Skip to main content
Top
Published in: The Journal of Headache and Pain 1/2022

01-12-2022 | Migraine | Consensus Article

European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update

Authors: Simona Sacco, Faisal Mohammad Amin, Messoud Ashina, Lars Bendtsen, Christina I. Deligianni, Raquel Gil-Gouveia, Zaza Katsarava, Antoinette MaassenVanDenBrink, Paolo Martelletti, Dimos-Dimitrios Mitsikostas, Raffaele Ornello, Uwe Reuter, Margarita Sanchez-del-Rio, Alexandra J. Sinclair, Gisela Terwindt, Derya Uluduz, Jan Versijpt, Christian Lampl

Published in: The Journal of Headache and Pain | Issue 1/2022

Login to get access

Abstract

Background

A previous European Headache Federation (EHF) guideline addressed the use of monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway to prevent migraine. Since then, randomized controlled trials (RCTs) and real-world evidence have expanded the evidence and knowledge for those treatments. Therefore, the EHF panel decided to provide an updated guideline on the use of those treatments.

Methods

The guideline was developed following the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach. The working group identified relevant questions, performed a systematic review and an analysis of the literature, assessed the quality of the available evidence, and wrote recommendations. Where the GRADE approach was not applicable, expert opinion was provided.

Results

We found moderate to high quality of evidence to recommend eptinezumab, erenumab, fremanezumab, and galcanezumab in individuals with episodic and chronic migraine. For several important clinical questions, we found not enough evidence to provide evidence-based recommendations and guidance relied on experts’ opinion. Nevertheless, we provided updated suggestions regarding the long-term management of those treatments and their place with respect to the other migraine preventatives.

