Nonspecific oral medications versus anti-calcitonin gene-related peptide monoclonal antibodies for migraine: A systematic review and meta-analysis of randomized controlled trials.
calcitonin gene–related peptide antagonist
calcitonin gene–related peptide monoclonal antibodies
insurance
migraine
preventive treatment
Journal
Headache
ISSN: 1526-4610
Titre abrégé: Headache
Pays: United States
ID NLM: 2985091R
Informations de publication
Date de publication:
18 Apr 2024
18 Apr 2024
Historique:
revised:
22
02
2024
received:
03
05
2023
accepted:
22
02
2024
medline:
18
4
2024
pubmed:
18
4
2024
entrez:
18
4
2024
Statut:
aheadofprint
Résumé
To compare calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) versus nonspecific oral migraine preventives (NOEPs). Insurers mandate step therapy with NOEPs before approving CGRP mAbs. Databases were searched for class I or II randomized controlled trials (RCTs) comparing CGRP mAbs or NOEPs versus placebo for migraine prevention in adults. The primary outcome measure was monthly migraine days (MMD) or moderate to severe headache days. Twelve RCTs for CGRP mAbs, 5 RCTs for topiramate, and 3 RCTs for divalproex were included in the meta-analysis. There was high certainty that CGRP mAbs are more effective than placebo, with weighted mean difference (WMD; 95% confidence interval) of -1.64 (-1.99 to -1.28) MMD, which is compatible with small effect size (Cohen's d -0.25 [-0.34 to -0.16]). Certainty of evidence that topiramate or divalproex is more effective than placebo was very low and low, respectively (WMD -1.45 [-1.52 to -1.38] and -1.65 [-2.30 to -1.00], respectively; Cohen's d -1.25 [-2.47 to -0.03] and -0.48 [-0.67 to -0.29], respectively). Trial sequential analysis showed that information size was adequate and that CGRP mAbs had clear benefit versus placebo. Network meta-analysis showed no statistically significant difference between CGRP mAbs and topiramate (WMD -0.19 [-0.56 to 0.17]) or divalproex (0.01 [-0.73 to 0.75]). No significant difference was seen between topiramate or divalproex (0.21 [-0.45 to 0.86]). There is high certainty that CGRP mAbs are more effective than placebo, but the effect size is small. When feasible, CGRP mAbs may be prescribed as first-line preventives; topiramate or divalproex could be as effective but are less well tolerated. The findings of this study support the recently published 2024 position of the American Headache Society on the use of CGRP mAbs as the first-line treatment.
Sections du résumé
OBJECTIVE
OBJECTIVE
To compare calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) versus nonspecific oral migraine preventives (NOEPs).
BACKGROUND
BACKGROUND
Insurers mandate step therapy with NOEPs before approving CGRP mAbs.
METHODS
METHODS
Databases were searched for class I or II randomized controlled trials (RCTs) comparing CGRP mAbs or NOEPs versus placebo for migraine prevention in adults. The primary outcome measure was monthly migraine days (MMD) or moderate to severe headache days.
RESULTS
RESULTS
Twelve RCTs for CGRP mAbs, 5 RCTs for topiramate, and 3 RCTs for divalproex were included in the meta-analysis. There was high certainty that CGRP mAbs are more effective than placebo, with weighted mean difference (WMD; 95% confidence interval) of -1.64 (-1.99 to -1.28) MMD, which is compatible with small effect size (Cohen's d -0.25 [-0.34 to -0.16]). Certainty of evidence that topiramate or divalproex is more effective than placebo was very low and low, respectively (WMD -1.45 [-1.52 to -1.38] and -1.65 [-2.30 to -1.00], respectively; Cohen's d -1.25 [-2.47 to -0.03] and -0.48 [-0.67 to -0.29], respectively). Trial sequential analysis showed that information size was adequate and that CGRP mAbs had clear benefit versus placebo. Network meta-analysis showed no statistically significant difference between CGRP mAbs and topiramate (WMD -0.19 [-0.56 to 0.17]) or divalproex (0.01 [-0.73 to 0.75]). No significant difference was seen between topiramate or divalproex (0.21 [-0.45 to 0.86]).
CONCLUSIONS
CONCLUSIONS
There is high certainty that CGRP mAbs are more effective than placebo, but the effect size is small. When feasible, CGRP mAbs may be prescribed as first-line preventives; topiramate or divalproex could be as effective but are less well tolerated. The findings of this study support the recently published 2024 position of the American Headache Society on the use of CGRP mAbs as the first-line treatment.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : American Academy of Pain Medicine (AAPM) Foundation
Organisme : AAPM
Informations de copyright
© 2024 American Headache Society.
Références
Loder E, Burch R, Rizzoli P. The 2012 AHS/AAN guidelines for prevention of episodic migraine: a summary and comparison with other recent clinical practice guidelines. Headache. 2012;52:930‐945.
Ailani J, Burch RC, Robbins MS. Board of Directors of the American Headache S. The American Headache Society Consensus Statement: update on integrating new migraine treatments into clinical practice. Headache. 2021;61:1021‐1039.
UnitedHealthcare Clinical Pharmacy Programs. Prior Authorization/Medical Necessity Program: Aimovig (erenumab), Ajovy (fremanezumab)*, Emgality (galcanezumab), 2023.
Cigna Drug and Biologic Coverage Policy. Calcitonin Gene‐Related Peptide (CGRP) Inhibitors – Preventative Migraine Treatment for Individual and Family Plans, 2021.
Gary S, Gronseth JC, Gloss D, et al. 2017 Edition Clinical Practice Guideline Process Manual. American Academy of Neurology; 2017.
Tassorelli C, Diener HC, Dodick DW, et al. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018;38:815‐832.
Diener HC, Tassorelli C, Dodick DW, et al. Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic migraine in adults. Cephalalgia. 2020;40:1026‐1044.
Gray RN, Goslin RE, McCrory DC, Eberlein K, Tulsky J, Hasselblad V. Drug Treatments for the Prevention of Migraine Headache. Agency for Health Care Policy and Research (US); 1999.
Silberstein SD. Practice parameter: evidence‐based guidelines for migraine headache (an evidence‐based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000;55:754‐762.
Hepp Z, Dodick DW, Varon SF, Gillard P, Hansen RN, Devine EB. Adherence to oral migraine‐preventive medications among patients with chronic migraine. Cephalalgia. 2015;35:478‐488.
Vo P, Wen S, Martel MJ, Mitsikostas D, Reuter U, Klatt J. Benefit‐risk assessment of erenumab and current migraine prophylactic treatments using the likelihood of being helped or harmed. Cephalalgia. 2019;39:608‐616.
Mansfield C, Gebben DJ, Sutphin J, et al. Patient preferences for preventive migraine treatments: a discrete‐choice experiment. Headache. 2019;59:715‐726.
Peres MF, Silberstein S, Moreira F, et al. Patients' preference for migraine preventive therapy. Headache. 2007;47:540‐545.
Cowan R, Cohen JM, Rosenman E, Iyer R. Physician and patient preferences for dosing options in migraine prevention. J Headache Pain. 2019;20:50.
Institute of Medicine (US) Committee on Standards for Systematic Reviews of Comparative Effectiveness Research. Finding What Works in Health Care: Standards for Systematic Reviews. National Academies Press (US); 2011.
Clowes M. Randomised Controlled Trials: CINAHL for Ebsco. Scottish Intercollegiate Guidelines Network, 2019.
BMJ Best Practice. Study Design Search Filters.
Watson RJ, Richardson PH. Identifying randomized controlled trials of cognitive therapy for depression: comparing the efficiency of Embase, Medline and PsycINFO bibliographic databases. Br J Med Psychol. 1999;72(Pt 4):535‐542.
