Calcitonin gene-related peptide (CGRP)-targeted therapies as preventive and acute treatments for migraine—The monoclonal antibodies and gepants

Allergan USA, Inc, 2019 Amgen USA, Inc, 2020. Aimovig [Package Insert]. Aradi, 2019, Ischemic stroke associated with calcitonin gene-related peptide inhibitor therapy for migraine: a case report, J. Stroke Cerebrovasc. Dis., 28, 104286, 10.1016/j.jstrokecerebrovasdis.2019.07.002 Ashina, 2017, Erenumab (AMG 334) in episodic migraine: interim analysis of an ongoing open-label study, Neurology, 89, 1237, 10.1212/WNL.0000000000004391 Ashina, 2019, Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: a pooled analysis of four placebo-controlled trials with long-term extensions, Cephalalgia, 39, 10.1177/0333102419888222 Ashina, 2020, Eptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study (PROMISE-1), Cephalalgia, 40, 10.1177/0333102420905132 Biohaven Pharmaceuticals Inc, 2020 BioPharmaceuticals LS, Inc, 2020 Camporeale, 2018, A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine, BMC Neurol., 18, 188, 10.1186/s12883-018-1193-2 Cernuda-Morollon, 2013, Interictal increase of CGRP levels in peripheral blood as a biomarker for chronic migraine, Neurology, 81, 1191, 10.1212/WNL.0b013e3182a6cb72 Cernuda-Morollón, 2015, OnabotulinumtoxinA decreases interictal CGRP plasma levels in patients with chronic migraine, Pain, 156, 820, 10.1097/j.pain.0000000000000119 Chiang, 2015, Treatment of medication-overuse headache: a systematic review, Cephalalgia, 36, 371, 10.1177/0333102415593088 Connor, 2010, Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial, Headache, 51, 73, 10.1111/j.1526-4610.2010.01799.x Croop, 2019, Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial, Lancet, 394, 737, 10.1016/S0140-6736(19)31606-X De Vries, 2020, Pharmacological treatment of migraine: CGRP and 5-HT beyond the triptans, Pharmacol. Ther., 211, 107528, 10.1016/j.pharmthera.2020.107528 Depre, 2018, A randomized, double-blind, placebo-controlled study to evaluate the effect of erenumab on exercise time during a treadmill test in patients with stable angina, Headache, 58, 715, 10.1111/head.13316 Detke, 2018, Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study, Neurology, 91, e2211, 10.1212/WNL.0000000000006640 Diener, 2010, BI 44370 TA, an oral CGRP antagonist for the treatment of acute migraine attacks: results from a phase II study, Cephalalgia, 31, 573, 10.1177/0333102410388435 Diener, 2010, OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial, Cephalalgia, 30, 804, 10.1177/0333102410364677 Dodick, 2018, ARISE: a phase 3 randomized trial of erenumab for episodic migraine, Cephalalgia, 38, 1026, 10.1177/0333102418759786 Dodick, 2018, Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial, JAMA, 319, 1999, 10.1001/jama.2018.4853 Dodick, 2019, Ubrogepant for the treatment of migraine, N. Engl. J. Med., 381, 2230, 10.1056/NEJMoa1813049 Dodick, 2020, Ubrogepant, an acute treatment for migraine, improved patient-reported functional disability and satisfaction in 2 single-attack phase 3 randomized trials, ACHIEVE I and II, Headache, 60, 686, 10.1111/head.13766 Eli Lilly and Company, 2019 Favoni, 2019, CGRP and migraine from a cardiovascular point of view: what do we expect from blocking CGRP?, J. Headache Pain, 20, 27, 10.1186/s10194-019-0979-y Ferri, 2016, Pharmacokinetics interactions of monoclonal antibodies, Pharmacol. Res., 111, 592, 10.1016/j.phrs.2016.07.015 Stovner, 2018, 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., 17, 954, 