Conclusion

Monoclonal antibodies targeting the CGRP pathway are recommended for migraine prevention as they are effective and safe also in the long-term.
Appendix
Available only for authorised users
Literature
1.
go back to reference Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD et al (2019) 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 20(1):6PubMedPubMedCentralCrossRef Sacco S, Bendtsen L, Ashina M, Reuter U, Terwindt G, Mitsikostas DD et al (2019) 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 20(1):6PubMedPubMedCentralCrossRef
2.
go back to reference Moher D, Liberati A, Tetzlaff J, Altman DG, Group P (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 339:b2535PubMedPubMedCentralCrossRef Moher D, Liberati A, Tetzlaff J, Altman DG, Group P (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 339:b2535PubMedPubMedCentralCrossRef
3.
go back to reference Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD et al (2021) The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 372:n71PubMedPubMedCentralCrossRef Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD et al (2021) The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 372:n71PubMedPubMedCentralCrossRef
5.
go back to reference Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P et al (2011) GRADE guidelines: 4. Rating the quality of evidence--study limitations (risk of bias). J Clin Epidemiol 64(4):407–415PubMedCrossRef Guyatt GH, Oxman AD, Vist G, Kunz R, Brozek J, Alonso-Coello P et al (2011) GRADE guidelines: 4. Rating the quality of evidence--study limitations (risk of bias). J Clin Epidemiol 64(4):407–415PubMedCrossRef
7.
go back to reference Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V et al (2018) ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia 38(6):1026–1037PubMedCrossRef Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, Osipova V et al (2018) ARISE: a phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia 38(6):1026–1037PubMedCrossRef
8.
go back to reference Mulleners WM, Kim BK, Lainez MJA, Lanteri-Minet M, Pozo-Rosich P, Wang S et al (2020) Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol 19(10):814–825PubMedCrossRef Mulleners WM, Kim BK, Lainez MJA, Lanteri-Minet M, Pozo-Rosich P, Wang S et al (2020) Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol 19(10):814–825PubMedCrossRef
9.
go back to reference Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY (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(8):1442–1454PubMedCrossRef Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY (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(8):1442–1454PubMedCrossRef
10.
go back to reference 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(9):1080–1088PubMedPubMedCentralCrossRef 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(9):1080–1088PubMedPubMedCentralCrossRef
11.
go back to reference Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R et al (2019) 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 394(10203):1030–1040PubMedCrossRef Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R et al (2019) 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 394(10203):1030–1040PubMedCrossRef
12.
go back to reference Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al (2018) Effect of Fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA 319(19):1999–2008PubMedCrossRef Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al (2018) Effect of Fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA 319(19):1999–2008PubMedCrossRef
13.
go back to reference Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al (2017) Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 377(22):2113–2122PubMedCrossRef Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al (2017) Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 377(22):2113–2122PubMedCrossRef
14.
go back to reference Reuter U, Ehrlich M, Gendolla A, Heinze A, Klatt J, Wen S et al (2022) Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia 42(2):108–118PubMedCrossRef Reuter U, Ehrlich M, Gendolla A, Heinze A, Klatt J, Wen S et al (2022) Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia 42(2):108–118PubMedCrossRef
15.
go back to reference Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD et al (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(10161):2280–2287PubMedCrossRef Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD et al (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(10161):2280–2287PubMedCrossRef
16.
go back to reference Sun H, Dodick DW, Silberstein S, Goadsby PJ, Reuter U, Ashina M et al (2016) Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol 15(4):382–390PubMedCrossRef Sun H, Dodick DW, Silberstein S, Goadsby PJ, Reuter U, Ashina M et al (2016) Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol 15(4):382–390PubMedCrossRef