Wong SS, Wilczynski NL, Haynes RB. Developing optimal search strategies for detecting clinically sound treatment studies in EMBASE. J Med Libr Assoc. 2006;94:41‐47.
Higgins JPT, Thomas J, Chandler J, et al. Searching for and selecting studies. Cochrane Handbook for Systematic Reviews of Interventions. The Cochrane Collaboration; 2022.
American Headache Society. The American Headache Society Position Statement on integrating new migraine treatments into clinical practice. Headache. 2019;59:1‐18.
Sterne JAC, Savovic J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.
Lipton RB, Stewart WF, Sawyer J, Edmeads JG. Clinical utility of an instrument assessing migraine disability: the migraine disability assessment (MIDAS) questionnaire. Headache. 2001;41:854‐861.
Trial Sequential Analysis (TSA) software. The Capital Region, Copenhagen University Hospital ‐ Rigshospitalet: The Copenhagen Trial Unit. Centre for Clinical Intervention Research; 2021.
DerSimonian R, Laird N. Meta‐analysis in clinical trials. Control Clin Trials. 1986;7:177‐188.
Furuya‐Kanamori L, Barendregt JJ, Doi SAR. A new improved graphical and quantitative method for detecting bias in meta‐analysis. Int J Evid Based Healthc. 2018;16:195‐203.
O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979;35:549‐556.
Lan KK, Hu M, Cappelieri J. Applying the law of the iterated logarithm to cumulative meta‐analysis of a continuous endpoint. Stat Sin. 2003;13:1135‐1145.
Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta‐analysis of randomized controlled trials. J Clin Epidemiol. 1997;50:683‐691.
Gomersall JD, Stuart A. Amitriptyline in migraine prophylaxis. Changes in pattern of attacks during a controlled clinical trial. J Neurol Neurosurg Psychiatry. 1973;36:684‐690.
Couch JR, Amitriptyline Versus Placebo Study Group. Amitriptyline in the prophylactic treatment of migraine and chronic daily headache. Headache. 2011;51:33‐51.
Ziegler DK, Hurwitz A, Preskorn S, Hassanein R, Seim J. Propranolol and amitriptyline in prophylaxis of migraine. Pharmacokinetic and therapeutic effects. Arch Neurol. 1993;50:825‐830.
Ziegler DK, Hurwitz A, Hassanein RS, et al. A comparison of propranolol and amitriptyline. Arch Neurol. 1987;44:486‐489.
Keskinbora K, Aydinli I. A double‐blind randomized controlled trial of topiramate and amitriptyline either alone or in combination for the prevention of migraine. Clin Neurol Neurosurg. 2008;110:979‐984.
Dodick DW, Freitag F, Banks J, et al. Topiramate versus amitriptyline in migraine prevention: a 26‐week, multicenter, randomized, double‐blind, double‐dummy, parallel‐group noninferiority trial in adult migraineurs. Clin Ther. 2009;31:542‐559.
Bulut S, Berilgen MS, Baran A, Tekatas A, Atmaca M, Mungen B. Venlafaxine versus amitriptyline in the prophylactic treatment of migraine: randomized, double‐blind, crossover study. Clin Neurol Neurosurg. 2004;107:44‐48.
Hedayat M, Nazarbaghi S, Heidari M, Sharifi H. Venlafaxine can reduce the migraine attacks as well as amitriptyline: a noninferiority randomized trial. Clin Neurol Neurosurg. 2022;214:107151.
Forssman B, Lindblad CJ, Zbornikova V. Atenolol for migraine prophylaxis. Headache. 1983;23:188‐190.
Johannsson V, Nilsson LR, Widelius T, et al. Atenolol in migraine prophylaxis a double‐blind cross‐over multicentre study. Headache. 1987;27:372‐374.
Stensrud P, Sjaastad O. Comparative trial of Tenormin (atenolol) and Inderal (propranolol) in migraine. Ups J Med Sci Suppl. 1980;31:37‐40.
