Abstract
ObjectiveTo assess the efficacy of monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor in chronic cluster headache (CCH) treatment under real world conditions.BackgroundCalcitonin gene-related peptide has an important pathophysiological role in cluster headache. Although the randomised controlled trial with the calcitonin gene-related peptide antibody galcanezumab was negative, chronic cluster headache patients with insufficient response to other preventive treatments have been receiving individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies.MethodsData from 22 chronic cluster headache patients who received at least one dose of a calcitonin gene-related peptide(-receptor) antibody and recorded attack frequency in a headache diary were retrospectively collected at eight headache centres.ResultsThe number of previous preventive therapies was 6.5 ± 2.4 (mean ± standard deviation, range: 2–11). The average number of attacks per week was 23.3 ± 16.4 at baseline and significantly decreased by −9.2 ± 9.7 in the first month of treatment with a calcitonin gene-related peptide(-receptor) antibody (p < 0.001). Fifty-five percent of the patients were 50% responders and 36% were 75% responders with respect to attack frequency. Significant reduction of attack frequency started at week 1 (−6.8 ± 2.8 attacks, p < 0.01). Results were corroborated by significant decreases in weekly uses of acute headache medication (−9.8 ± 7.6, p < 0.001) and pain intensity during attacks (−1.2 ± 2.0, numerical rating scale (NRS) [0–10], p < 0.01) in the first month. In months 2 (n = 14) and 3 (n = 10), reduction of attack frequency from baseline was −8.0 ± 8.4 (p = 0.004) and −9.1 ± 10.0 (p = 0.024), respectively.ConclusionUnder real-world conditions, individual treatment with calcitonin gene-related peptide(-receptor) antibodies was effective in 55% of our chronic cluster headache patients. This finding supports individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies in chronic cluster headache patients insufficiently responding to other therapies.
Highlights
Cluster headache is characterised by excruciatingly painful side-locked headache attacks with ipsilateral cranial autonomic symptoms and restlessness, often recurring several times a day
Pain intensity and use of abortive treatment were analysed. This is a retrospective case series based on headache diary data of cluster headache (CCH) patients, conceived during a meeting on the role of calcitonin gene-related peptide (CGRP) in headache organised by the German Migraine and Headache Society (DMKG) in February 2020
It includes adult (!18 years old) patients diagnosed with chronic cluster headache (CCH) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria (4), who received at least one treatment with a CGRP(R) antibody between December 2018 and March 2020, who did not change their concomitant cluster headache preventive therapy during the observation period (4-week baseline and months [1,2,3] as applicable), with one exception, and who documented the frequency of their cluster headache attacks in a headache diary as part of their standard care
Summary
Cluster headache is characterised by excruciatingly painful side-locked headache attacks with ipsilateral cranial autonomic symptoms and restlessness, often recurring several times a day. It has a prevalence of $0.1%, a male preponderance, and is one of the primary headache disorders associated with the highest disability, especially in its chronic form (1–3). Mainstays of long-term preventive treatment in Europe are verapamil, lithium and topiramate, complemented by neuromodulatory approaches and other drugs with less evidence (6,7) While these treatments work well for many patients, there is a relevant proportion that does not respond sufficiently, or does not tolerate treatment (8). There clearly is an unmet need for new therapies in CCH
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