17.
go back to reference Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC et al (2015) 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(11):1091–1100PubMedCrossRef Bigal ME, Edvinsson L, Rapoport AM, Lipton RB, Spierings EL, Diener HC et al (2015) 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(11):1091–1100PubMedCrossRef
18.
go back to reference Bigal ME, Dodick DW, Rapoport AM, Silberstein SD, Ma Y, Yang R et al (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(11):1081–1090PubMedCrossRef Bigal ME, Dodick DW, Rapoport AM, Silberstein SD, Ma Y, Yang R et al (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(11):1081–1090PubMedCrossRef
19.
go back to reference Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S et al (2017) Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol 16(6):425–434PubMedCrossRef Tepper S, Ashina M, Reuter U, Brandes JL, Dolezil D, Silberstein S et al (2017) Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol 16(6):425–434PubMedCrossRef
20.
go back to reference Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J et al (2019) Eptinezumab for prevention of chronic migraine: a randomized phase 2b clinical trial. Cephalalgia 39(9):1075–1085PubMedCrossRef Dodick DW, Lipton RB, Silberstein S, Goadsby PJ, Biondi D, Hirman J et al (2019) Eptinezumab for prevention of chronic migraine: a randomized phase 2b clinical trial. Cephalalgia 39(9):1075–1085PubMedCrossRef
21.
go back to reference Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J et al (2020) Eptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia 40(3):241–254PubMedPubMedCentralCrossRef Ashina M, Saper J, Cady R, Schaeffler BA, Biondi DM, Hirman J et al (2020) Eptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia 40(3):241–254PubMedPubMedCentralCrossRef
22.
go back to reference Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J et al (2020) Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology 94(13):e1365–e1377PubMedPubMedCentralCrossRef Lipton RB, Goadsby PJ, Smith J, Schaeffler BA, Biondi DM, Hirman J et al (2020) Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology 94(13):e1365–e1377PubMedPubMedCentralCrossRef
23.
go back to reference 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(24):e2211–e2221PubMedPubMedCentralCrossRef 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(24):e2211–e2221PubMedPubMedCentralCrossRef
24.
go back to reference Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F et al (2017) A controlled trial of erenumab for episodic migraine. N Engl J Med 377(22):2123–2132PubMedCrossRef Goadsby PJ, Reuter U, Hallstrom Y, Broessner G, Bonner JH, Zhang F et al (2017) A controlled trial of erenumab for episodic migraine. N Engl J Med 377(22):2123–2132PubMedCrossRef
25.
go back to reference Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Lenz R, Wang Y et al (2019) A randomized phase 2 study of erenumab for the prevention of episodic migraine in Japanese adults. Headache 59(10):1731–1742PubMedPubMedCentralCrossRef Sakai F, Takeshima T, Tatsuoka Y, Hirata K, Lenz R, Wang Y et al (2019) A randomized phase 2 study of erenumab for the prevention of episodic migraine in Japanese adults. Headache 59(10):1731–1742PubMedPubMedCentralCrossRef
26.
go back to reference Wang SJ, Roxas AA Jr, Saravia B, Kim BK, Chowdhury D, Riachi N et al (2021) Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: the EMPOwER study. Cephalalgia 41(13):1285–1297PubMedPubMedCentralCrossRef Wang SJ, Roxas AA Jr, Saravia B, Kim BK, Chowdhury D, Riachi N et al (2021) Randomised, controlled trial of erenumab for the prevention of episodic migraine in patients from Asia, the Middle East, and Latin America: the EMPOwER study. Cephalalgia 41(13):1285–1297PubMedPubMedCentralCrossRef
27.
go back to reference Sakai F, Suzuki N, Kim BK, Igarashi H, Hirata K, Takeshima T et al (2021) Efficacy and safety of fremanezumab for chronic migraine prevention: multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache 61(7):1092–1101PubMedPubMedCentralCrossRef Sakai F, Suzuki N, Kim BK, Igarashi H, Hirata K, Takeshima T et al (2021) Efficacy and safety of fremanezumab for chronic migraine prevention: multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache 61(7):1092–1101PubMedPubMedCentralCrossRef
28.
go back to reference Sakai F, Suzuki N, Kim BK, Tatsuoka Y, Imai N, Ning X et al (2021) Efficacy and safety of fremanezumab for episodic migraine prevention: multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache 61(7):1102–1111PubMedPubMedCentralCrossRef Sakai F, Suzuki N, Kim BK, Tatsuoka Y, Imai N, Ning X et al (2021) Efficacy and safety of fremanezumab for episodic migraine prevention: multicenter, randomized, double-blind, placebo-controlled, parallel-group trial in Japanese and Korean patients. Headache 61(7):1102–1111PubMedPubMedCentralCrossRef
