What is changing in chronic migraine treatment? An algorithm for onabotulinumtoxinA treatment by the Italian chronic migraine group

References

• GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet Neurol. 2019;18:459–480.
   PubMed Web of Science ®Google Scholar
• GBD Headache Collaborators. 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. 2018;17:954–976.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Silberstein SD. Episodic and chronic migraine headache: breaking down barriers to optimal treatment and prevention. Headache. 2015;55:103–122.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Munjal S, Alam A, et al. Migraine in America Symptoms and Treatment (MAST) Study: baseline study methods, treatment patterns, and gender differences. Headache. 2018;58:1408–1426.
   PubMed Web of Science ®Google Scholar
• Medrea I, Christi S. Chronic migraine - evolution of the concept and clinical implications. Headache. 2018;58:1495–1500.
   PubMed Web of Science ®Google Scholar
• Headache Classification Committee of the International Headache Society. The international classification of headache disorders, 3rd edition (beta version). Cephalalgia. 2013;33:629–808.
   PubMed Web of Science ®Google Scholar
• Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: the Chronic Migraine Epidemiology and Outcomes (CaMEO) study methods and baseline results. Cephalalgia. 2015;35:563–578.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Fanning KM, Buse DC, et al. Identifying natural subgroups of migraine based on comorbidity and concomitant condition profiles: results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) study. Headache. 2018;58:933–947.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Manack Adams A, Buse DC, et al. A Comparison of the Chronic Migraine Epidemiology and Outcomes (CaMEO) study and American Migraine Prevalence and Prevention (AMPP) Study: demographics and headache-related disability. Headache. 2016;56:1280–1289.
   PubMed Web of Science ®Google Scholar
• Blumenfeld AM, Varon SF, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301–315.
   PubMed Web of Science ®Google Scholar
• Buse D, Manack A, Serrano D, et al. Headache impact of chronic and episodic migraine: results from the American migraine prevalence and prevention study. Headache. 2012;52:3–17.
   PubMed Web of Science ®Google Scholar
• Leonardi M, Raggi A. A narrative review on the burden of migraine: when the burden is the impact on people’s life. J Headache Pain. 2019;20:41.
   PubMed Web of Science ®Google Scholar
• Minen MT, Begasse De Dhaem O, Kroon Van Diest A, et al. Migraine and its psychiatric comorbidities. J Neurol Neurosurg Psychiatry. 2016;87:741–749.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Loder EW, Manack Adams A, et al. Assessing barriers to chronic migraine consultation, diagnosis, and treatment: results from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study. Headache. 2016;56:821–834.
   PubMed Web of Science ®Google Scholar
• D’Amico D, Sansone E, Grazzi L, et al. Multimorbidity in patients with chronic migraine and medication overuse headache. Acta Neurol Scand. 2018;138:515–522.
   PubMed Web of Science ®Google Scholar
• Silberstein S, Lipton R, Dodick D, et al. Topiramate treatment of chronic migraine: a randomized, placebo-controlled trial of quality of life and other efficacy measures. Headache. 2009;49:1153–1162.
   PubMed Web of Science ®Google Scholar
• Escher CM, Paracka L, Dressler D, et al. Botulinum toxin in the management of chronic migraine: clinical evidence and experience. Ther Adv Neurol Disord. 2017;10:127–135.
   PubMed Web of Science ®Google Scholar
• Israel H, Neeb L, Reuter U. CGRP monoclonal antibodies for the preventative treatment of migraine. Curr Pain Headache Rep. 2018;22:38.
   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. 2013;53:644–655.
   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. 2010;30:793–803.
   PubMed Web of Science ®Google 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. 2010;30:804–814.
   PubMed Web of Science ®Google Scholar
• Khalil M, Zafar HW, Quarshie V, et al. Prospective analysis of the use of OnabotulinumtoxinA (BOTOX) in the treatment of chronic migraine; real-life data in 254 patients from Hull, U.K. J Headache Pain. 2014;15:54.
   PubMed Web of Science ®Google Scholar
• Boudreau GP, Grosberg BM, McAllister PJ, et al. Prophylactic onabotulinumtoxinA in patients with chronic migraine and comorbid depression: an open-label, multicenter, pilot study of efficacy, safety and effect on headache-related disability, depression, and anxiety. Int J Gen Med. 2015;8:79–86.
