000K utf8 1100 2022$c2022-06-10 1500 eng 2050 urn:nbn:de:hbz:465-20231121-151949-4 2051 10.1002/brb3.2662 3000 Nsaka, Michael 3010 Glas, Martin 3010 Holle, Dagny 3010 Kleinschnitz, Christoph 3010 Scheffler, Armin 3010 Schenk, Hannah 3010 Wurthmann, Sebastian 4000 Real-world evidence following a mandatory treatment break after a 1-year prophylactic treatment with calcitonin gene-related peptide (pathway) monoclonal antibodies [Nsaka, Michael] 4209 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. 4950 https://doi.org/10.1002/brb3.2662$xR$3Volltext$534 4950 https://nbn-resolving.org/urn:nbn:de:hbz:465-20231121-151949-4$xR$3Volltext$534 4961 https://duepublico2.uni-due.de/receive/duepublico_mods_00078909 5051 610 5550 CGRP (pathway) antibodies 5550 disease modification 5550 guidelines 5550 migraine 5550 one-year prophylactictreatment 5550 treatmentbreak