29.
go back to reference Takeshima T, Sakai F, Hirata K, Imai N, Matsumori Y, Yoshida R et al (2021) Erenumab treatment for migraine prevention in Japanese patients: efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. Headache 61(6):927–935PubMedPubMedCentralCrossRef Takeshima T, Sakai F, Hirata K, Imai N, Matsumori Y, Yoshida R et al (2021) Erenumab treatment for migraine prevention in Japanese patients: efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. Headache 61(6):927–935PubMedPubMedCentralCrossRef
30.
go back to reference Skljarevski V, Oakes TM, Zhang Q, Ferguson MB, Martinez J, Camporeale A et al (2018) Effect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trial. JAMA Neurol 75(2):187–193PubMedCrossRef Skljarevski V, Oakes TM, Zhang Q, Ferguson MB, Martinez J, Camporeale A et al (2018) Effect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trial. JAMA Neurol 75(2):187–193PubMedCrossRef
31.
go back to reference Caronna E, Gallardo VJ, Alpuente A, Torres-Ferrus M, Pozo-Rosich P (2021) Anti-CGRP monoclonal antibodies in chronic migraine with medication overuse: real-life effectiveness and predictors of response at 6 months. J Headache Pain 22(1):120PubMedPubMedCentralCrossRef Caronna E, Gallardo VJ, Alpuente A, Torres-Ferrus M, Pozo-Rosich P (2021) Anti-CGRP monoclonal antibodies in chronic migraine with medication overuse: real-life effectiveness and predictors of response at 6 months. J Headache Pain 22(1):120PubMedPubMedCentralCrossRef
32.
go back to reference McAllister P, Lamerato L, Krasenbaum LJ, Cohen JM, Tangirala K, Thompson S et al (2021) Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States. J Headache Pain 22(1):156PubMedPubMedCentralCrossRef McAllister P, Lamerato L, Krasenbaum LJ, Cohen JM, Tangirala K, Thompson S et al (2021) Real-world impact of fremanezumab on migraine symptoms and resource utilization in the United States. J Headache Pain 22(1):156PubMedPubMedCentralCrossRef
33.
go back to reference Ornello R, Casalena A, Frattale I, Gabriele A, Affaitati G, Giamberardino MA et al (2020) Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. J Headache Pain 21(1):32PubMedPubMedCentralCrossRef Ornello R, Casalena A, Frattale I, Gabriele A, Affaitati G, Giamberardino MA et al (2020) Real-life data on the efficacy and safety of erenumab in the Abruzzo region, central Italy. J Headache Pain 21(1):32PubMedPubMedCentralCrossRef
34.
go back to reference Straube A, Stude P, Gaul C, Schuh K, Koch M (2021) Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany. J Headache Pain 22(1):133PubMedPubMedCentralCrossRef Straube A, Stude P, Gaul C, Schuh K, Koch M (2021) Real-world evidence data on the monoclonal antibody erenumab in migraine prevention: perspectives of treating physicians in Germany. J Headache Pain 22(1):133PubMedPubMedCentralCrossRef
35.
go back to reference Hepp Z, Dodick DW, Varon SF, Chia J, Matthew N, Gillard P et al (2017) Persistence and switching patterns of oral migraine prophylactic medications among patients with chronic migraine: a retrospective claims analysis. Cephalalgia 37(5):470–485PubMedCrossRef Hepp Z, Dodick DW, Varon SF, Chia J, Matthew N, Gillard P et al (2017) Persistence and switching patterns of oral migraine prophylactic medications among patients with chronic migraine: a retrospective claims analysis. Cephalalgia 37(5):470–485PubMedCrossRef
36.
go back to reference 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(6):478–488PubMedCrossRef 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(6):478–488PubMedCrossRef
37.
go back to reference Vandervorst F, Van Deun L, Van Dycke A, Paemeleire K, Reuter U, Schoenen J et al (2021) CGRP monoclonal antibodies in migraine: an efficacy and tolerability comparison with standard prophylactic drugs. J Headache Pain 22(1):128PubMedPubMedCentralCrossRef Vandervorst F, Van Deun L, Van Dycke A, Paemeleire K, Reuter U, Schoenen J et al (2021) CGRP monoclonal antibodies in migraine: an efficacy and tolerability comparison with standard prophylactic drugs. J Headache Pain 22(1):128PubMedPubMedCentralCrossRef
38.
go back to reference Dapkute A, Vainauskiene J, Ryliskiene K (2022) Patient-reported outcomes of migraine treatment with erenumab: results from a national patient survey. Neurol Sci 43(5):3305–3312PubMedCrossRef Dapkute A, Vainauskiene J, Ryliskiene K (2022) Patient-reported outcomes of migraine treatment with erenumab: results from a national patient survey. Neurol Sci 43(5):3305–3312PubMedCrossRef
39.
go back to reference Ornello R, Baraldi C, Guerzoni S, Lambru G, Andreou AP, Raffaelli B et al (2022) Comparing the relative and absolute effect of erenumab: is a 50% response enough? Results from the ESTEEMen study. J Headache Pain 23(1):38PubMedPubMedCentralCrossRef Ornello R, Baraldi C, Guerzoni S, Lambru G, Andreou AP, Raffaelli B et al (2022) Comparing the relative and absolute effect of erenumab: is a 50% response enough? Results from the ESTEEMen study. J Headache Pain 23(1):38PubMedPubMedCentralCrossRef
40.
go back to reference Detke HC, Millen BA, Zhang Q, Samaan K, Ailani J, Dodick DW et al (2020) Rapid onset of effect of galcanezumab for the prevention of episodic migraine: analysis of the EVOLVE studies. Headache 60(2):348–359PubMedCrossRef Detke HC, Millen BA, Zhang Q, Samaan K, Ailani J, Dodick DW et al (2020) Rapid onset of effect of galcanezumab for the prevention of episodic migraine: analysis of the EVOLVE studies. Headache 60(2):348–359PubMedCrossRef
41.
go back to reference Igarashi H, Shibata M, Ozeki A, Day KA, Matsumura T (2021) Early onset and maintenance effect of galcanezumab in Japanese patients with episodic migraine. J Pain Res 14:3555–3564PubMedPubMedCentralCrossRef Igarashi H, Shibata M, Ozeki A, Day KA, Matsumura T (2021) Early onset and maintenance effect of galcanezumab in Japanese patients with episodic migraine. J Pain Res 14:3555–3564PubMedPubMedCentralCrossRef
42.
go back to reference Schwedt T, Reuter U, Tepper S, Ashina M, Kudrow D, Broessner G et al (2018) Early onset of efficacy with erenumab in patients with episodic and chronic migraine. J Headache Pain 19(1):92PubMedPubMedCentralCrossRef Schwedt T, Reuter U, Tepper S, Ashina M, Kudrow D, Broessner G et al (2018) Early onset of efficacy with erenumab in patients with episodic and chronic migraine. J Headache Pain 19(1):92PubMedPubMedCentralCrossRef
43.
go back to reference Schwedt TJ, Kuruppu DK, Dong Y, Standley K, Yunes-Medina L, Pearlman E (2021) Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain 22(1):15PubMedPubMedCentralCrossRef Schwedt TJ, Kuruppu DK, Dong Y, Standley K, Yunes-Medina L, Pearlman E (2021) Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain 22(1):15PubMedPubMedCentralCrossRef
44.
go back to reference Takeshima T, Nakai M, Shibasaki Y, Ishida M, Kim BK, Ning X et al (2022) Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients. J Headache Pain 23(1):24PubMedPubMedCentralCrossRef Takeshima T, Nakai M, Shibasaki Y, Ishida M, Kim BK, Ning X et al (2022) Early onset of efficacy with fremanezumab in patients with episodic and chronic migraine: subanalysis of two phase 2b/3 trials in Japanese and Korean patients. J Headache Pain 23(1):24PubMedPubMedCentralCrossRef
45.
go back to reference Winner PK, Spierings ELH, Yeung PP, Aycardi E, Blankenbiller T, Grozinski-Wolff M et al (2019) Early onset of efficacy with fremanezumab for the preventive treatment of chronic migraine. Headache 59(10):1743–1752PubMedCrossRef Winner PK, Spierings ELH, Yeung PP, Aycardi E, Blankenbiller T, Grozinski-Wolff M et al (2019) Early onset of efficacy with fremanezumab for the preventive treatment of chronic migraine. Headache 59(10):1743–1752PubMedCrossRef
46.
go back to reference Lambru G, Hill B, Murphy M, Tylova I, Andreou AP (2020) A prospective real-world analysis of erenumab in refractory chronic migraine. J Headache Pain 21(1):61PubMedPubMedCentralCrossRef Lambru G, Hill B, Murphy M, Tylova I, Andreou AP (2020) A prospective real-world analysis of erenumab in refractory chronic migraine. J Headache Pain 21(1):61PubMedPubMedCentralCrossRef
47.
go back to reference Russo A, Silvestro M, Scotto di Clemente F, Trojsi F, Bisecco A, Bonavita S et al (2020) Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: a comprehensive real-world experience. J Headache Pain 21(1):69PubMedPubMedCentralCrossRef Russo A, Silvestro M, Scotto di Clemente F, Trojsi F, Bisecco A, Bonavita S et al (2020) Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: a comprehensive real-world experience. J Headache Pain 21(1):69PubMedPubMedCentralCrossRef
48.
go back to reference Goadsby PJ, Dodick DW, Martinez JM, Ferguson MB, Oakes TM, Zhang Q et al (2019) Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis. J Neurol Neurosurg Psychiatry 90(8):939–944PubMedCrossRef Goadsby PJ, Dodick DW, Martinez JM, Ferguson MB, Oakes TM, Zhang Q et al (2019) Onset of efficacy and duration of response of galcanezumab for the prevention of episodic migraine: a post-hoc analysis. J Neurol Neurosurg Psychiatry 90(8):939–944PubMedCrossRef
49.
go back to reference McAllister PJ, Turner I, Reuter U, Wang A, Scanlon J, Klatt J et al (2021) Timing and durability of response to erenumab in patients with episodic migraine. Headache 61(10):1553–1561PubMedCrossRef McAllister PJ, Turner I, Reuter U, Wang A, Scanlon J, Klatt J et al (2021) Timing and durability of response to erenumab in patients with episodic migraine. Headache 61(10):1553–1561PubMedCrossRef
50.
go back to reference Kuruppu DK, North JM, Kovacik AJ, Dong Y, Pearlman EM, Hutchinson SL (2021) Onset, maintenance, and cessation of effect of galcanezumab for prevention of migraine: a narrative review of three randomized placebo-controlled trials. Adv Ther 38(3):1614–1626PubMedPubMedCentralCrossRef Kuruppu DK, North JM, Kovacik AJ, Dong Y, Pearlman EM, Hutchinson SL (2021) Onset, maintenance, and cessation of effect of galcanezumab for prevention of migraine: a narrative review of three randomized placebo-controlled trials. Adv Ther 38(3):1614–1626PubMedPubMedCentralCrossRef
51.
go back to reference Tepper SJ, Lucas S, Ashina M, Schwedt TJ, Ailani J, Scanlon J et al (2021) Timing and durability of response to erenumab in patients with chronic migraine. Headache 61(8):1255–1263PubMedPubMedCentralCrossRef Tepper SJ, Lucas S, Ashina M, Schwedt TJ, Ailani J, Scanlon J et al (2021) Timing and durability of response to erenumab in patients with chronic migraine. Headache 61(8):1255–1263PubMedPubMedCentralCrossRef
52.
go back to reference Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z (2020) The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain 21(1):114PubMedPubMedCentralCrossRef Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z (2020) The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain 21(1):114PubMedPubMedCentralCrossRef
53.
go back to reference Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J et al (2021) Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia 41(3):340–352PubMedCrossRef Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J et al (2021) Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia 41(3):340–352PubMedCrossRef
54.
go back to reference Diener HC, Marmura MJ, Tepper SJ, Cowan R, Starling AJ, Diamond ML et al (2021) Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication-overuse headache: subgroup analysis of PROMISE-2. Headache 61(1):125–136PubMedCrossRef Diener HC, Marmura MJ, Tepper SJ, Cowan R, Starling AJ, Diamond ML et al (2021) Efficacy, tolerability, and safety of eptinezumab in patients with a dual diagnosis of chronic migraine and medication-overuse headache: subgroup analysis of PROMISE-2. Headache 61(1):125–136PubMedCrossRef
55.
go back to reference Pijpers JA, Louter MA, de Bruin ME, van Zwet EW, Zitman FG, Ferrari MD et al (2016) Detoxification in medication-overuse headache, a retrospective controlled follow-up study: does care by a headache nurse lead to cure? Cephalalgia 36(2):122–130PubMedCrossRef Pijpers JA, Louter MA, de Bruin ME, van Zwet EW, Zitman FG, Ferrari MD et al (2016) Detoxification in medication-overuse headache, a retrospective controlled follow-up study: does care by a headache nurse lead to cure? Cephalalgia 36(2):122–130PubMedCrossRef
56.
go back to reference Ornello R, Casalena A, Frattale I, Caponnetto V, Gabriele A, Affaitati G et al (2020) Conversion from chronic to episodic migraine in patients treated with erenumab: real-life data from an Italian region. J Headache Pain 21(1):102PubMedPubMedCentralCrossRef Ornello R, Casalena A, Frattale I, Caponnetto V, Gabriele A, Affaitati G et al (2020) Conversion from chronic to episodic migraine in patients treated with erenumab: real-life data from an Italian region. J Headache Pain 21(1):102PubMedPubMedCentralCrossRef
57.
58.
go back to reference Cainazzo MM, Baraldi C, Ferrari A, Lo Castro F, Pani L, Guerzoni S (2021) Erenumab for the preventive treatment of chronic migraine complicated with medication overuse headache: an observational, retrospective, 12-month real-life study. Neurol Sci 42(10):4193–4202PubMedCrossRef Cainazzo MM, Baraldi C, Ferrari A, Lo Castro F, Pani L, Guerzoni S (2021) Erenumab for the preventive treatment of chronic migraine complicated with medication overuse headache: an observational, retrospective, 12-month real-life study. Neurol Sci 42(10):4193–4202PubMedCrossRef
59.
go back to reference Pham A, Burch R (2020) A real-world comparison of erenumab and galcanezumab in a tertiary headache center. Headache 60:4–5 Pham A, Burch R (2020) A real-world comparison of erenumab and galcanezumab in a tertiary headache center. Headache 60:4–5
60.
go back to reference Sacco S, Lampl C, Maassen van den Brink A, Caponnetto V, Braschinsky M, Ducros A et al (2021) Burden and attitude to resistant and refractory migraine: a survey from the European Headache Federation with the endorsement of the European Migraine & Headache Alliance. J Headache Pain 22(1):39PubMedPubMedCentralCrossRef Sacco S, Lampl C, Maassen van den Brink A, Caponnetto V, Braschinsky M, Ducros A et al (2021) Burden and attitude to resistant and refractory migraine: a survey from the European Headache Federation with the endorsement of the European Migraine & Headache Alliance. J Headache Pain 22(1):39PubMedPubMedCentralCrossRef
61.
go back to reference Al-Hassany L, Goadsby PJ, Danser AHJ, MaassenVanDenBrink A (2022) Calcitonin gene-related peptide-targeting drugs for migraine: how pharmacology might inform treatment decisions. Lancet Neurol 21(3):284–294PubMedCrossRef Al-Hassany L, Goadsby PJ, Danser AHJ, MaassenVanDenBrink A (2022) Calcitonin gene-related peptide-targeting drugs for migraine: how pharmacology might inform treatment decisions. Lancet Neurol 21(3):284–294PubMedCrossRef
62.
go back to reference Overeem LH, Peikert A, Hofacker MD, Kamm K, Ruscheweyh R, Gendolla A et al (2022) Effect of antibody switch in non-responders to a CGRP receptor antibody treatment in migraine: a multi-center retrospective cohort study. Cephalalgia 42:291–301 Overeem LH, Peikert A, Hofacker MD, Kamm K, Ruscheweyh R, Gendolla A et al (2022) Effect of antibody switch in non-responders to a CGRP receptor antibody treatment in migraine: a multi-center retrospective cohort study. Cephalalgia 42:291–301
63.
go back to reference Patier Ruiz I, Sanchez-Rubio Ferrandez J, Carcamo Fonfria A, Molina Garcia T (2022) Early experiences in switching between monoclonal antibodies in patients with nonresponsive migraine in Spain: a case series. Eur Neurol 85:132–135 Patier Ruiz I, Sanchez-Rubio Ferrandez J, Carcamo Fonfria A, Molina Garcia T (2022) Early experiences in switching between monoclonal antibodies in patients with nonresponsive migraine in Spain: a case series. Eur Neurol 85:132–135
64.
go back to reference Ziegeler C, May A (2020) Non-responders to treatment with antibodies to the CGRP-receptor May profit from a switch of antibody class. Headache 60(2):469–470PubMedCrossRef Ziegeler C, May A (2020) Non-responders to treatment with antibodies to the CGRP-receptor May profit from a switch of antibody class. Headache 60(2):469–470PubMedCrossRef
65.
go back to reference Noseda R, Bedussi F, Gobbi C, Zecca C, Ceschi A (2021) Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: analysis of the WHO pharmacovigilance database. Cephalalgia 41(7):789–798PubMedCrossRef Noseda R, Bedussi F, Gobbi C, Zecca C, Ceschi A (2021) Safety profile of erenumab, galcanezumab and fremanezumab in pregnancy and lactation: analysis of the WHO pharmacovigilance database. Cephalalgia 41(7):789–798PubMedCrossRef
66.
go back to reference Bussiere JL, Davies R, Dean C, Xu C, Kim KH, Vargas HM et al (2019) Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine. Regul Toxicol Pharmacol 106:224–238PubMedCrossRef Bussiere JL, Davies R, Dean C, Xu C, Kim KH, Vargas HM et al (2019) Nonclinical safety evaluation of erenumab, a CGRP receptor inhibitor for the prevention of migraine. Regul Toxicol Pharmacol 106:224–238PubMedCrossRef
67.
go back to reference Yadav S, Yadav YS, Goel MM, Singh U, Natu SM, Negi MP (2014) Calcitonin gene- and parathyroid hormone-related peptides in normotensive and preeclamptic pregnancies: a nested case-control study. Arch Gynecol Obstet 290(5):897–903PubMedCrossRef Yadav S, Yadav YS, Goel MM, Singh U, Natu SM, Negi MP (2014) Calcitonin gene- and parathyroid hormone-related peptides in normotensive and preeclamptic pregnancies: a nested case-control study. Arch Gynecol Obstet 290(5):897–903PubMedCrossRef
68.
go back to reference Favoni V, Giani L, Al-Hassany L, Asioli GM, Butera C, de Boer I et al (2019) CGRP and migraine from a cardiovascular point of view: what do we expect from blocking CGRP? J Headache Pain 20(1):27PubMedPubMedCentralCrossRef Favoni V, Giani L, Al-Hassany L, Asioli GM, Butera C, de Boer I et al (2019) CGRP and migraine from a cardiovascular point of view: what do we expect from blocking CGRP? J Headache Pain 20(1):27PubMedPubMedCentralCrossRef
69.
go back to reference MaassenVanDenBrink A, Meijer J, Villalon CM, Ferrari MD (2016) Wiping out CGRP: potential cardiovascular risks. Trends Pharmacol Sci 37(9):779–788PubMedCrossRef MaassenVanDenBrink A, Meijer J, Villalon CM, Ferrari MD (2016) Wiping out CGRP: potential cardiovascular risks. Trends Pharmacol Sci 37(9):779–788PubMedCrossRef
70.
go back to reference Russell FA, King R, Smillie SJ, Kodji X, Brain SD (2014) Calcitonin gene-related peptide: physiology and pathophysiology. Physiol Rev 94(4):1099–1142PubMedPubMedCentralCrossRef Russell FA, King R, Smillie SJ, Kodji X, Brain SD (2014) Calcitonin gene-related peptide: physiology and pathophysiology. Physiol Rev 94(4):1099–1142PubMedPubMedCentralCrossRef
71.
go back to reference Mulder IA, Li M, de Vries T, Qin T, Yanagisawa T, Sugimoto K et al (2020) Anti-migraine calcitonin gene-related peptide receptor antagonists worsen cerebral ischemic outcome in mice. Ann Neurol 88(4):771–784PubMedPubMedCentralCrossRef Mulder IA, Li M, de Vries T, Qin T, Yanagisawa T, Sugimoto K et al (2020) Anti-migraine calcitonin gene-related peptide receptor antagonists worsen cerebral ischemic outcome in mice. Ann Neurol 88(4):771–784PubMedPubMedCentralCrossRef
72.
go back to reference Depre C, Antalik L, Starling A, Koren M, Eisele O, Lenz RA et al (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(5):715–723PubMedPubMedCentralCrossRef Depre C, Antalik L, Starling A, Koren M, Eisele O, Lenz RA et al (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(5):715–723PubMedPubMedCentralCrossRef
73.
go back to reference Maassen van den Brink A, Rubio-Beltran E, Duncker D, Villalon CM (2018) Is CGRP receptor blockade cardiovascularly safe? Appropriate studies are needed. Headache 58(8):1257–1258PubMedCrossRef Maassen van den Brink A, Rubio-Beltran E, Duncker D, Villalon CM (2018) Is CGRP receptor blockade cardiovascularly safe? Appropriate studies are needed. Headache 58(8):1257–1258PubMedCrossRef
74.
go back to reference Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick DW, Xue F et al (2021) Long-term efficacy and safety of erenumab in migraine prevention: results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol 28(5):1716–1725PubMedPubMedCentralCrossRef Ashina M, Goadsby PJ, Reuter U, Silberstein S, Dodick DW, Xue F et al (2021) Long-term efficacy and safety of erenumab in migraine prevention: results from a 5-year, open-label treatment phase of a randomized clinical trial. Eur J Neurol 28(5):1716–1725PubMedPubMedCentralCrossRef
75.
go back to reference Saely S, Croteau D, Jawidzik L, Brinker A, Kortepeter C (2021) Hypertension: a new safety risk for patients treated with erenumab. Headache 61(1):202–208PubMedCrossRef Saely S, Croteau D, Jawidzik L, Brinker A, Kortepeter C (2021) Hypertension: a new safety risk for patients treated with erenumab. Headache 61(1):202–208PubMedCrossRef
76.
go back to reference Breen ID, Brumfiel CM, Patel MH, Butterfield RJ, VanderPluym JH, Griffing L et al (2021) Evaluation of the safety of calcitonin gene-related peptide antagonists for migraine treatment among adults with Raynaud phenomenon. JAMA Netw Open 4(4):e217934PubMedPubMedCentralCrossRef Breen ID, Brumfiel CM, Patel MH, Butterfield RJ, VanderPluym JH, Griffing L et al (2021) Evaluation of the safety of calcitonin gene-related peptide antagonists for migraine treatment among adults with Raynaud phenomenon. JAMA Netw Open 4(4):e217934PubMedPubMedCentralCrossRef
77.
go back to reference Evans RW (2019) Raynaud's phenomenon associated with calcitonin gene-related peptide monoclonal antibody antagonists. Headache 59(8):1360–1364PubMedCrossRef Evans RW (2019) Raynaud's phenomenon associated with calcitonin gene-related peptide monoclonal antibody antagonists. Headache 59(8):1360–1364PubMedCrossRef
78.
go back to reference Manickam AH, Buture A, Tomkins E, Ruttledge M (2021) Raynaud’s phenomenon secondary to erenumab in a patient with chronic migraine. Clin Case Rep 9(8):e04625PubMedPubMedCentralCrossRef Manickam AH, Buture A, Tomkins E, Ruttledge M (2021) Raynaud’s phenomenon secondary to erenumab in a patient with chronic migraine. Clin Case Rep 9(8):e04625PubMedPubMedCentralCrossRef
80.
go back to reference Holzer P, Holzer-Petsche U (2021) Constipation caused by anti-calcitonin gene-related peptide migraine therapeutics explained by antagonism of calcitonin gene-related Peptide's motor-stimulating and prosecretory function in the intestine. Front Physiol 12:820006PubMedCrossRef Holzer P, Holzer-Petsche U (2021) Constipation caused by anti-calcitonin gene-related peptide migraine therapeutics explained by antagonism of calcitonin gene-related Peptide's motor-stimulating and prosecretory function in the intestine. Front Physiol 12:820006PubMedCrossRef
81.
go back to reference Frattale I, Ornello R, Pistoia F, Caponnetto V, Colangeli E, Sacco S (2021) Paralytic ileus after planned abdominal surgery in a patient on treatment with erenumab. Intern Emerg Med 16(1):227–228PubMedCrossRef Frattale I, Ornello R, Pistoia F, Caponnetto V, Colangeli E, Sacco S (2021) Paralytic ileus after planned abdominal surgery in a patient on treatment with erenumab. Intern Emerg Med 16(1):227–228PubMedCrossRef
Metadata
Title
European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update
Authors
Simona Sacco
Faisal Mohammad Amin
Messoud Ashina
Lars Bendtsen
Christina I. Deligianni
Raquel Gil-Gouveia
Zaza Katsarava
Antoinette MaassenVanDenBrink
Paolo Martelletti
Dimos-Dimitrios Mitsikostas
Raffaele Ornello
Uwe Reuter
Margarita Sanchez-del-Rio
Alexandra J. Sinclair
Gisela Terwindt
Derya Uluduz
Jan Versijpt
Christian Lampl
Publication date
01-12-2022
Publisher
Springer Milan
Published in
The Journal of Headache and Pain / Issue 1/2022
Print ISSN: 1129-2369
Electronic ISSN: 1129-2377
DOI
https://doi.org/10.1186/s10194-022-01431-x

Other articles of this Issue 1/2022

The Journal of Headache and Pain 1/2022 Go to the issue