelli B, Neeb L, Reuter U. Monoclonal antibodies for the prevention of migraine. Expert Opin Biol Ther. 2019;19:1307–1317.
   PubMed Web of Science ®Google Scholar
• 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;394:1030–1040.
   PubMed Web of Science ®Google Scholar
• Ruff DD, Ford JH, Tockhorn-Heidenreich A, et al. Efficacy of galcanezumab in patients with episodic migraine and a history of preventive treatment failure: results from two global randomized clinical trials. Eur J Neurol. 2020;27:609–618.
   PubMed Web of Science ®Google Scholar
• Kuruppu DK, Tobin J, Dong Y, et al. Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments. BMC Neurol. 2021;21:175.
   PubMedGoogle Scholar
• American Headache Society. The American headache society position statement on integrating new migraine treatments into clinical practice. Headache. 2019;59:1–18.
   PubMed Web of Science ®Google Scholar
• 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;20:6.
   PubMed Web of Science ®Google Scholar
• Goadsby P, Schoenen J, Ferrari M, et al. Towards a definition of intractable headache for use in clinical practice and trials. Cephalalgia. 2006;26:1168–1170.
   PubMed Web of Science ®Google Scholar
• Schulman EA, Lake IIIAE, Goadsby PJ, et al. Defining refractory migraine and refractory chronic migraine: proposed criteria from the refractory headache special interest section of the American headache society. Headache J Head Face Pain. 2008;48:778–782.
   PubMed Web of Science ®Google Scholar
• Schulman EA, Lipton R, Peterlin BL, et al. Commentary from the refractory headache special interest section on defining the pharmacologically intractable headache for clinical trials and clinical practice. Headache J Head Face Pain. 2010;50:1637–1639.
   PubMedGoogle Scholar
• Martelletti P, Katsarava Z, Lampl C, et al. Refractory chronic migraine: a consensus statement on clinical definition from the European headache federation. J Headache Pain. 2014;15:47.
   PubMed Web of Science ®Google Scholar
• Sacco S, Braschinsky M, Ducros A, et al. European headache federation consensus on the definition of resistant and refractory migraine: developed with the endorsement of the European migraine & headache alliance (EMHA). J Headache Pain. 2020;21:76.
   PubMed Web of Science ®Google Scholar
• Mansoureh T, Rahmat Jirde M, Nilavari K, et al. Cinnarizine in refractory migraine prophylaxis: efficacy and tolerability. A comparison with sodium valproate. J Headache Pain. 2008;9:77–82.
   PubMed Web of Science ®Google Scholar
• Kemal Erdemoglu A, Ozbakır S. Valproic acid in prophylaxis of refractory migraine. Acta Neurol Scand. 2000;102:354–358.
   PubMedGoogle Scholar
• Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia Int J Headache. 2010;30:804–814.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Turkel CC, DeGryse RE, et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. 2010;50:921–936.
   PubMed Web of Science ®Google Scholar
• Aurora SK, Winner P, Freeman MC, et al. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011;51:1358–1373.
   PubMed Web of Science ®Google Scholar
• Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia Int J Headache. 2010;30:793–803.
   PubMed Web of Science ®Google Scholar
• Dolly O. Synaptic transmission: inhibition of neurotransmitter release by botulinum toxins. Headache. 2003;43(Suppl 1):S16–24.
   PubMedGoogle Scholar
• Aoki KR. Evidence for antinociceptive activity of botulinum toxin Type A in pain management. Headache J Head Face Pain. 2003;43:9–15.
   PubMed Web of Science ®Google Scholar
• Deleu D, Hanssens Y, Worthing E. Symptomatic and prophylactic treatment of migraine: a critical reappraisal. Clin Neuropharmacol. 1998;21:267–279.
   PubMed Web of Science ®Google Scholar
• Ahmed F, Gaul C, García-Moncó JC, et al. An open-label prospective study of the real-life use of onabotulinumtoxinA for the treatment of chronic migraine: the REPOSE study. J Headache Pain. 2019;20:26.
   PubMed Web of Science ®Google Scholar
• de Tommaso M, Delussi M, Ricci K, et al. Effects of OnabotulintoxinA on habituation of laser evoked responses in chronic migraine. Toxins (Basel). 2016;8:E163.
   PubMedGoogle Scholar
• Goadsby PJ, Holland PR, Martins-Oliveira M, et al. Pathophysiology of migraine: a disorder of sensory processing. Physiol Rev. 2017;97:553–622.
   PubMed Web of Science ®Google Scholar
• Uddman R, Edvinsson L, Ekman R, et al. Innervation of the feline cerebral vasculature by nerve fibers containing calcitonin gene-related peptide: trigeminal origin and co-existence with substance P. Neurosci Lett. 1985;62:131–136.
   PubMed Web of Science ®Google Scholar
• Bigal ME, Walter S, Rapoport AM. Calcitonin Gene-Related Peptide (CGRP) and migraine current understanding and State of development. Headache J Head Face Pain. 2013;53:1230–1244.
   PubMed Web of Science ®Google Scholar
• Edvinsson L, Haanes KA, Warfvinge K, et al. CGRP as the target of new migraine therapies - successful translation from bench to clinic. Nat Rev Neurol. 2018;14:338–350.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Edvinsson L, Ekman R. Release of vasoactive peptides in the extracerebral circulation of humans and the cat during activation of the trigeminovascular system. Ann Neurol. 1988;23:193–196.
   PubMed Web of Science ®Google Scholar
• Denekas T, Tröltzsch M, Vater A, et al. Inhibition of stimulated meningeal blood flow by a calcitonin gene-related peptide binding mirror-image RNA oligonucleotide. Br J Pharmacol. 2006;148:536–543.
   PubMed Web of Science ®Google Scholar
• Raddant AC, Russo AF. Calcitonin gene-related peptide in migraine: intersection of peripheral inflammation and central modulation. Expert Rev Mol Med. 2011;13:e36.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Reuter U, Hallström Y, et al. A controlled trial of erenumab for episodic migraine. N Engl J Med. 2017;377:2123–2132.
   PubMed Web of Science ®Google Scholar
• Silberstein SD, Dodick DW, Bigal ME, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377:2113–2122.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Goadsby PJ, Spierings ELH, et al. Safety and efficacy of LY2951742, a monoclonal antibody to calcitonin gene-related peptide, for the prevention of migraine: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Neurol. 2014;13:885–892.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Goadsby PJ, Silberstein SD, et al. Safety and efficacy of ALD403, an antibody to calcitonin gene-related peptide, for the prevention of frequent episodic migraine: a randomised, double-blind, placebo-controlled, exploratory phase 2 trial. Lancet Neurol. 2014;13:1100–1107.
   PubMed Web of Science ®Google Scholar
• Bigal ME, Dodick DW, Rapoport AM, et al. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of high-frequency episodic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol. 2015;14:1081–1090.
   PubMed Web of Science ®Google Scholar
• 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;319:1999–2008.
   PubMed Web of Science ®Google Scholar
• Förderreuther S, Zhang Q, Stauffer VL, et al. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. 2018;19:121.
   PubMed Web of Science ®Google Scholar
• 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;16:425–434.
   PubMed Web of Science ®Google Scholar
• Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24 weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy-2) study – PubMed. [Internet]. [cited 2022 Jan 10]. Available from: https://pubmed.ncbi.nlm.nih.gov/33023473/.
   Google Scholar
• Mitsikostas DD, Reuter U. Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: comparisons across randomized controlled studies. Curr Opin Neurol. 2017;30:272–280.
   PubMed Web of Science ®Google Scholar
• Raffaelli B, Reuter U. The biology of monoclonal antibodies: focus on Calcitonin Gene-Related Peptide for prophylactic migraine therapy. Neurother J Am Soc Exp Neurother. 2018;15:324–335.
   Google Scholar
• Shi L, Lehto SG, Zhu DXD, et al. Pharmacologic characterization of AMG 334, a potent and selective human monoclonal antibody against the Calcitonin Gene-Related Peptide receptor. J Pharmacol Exp Ther. 2016;356:223–231.
