The ultimate guide to the anti-CGRP monoclonal antibodies galaxy.
Anti-CGRP monoclonal antibodies
CGRP
Calcitonin gene related peptide
Cluster headache
Migraine
Migraine treatment
Journal
Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
ISSN: 1590-3478
Titre abrégé: Neurol Sci
Pays: Italy
ID NLM: 100959175
Informations de publication
Date de publication:
Sep 2022
Sep 2022
Historique:
received:
02
05
2022
accepted:
01
06
2022
pubmed:
22
6
2022
medline:
20
8
2022
entrez:
21
6
2022
Statut:
ppublish
Résumé
Anti-CGRP monoclonal antibodies have represented a real revolution in the field of headaches, being the result of an extraordinary process of translation of new pathophysiological discoveries into successful therapies. Nonetheless, clinical practice is far more complex than pivotal trials setting, and real-world studies are blooming to deepen knowledge of these revolutionary medications. To provide an updated guide for evidence-based clinical practice. Pivotal phase 3 randomised clinical trials for each anti-CGRP(-R) monoclonal antibody were considered. We evaluated prospective real-world studies and summarised evidence on anti-CGRP mAbs use beyond episodic and chronic migraine. All phase 3 RCTs showed an unprecedented profile of efficacy and safety in migraine prevention for the four anti-CGRP mAbs. However, plenty of questions remained open after the approval process. Real-world studies filled the gap and effectiveness results equalled or unexpectedly outperformed RCTs figures in most cases; safety results showed a lower incidence of adverse events, but a higher frequency of reported constipation compared to RCTs. Almost all studies displayed a rapid and progressive headache worsening following treatment suspension. Several positive response predictors were suggested, such as unilateral pain, allodynia in episodic migraineurs, response to triptans, and a lower number of failed prophylaxes. Comparable effectiveness was observed in resistant/refractory patients. In medication overuse headache patients, a clear clinical benefit was observed irrespective of any possible detoxification program. Our narrative review restates the remarkable efficacy, effectiveness, and safety profile in both RCTs and real-world settings and provides scientific evidence for clinical practice.
Sections du résumé
BACKGROUND
BACKGROUND
Anti-CGRP monoclonal antibodies have represented a real revolution in the field of headaches, being the result of an extraordinary process of translation of new pathophysiological discoveries into successful therapies. Nonetheless, clinical practice is far more complex than pivotal trials setting, and real-world studies are blooming to deepen knowledge of these revolutionary medications.
OBJECTIVE
OBJECTIVE
To provide an updated guide for evidence-based clinical practice.
METHODS
METHODS
Pivotal phase 3 randomised clinical trials for each anti-CGRP(-R) monoclonal antibody were considered. We evaluated prospective real-world studies and summarised evidence on anti-CGRP mAbs use beyond episodic and chronic migraine.
RESULTS
RESULTS
All phase 3 RCTs showed an unprecedented profile of efficacy and safety in migraine prevention for the four anti-CGRP mAbs. However, plenty of questions remained open after the approval process. Real-world studies filled the gap and effectiveness results equalled or unexpectedly outperformed RCTs figures in most cases; safety results showed a lower incidence of adverse events, but a higher frequency of reported constipation compared to RCTs. Almost all studies displayed a rapid and progressive headache worsening following treatment suspension. Several positive response predictors were suggested, such as unilateral pain, allodynia in episodic migraineurs, response to triptans, and a lower number of failed prophylaxes. Comparable effectiveness was observed in resistant/refractory patients. In medication overuse headache patients, a clear clinical benefit was observed irrespective of any possible detoxification program.
CONCLUSIONS
CONCLUSIONS
Our narrative review restates the remarkable efficacy, effectiveness, and safety profile in both RCTs and real-world settings and provides scientific evidence for clinical practice.
Identifiants
pubmed: 35725856
doi: 10.1007/s10072-022-06199-1
pii: 10.1007/s10072-022-06199-1
doi:
Substances chimiques
Antibodies, Monoclonal
0
Calcitonin Gene-Related Peptide
JHB2QIZ69Z
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
5673-5685Informations de copyright
© 2022. Fondazione Società Italiana di Neurologia.