Andersson PG, Dahl S, Hansen JH, et al. Prophylactic treatment of classical and non‐classical migraine with metoprolol—a comparison with placebo. Cephalalgia. 1983;3:207‐212.
Kangasniemi P, Andersen AR, Andersson PG, et al. Classic migraine: effective prophylaxis with metoprolol. Cephalalgia. 1987;7:231‐238.
Steiner TJ, Joseph R, Hedman C, Rose FC. Metoprolol in the prophylaxis of migraine: parallel‐groups comparison with placebo and dose‐ranging follow‐up. Headache. 1988;28:15‐23.
Siniatchkin M, Andrasik F, Kropp P, et al. Central mechanisms of controlled‐release metoprolol in migraine: a double‐blind, placebo‐controlled study. Cephalalgia. 2007;27:1024‐1032.
Kangasniemi P, Hedman C. Metoprolol and propranolol in the prophylactic treatment of classical and common migraine. A double‐blind study. Cephalalgia. 1984;4:91‐96.
Olsson JE, Behring HC, Forssman B, et al. Metoprolol and propranolol in migraine prophylaxis: a double‐blind multicentre study. Acta Neurol Scand. 1984;70:160‐168.
Ryan RE Sr, Ryan RE Jr, Sudilovsky A. Nadolol: its use in the prophylactic treatment of migraine. Headache. 1983;23:26‐31.
Freitag FG, Diamond S. Nadolol and placebo comparison study in the prophylactic treatment of migraine. J Am Osteopath Assoc. 1984;84:343‐347.
Ryan RE Sr. Comparative study of nadolol and propranolol in prophylactic treatment of migraine. Am Heart J. 1984;108:1156‐1159.
Olerud B, Gustavsson CL, Furberg B. Nadolol and propranolol in migraine management. Headache. 1986;26:490‐493.
Sudilovsky A, Elkind AH, Ryan RE Sr, Saper JR, Stern MA, Meyer JH. Comparative efficacy of nadolol and propranolol in the management of migraine. Headache. 1987;27:421‐426.
Weber RB, Reinmuth OM. The treatment of migraine with propranolol. Neurology. 1972;22:366‐369.
Malvea BP, Gwon N, Graham JR. Propranolol prophylaxis of migraine. Headache. 1973;12:163‐167.
Borgesen SE, Nielsen JL, Moller CE. Prophylactic treatment of migraine with propranolol. A clinical trial. Acta Neurol Scand. 1974;50:651‐656.
Wideroe TE, Vigander T. Propranolol in the treatment of migraine. Br Med J. 1974;2:699‐701.
Diamond S, Medina JL. Double blind study of propranolol for migraine prophylaxis. Headache. 1976;16:24‐27.
Forssman B, Henriksson KG, Johannsson V, Lindvall L, Lundin H. Propranolol for migraine prophylaxis. Headache. 1976;16:238‐245.
Stensrud P, Sjaastad O. Short‐term clinical trial of phopranolol in racemic form (Inderal), D‐propranolol and placebo in migraine. Acta Neurol Scand. 1976;53:229‐232.
Pita E, Higueras A, Bolanos J, Perez N, Mundo A. Propranolol and migraine. A clinical trial. Arch Farmacol Toxicol. 1977;3:273‐278.
Palferman TG, Gibberd FB, Simmonds JP. Prophylactic propranolol in the treatment of headache. Br J Clin Pract. 1983;37:28‐29.
Ahuja GK, Verma AK. Propranolol in prophylaxis of migraine. Indian J Med Res. 1985;82:263‐265.
Dahlöf C. No clearcut longterm prophylactic effect of one month of treatment with propranolol in migraineurs. Cephalalgia. 2016;7:459‐460.
Kuritzky A, Hering R. Prophylactic treatment of migraine with long acting propranolol—a comparison with placebo. Cephalalgia. 2016;7:457‐458.
Carroll JD, Reidy M, Savundra PA, Cleave N, McAinsh J. Long‐acting propranolol in the prophylaxis of migraine: a comparative study of two doses. Cephalalgia. 1990;10:101‐105.
al‐Qassab HK, Findley LJ. Comparison of propranolol LA 80 mg and propranolol LA 160 mg in migraine prophylaxis: a placebo controlled study. Cephalalgia. 1993;13:128‐131.
Pradalier A, Serratrice G, Collard M, et al. Long‐acting propranolol in migraine prophylaxis: results of a double‐blind, placebo‐controlled study. Cephalalgia. 1989;9:247‐253.
Kaniecki RG. A comparison of divalproex with propranolol and placebo for the prophylaxis of migraine without aura. Arch Neurol. 1997;54:1141‐1145.
Tfelt‐Hansen P, Standnes B, Kangasneimi P, Hakkarainen H, Olesen J. Timolol vs propranolol vs placebo in common migraine prophylaxis: a double‐blind multicenter trial. Acta Neurol Scand. 1984;69:1‐8.
Diener H‐C, Tfelt‐Hansen P, Dahlöf C, et al. Topiramate in migraine prophylaxis—results from a placebo‐controlled trial with propranolol as an active control. J Neurol. 2004;251:943‐950.
Ashtari F, Shaygannejad V, Akbari M. A double‐blind, randomized trial of low‐dose topiramate vs propranolol in migraine prophylaxis. Acta Neurol Scand. 2008;118:301‐305.
Chowdhury D, Bansal L, Duggal A, et al. TOP‐PRO study: a randomized double‐blind controlled trial of topiramate versus propranolol for prevention of chronic migraine. Cephalalgia. 2022;42:396‐408.
Briggs RS, Millac PA. Timolol in migraine prophylaxis. Headache. 1979;19:379‐381.
Stellar S, Ahrens SP, Meibohm AR, Reines SA. Migraine prevention with timolol. A double‐blind crossover study. JAMA. 1984;252:2576‐2580.
Hering R, Kuritzky A. Sodium valproate in the prophylactic treatment of migraine: a double‐blind study versus placebo. Cephalalgia. 1992;12:81‐84.
Jensen R, Brinck T, Olesen J. Sodium valproate has a prophylactic effect in migraine without aura: a triple‐blind, placebo‐controlled crossover study. Neurology. 1994;44:647‐651.
Mathew NT, Saper JR, Silberstein SD, et al. Migraine prophylaxis with divalproex. Arch Neurol. 1995;52:281‐286.
Klapper J. Divalproex sodium in migraine prophylaxis: a dose‐controlled study. Cephalalgia. 1997;17:103‐108.
Freitag FG, Collins SD, Carlson HA, et al. A randomized trial of divalproex sodium extended‐release tablets in migraine prophylaxis. Neurology. 2002;58:1652‐1659.
Shaygannejad V, Janghorbani M, Ghorbani A, Ashtary F, Zakizade N, Nasr V. Comparison of the effect of topiramate and sodium valporate in migraine prevention: a randomized blinded crossover study. Headache. 2006;46:642‐648.
Bavrasad R, Nejad SEM, Yarahmadi AR, Sajedi SI, Rahim F. Assessment of the Mmddle dose of topiramate in comparison with sodium valproate for migraine prophylaxis: a randomized‐double‐blind study. Int J Pharmacol. 2010;6:670‐675N.
Afshari D, Rafizadeh S, Rezaei M. A comparative study of the effects of low‐dose topiramate versus sodium valproate in migraine prophylaxis. Int J Neurosci. 2012;122:60‐68.
Storey JR, Calder CS, Hart DE, Potter DL. Topiramate in migraine prevention: a double‐blind, placebo‐controlled study. Headache. 2001;41:968‐975.
Brandes JL, Saper JR, Diamond M, et al. Topiramate for migraine prevention: a randomized controlled trial. JAMA. 2004;291:965‐973.
Mei D, Capuano A, Vollono C, et al. Topiramate in migraine prophylaxis: a randomised double‐blind versus placebo study. Neurol Sci. 2004;25:245‐250.