10.1016/S1474-4422(18)30322-3 Goadsby, 1993, The trigeminovascular system and migraine: studies characterizing cerebrovascular and neuropeptide changes seen in humans and cats, Ann. Neurol., 33, 48, 10.1002/ana.410330109 Goadsby, 2017, A controlled trial of erenumab for episodic migraine, N. Engl J. Med., 377, 2123, 10.1056/NEJMoa1705848 Goadsby, 2019, Orally administered atogepant was efficacious, safe, and tolerable for the prevention of migraine: results from a phase 2b/3 study, Neurology, 92 Goadsby, 2019, Safety and tolerability of ubrogepant following intermittent, high-frequency dosing: randomized, placebo-controlled trial in healthy adults, Cephalalgia, 39, 10.1177/0333102419869918 Goldberg, 2015, Targeting CGRP: A new era for migraine treatment, CNS Drugs, 29, 443, 10.1007/s40263-015-0253-z Grundy, 2004, Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines, Circulation, 110, 227, 10.1161/01.CIR.0000133317.49796.0E Hansen, 2010, Calcitonin gene-related peptide triggers migraine-like attacks in patients with migraine with aura, Cephalalgia, 30, 1179, 10.1177/0333102410368444 Hansen, 2011, Calcitonin gene-related peptide does not cause migraine attacks in patients with familial hemiplegic migraine, Headache, 51, 544, 10.1111/j.1526-4610.2011.01861.x Hewitt, 2011, Randomized controlled trial of the CGRP receptor antagonist MK-3207 in the acute treatment of migraine, Cephalalgia, 31, 712, 10.1177/0333102411398399 Ho, 2008, Efficacy and tolerability of MK-0974 (telcagepant), a new oral antagonist of calcitonin gene-related peptide receptor, compared with zolmitriptan for acute migraine: a randomised, placebo-controlled, parallel-treatment trial, Lancet, 372, 2115, 10.1016/S0140-6736(08)61626-8 Ho, 2014, Randomized controlled trial of the CGRP receptor antagonist telcagepant for migraine prevention, Neurology, 83, 958, 10.1212/WNL.0000000000000771 Kaiser, 2013, CGRP and migraine: could PACAP play a role too?, Neuropeptides, 47, 451, 10.1016/j.npep.2013.10.010 Kielbasa, 2019, A new era for migraine: pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody, Cephalalgia, 39, 1284, 10.1177/0333102419840780 Levin, 2018, Basic considerations for the use of monoclonal antibodies in migraine, Headache, 58, 1689, 10.1111/head.13439 Lipton, 2019, Rimegepant, an oral calcitonin gene–related peptide receptor antagonist, for migraine, N. Engl. J. Med., 381, 142, 10.1056/NEJMoa1811090 Lipton, 2019, Effect of ubrogepant vs placebo on pain and the most bothersome associated symptom in the acute treatment of migraine: the ACHIEVE II randomized clinical trial, JAMA, 322, 1887, 10.1001/jama.2019.16711 Lipton, 2020, Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2, Neurology, 94, e1365, 10.1212/WNL.0000000000009169 Mayrhofer, 2019, Nomenclature of humanized mAbs: early concepts, current challenges and future perspectives, Hum. Antibodies, 27, 37, 10.3233/HAB-180347 Moreno-Ajona, 2020, Gepants, calcitonin-gene-related peptide receptor antagonists: what could be their role in migraine treatment?, Curr. Opin. Neurol., 33, 309, 10.1097/WCO.0000000000000806 Olesen, 2004, Calcitonin gene–related peptide receptor antagonist BIBN 4096 BS for the acute treatment of migraine, N. Engl. J. Med., 350, 1104, 10.1056/NEJMoa030505 Ornello, 2020, Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy, J. Headache Pain, 21, 32, 10.1186/s10194-020-01102-9 Poyner, 2002, International Union of Pharmacology. XXXII. The mammalian calcitonin gene-related peptides, adrenomedullin, amylin, and calcitonin receptors, Pharmacol. Rev., 54, 233, 10.1124/pr.54.2.233 Reuter, 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, 10.1016/S0140-6736(18)32534-0 Rimegepant: Drug Information, Lexicomp, UpToDate, Waltham, MA Robblee, 2019, Fremanezumab in the treatment of migraines: evidence to date, J. Pain Res., 12, 2589, 10.2147/JPR.S166427 Rubio-Beltran, 2019, Characterisation of the calcitonin gene-related peptide receptor antagonists ubrogepant and atogepant in human isolated coronary, cerebral and middle meningeal arteries, Cephalalgia, 40, 357, 10.1177/0333102419884943 Sarchielli, 2000, Nitric oxide metabolites, prostaglandins and trigeminal vasoactive peptides in internal jugular vein blood during spontaneous migraine attacks, Cephalalgia, 20, 907, 10.1046/j.1468-2982.2000.00146.x Silberstein, 2006, Preventive treatment of migraine, Trends Pharmacol. Sci., 27, 410, 10.1016/j.tips.2006.06.003 Silberstein, 2012, Emerging target-based paradigms to prevent and treat migraine, Clin. Pharmacol. Ther., 93, 78, 10.1038/clpt.2012.198 Silberstein, 2018, The impact of fremanezumab on medication overuse in patients with chronic migraine Silberstein, 2004, Topiramate in migraine prevention: results of a large controlled trial, Arch. Neurol., 61, 490, 10.1001/archneur.61.4.490 Silberstein, 2007, Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double-blind, placebo-controlled trial, Headache, 47, 170, 10.1111/j.1526-4610.2006.00684.x Silberstein, 2013, OnabotulinumtoxinA for treatment of chronic migraine: PREEMPT 24-week pooled subgroup analysis of patients who had acute headache medication overuse at baseline, J. Neurol. Sci., 331, 48, 10.1016/j.jns.2013.05.003 Silberstein, 2017, Fremanezumab for the preventive treatment of chronic migraine, N. Engl. J. Med., 377, 2113, 10.1056/NEJMoa1709038 Skljarevski, 2018, Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial, Cephalalgia, 38, 10.1177/0333102418779543 Stauffer, 2018, Evaluation of Galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial, JAMA Neurol., 75, 1080, 10.1001/jamaneurol.2018.1212 Tepper, 2018, 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, 58, 276, 10.1111/head.13417 Tepper, 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, 10.1016/S1474-4422(17)30083-2 Tepper, 2019, Erenumab in chronic migraine with medication overuse: subgroup analysis of a randomized trial, Neurology, 92, e2309, 10.1212/WNL.0000000000007497 Tepper, 2020, Long-term safety and efficacy of erenumab in patients with chronic migraine: results from a 52-week, open-label extension study, Cephalalgia, 40, 543, 10.1177/0333102420912726 Teva Pharmaceuticals Inc. USA, 2018 Ubrogepant: Drug Information, Lexicomp, UpToDate, Waltham, MA Uddman, 1986, Calcitonin gene-related peptide (CGRP): perivascular distribution and vasodilatory effects, Regul Pept., 15, 1, 10.1016/0167-0115(86)90071-6 VanderPluym, 2018, Fremanezumab for preventive treatment of migraine: functional status on headache-free days, Neurology, 91, e1152, 10.1212/01.wnl.0000544321.19316.40 Walter, 2014, Evaluation of cardiovascular parameters in cynomolgus monkeys following IV administration of LBR-101, a monoclonal antibody against calcitonin gene-related peptide, MAbs, 6, 871, 10.4161/mabs.29242 Yuan, 2019, Targeting CGRP for the prevention of migraine and cluster Headache: a narrative review, Headache, 59, 20, 10.1111/head.13583 Zhai, 2018, Endogenous calcitonin gene-related peptide suppresses ischemic brain injuries and progression of cognitive decline, J. Hypertens., 36, 876, 10.1097/HJH.0000000000001649