Références
Edvinsson L, finestra C a un sito esterno I contenuti a cui indirizza il collegamento verranno aperti in una nuova, Haanes KA, Warfvinge K, Krause DN (2018) CGRP as the target of new migraine therapies — successful translation from bench to clinic. Nat Rev Neuro 14(6):338-350
Migraine AM (2020) N Engl J Med 383(19):1866–1876. https://doi.org/10.1056/NEJMra1915327
doi: 10.1056/NEJMra1915327
Eftekhari S, Salvatore CA, Calamari A, Kane SA, Tajti J, Edvinsson L (2010) Differential distribution of calcitonin gene-related peptide and its receptor components in the human trigeminal ganglion. Neuroscience 169(2):683–696. https://doi.org/10.1016/j.neuroscience.2010.05.016
doi: 10.1016/j.neuroscience.2010.05.016
pubmed: 20472035
Lundblad C, Haanes KA, Grände G, Edvinsson L (2015) Experimental inflammation following dural application of complete Freund’s adjuvant or inflammatory soup does not alter brain and trigeminal microvascular passage. J Headache Pain 16(1):91. https://doi.org/10.1186/s10194-015-0575-8
doi: 10.1186/s10194-015-0575-8
pubmed: 26512021
pmcid: 4627622
Goadsby PJ, Edvinsson L, Ekman R (1990) Vasoactive peptide release in the extracerebral circulation of humans during migraine headache. Ann Neurol 28(2):183–187. https://doi.org/10.1002/ana.410280213
doi: 10.1002/ana.410280213
pubmed: 1699472
Hansen JM, Hauge AW, Olesen J, Ashina M (2010) Calcitonin gene-related peptide triggers migraine-like attacks in patients with migraine with aura. Cephalalgia 30(10):1179–1186. https://doi.org/10.1177/0333102410368444
doi: 10.1177/0333102410368444
pubmed: 20855363
Amara SG, Jonas V, Rosenfeld MG, Ong ES, Evans RM (1982) Alternative RNA processing in calcitonin gene expression generates mRNAs encoding different polypeptide products. Nature 298(5871):240–244. https://doi.org/10.1038/298240a0
doi: 10.1038/298240a0
pubmed: 6283379
Edvinsson L (2007) Novel migraine therapy with calcitonin gene-regulated peptide receptor antagonists. Expert Opin Ther Targets 11(9):1179–1188. https://doi.org/10.1517/14728222.11.9.1179
doi: 10.1517/14728222.11.9.1179
pubmed: 17845144
Goadsby PJ, Reuter U, Hallström Y et al (2020) One-year sustained efficacy of erenumab in episodic migraine: results of the STRIVE study. Neurology 95(5):e469–e479. https://doi.org/10.1212/WNL.0000000000010019
doi: 10.1212/WNL.0000000000010019
pubmed: 32636324
pmcid: 7455346
Dodick DW, Ashina M, Brandes JL et al (2018) ARISE: A phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia 38(6):1026–1037. https://doi.org/10.1177/0333102418759786
doi: 10.1177/0333102418759786
pubmed: 29471679
Reuter U, Goadsby PJ, Lanteri-Minet M 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. The Lancet 392(10161):2280–2287. https://doi.org/10.1016/S0140-6736(18)32534-0
doi: 10.1016/S0140-6736(18)32534-0
Goadsby PJ, Reuter U, Lanteri-Minet M et al (2021) Long-term efficacy and safety of erenumab: results from 64 weeks of the LIBERTY study. Neurology 96(22):e2724–e2735. https://doi.org/10.1212/WNL.0000000000012029
doi: 10.1212/WNL.0000000000012029
pmcid: 8205467
Tepper S, Ashina M, Reuter U 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):425–434. https://doi.org/10.1016/S1474-4422(17)30083-2
doi: 10.1016/S1474-4422(17)30083-2
pubmed: 28460892
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. https://doi.org/10.1001/jamaneurol.2018.1212
doi: 10.1001/jamaneurol.2018.1212
pubmed: 29813147
pmcid: 6143119
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):1442–1454. https://doi.org/10.1177/0333102418779543
