Efficacy and safety of galcanezumab as a treatment of refractory episodic and chronic cluster headache: Case series and narrative review.


Journal

Headache
ISSN: 1526-4610
Titre abrégé: Headache
Pays: United States
ID NLM: 2985091R

Informations de publication

Date de publication:
11 2022
Historique:
revised: 14 07 2022
received: 01 04 2022
accepted: 18 07 2022
pubmed: 3 11 2022
medline: 15 12 2022
entrez: 2 11 2022
Statut: ppublish

Résumé

Galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP), has demonstrated clinical benefit as a preventive treatment of episodic cluster headache (ECH) but not in chronic cluster headache (CCH) to this date. Our objective was to analyze our clinical experience of the compassionate use of galcanezumab in cluster headache and to conduct a narrative review of the published literature. We present a case series of patients with refractory ECH and CCH treated with 240 mg galcanezumab monthly in an outpatient headache clinic. We recorded epidemiologic and clinical data and analyzed the disease evolution after 3 and 6 months. The review was performed following the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included three patients with ECH who were treated during a refractory cluster bout (mean duration of 83.7 days since the first attack, range 46.0-105.0 days) and six patients with CCH who had a high frequency of attacks (mean 35.8 attacks/week, range 7-56) and refractory to a mean of 5.2 preventive treatments (range, 3-9). In the CCH group, >50% frequency reduction was seen in 83% (5/6 patients) and the number of attacks per week showed a mean reduction of -24.2 at month 3 (range, -6 to -49) and -27.6 at month 6 (range, -7 to -49). In the ECH group, the bout ended a mean 17.3 days (range, 10-28) after galcanezumab administration. One third of patients reported mild adverse events, none of them leading to discontinuation. In conclusion, our clinical experience supports the use of galcanezumab in patients with refractory cluster headache. These results might encourage the possibility of continuing clinical development with randomized controlled trials of anti-CGRP treatments in patients with cluster headache.

Sections du résumé

BACKGROUND
Galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP), has demonstrated clinical benefit as a preventive treatment of episodic cluster headache (ECH) but not in chronic cluster headache (CCH) to this date. Our objective was to analyze our clinical experience of the compassionate use of galcanezumab in cluster headache and to conduct a narrative review of the published literature.
METHODS
We present a case series of patients with refractory ECH and CCH treated with 240 mg galcanezumab monthly in an outpatient headache clinic. We recorded epidemiologic and clinical data and analyzed the disease evolution after 3 and 6 months. The review was performed following the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
RESULTS
We included three patients with ECH who were treated during a refractory cluster bout (mean duration of 83.7 days since the first attack, range 46.0-105.0 days) and six patients with CCH who had a high frequency of attacks (mean 35.8 attacks/week, range 7-56) and refractory to a mean of 5.2 preventive treatments (range, 3-9). In the CCH group, >50% frequency reduction was seen in 83% (5/6 patients) and the number of attacks per week showed a mean reduction of -24.2 at month 3 (range, -6 to -49) and -27.6 at month 6 (range, -7 to -49). In the ECH group, the bout ended a mean 17.3 days (range, 10-28) after galcanezumab administration. One third of patients reported mild adverse events, none of them leading to discontinuation.
CONCLUSION
In conclusion, our clinical experience supports the use of galcanezumab in patients with refractory cluster headache. These results might encourage the possibility of continuing clinical development with randomized controlled trials of anti-CGRP treatments in patients with cluster headache.

Identifiants

pubmed: 36321947
doi: 10.1111/head.14404
doi:

Substances chimiques

Calcitonin Gene-Related Peptide JHB2QIZ69Z

Types de publication

Case Reports Review Journal Article Comment

Langues

eng

Sous-ensembles de citation

IM

Pagination

1395-1405

Commentaires et corrections

Type : CommentOn

Informations de copyright

© 2022 American Headache Society.