   PubMed Web of Science ®Google Scholar
• Walter S, Bigal ME. TEV-48125: a review of a monoclonal CGRP antibody in development for the preventive treatment of migraine. Curr Pain Headache Rep. 2015;19:6.
   PubMed Web of Science ®Google Scholar
• Hoy SM. Fremanezumab: first global approval. Drugs. 2018;78:1829–1834.
   PubMed Web of Science ®Google Scholar
• Reuter U, Lucas C, Dolezil D, et al. Galcanezumab in patients with multiple previous migraine preventive medication category failures: results from the open-label period of the CONQUER trial. Adv Ther. 2021;38:5465–5483.
   PubMedGoogle Scholar
• Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91:e2211–e2221.
   PubMed Web of Science ®Google Scholar
• Mulleners WM, Kim B-K, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19:814–825.
   PubMed Web of Science ®Google Scholar
• Schwedt TJ, Kuruppu DK, Dong Y, et al. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain. 2021;22:15.
   PubMedGoogle Scholar
• Ruff DD, Ford JH, Tockhorn-Heidenreich A, et al. Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure. Cephalalgia. 2019;39:931–944.
   PubMed Web of Science ®Google Scholar
• Ailani J, Pearlman E, Zhang Q, et al. Positive response to galcanezumab following treatment failure to onabotulinumtoxinA in patients with migraine: post hoc analyses of three randomized double-blind studies. Eur J Neurol. 2020;27:542–549.
   PubMed Web of Science ®Google Scholar
• Lattanzi S, Brigo F, Trinka E, et al. Erenumab for preventive treatment of migraine: a systematic review and Meta-analysis of efficacy and safety. Drugs. 2019;79:417–431.
   PubMed Web of Science ®Google Scholar
• Ashina M, Tepper S, Brandes JL, et al. Efficacy and safety of erenumab (AMG334) in chronic migraine patients with prior preventive treatment failure: a subgroup analysis of a randomized, double-blind, placebo-controlled study. Cephalalgia. 2018;38:1611–1621.
   PubMed Web of Science ®Google Scholar
• Goadsby PJ, Paemeleire K, Broessner G, et al. Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure: a subgroup analysis of a randomized, double-blind, placebo-controlled study. Cephalalgia. 2019;39:817–826.
   PubMedGoogle Scholar
• 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;392:2280–2287.
   PubMed Web of Science ®Google Scholar
• Hirata K, Sakai F, Takeshima T, et al. Efficacy and safety of erenumab in Japanese migraine patients with prior preventive treatment failure or concomitant preventive treatment: subgroup analyses of a phase 3, randomized trial. J Headache Pain. 2021;22:110.
   PubMedGoogle Scholar
• Russo A, Silvestro M, Scotto Di Clemente F, et al. Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: a comprehensive real-world experience. J Headache Pain. 2020;21:69.
   PubMed Web of Science ®Google Scholar
• 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;21:32.
   PubMed Web of Science ®Google Scholar
• Raffaelli B, Kalantzis R, Mecklenburg J, et al. Erenumab in Chronic migraine patients who previously failed five first-line oral prophylactics and OnabotulinumtoxinA: a dual-center retrospective observational study. Front Neurol. 2020;11:417.
   PubMed Web of Science ®Google Scholar
• Lundbeck reports positive results for Vyepti[®] (eptinezumab) from the DELIVER study in patients with migraine and prior preventive treatment failures [Internet]. News Powered Cision. [cited 2022 Feb 26]. Available from: https://news.cision.com/h–lundbeck-a-s/r/lundbeck-reports-positive-results-for-vyepti—eptinezumab–from-the-deliver-study-in-patients-with-,c3443462.
   Google Scholar
• Overeem LH, Peikert A, Hofacker MD, et al. Effect of antibody switch in non-responders to a CGRP receptor antibody treatment in migraine: a multi-center retrospective cohort study. Cephalalgia. 2022;42:291–301.