doi: 10.1177/0333102418779543
pubmed: 29848108
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–e2221. https://doi.org/10.1212/WNL.0000000000006640
doi: 10.1212/WNL.0000000000006640
pubmed: 30446596
pmcid: 6329331
Mulleners WM, Kim BK, Láinez MJA 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. The Lancet Neurology. 19(10):814–825. https://doi.org/10.1016/S1474-4422(20)30279-9
doi: 10.1016/S1474-4422(20)30279-9
pubmed: 32949542
Dodick DW, Silberstein SD, Bigal ME et al (2018) Effect of fremanezumab compared with placebo for prevention of episodic migraine: a randomized clinical trial. JAMA 319(19):1999. https://doi.org/10.1001/jama.2018.4853
doi: 10.1001/jama.2018.4853
pubmed: 29800211
Silberstein SD, Dodick DW, Bigal ME et al (2017) Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med 377(22):2113–2122. https://doi.org/10.1056/NEJMoa1709038
doi: 10.1056/NEJMoa1709038
pubmed: 29171818
Ferrari MD, Diener HC, Ning X 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. The Lancet 394(10203):1030–1040. https://doi.org/10.1016/S0140-6736(19)31946-4
doi: 10.1016/S0140-6736(19)31946-4
Ashina M, Saper J, Cady R et al (2020) Eptinezumab in episodic migraine: a randomized, double-blind, placebo-controlled study (PROMISE-1). Cephalalgia 40(3):241–254. https://doi.org/10.1177/0333102420905132
doi: 10.1177/0333102420905132
pubmed: 32075406
pmcid: 7066477
Lipton RB, Goadsby PJ, Smith J et al (2020) Efficacy and safety of eptinezumab in patients with chronic migraine: PROMISE-2. Neurology 94(13):e1365–e1377. https://doi.org/10.1212/WNL.0000000000009169
doi: 10.1212/WNL.0000000000009169
pubmed: 32209650
pmcid: 7274916
Lipton RB, Cohen JM, Bibeau K et al (2020) Reversion from chronic migraine to episodic migraine in patients treated with fremanezumab: post hoc analysis from HALO CM study. Headache J Head Face Pain 60(10):2444–2453. https://doi.org/10.1111/head.13997
doi: 10.1111/head.13997
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):114. https://doi.org/10.1186/s10194-020-01173-8
doi: 10.1186/s10194-020-01173-8
pubmed: 32958075
pmcid: 7507645
Tepper SJ, Diener HC, Ashina M et al (2019) Erenumab in chronic migraine with medication overuse: subgroup analysis of a randomized trial. Neurology 92(20):e2309–e2320. https://doi.org/10.1212/WNL.0000000000007497
doi: 10.1212/WNL.0000000000007497
pubmed: 30996056
pmcid: 6598821
Lipton RB, Burstein R, Buse DC et al (2021) Efficacy of erenumab in chronic migraine patients with and without ictal allodynia. Cephalalgia 41(11–12):1152–1160. https://doi.org/10.1177/03331024211010305
doi: 10.1177/03331024211010305
pubmed: 33982623
Barbanti P, Aurilia C, Egeo G et al (2021) Erenumab in the prevention of high-frequency episodic and chronic migraine: Erenumab in Real Life in Italy (EARLY), the first Italian multicenter, prospective real-life study. Headache J Head Face Pain 61(2):363–372. https://doi.org/10.1111/head.14032
doi: 10.1111/head.14032
Barbanti P, Aurilia C, Cevoli S et al (2021) Long-term (48 weeks) effectiveness, safety, and tolerability of erenumab in the prevention of high-frequency episodic and chronic migraine in a real world: results of the EARLY 2 study. Headache J Head Face Pain 61(9):1351–1363. https://doi.org/10.1111/head.14194
doi: 10.1111/head.14194
for the GARLIT Study Group, Vernieri F, Altamura C et al (2021) Galcanezumab for the prevention of high frequency episodic and chronic migraine in real life in Italy: a multicenter prospective cohort study (the GARLIT study). J Headache Pain 22(1):35. https://doi.org/10.1186/s10194-021-01247-1
