European headache federation guideline on the use of monoclonal antibodies acting on the calcitonin gene related peptide or its receptor for migraine prevention
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GBD 2015 Disease and injury incidence and prevalence collaborators (2016) Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet 388:1545–1602
Stovner LJ, Andree C (2010) Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain 11:289–299
Victor T, Hu X, Campbell J, Buse D, Lipton R (2010) Migraine prevalence by age and sex in the United States: a life-span study. Cephalalgia 30:1065–1072
Bigal ME, Serrano D, Reed M, Lipton RB (2008) Chronic migraine in the population - burden, diagnosis, and satisfaction with treatment. Neurology 71:559–566
Friedman AP, Losin S (1961) Evaluation of UML-491 in the treatment of vascular headaches. An analysis of the effects of 1-methyl-D-lysergic acid (plus) butanolamide bimaleate (methysergide). Arch Neurol 4:241–245
Aurora SK, Dodick DW, Turkel CC, DeGryse RE, Silberstein SD, Lipton RB, Diener HC, Brin MF (2010) OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia 30:793–803
Diener HC, Dodick DW, Aurora SK, Turkel CC, DeGryse RE, Lipton RB, Silberstein SD, Brin MF (2010) PREEMPT 2 chronic migraine study group. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia 30:804–814
Silberstein SD, Neto W, Schmitt J, Jacobs D, Group MS (2004) Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol 61:490–495
Silberstein SD, Holland S, Freitag F, Dodick DW, Argoff C, Ashman E (2012) Quality standards Subcommittee of the American Academy of neurology and the American headache society. 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 78:1337–1345
Luykx J, Mason M, Ferrari MD, Carpay J (2009) Are migraineurs at increased risk of adverse drug responses? A meta-analytic comparison of topiramate-related adverse drug reactions in epilepsy and migraine. Clin Pharmacol Ther 85:283–288
Berger A, Bloudek LM, Varon SF, Oster G (2012) Adherence with migraine prophylaxis in clinical practice. Pain Pract 12:541–549
Diamond S, Bigal ME, Silberstein S, Loder E, Reed M, Lipton RB (2007) Patterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American migraine prevalence and prevention study. Headache 47:355–363
Loder EW, Rizzoli P (2011) Tolerance and loss of beneficial effect during migraine prophylaxis: clinical considerations. Headache 51:1336–1345
Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB (2015) Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia 35:478–488
Martelletti P (2017) The application of CGRP(r) monoclonal antibodies in migraine spectrum: needs and priorities. BioDrugs 31:483–485
Mitsikostas DD, Reuter U (2017) Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: comparisons across randomized controlled studies. Curr Opin Neurol 30:272–280
Reuter U (2018) A review of monoclonal antibody therapies and other preventative treatments in migraine. Headache 58 Suppl 1:48–59
The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system http://gdt.guidelinedevelopment.org/app/handbook/handbook.html (Accessed, 12 June 2018)
Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med 6:e1000097
Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P, Montori V, Akl EA, Djulbegovic B, Falck-Ytter Y, Norris SL, Williams JW Jr, Atkins D, Meerpohl J, Schünemann HJ (2011) GRADE guidelines: 4. Rating the quality of evidence--study limitations (risk of bias). J Clin Epidemiol 64:407–415
Guyatt GH, Oxman AD, Sultan S, Glasziou P, Akl EA, Alonso-Coello P, Atkins D, Kunz R, Brozek J, Montori V, Jaeschke R, Rind D, Dahm P, Meerpohl J, Vist G, Berliner E, Norris S, Falck-Ytter Y, Murad MH, Schünemann HJ (2011) GRADE working group. GRADE guidelines: 9. Rating up the quality of evidence. J Clin Epidemiol 64:1311–1316
Dalkey NC, Helmer-Hirschberg O (1962) An experimental application of the delphi method to the use of experts. Rand Corp, Santa Monica
Ayer DW, Skljarevski V, Ford JH, Nyhuis AW, Lipton RB, Aurora SK (2018) Measures of functioning in patients with episodic migraine: findings from a double-blind, randomized, placebo-controlled phase 2b trial with galcanezumab. Headache 58:1225–1235
Ashina M, Dodick D, Goadsby PJ, Reuter U, Silberstein S, Zhang F, Gage JR, Cheng S, Mikol DD, Lenz RA (2017) Erenumab (AMG 334) in episodic migraine: interim analysis of an ongoing open-label study. Neurology 89:1237–1243
Ashina M, Tepper S, Brandes JL, Reuter U, Boudreau G, Dolezil D, Cheng S, Zhang F, Lenz R, Klatt J, Mikol DD (2018) 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 38:1611–1621
Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC, Burstein R, Loupe PS, Ma Y, Yang R (2015) Silberstein SD (2015a) safety, tolerability, and efficacy of TEV-48125 for preventive treatment of chronic migraine: a multicentre, randomised, double-blind, placebo-controlled, phase 2b study. Lancet Neurol 14:1091–1100
Bigal ME, Dodick DW, Rapoport AM, Silberstein SD, Ma Y, Yang R, Loupe PS, Burstein R, Newman LC, Lipton RB (2015) 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 14:1081–1090
Bigal ME, Dodick DW, Krymchantowski AV, VanderPluym JH, Tepper SJ, Aycardi E, Loupe PS, Ma Y, Goadsby PJ (2016) TEV-48125 for the preventive treatment of chronic migraine: efficacy at early time points. Neurology 87:41–48
Buse DC, Lipton RB, Hallström Y, Reuter U, Tepper SJ, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA (2018) Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. Cephalalgia 38:1622–1631
Cohen JM, Dodick DW, Yang R, Newman LC, Li T, Aycardi E, Bigal ME (2017) Fremanezumab as add-on treatment for patients treated with other migraine preventive medicines. Headache 57:1375–1384
Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK (2018) Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology 91:e1–e11. https://doi.org/10.1212/WNL.0000000000006640.
Dodick DW, Goadsby PJ, Silberstein SD, Lipton RB, Olesen J, Ashina M, Wilks K, Kudrow D, Kroll R, Kohrman B, Bargar R, Hirman J, Smith J (2014) ALD403 study investigators. 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 13:1100–1107
Dodick DW, Goadsby PJ, Spierings EL, Scherer JC, Sweeney SP (2014) Grayzel. 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 13:885–892
Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E (2018) Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA 319:1999–2008
Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V, Palmer K, Picard H, Mikol DD, Lenz RA (2018) ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia 38:1026–1037
Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, Zhang F, Sapra S, Picard H, Mikol DD, Lenz RA (2017) A controlled trial of erenumab for episodic migraine. N Engl J Med 377:2123–2132
Halker Singh RB, Aycardi E, Bigal ME, Loupe PS, McDonald M, Dodick DW (2018) Sustained reductions in migraine days, moderate-to-severe headache days and days with acute medication use for HFEM and CM patients taking fremanezumab: post-hoc analyses from phase 2 trials. Cephalalgia. https://doi.org/10.1177/0333102418772585
Oakes TMM, Skljarevski V, Zhang Q, Kielbasa W, Hodsdon ME, Detke HC, Camporeale A, Saper JR (2018) Safety of galcanezumab in patients with episodic migraine: a randomized placebo-controlled dose-ranging phase 2b study. Cephalalgia 38:1015–1025
Rosen N, Pearlman E, Ruff D, Day K, Jim Nagy A (2018) 100% response rate to galcanezumab in patients with episodic migraine: a post hoc analysis of the results from phase 3, randomized, double-blind, placebo-controlled EVOLVE-1 and EVOLVE-2 studies. Headache 58:1347–1357
Schwedt T, Reuter U, Tepper S, Ashina M, Kudrow D, Broessner G, Boudreau GP, McAllister P, Vu T, Zhang F, Cheng S, Picard H, Wen S, Kahn J, Klatt J, Mikol D (2018) Early onset of efficacy with erenumab in patients with episodic and chronic migraine. J Headache Pain 19:92
Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E (2017) Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 377:2113–2122
Skljarevski V, Oakes TM, Zhang Q, Ferguson MB, Martinez J, Camporeale A, Johnson KW, Shan Q, Carter J, Schacht A, Goadsby PJ, Dodick DW (2018) Effect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trial. JAMA Neurol 75:187–193
Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR (2018) Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol 75:1080–1088
Sun H, Dodick DW, Silberstein S, Goadsby PJ, Reuter U, Ashina M, Saper J, Cady R, Chon Y, Dietrich J, Lenz R (2016) Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol 15:382–390
Tepper S, Ashina M, Reuter U, Brandes JL, Doležil D, Silberstein S, Winner P, Leonardi D, Mikol D, Lenz R (2017) Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol 16:425–434
VanderPluym J, Dodick DW, Lipton RB, Ma Y, Loupe PS, Bigal ME (2018) Fremanezumab for preventive treatment of migraine: functional status on headache-free days. Neurology 91:e1152–e1165
Camporeale A, Kudrow D, Sides R, Wang S, Van Dycke A, Selzler KJ, Stauffer VL (2018) A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. BMC Neurol 18:188
Ford JH, Foster SA, Stauffer VL, Ruff DD, Aurora SK, Versijpt J (2018) Patient satisfaction, health care resource utilization, and acute headache medication use with galcanezumab: results from a 12-month open-label study in patients with migraine. Patient Prefer Adherence 12:2413–2424
Nichols R, Doty E, Sacco S, Ruff D, Pearlman E, Aurora SK (2018) Analysis of initial nonresponders to galcanezumab in patients with episodic or chronic migraine: results from the EVOLVE-1, EVOLVE-2, and REGAIN randomized, double-blind, placebo-controlled studies. Headache. https://doi.org/10.1111/head.13443
Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J (2018) 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 392:2280–2287
Blumenfeld AM, Bloudek LM, Becker WJ, Buse DC, Varon SF, Maglinte GA, Wilcox TK, Kawata AK, Lipton RB (2013) 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 53:644–655
Rapoport A, Mauskop A, Diener HC, Schwalen S, Pfeil J (2006) Long-term migraine prevention with topiramate: open label extension of pivotal trials. Headache 46:1151–1160
Pijpers JA, Louter MA, de Bruin ME, van Zwet EW, Zitman FG, Ferrari MD, Terwindt GM (2016) Detoxification in medication-overuse headache, a retrospective controlled follow-up study: does care by a headache nurse lead to cure? Cephalalgia 36:122–130
Russell FA, King R, Smillie SJ, Kodji X, Brain SD (2014) Calcitonin gene-related peptide: physiology and pathophysiology. Physiol Rev 94:1099–1142
Deen M, Hougaard A, Hansen HD, Svarer C, Eiberg H, Lehel S, Knudsen GM, Ashina M (2018) Migraine is associated with high brain 5-HT levels as indexed by 5-HT4 receptor binding. Cephalalgia. https://doi.org/10.1177/0333102418793642
Chaitman BR, Ho AP, Behm MO, Rowe JF, Palcza JS, Laethem T, Heirman I, Panebianco DL, Kobalava Z, Martsevich SY, Free AL, Bittar N, Chrysant SG, Ho TW, Chodakewitz JA, Murphy MG, Blanchard RL (2012) A randomized, placebo-controlled study of the effects of telcagepant on exercise time in patients with stable angina. Clin Pharmacol Ther 91:459–466