   PubMed Web of Science ®Google Scholar
• Cernuda-Morollon E, Ramon C, Larrosa D, et al. Long-term experience with onabotulinumtoxinA in the treatment of chronic migraine: what happens after one year? Cephalalgia. 2015;35:864–868.
   PubMed Web of Science ®Google Scholar
• Grazzi L, Usai S. Onabotulinum toxin A (Botox) for chronic migraine treatment: an Italian experience. Neurol Sci. 2015;36(Suppl 1):33–35.
   PubMed Web of Science ®Google Scholar
• Guerzoni S, Pellesi L, Baraldi C, et al. Increased efficacy of regularly repeated cycles with onabotulinumtoxinA in MOH patients beyond the first year of treatment. J Headache Pain. 2015;17:48.
   PubMed Web of Science ®Google Scholar
• Pedraza MI, de la Cruz C, Ruiz M, et al. OnabotulinumtoxinA treatment for chronic migraine: experience in 52 patients treated with the PREEMPT paradigm. Springerplus. 2015;4:176.
   PubMed Web of Science ®Google Scholar
• Negro A, Curto M, Lionetto L, et al. OnabotulinumtoxinA 155 U in medication overuse headache: a two years prospective study. Springerplus. 2015;4:826.
   PubMed Web of Science ®Google Scholar
• Negro A, Curto M, Lionetto L, et al. A two years open-label prospective study of onabotulinumtoxinA 195 U in medication overuse headache: a real-world experience. J Headache Pain. 2015;17:1.
   PubMed Web of Science ®Google Scholar
• Aicua-Rapun I, Martinez-Velasco E, Rojo A, et al. Real-life data in 115 chronic migraine patients treated with onabotulinumtoxin A during more than one year. J Headache Pain. 2016;17:112.
   PubMed Web of Science ®Google Scholar
• Butera C, Colombo B, Bianchi F, et al. Refractory chronic migraine: is drug withdrawal necessary before starting a therapy with onabotulinum toxin type A? Neurol Sci. 2016;37:1701–1706.
   PubMed Web of Science ®Google Scholar
• Demiryurek BE, Ertem DH, Tekin A, et al. Effects of onabotulinumtoxinA treatment on efficacy, depression, anxiety, and disability in Turkish patients with chronic migraine. Neurol Sci. 2016;37:1779–1784.
   PubMed Web of Science ®Google Scholar
• Kollewe K, Escher CM, Wulff DU, et al. Long-term treatment of chronic migraine with onabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting. J Neural Transm (Vienna). 2016;123:533–540.
   PubMed Web of Science ®Google Scholar
• Russo M, Manzoni GC, Taga A, et al. The use of onabotulinum toxin A (Botox((R))) in the treatment of chronic migraine at the parma headache centre: a prospective observational study. Neurol Sci. 2016;37:1127–1131.
   PubMed Web of Science ®Google Scholar
• Grazzi L. Onabotulinumtoxin A for chronic migraine with medication overuse: clinical results of a long-term treatment. Neurol Sci. 2017;38:141–143.
   PubMed Web of Science ®Google Scholar
• Matharu M, Pascual J, Nilsson Remahl I, et al. Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe. Cephalalgia. 2017;37:1384–1397.
   PubMed Web of Science ®Google Scholar
• Andreou AP, Trimboli M, Al-Kaisy A, et al. Prospective real-world analysis of OnabotulinumtoxinA in chronic migraine post-national institute for health and care excellence UK technology appraisal. Eur J Neurol. 2018;25:1069–e83.
   PubMed Web of Science ®Google Scholar
• Dikmen PY, Kosak S, Aydinlar EI, et al. A single-center retrospective study of onabotulinumtoxinA for treatment of 245 chronic migraine patients: survey results of a real-world experience. Acta Neurol Belg. 2018;118:475–484.
   PubMed Web of Science ®Google Scholar
• Stark C, Stark R, Limberg N, et al. Real-world effectiveness of onabotulinumtoxinA treatment for the prevention of headaches in adults with chronic migraine in Australia: a retrospective study. J Headache Pain. 2019;20:81.
   PubMed Web of Science ®Google Scholar
• Ahmed F, Gaul C, Garcia-Monco 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
• Rothrock JF, Adams AM, Lipton RB, et al. FORWARD Study: evaluating the comparative effectiveness of onabotulinumtoxinA and topiramate for headache prevention in adults with chronic migraine. Headache. 2019;59:1700–1713.
   PubMed Web of Science ®Google Scholar
• Blumenfeld AM, Stark RJ, Freeman MC, et al. Long-term study of the efficacy and safety of onabotulinumtoxinA for the prevention of chronic migraine: COMPEL study. J Headache Pain. 2018;19:13.
   PubMed Web of Science ®Google Scholar
• Young WB, Ivan Lopez J, Rothrock JF, et al. Effects of onabotulinumtoxinA treatment in chronic migraine patients with and without daily headache at baseline: results from the COMPEL study. J Headache Pain. 2019;20:12.
   PubMedGoogle Scholar
• Young WB, Ivan Lopez J, Rothrock JF, et al. Effects of onabotulinumtoxinA treatment in patients with and without allodynia: results of the COMPEL study. J Headache Pain. 2019;20:10.
   PubMed Web of Science ®Google Scholar
• Ornello R, Guerzoni S, Baraldi C, et al. Sustained response to onabotulinumtoxin A in patients with chronic migraine: real-life data. J Headache Pain. 2020;21:40.
   PubMed Web of Science ®Google Scholar
• Allergan Inc. BOTOX (onabotulinumtoxinA) full prescribing information; 2017 [cited Mar 2020].
   Google Scholar
• Tassorelli C, Tedeschi G, Sarchielli P, et al. Optimizing the long-term management of chronic migraine with onabotulinumtoxinA in real life. Expert Rev Neurother. 2018;18:167–176.
   PubMed Web of Science ®Google Scholar
• Bendtsen L, Sacco S, Ashina M, et al. Guideline on the use of onabotulinumtoxinA in chronic migraine: a consensus statement from the European headache federation. J Headache Pain. 2018 Sep 26;19:91.
   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
• Sacco S, Bendtsen L, Ashina M, et al. Correction to: 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;20:58.
   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
• Lipton RB, Rosen NL, Ailani J, et al. OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: pooled results from the PREEMPT randomized clinical trial program. Cephalalgia. 2016;36:899–908.
   PubMed Web of Science ®Google Scholar
• Mathew NT, Jaffri SF. A double-blind comparison of onabotulinumtoxinA (BOTOX) and topiramate (TOPAMAX) for the prophylactic treatment of chronic migraine: a pilot study. Headache. 2009;49:1466–1478.
   PubMed Web of Science ®Google Scholar
• Magalhães E, Menezes C, Cardeal M, et al. Botulinum toxin type A versus amitriptyline for the treatment of chronic daily migraine. Clin Neurol Neurosurg. 2010;112:463–466.
   PubMed Web of Science ®Google Scholar
• Blumenfeld AM, Schim JD, Chippendale TJ. Botulinum toxin type A and divalproex sodium for prophylactic treatment of episodic or chronic migraine. Headache. 2008;48:210–220.
   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
• 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
• 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
• Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91:e2211–21.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Lipton RB, Silberstein S, et al. Eptinezumab for prevention of chronic migraine: A randomized phase 2b clinical trial. Cephalalgia. 2019;39:1075–1085.
   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
• Tepper SJ, Diener HC, Ashina M, et al. Erenumab in chronic migraine with medication overuse: subgroup analysis of a randomized trial. Neurology. 2019;92:e2309–20.
   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
• 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
• National Institute for Health and Clinical Excellence. Management of migraine (with or without aura); [ cited 2020 Mar]. Available from: https://pathways.nice.org.uk/pathways/headaches/management-of-migraine-with-or-without-aura#content=view-node%3Anodes-prophylactic-treatment
   Google Scholar
• American Academy of Neurology. Practice guideline update summary: botulinum neurotoxin for the treatment of blepharospasm, cervical dystonia, adult spasticity, and headache; [ cited 2020 Mar]. Available from: https://www.aan.com/Guidelines/home/GetGuidelineContent/737
   Google Scholar
• National Institute for Health and Clinical Excellence. Botulinum toxin type A for the prevention of headaches in adults with chronic migraine; [ cited 2020 Mar]. Available from: https://www.nice.org.uk/guidance/ta260
   Google Scholar
• National Institute for Health and Clinical Excellence. Erenumab for preventing migraine [ID1188]; [ cited 2020 Mar]. Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta10302
   Google Scholar
• Kouremenos E, Arvaniti C, Constantinidis TS, et al. Hellenic headache society. Consensus of the hellenic headache society on the diagnosis and treatment of migraine. J Headache Pain. 2019;20:113.