Silberstein SD, Neto W, Schmitt J, Jacobs D, MIGR‐001 Study Group. Topiramate in migraine prevention: results of a large controlled trial. Arch Neurol. 2004;61:490‐495.
Silberstein SD, Hulihan J, Karim MR, et al. Efficacy and tolerability of topiramate 200 mg/d in the prevention of migraine with/without aura in adults: a randomized, placebo‐controlled, double‐blind, 12‐week pilot study. Clin Ther. 2006;28:1002‐1011.
Diener HC, Bussone G, Van Oene JC, et al. Topiramate reduces headache days in chronic migraine: a randomized, double‐blind, placebo‐controlled study. Cephalalgia. 2007;27:814‐823.
Silberstein SD, Lipton RB, Dodick DW, et al. Efficacy and safety of topiramate for the treatment of chronic migraine: a randomized, double‐blind, placebo‐controlled trial. Headache. 2007;47:170‐180.
Lipton RB, Silberstein S, Dodick D, et al. Topiramate intervention to prevent transformation of episodic migraine: the topiramate INTREPID study. Cephalalgia. 2011;31:18‐30.
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. 2022;42:108‐118.
Ozyalcin SN, Talu GK, Kiziltan E, Yucel B, Ertas M, Disci R. The efficacy and safety of venlafaxine in the prophylaxis of migraine. Headache. 2005;45:144‐152.
Ashina M, Saper J, Cady R, et al. Eptinezumab in episodic migraine: a randomized, double‐blind, placebo‐controlled study (PROMISE‐1). Cephalalgia. 2020;40:241‐254.
Lipton RB, Goadsby PJ, Smith J, et al. Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE‐2. Neurology. 2020;94:e1365‐e1377.
Goadsby PJ, Reuter U, Hallstrom Y, et al. A controlled trial of Erenumab for episodic migraine. N Engl J Med. 2017;377:2123‐2132.
Dodick DW, Ashina M, Brandes JL, et al. ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018;38:1026‐1037.
Takeshima T, Sakai F, Hirata K, et al. Erenumab treatment for migraine prevention in Japanese patients: efficacy and safety results from a phase 3, randomized, double‐blind, placebo‐controlled study. Headache. 2021;61:927‐935.
Silberstein SD, Dodick DW, Bigal ME, et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377:2113‐2122.
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.
Sakai F, Suzuki N, Kim BK, et al. Efficacy and safety of fremanezumab for episodic migraine prevention: multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group trial in Japanese and Korean patients. Headache. 2021;61:1102‐1111.
Sakai F, Suzuki N, Kim BK, et al. Efficacy and safety of fremanezumab for chronic migraine prevention: multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group trial in Japanese and Korean patients. Headache. 2021;61:1092‐1101.
Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: the randomized, double‐blind, placebo‐controlled REGAIN study. Neurology. 2018;91:e2211‐e2221.
Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE‐2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38:1442‐1454.
Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the prevention of episodic migraine: the EVOLVE‐1 randomized clinical trial. JAMA Neurol. 2018;75:1080‐1088.
Ad Hoc Committee on Classification of Headache. Classification of headache. Arch Neurol. 1962;6:173‐176.
Headache Classification Committee of the International Headache Society. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Headache Classification Committee of the International Headache Society. Cephalalgia. 1988;8(Suppl 7):1‐96.
Olesen J, Steiner TJ. The International Classification Of Headache Disorders, 2nd edn (ICDH‐II). J Neurol Neurosurg Psychiatry. 2004;75:808‐811.
Headache Classification Committee of the International Headache S. The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013;33:629‐808.
Hakami T. Neuropharmacology of antiseizure drugs. Neuropsychopharmacol Rep. 2021;41:336‐351.
Saely S, Croteau D, Jawidzik L, Brinker A, Kortepeter C. Hypertension: a new safety risk for patients treated with erenumab. Headache. 2021;61:202‐208.