doi: 10.1186/s10194-021-01247-1
de Vries LS, Verhagen IE, van den Hoek TC, MaassenVanDenBrink A, Terwindt GM (2021) Treatment with the monoclonal calcitonin gene-related peptide receptor antibody erenumab: A real-life study. Eur J Neurol 28(12):4194–4203. https://doi.org/10.1111/ene.15075
doi: 10.1111/ene.15075
Belvís R, Irimia P, Pozo-Rosich P et al (2021) MAB-MIG: registry of the spanish neurological society of erenumab for migraine prevention. J Headache Pain 22(1):74. https://doi.org/10.1186/s10194-021-01267-x
doi: 10.1186/s10194-021-01267-x
pubmed: 34273947
pmcid: 8285868
Schoenen J, Timmermans G, Nonis R, Manise M, Fumal A, Gérard P (2021) Erenumab for migraine prevention in a 1-year compassionate use program: efficacy, tolerability, and differences between clinical phenotypes. Front Neurol 12:805334. https://doi.org/10.3389/fneur.2021.805334
doi: 10.3389/fneur.2021.805334
pubmed: 34956071
pmcid: 8703164
Torres-Ferrús M, Gallardo VJ, Alpuente A, Caronna E, Gine-Cipres E, Pozo-Rosich P (2021) The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study. J Neurol 268(10):3789–3798. https://doi.org/10.1007/s00415-021-10523-8
doi: 10.1007/s00415-021-10523-8
pubmed: 33772636
Cheng S, Jenkins B, Limberg N, Hutton E (2020) Erenumab in chronic migraine: an Australian experience. Headache J Head Face Pain 60(10):2555–2562. https://doi.org/10.1111/head.13968
doi: 10.1111/head.13968
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):61. https://doi.org/10.1186/s10194-020-01127-0
doi: 10.1186/s10194-020-01127-0
pubmed: 32487102
pmcid: 7268737
Pensato U, Baraldi C, Favoni V et al (2022) Real-life assessment of erenumab in refractory chronic migraine with medication overuse headache. Neurol Sci 43(2):1273–1280. https://doi.org/10.1007/s10072-021-05426-5
doi: 10.1007/s10072-021-05426-5
pubmed: 34224026
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):120. https://doi.org/10.1186/s10194-021-01328-1
doi: 10.1186/s10194-021-01328-1
pubmed: 34620085
pmcid: 8499507
Boudreau GP (2020) Treatment of chronic migraine with erenumab alone or as an add on therapy: a real-world observational study. Anesth Pain Res. 4(1). https://doi.org/10.33425/2639-846X.1037
Barbanti P, Egeo G, Aurilia C et al (2022) Fremanezumab in the prevention of high-frequency episodic and chronic migraine: a 12-week, multicenter, real-life, cohort study (the FRIEND study). J Headache Pain 23(1):46. https://doi.org/10.1186/s10194-022-01396-x
doi: 10.1186/s10194-022-01396-x
pubmed: 35397503
pmcid: 8994302
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):1614–1626. https://doi.org/10.1007/s12325-021-01632-x
doi: 10.1007/s12325-021-01632-x
pubmed: 33544305
pmcid: 7932975
Vernieri F, Brunelli N, Messina R et al (2021) Discontinuing monoclonal antibodies targeting CGRP pathway after one-year treatment: an observational longitudinal cohort study. J Headache Pain 22(1):154. https://doi.org/10.1186/s10194-021-01363-y
doi: 10.1186/s10194-021-01363-y
pubmed: 34922444
pmcid: 8903705
Guerzoni S, Baraldi C, Pensato U, et al (2022) Chronic migraine evolution after 3 months from erenumab suspension: real-world-evidence-life data. Neurol Sci. Published online https://doi.org/10.1007/s10072-022-05870-x
Raffaelli B, Terhart M, Overeem LH et al (2022) Migraine evolution after the cessation of CGRP(-receptor) antibody prophylaxis: a prospective, longitudinal cohort study. Cephalalgia 42(4–5):326–334. https://doi.org/10.1177/03331024211046617
doi: 10.1177/03331024211046617
pubmed: 34579559