   PubMed Web of Science ®Google Scholar
• Agostoni EC, Barbanti P, Calabresi P, et al. Current and emerging evidence-based treatment options in chronic migraine: a narrative review. J Headache Pain. 2019;20:92.
   PubMed Web of Science ®Google Scholar
• Silberstein S, Tfelt-Hansen P, Dodick DW, et al. Guidelines for controlled trials of prophylactic treatment of chronic migraine in adults. Cephalalgia. 2008;28:484–495.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Turkel CC, DeGryse RE, et al. Assessing clinically meaningful treatment effects in controlled trials: chronic migraine as an example. J Pain. 2015;16:164–175.
   PubMed Web of Science ®Google Scholar
• Silberstein SD, Dodick DW, Aurora SK, et al. Per cent of patients with chronic migraine who responded per onabotulinumtoxinA treatment cycle: PREEMPT. J Neurol Neurosurg Psychiatry. 2015;86:996–1001.
   PubMed Web of Science ®Google Scholar
• Stewart WF, Lipton RB, Dowson AJ, et al. Development and testing of the Migraine Disability Assessment (MIDAS) questionnaire to assess headache-related disability. Neurology. 2001;56:S20–8.
   PubMed Web of Science ®Google Scholar
• Haywood KL, Mars TS, Potter R, et al. Assessing the impact of headaches and the outcomes of treatment: A systematic review of patient-reported outcome measures (PROMs). Cephalalgia. 2018;38:1374–1386.
   PubMed Web of Science ®Google Scholar
• Ford JH, Foster SA, Stauffer VL, et al. 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. 2018 Nov 13;12:2413–2424.
   PubMed Web of Science ®Google Scholar
• Skovlund E, Flaten O. Response measures in the acute treatment of migraine. Cephalalgia. 1995;15:519–522. discussion 450–511.
   PubMedGoogle Scholar
• Bagley CL, Rendas-Baum R, Maglinte GA, et al. Validating migraine-specific quality of life questionnaire v2.1 in episodic and chronic migraine. Headache. 2012;52:409–421.
   PubMed Web of Science ®Google Scholar
• Stewart WF, Lipton RB, Dowson AJ, et al. Developmentand testing of the Migraine Disability Assessment (MIDAS) questionnaire to assess headache-related disability. Neurology. 2001;56:S20–8.
   PubMed Web of Science ®Google Scholar
• Cole JC, Lin P, Rupnow MF. Minimal important differences in the Migraine-Specific Quality of Life Questionnaire (MSQ) version. Cephalalgia. 2009;29:1180–1187.
   PubMed Web of Science ®Google Scholar
• Fischer D, Stewart AL, Bloch DA, et al. Capturing the patient’s view of change as a clinical outcome measure. JAMA. 1999;282:1157–1162.
   PubMed Web of Science ®Google Scholar
• Schwedt TJ. Chronic migraine. BMJ. 2014;348:g1416.
   PubMed Web of Science ®Google Scholar
• Tassorelli C, Aguggia M, De Tommaso M, et al. Onabotulinumtoxin A for the management of chronic migraine in current clinical practice: results of a survey of sixty-three Italian headache centers. J Headache Pain. 2017;18:66.
   PubMed Web of Science ®Google Scholar
• Sun-Edelstein C, Rapoport AM. Update on the pharmacological treatment of chronic migraine. Curr Pain Headache Rep. 2016;20:6.
   PubMed Web of Science ®Google Scholar
• Sarchielli P, Granella F, Prudenzano MP, et al. Italian guidelines for primary headaches: 2012 revised version. J Headache Pain. 2012;13:S31–70.
   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. 2017;57:1532–1544.
   PubMed Web of Science ®Google Scholar
• Hepp Z, Bloudek LM, Varon SF. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm. 2014;20:22–33.
   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