   PubMedGoogle Scholar
• D’Amico D, Curone M, Tullo V, et al. Polytherapy for the prophylaxis of chronic migraine: an Italian survey. Neurol Sci Off J Ital Neurol Soc Ital Soc Clin Neurophysiol. 2011;32(Suppl 1):S185–188.
   Google Scholar
• Casucci G, Villani V, Cologno D, et al. Polytherapy for migraine prophylaxis. Neurol Sci. 2012;33:147–150.
   PubMedGoogle Scholar
• Tinsley A, Rothrock JF. Safety and tolerability of preventive treatment options for chronic migraine. Expert Opin Drug Saf. 2021;20:1523–1533.
   PubMedGoogle Scholar
• Ailani J, Burch RC, Robbins MS, et al. The American headache society consensus statement: update on integrating new migraine treatments into clinical practice. Headache J Head Face Pain. 2021;61:1021–1039.
   PubMed Web of Science ®Google Scholar
• Pharmacokinetics S-FD. Pharmacodynamics and drug–drug interactions of new anti-migraine drugs—Lasmiditan, gepants, and Calcitonin-Gene-Related Peptide (CGRP) receptor monoclonal antibodies. Pharmaceutics. 2020;12:1180.
   Google Scholar
• Ailani J, Blumenfeld AM. Combination CGRP monoclonal antibody and onabotulinumtoxinA treatment for preventive treatment in chronic migraine. Headache J Head Face Pain. 2022;62:106–108.
   PubMedGoogle Scholar
• Pellesi L, Do TP, Ashina H, et al. dual therapy with anti-CGRP monoclonal antibodies and botulinum toxin for migraine prevention: is there a rationale? Headache. 2020;60:1056–1065.
   PubMed Web of Science ®Google Scholar
• Cohen F, Armand C, Lipton RB, et al. Efficacy and tolerability of Calcitonin Gene-Related Peptide-targeted monoclonal antibody medications as add-on therapy to OnabotulinumtoxinA in patients with chronic migraine. Pain Med Malden Mass. 2021;22:1857–1863.
   PubMedGoogle Scholar
• Blumenfeld AM, Frishberg BM, Schim JD, et al. Real-world evidence for control of Chronic Migraine Patients Receiving CGRP monoclonal antibody therapy added to OnabotulinumtoxinA: a retrospective chart review. Pain Ther. 2021;10:809–826.
   PubMed Web of Science ®Google Scholar
• Silvestro M, Tessitore A, Scotto Di Clemente F, et al. Additive interaction between Onabotulinumtoxin-A and erenumab in patients with refractory migraine. Front Neurol. 2021;12:656294.
   PubMed Web of Science ®Google Scholar
• Tajti J, Majláth Z, Szok D, et al. Drug safety in acute migraine treatment. Expert Opin Drug Saf. 2015;14:891–909.
   PubMed Web of Science ®Google Scholar
• Negro A, Martelletti P. Chronic migraine plus medication overuse headache: two entities or not? J Headache Pain. 2011;12:593–601.
   PubMed Web of Science ®Google Scholar
• Greene KA, Gentile CP, Szperka CL, et al. CGRP monoclonal antibody use for the preventive treatment of refractory headache disorders in adolescents. Pediatr Neurol. 2021;114:62–67.
   PubMedGoogle Scholar
• Cohen JM, Ning X, Kessler Y, et al. Immunogenicity of biologic therapies for migraine: a review of current evidence. J Headache Pain. 2021;22:3.
   PubMedGoogle Scholar
• Reuter U, Ehrlich M, Gendolla A, et al. Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia Int J Headache. 2022;42:108–118.
   PubMedGoogle Scholar
• Vandervorst F, Van Deun L, Van Dycke A, et al. CGRP monoclonal antibodies in migraine: an efficacy and tolerability comparison with standard prophylactic drugs. J Headache Pain. 2021;22:128.
   PubMed Web of Science ®Google Scholar
• Drellia K, Kokoti L, Deligianni CI, et al. Anti-CGRP monoclonal antibodies for migraine prevention: a systematic review and likelihood to help or harm analysis. Cephalalgia. 2021;41:851–864.
   PubMedGoogle Scholar