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. 2024 Sep;14(9):491-495.
doi: 10.1080/17581869.2024.2427564. Epub 2024 Nov 18.

Galcanezumab add-on in refractory cluster headache. A case series

Georgios Karagiorgis  1   2 , Savvas Christofilos  1   3 , Christina Deligianni  1   4 , Ioanna Spanou  1   5 , Sofia Vassilopoulou  1 , Dimos-Dimitrios D Mitsikostas  1
Affiliations

Galcanezumab add-on in refractory cluster headache. A case series

Georgios Karagiorgis et al. Pain Manag. 2024 Sep.

Abstract

Cluster headache (CH), a highly disabling condition, lacks disease-specific, mechanism-based prophylactic treatment. Galganezumab, a monoclonal antibody targeting the calcitonin gene-related peptide, reduced the weekly attacks of CH in one randomized, placebo-controlled trial for the prevention of episodic CH (eCH), but this effect was not detected in people with chronic CH (cCH). In this case series, we systematically monitored the efficacy and safety outcomes of adjunctive therapy in 11 people with refractory CH (failure of ≥ 3 prophylactic treatments; eCH n = 5, cCH, n = 6) who received galcanezumab (120-360 mg monthly) for 3 consecutive months. All participants received intermediate treatment with oral steroids or a great occipital nerve block ≥ 2 months before starting galcanezumab treatment. After galcanezumab treatment, the average number of weekly CH attacks and weekly days with any symptomatic treatment for CH decreased significantly from 16.0 ± 9.4 and 6.50 ± 3.59 before treatment to 1.8 ± 1.32 (p = 0.002) and 1.8 ± 3.36 (p = 0.001) at month 3 of treatment, respectively. Two participants with cCH showed no change in the number of attacks with galcanezumab. No serious adverse events were recorded. These data, along with those of previous real-world reports, suggest that galcanezumab may help people with refractory CH as an add-on treatment.

Keywords: Episodic cluster headache; calcitonin gene-related peptide; chronic cluster headache; galcanezumab; treatment.

Plain language summary

Cluster headache (CH) is a very painful medical problem. Today, there is no specific treatment of the disease. Headaches typically take place in periods of a couple of weeks and then after they disappear. Rarely, however, headaches do not go away over time and occur permanently. In the first case the persons have the episodic form of CH and in the second the chronic form. A few traditional treatments taken from other medical conditions are on hand to treat CH at this time. A few specific treatments have been tested but only one is approved by FDA for episodic CH. This is Galcanezumab, a monoclonal antibody that targets a peptide called CGRP. Chronic CH does not have a specific treatment. In the series of patients who are presented in this article, 11 people suffering from CH were treated with Galcanezumab. Most of these patients suffered from chronic CH and others from episodic CH that did not go away with traditional treatments. Galcanezumab was given also to the standard treatment they were already using without success. In 8 of the 11 patients, the headaches became less frequent or disappeared. No significant side effects occurred. These results show that Galcanezumab may help people with episodic CH that is hard to treat or chronic CH. But, we should keep in mind that in this study the number of patients included is small and there was no control group for comparison, so the upshot should be checked up in a more scientific way.

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Conflict of interest statement

GK has received travel grants from Novartis, Teva, and Pfizer. SC and IS have no disclosures. CD received an International Headache Society 2021 research grant, and she is a member of the Executive Board of the European Headache Federation. SV received travel grants from Abbot, Bayer and Pfizer. DDM has received honoraria, research, and travel grants from AbbVie, AstraZeneca, Genesis Pharma, Eli Lilly, Lundbeck, Merk, Novartis, Pfizer, Roche, and Teva Pharmaceuticals; participated in clinical trials for AbbVie, Amgen, Cefaly, Electrocore, Eli Lilly, Genesis Pharma, Lundbeck, Mertz, Novartis, Pfizer and Teva Pharmaceuticals as principal investigator; and is President of the board of the Hellenic Headache Society, member of the management group of the Headache Scientific Panel and of Coordinating Panel on Functional Neurological Disorders at the European Academy of Neurology.

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