Current treatment of migraine
Keywords:
migraineAbstract
About 8% of the patients with episodic migraine have more than 10 attacks monthly, and they are at high risk for transformation in chronic migraine. Chronic migraine is defined as headaches occurring at least 15 days per month, with at least 8 days of migraine per month, lasting for 3 or more months. The disorder affects 1–3% of the adult population. The prophylactic treatment is used to decrease the frequency and severity of migraine attacks. Valproates, topiramate, propranolol, flunarizine, botulinum toxin and amitriptyline are usually used. More than 80% of the patients stop the prophylactic treatment during the first year due to side effect and lack of efficacy.
Inhibition of the calcitonin gene related peptide (CGRP) pathway prevents its coupling with the receptors. It is effective for influence on the central and peripheral mechanisms of migraine, for treatment and prevention of migraine attacks. Botulinum toxin type A is effective for prophylactic treatment of migraine and its effect is connected mainly with blocking of CGRP. Small molecules CGRP receptor antagonists and anti-CGRP antibodies are effective for prophylactic treatment of migraine. CGRP receptor antagonists, small molecule CGRP inhibitors (gepants), are effective for treatment of migraine attack, but most of them are not in the clinical practice due to potential hepatotoxicity. At least six different drugs have been developed - olcegepant, telcagepant, rimegepant, BI 44370 TA, MK-3207 and ubrogepant. Ubrogepant and rimegepant are still in phase III clinical trials. Monoclonal antibodies are developed for prophylactic treatment of migraine. They are macromolecules of proteins that directly target CGRP or its receptors. Four monoclonal antibodies are already developed and one (erenumab) targets the CGRP, while the other three (eptinezumab, fremanezumab и galcanezumab) – CGRP. This new prophylactic treatment is specific for migraine, while the other used drugs have been developed for different indications and the mode of their action on the pathophysiological mechanisms of migraine is not clear.
Erenumab, fremanezumab and galcanezumab were approved by FDA in 2018 for prophylactic treatment of migraine.
According to the guidelines of the European Headache Federation treatment with monoclonal antibodies should be applied for patients with episodic migraine after unsuccessful treatment with two other drugs for migraine prophylaxis or for patients that are not able to use different drugs due to the side effects or accompanying diseases.
References
Grozeva, V., Popivanova, B., Todorov, V., Milanov, Iv. Botulinov toksin – aktivirasht deĭstvieto i svetoven opit v lechenieto na nyakoi pŭrvichni glavi. Tsefalgiya, 2014, 16, 2, 40-49.
Arvieu, L., Mauborgne, A., Bourgoin, S., Oliver, C., Feltz, P., Hamon, M., Cesselin, F. Sumatriptan inhibits the release of CGRP and substance P from the rat spinal cord. Neuroreport, 1996, 7, 1973–1976.
Ashina, M., Dodick, D., Goadsby, P.J., Reuter, U., Silberstein, S., Zhang, F., Gage, J.R., Cheng, S., Mikol, D.D., Lenz, R.A. Erenumab (AMG 334) in episodic migraine. Neurology, 2017, 89, 1-7.
Aurora, S.K., Dodick, D.W., Turkel, C.C., DeGryse, R.E., Silberstein, S.D., Lipton, R.B., Diener, H.C., Brin, M.F., PREEMPT 1 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from a double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia, 2010, 30, 7, 793-803.
Bigal, M.E., Dodick, D.W., Rapoport, A.M., Silberstein, S.D., Ma, Y., Yang, R., Loupe, P.S., Burstein, R., Newman, L.C., Lipton, R.B. 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. The Lancet Neurology, 2015, 14, 1081-1090.
Bigal, M.E., Edvinsson, L., Rapoport, A.M., Lipton, R.B., Spierings, E.L.H., Diener, H.C., Burstein, R., Loupe, P.S., Ma, Y., Yang, R., Silberstein, S.D. Safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. The Lancet Neurology, 2015, 14, 1091-1100.
Blitzer, A., Gallagher, C.J. Pharmacology of botulinum neurotoxins. In: Botulinum neurotoxin for head and neck disorders. Blitzer, A., Benson, B.E., Guss, J., eds., New York, Thieme Medical Publishers, 2012, 1-10.
Burley, D.S., Ferdinandy, P., Baxter, G.F. Cyclic GMP and protein kinase-G in myocardial ischaemia-reperfusion: opportunities and obstacles for survival signaling. Br. J. Pharmacol., 2007, 152, 855–869.
Diener, H.C., Dodick, D.W., Aurora, S.K., Turkel, C.C., DeGryse, R.E., Lipton, R.B., Silberstein, S.D., Brin, M.F., on behalf of the PREEMPT 2 Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: results from the doubleblind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia, 2010, 30, 7, 804-814.
Dodick, D.W., Ashina, M., Brandes, J.L., Kudrow, D., Lanteri-Minet, M., Osipova, V., Palmer, K., Picard, H., Mikol, D.D., Lenz, R.A. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia, 2018, 38, 6, 1026–1037.
Dodick, D.W., Loder, E.W., Manack Adams, A., Buse, D.C., Fanning, K.M., Reed, M.L., Lipton, R.B. Assessing barriers to chronic migraine consultation, diagnosis, and treatment: results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study. Headache Epub., 2016, 56, 5, 821-834.
Dodick, D.W., Silberstein, S.D., Bigal, M.E., Yeung, P.P., Goadsby, P.J. Blankenbiller, T., Grozinski-Wolff, M., Yang, R., Ma, Y., Aycardi, E. Effect of Fremanezumab compared with placebo for prevention of episodic migraine. JAMA. 2018, 319, 19, 1999-2008.
Dodick, D.W., Turkel, C.C., DeGryse, R.E., Aurora, S.K., Silberstein, S.D., Lipton, R.B., Diener, H.C., Brin, M.F., PREEMPT Chronic Migraine Study Group. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind, randomized, placebo-controlled phases of the PREEMPT clinical program. Headache, 2010, 50, 6, 921-936.
Ferrari, M.D., Diener, H.C., Ning, X., Galic, M., Cohen, J.M., Yang, R., Mueller, M., Ahn, A.H., Schwartz, Y.C., Grozinski-Wolff, M., Janka, L., Ashina, M. 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. The Lancet, 2019.
Goadsby, P.J., Reuter, U., Hallstrom, Y., Broessner, G., Bonner, J.H., Zhang, F., Sapra, S., Picard, H., Mikol, D.D., Lenz, R.A. A controlled trial of erenumab for episodic migraine. N. Engl. J. Med., 2017, 377, 2123-2132.
Goadsby, P.J., Sprenger, T. Current practice and future directions in the prevention and acute management of migraine. Lancet Neurol., 2010, 9, 285–298.
Gobel, H. Botulinum toxin in migraine prophylaxis. J. Neurol., 2004, 251, Suppl. 1, 8-11.
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.
Holland, P.R., Goadsby, P.J. Targeted CGRP small molecule antagonists for acute migraine therapy. Neurotherapeutics, 2018, 15, 304–312.
Hong, P., Wu, X., Liu, Y. Calcitonin gene-related peptide monoclonal antibody for preventive treatment of episodic migraine: A meta analysis. Clinical Neurology and Neurosurgery, 2017, 154,74–78.
Hou, M., Xing, H., Cai, Y., Li, B., Wang, X., Li, P., Hu, X., Chen, J. The effect and safety of monoclonal antibodies to calcitonin gene-related peptide and its receptor on migraine: a systematic review and meta-analysis. The Journal of Headache and Pain, 2017, 18, 42.
Hoy, S.M. Fremanezumab: first global approval. Drugs, 2018, 78, 1829–1834.
Kageneck, C., Nixdorf-Bergweiler, B.E., Messlinger, K., Fischer, M.J. Release of CGRP from mouse brainstem slices indicates central inhibitory effect of triptans and kynurenate. J. Headache Pain, 2014, 15, 7.
Lipton, R.B., Bigal, M.E., Diamond, M., Freitag, F., Reed, M.L., Stewart, W.F., AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology, 2007, 68, 343–349.
Mathew, N.T., Jaffri, S.F.A. A Double-blind comparison of onabotulinumtoxinA (BOTOX®) and topiramate (TOPAMAX®) for the prophylactic treatment of chronic migraine: a pilot study. Headache, 2009, 49, 10, 1466–1478.
Pluym, J.V., Dodick, D.W., Lipton, R.B., Ma, Y., Loupe, P.S., Bigal, M.E. Fremanezumab for preventive treatment of migraine. Neurology, 2018, 91, e1152-e1165.
Reuter, U., Goadsby, P.J., Lanteri-Minet, M., Wen, S., Hours-Zesiger, P., Ferrari, M.D., Klatt, J. 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. The Lancet, 2018, 392 (10161), 2280-2287.
Robertson, C.E., Garza, I. Critical analysis of the use of onabotulinumtoxinA (botulinum toxin type A) in migraine. Neuropsychiatric Disease and Treatment, 2012, 8, 35–48.
Russo, A., Coppola, G., Pierelli, F., Parisi, V., Silvestro, M., Tessitore, A., Tedeschi, G. Pain Perception and Migraine. Front. Neurol., 2018, 2, 9, 576.
Sacco, S., Bendtsen, L., Ashina, M., Reuter, U., Terwindt, G., Mitsikostas, D.D., Martelletti, P. European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention. The Journal of Headache and Pain, 2019, 20, 6.
Salazar, G., Fragoso, M., Rey, A., Sanchez, L., Navarro, M.G. IncobotulinumtoxinA (Xeomin®) and OnabotulinumtoxinA (Botox®) for chronic migraine headache: experience with higher doses and changes to the injection technique. J. Neurol. Disord., 2014, 2, 6, 1000192.
Schwartz, J.S., Blitzer, A., Young, N., Benson, B.E. Migraine. In: Botulinum neurotoxin for head and neck disorders. Blitzer, A., Benson, B.E., Guss, J., eds., New York, Thieme Medical Publishers, 2012, 165-184.
Silberstein, S.D. The use of botulinum neurotoxin in the management of headache disorders. In: Manual of botulinum toxin therapy. IInd ed. Truong, D., Hallett, M., Zachary, C., Dressler, D., eds., Cambridge, Cambridge University Press, 2013, 222-232.
Silberstein, S.D. Preventive migraine treatment. Continuum, 2015, 21, 973–989.
Silberstein, S.D., Dodick, D.W., Bigal, M.E., Yeung, P.P., Goadsby, P.J., Blankenbiller, T., Grozinski-Wolff, M., Yang, R., Ma, Y., Aycardi, E. Fremanezumab for the preventive treatment of chronic migraine. N. Engl. J. Med., 2017, 377, 2113-2122.
Silberstein, S.D., Freitag, F.G., Bigal, M.E. Migraine treatment. In: Wolf’s headache and other head pain. VIII edition. Silberstein, S.D., Lipton, R.B., Dodick, D.W., eds., Oxford University Press, Inc., Oxford, 2008, 177-292.
Silberstein, S.D., Lipton, R.B., Saper, J.R. Chronic daily headache including transformed migraine, chronic tension-type headache, and medication overuse headache. In: Wolf’s headache and other head pain. VIII edition. Silberstein, S.D., Lipton, R.B., Dodick, D.W., eds., Oxford University Press, Inc., Oxford, 2008, 315-377.
Tepper, S.J. Anti-calcitonin gene-related peptide (CGRP) therapies: update on a previous review after the American headache society 60th scientific meeting, San Francisco, June 2018. Headache, 2018, 58, 276-290.
Tepper, S., Ashina, M., Reuter, U., Brandes, D., Dolezil, J.L., Silberstein, S., Winner, P., Leonardi, D., Mikol, D., Lenz, R. Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. The Lancet Neurol., 2017, 16, 6, 425-434.
Yang, S.K., Hu, C.J. Use of botulinum neurotoxin in neuropathic pain. In: Manual of botulinum toxin therapy. IInd ed. Truong, D., Hallett, M., Zachary, C., Dressler, D., eds., Cambridge, Cambridge University Press, 2013, 216-221.
Zhu, Y., Liu, Y., Zhao, J., Han, Q., Liu, L., Shen, X. The efficacy and safety of calcitonin gene-related peptide monoclonal antibody for episodic migraine: a meta-analysis. Neurological Sciences, 2018, 39, 2097–2106.
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