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Real‐world evidence following a mandatory treatment break after a 1‐year prophylactic treatment with calcitonin gene‐related peptide (pathway) monoclonal antibodies
Author(s) -
Nsaka Michael,
Scheffler Armin,
Wurthmann Sebastian,
Schenk Hannah,
Kleinschnitz Christoph,
Glas Martin,
Holle Dagny
Publication year - 2022
Publication title -
brain and behavior
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.915
H-Index - 41
ISSN - 2162-3279
DOI - 10.1002/brb3.2662
Subject(s) - calcitonin gene related peptide , migraine , medicine , chronic migraine , monoclonal antibody , antibody , monoclonal , calcitonin , gastroenterology , pediatrics , immunology , receptor , neuropeptide
Background Current German and European guidelines suggest migraine patients undertake a treatment break after 9 to 12 months of treatment with CGRP (pathway) monoclonal antibodies. Methods Clinical routine data of highly resistant migraine patients were analyzed before treatment with CGRP monoclonal antibodies (baseline), after 12 months of treatment, and following a treatment break between November 2018 and December 2020 in the West German Headache Centre, University Hospital Essen, Germany. Monthly migraine days (MMD), monthly headache days (MHD), and days of acute medication intake (AMD) were assessed. Results Complete clinical data from 46 migraine patients (14 episodic migraine (EM), 32 chronic migraine (CM) patients) treated with erenumab ( n  = 40), galcanezumab ( n  = 4), and fremanezumab ( n  = 2) were analyzed. The mean number of MMDs among EM and CM patients after 12 months of CGRP antibody treatment increased during the treatment break by 5.18 (SE 0.92, p  < .001) and 5.06 (SE 1.22, p =  .003) days, respectively. There was an increased intake of acute medications among episodic (4.72, SE 0.87, p  = .004) and chronic migraine patients (3.01, SE 1.08, p  = .013) during treatment break. Eighty‐three percent of patients ( n  = 38) were dissatisfied with the mandatory treatment break. All patients continued with a CGRP (pathway) monoclonal antibody after the mandatory treatment break. Conclusion A mandatory break in CGRP (pathway) monoclonal antibody therapy had a negative short‐term impact on migraine patients.

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