Références

Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211. doi:10.1177/0333102417738202
May A, Schwedt TJ, Magis D, Pozo-Rosich P, Evers S, Wang S-J. Cluster headache. Nat Rev Dis Prim. 2018;4(1):18006. doi:10.1038/nrdp.2018.6
Hoffmann J, May A. Diagnosis, pathophysiology, and management of cluster headache. Lancet Neurol. 2018;17(1):75-83. doi:10.1016/S1474-4422(17)30405-2
Eftekhari S, Warfvinge K, Blixt FW, Edvinsson L. Differentiation of nerve fibers storing CGRP and CGRP receptors in the peripheral Trigeminovascular system. J Pain. 2013;14(11):1289-1303. doi:10.1016/j.jpain.2013.03.010
Goadsby PJ, Edvinsson L. Human in vivo evidence for trigeminovascular activation in cluster headache neuropeptide changes and effects of acute attacks therapies. Brain. 1994;117(3):427-434. doi:10.1093/brain/117.3.427
Fanciullacci M, Alessandri M, Figini M, Geppetti P, Michelacci S. Increase in plasma calcitonin gene-related peptide from the extracerebral circulation during nitroglycerin-induced cluster headache attack. Pain. 1995;60(2):119-123. doi:10.1016/0304-3959(94)00097-X
Carmine Belin A, Ran C, Edvinsson L. Calcitonin gene-related peptide (CGRP) and cluster headache. Brain Sci. 2020;10(1):30. doi:10.3390/brainsci10010030
Goadsby PJ, Dodick DW, Leone M, et al. Trial of Galcanezumab in prevention of episodic cluster headache. N Engl J Med. 2019;381(2):132-141. doi:10.1056/NEJMoa1813440
U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Aproval Letter of Emgality (Galcanezumab-Gnlm). November 7, 2018 (Revised 06/2019). Eli Lilly and Company; 2018. Accessed November 2, 2021. Https://Www.Accessdata.Fda.Gov/Drugsatfda_docs/Label/2019/761063s003lbl.Pdf
European Medicines Agency, Committee for Medicinal Products for Human Use. Assessment Report: Emgality. Procedure No. EMEA/H/C/004648/X/0004. 27. European Medicines Agency; 2020. Accessed November 2, 2021. https://www.ema.europa.eu/en/documents/assessment-report/emgality-h-c-04648-x-0004-epar-refusal-public-assessment-report_en.pdf
Santos-Lasaosa S, Pozo-Rosich P, Belvis R, Latorre G, González-Oria C. Manual de Cefaleas de Práctica Clínica En Cefaleas. Recomendaciones de La Sociedad Española de. Neurologia. 2020;1:171-177.
Steinberg A, Fourier C, Ran C, Waldenlind E, Sjöstrand C, Belin AC. Cluster headache - clinical pattern and a new severity scale in a Swedish cohort. Cephalalgia. 2018;38(7):1286-1295. doi:10.1177/0333102417731773
Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71
Higgins JPT, Thomas J, Chandler J, et al., eds. Cochrane Handbook for Systematic Reviews of Interventions. Wiley; 2019. doi:10.1002/9781119536604
Bero L, Chartres N, Diong J, et al. The risk of bias in observational studies of exposures (ROBINS-E) tool: concerns arising from application to observational studies of exposures. Syst Rev. 2018;7(1):242. doi:10.1186/s13643-018-0915-2
Kudrow D, Andrews JS, Rettiganti M, et al. Treatment outcomes in patients treated with Galcanezumab vs placebo: post hoc analyses from a phase 3 randomized study in patients with episodic cluster headache. Headache J Head Face Pain. 2020;60(10):2254-2264. doi:10.1111/head.14011
Andrews JS, Kudrow D, Rettiganti M, et al. Impact of Galcanezumab on Total pain burden: a post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study in patients with episodic cluster headache. J Pain Res. 2021;14:2059-2070. doi:10.2147/JPR.S305066
Plato B, Andrews JS, Rettiganti M, et al. Efficacy of galcanezumab in patients with episodic cluster headaches and a history of preventive treatment failure. Cephalalgia Rep. 2021;4:251581632110156. doi:10.1177/25158163211015654
Dodick DW, Goadsby PJ, Lucas C, et al. Phase 3 randomized trial of galcanezumab in chronic cluster headache: double-blind treatment. Cephalalgia. 2019;39(1):46-47. doi:10.1177/0333102419859835
Ruscheweyh R, Broessner G, Goßrau G, et al. Effect of calcitonin gene-related peptide (−receptor) antibodies in chronic cluster headache: results from a retrospective case series support individual treatment attempts. Cephalalgia. 2020;40(14):1574-1584. doi:10.1177/0333102420949866
Iannone LF, Fattori D, Geppetti P, De Cesaris F. Galcanezumab effectiveness on comorbid cluster headache and chronic migraine: a prospective case series. Neurol Sci. 2021;29:697-703. doi:10.1007/s10072-021-05624-1
Plato B, Andrews J, Rettiganti M, et al. Consistency of effect with galcanezumab across multiple cluster periods in episodic cluster headache. Neurology. 2021;96(15 SUPPL 1). Accessed May 1, 2022. https://www.embase.com/search/results?subaction=viewrecord&id=L635944703&from=export
Lainez MJA, Schoenen J, Stroud CE, et al. Safety and tolerability of galcanezumab in patients with chronic cluster headache with up to 15 months of galcanezumab treatment. Headache. 2020;60:123-124. doi:10.1111/head.13854
Fahimi G, Joseph R. Galcanezumab effective for chronic refractory cluster headaches: a case report. Headache. 2021;61(suppl 1):128-129. doi:10.1111/head.14130
Mo H, Kim BK, Moon HS, Cho SJ. Patient satisfaction and adverse response from prevention with 240mg galcanezumab of episodic cluster headache. J Headache Pain. 2021;22(suppl 1):67. doi:10.1186/s10194-021-01293-9
Karagiorgis G, Kasioti E, Mitropoulou E, Tsanoula S, Mavridis T, Mitsikostas D. Add on treatment with galacanezumab improved refractory cluster headache in 5 out of 6 tested cases. J Headache Pain. 2021;22(Suppl 1):26. doi:10.1186/s10194-021-01293-9
Láinez MJA, Schoenen J, Stroud C, et al. Tolerability and safety of galcanezumab in patients with chronic cluster headache with up to 15 months of galcanezumab treatment. Headache J Head Face Pain. 2022;62(1):65-77. doi:10.1111/head.14234
Ailani J, Andrews JS, Rettiganti M, Nicholson RA. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). J Headache Pain. 2020 Oct 17;21(1):123. doi:10.1186/s10194-020-01190-7
Vollesen ALH, Snoer A, Beske RP, et al. Effect of infusion of calcitonin gene-related peptide on cluster headache attacks: a randomized clinical trial. JAMA Neurol. 2018;75(10):1187-1197. doi:10.1001/jamaneurol.2018.1675
Lipton RB, Micieli G, Russell D, Solomon S, Tfelt-Hansen P, Waldenlind E. Guidelines for controlled trials of drugs in cluster headache. Cephalalgia. 1995;15(6):452-45262.

Auteurs

Javier A Membrilla (JA)

Neurology Department, University Hospital La Paz, Madrid, Spain.

Marta Torres-Ferrus (M)

Headache Unit, Neurology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.

Alicia Alpuente (A)

Headache Unit, Neurology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.

Edoardo Caronna (E)

Headache Unit, Neurology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.

Patricia Pozo-Rosich (P)

Headache Unit, Neurology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH