Authors: Ruth Ruscheweyh, Gregor Broessner, Gudrun Goßrau, Katja Heinze-Kuhn, Tim P Jürgens, Katharina Kaltseis, Katharina Kamm, Andreas Peikert, Bianca Raffaelli, Florian Rimmele, and Stefan Evers
Source: Cephalalgia, 2020, Vol. 40(14) 1574–1584
Objective: To 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.
Background: Calcitonin 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.
Methods: Data 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.
Results: The number of previous preventive therapies was 6.52.4 (meanstandard deviation, range: 2–11). The average number of attacks per week was 23.316.4 at baseline and significantly decreased by 9.29.7 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 (6.82.8 attacks, p<0.01). Results were corroborated by significant decreases in weekly uses of acute headache medication (9.87.6, p<0.001) and pain intensity during attacks (1.22.0, numerical rating scale (NRS) [0–10], p<0.01) in the first month. In months 2 (n¼14) and 3 (n¼10), reduction of attack frequency from baseline was 8.08.4 (p¼0.004) and 9.110.0 (p¼0.024), respectively.
Conclusion: Under 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.0333102420949866