Iannone LF, Fattori D, Benemei S, Chiarugi A, Geppetti P, De Cesaris F (2022) Predictors of sustained response and effects of the discontinuation of anti‐calcitonin gene related peptide antibodies and reinitiation in resistant chronic migraine. Euro J of Neurology. Published online February 13, 2022:ene.15260. https://doi.org/10.1111/ene.15260
Schiano di Cola F, Caratozzolo S, Venturelli E, et al (2021) Erenumab discontinuation following 12-month treatment: a multicentric observational real-life study. Neurol Clin Pract. Published online July 1, 2021: https://doi.org/10.1212/CPJ.0000000000001112
Gantenbein AR, Agosti R, Gobbi C et al (2021) Impact on monthly migraine days of discontinuing anti-CGRP antibodies after one year of treatment – a real-life cohort study. Cephalalgia 41(11–12):1181–1186. https://doi.org/10.1177/03331024211014616
doi: 10.1177/03331024211014616
pubmed: 34000847
pmcid: 8504406
Ashina M, Goadsby PJ, Reuter U 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):1716–1725. https://doi.org/10.1111/ene.14715
doi: 10.1111/ene.14715
pubmed: 33400330
pmcid: 8248354
Pensato U, Baraldi C, Favoni V et al (2022) Real-life assessment of erenumab in refractory chronic migraine with medication overuse headache. Neurol Sci 43(2):1273–1280. https://doi.org/10.1007/s10072-021-05426-5
doi: 10.1007/s10072-021-05426-5
pubmed: 34224026
Iannone LF, Fattori D, Benemei S, Chiarugi A, Geppetti P, De Cesaris F (2022) Predictors of sustained response and effects of the discontinuation of anti-calcitonin gene related peptide antibodies and reinitiation in resistant chronic migraine. Euro J Neurol 29(5):1505–1513. https://doi.org/10.1111/ene.15260
doi: 10.1111/ene.15260
Vernieri F, Altamura C, Brunelli N, et al (2021) Rapid response to galcanezumab and predictive factors in chronic migraine patients: a 3‐month observational, longitudinal, cohort, multicenter, Italian real‐life study. Eur J Neurol. Published online December 6, 2021:ene.15197. https://doi.org/10.1111/ene.15197
Peng KP, Basedau H, Oppermann T, May A (2022) Trigeminal sensory modulatory effects of galcanezumab and clinical response prediction. Pain. 2022;Publish Ahead of Print. https://doi.org/10.1097/j.pain.0000000000002614
Zecca C, Cargnin S, Schankin C, et al (2022) Clinic and genetic predictors in response to erenumab. Euro J of Neurology. Published online January 21, 2022:ene.15236. https://doi.org/10.1111/ene.15236
Baraldi C, Castro FL, Cainazzo MM, Pani L, Guerzoni S (2021) Predictors of response to erenumab after 12 months of treatment. Brain Behav. 2021;11(8). https://doi.org/10.1002/brb3.2260
Frattale I, Caponnetto V, Casalena A et al (2021) Association between response to triptans and response to erenumab: real-life data. J Headache Pain 22(1):1. https://doi.org/10.1186/s10194-020-01213-3
doi: 10.1186/s10194-020-01213-3
pubmed: 33407070
pmcid: 7789681
Bottiroli S, De Icco R, Vaghi G et al (2021) Psychological predictors of negative treatment outcome with erenumab in chronic migraine: data from an open label long-term prospective study. J Headache Pain 22(1):114. https://doi.org/10.1186/s10194-021-01333-4
doi: 10.1186/s10194-021-01333-4
pubmed: 34600468
Sacco S, Braschinsky M, Ducros A et al (2020) 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 21(1):76. https://doi.org/10.1186/s10194-020-01130-5
doi: 10.1186/s10194-020-01130-5
pubmed: 32546227
pmcid: 7296705
Diener HC, Holle D, Solbach K, Gaul C (2016) Medication-overuse headache: risk factors, pathophysiology and management. Nat Rev Neurol 12(10):575–583. https://doi.org/10.1038/nrneurol.2016.124
doi: 10.1038/nrneurol.2016.124
pubmed: 27615418
Scheffler A, Messel O, Wurthmann S et al (2020) Erenumab in highly therapy-refractory migraine patients: first German real-world evidence. J Headache Pain 21(1):84. https://doi.org/10.1186/s10194-020-01151-0
doi: 10.1186/s10194-020-01151-0
pubmed: 32620151
pmcid: 7333436
Pensato U, Baraldi C, Favoni V, et al (2022) Detoxification vs non-detoxification before starting an anti-CGRP monoclonal antibody in medication overuse headache. Cephalalgia. Published online February 9, 2022:033310242110677. https://doi.org/10.1177/03331024211067791
Teva Branded Pharmaceutical Products R&D, Inc (2021) A multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study comparing the efficacy and safety of 2 dose regimens (intravenous/subcutaneous and subcutaneous) of TEV-48125 versus placebo for the prevention of epidosic cluster headache. clinicaltrials.gov; 2021. Accessed 13 Apr 2022. https://clinicaltrials.gov/ct2/show/study/NCT02945046
Teva Branded Pharmaceutical Products R&D, Inc (2021) A multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study comparing the efficacy and safety of 2 dose regimens (intravenous/subcutaneous and subcutaneous) of TEV-48125 versus placebo for the prevention of chronic cluster headache. clinicaltrials.gov; 2021. Accessed 13 Apr 2022. https://clinicaltrials.gov/ct2/show/nct02964338
Goadsby PJ, Dodick DW, Leone M et al (2019) Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med 381(2):132–141. https://doi.org/10.1056/NEJMoa1813440
doi: 10.1056/NEJMoa1813440
pubmed: 31291515
Dodick DW, Goadsby PJ, Lucas C et al (2020) Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: results from 3-month double-blind treatment. Cephalalgia 40(9):935–948. https://doi.org/10.1177/0333102420905321
doi: 10.1177/0333102420905321
pubmed: 32050782
pmcid: 7787002
Ruscheweyh R, Broessner G, Goßrau G et al (2020) Effect of calcitonin gene-related peptide (-receptor) antibodies in chronic cluster headache: results from a retrospective case series support individual treatment attempts. Cephalalgia 40(14):1574–1584. https://doi.org/10.1177/0333102420949866
doi: 10.1177/0333102420949866
pubmed: 32806953
pmcid: 7691634
H. Lundbeck (2022) A/S Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic cluster headache. clinicaltrials.gov; 2022. Accessed 11 Apr 2022. https://clinicaltrials.gov/ct2/show/NCT04688775
H. Lundbeck (2022) A/S. Interventional, open-label, fixed-dose multiple administration study to evaluate long-term treatment with eptinezumab in patients with chronic cluster headache. clinicaltrials.gov; 2022. Accessed 11 Apr 2022. https://clinicaltrials.gov/ct2/show/NCT05064397
Pavlovic JM, Paemeleire K, Göbel H et al (2020) Efficacy and safety of erenumab in women with a history of menstrual migraine. J Headache Pain 21(1):95. https://doi.org/10.1186/s10194-020-01167-6
doi: 10.1186/s10194-020-01167-6
pubmed: 32746775
pmcid: 7398400
Ornello R, Frattale I, Caponnetto V, De Matteis E, Pistoia F, Sacco S (2021) Menstrual headache in women with chronic migraine treated with erenumab: an observational case series. Brain Sci 11(3):370. https://doi.org/10.3390/brainsci11030370
doi: 10.3390/brainsci11030370
pubmed: 33805838
pmcid: 8000210
Silvestro M, Orologio I, Bonavita S et al (2021) Effectiveness and safety of CGRP-mAbs in menstrual-related migraine: a real-world experience. Pain Ther 10(2):1203–1214. https://doi.org/10.1007/s40122-021-00273-w
doi: 10.1007/s40122-021-00273-w
pubmed: 34106431
pmcid: 8586402