Ruiz M, Cocores A, Tosti A, Goadsby PJ, Monteith TS. Alopecia as an emerging adverse event to CGRP monoclonal antibodies: cases series, evaluation of FAERS, and literature review. Cephalalgia. 2023;43:3331024221143538.
Evans RW. Raynaud's phenomenon associated with calcitonin gene‐related peptide monoclonal antibody antagonists. Headache. 2019;59:1360‐1364.
Szperka CL, VanderPluym J, Orr SL, et al. Recommendations on the use of anti‐CGRP monoclonal antibodies in children and adolescents. Headache. 2018;58:1658‐1669.
Vig SJ, Garza J, Tao Y. The use of erenumab for migraine prophylaxis during pregnancy: a case report and narrative review. Headache. 2022;62:1256‐1263.
Barad M, Ailani J, Hakim SM, Kissoon NR, Schuster NM. Percutaneous interventional strategies for migraine prevention: a systematic review and practice guideline. Pain Med. 2022;23:164‐188.
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.
Centers for Disease Control and Prevention. Understanding Value‐Based Insurance Design. ICF International; 2015.
Gulur P, Buonanno FS. Intracranial hypotension caused by anterior cervical CSF leak alleviated by an epidural blood patch [corrected]. Headache. 2013;53:838‐841.
Kim DD, Basu A. How does cost‐effectiveness analysis inform health care decisions? AMA J Ethics. 2021;23:E639‐E647.
Sculpher M, Millson D, Meddis D, Poole L. Cost‐effectiveness analysis of stratified versus stepped care strategies for acute treatment of migraine: the Disability in Strategies for Care (DISC) study. PharmacoEconomics. 2002;20:91‐100.
Kawata AK, Shah N, Poon JL, et al. Understanding the migraine treatment landscape prior to the introduction of calcitonin gene‐related peptide inhibitors: results from the Assessment of TolerabiliTy and Effectiveness in MigrAINe Patients using Preventive Treatment (ATTAIN) study. Headache. 2021;61:438‐454.
Lipton RB, Brennan A, Palmer S, et al. Estimating the clinical effectiveness and value‐based price range of erenumab for the prevention of migraine in patients with prior treatment failures: a US societal perspective. J Med Econ. 2018;21:666‐675.
Sussman M, Benner J, Neumann P, Menzin J. Cost‐effectiveness analysis of erenumab for the preventive treatment of episodic and chronic migraine: results from the US societal and payer perspectives. Cephalalgia. 2018;38:1644‐1657.
McAllister P, Lamerato L, Krasenbaum LJ, et al. Real‐world impact of fremanezumab on migraine symptoms and resource utilization in the United States. J Headache Pain. 2021;22:156.
Ambrosini A, Estemalik E, Pascual J, et al. Changes in acute headache medication use and health care resource utilization: results from a randomized, double‐blind, placebo‐controlled clinical trial evaluating galcanezumab in adults with treatment‐resistant migraine (CONQUER). J Manag Care Spec Pharm. 2022;28:645‐656.
Chandler D, Szekely C, Aggarwal S, Cyprien L, Bensink M. Migraine characteristics, comorbidities, healthcare resource utilization, and associated costs of early users of erenumab in the USA: a retrospective cohort study using administrative claims data. Pain Ther. 2021;10:1551‐1566.
Lilly Announces the Launch of TRIUMPH, the First, Long‐Term, Real‐World Evidence Study of Emgality® (galcanezumab‐gnlm). In Cision PR Newswire. 2019.
Sacco S, Amin FM, Ashina M, et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention ‐ 2022 update. J Headache Pain. 2022;23:67.
National Headache Foundation. National Headache Foundation Position Statement on the Treatment of Migraine. 2022.
Charles AC, Digre KB, Goadsby PJ, Robbins MS, Hershey A. American Headache Society. Calcitonin gene‐related peptide‐targeting therapies are a first‐line option for the prevention of migraine: An American Headache Society position statement update. Headache. 2024. doi:10.1111/head.14692