PT Unknown
AU Nsaka, M
TI Is a mandatory treatment break after a one-year prophylactic treatment with calcitonin gene-related peptide antibodies (receptor) monoclonal antibodies reasonable? Real World Evidence
PD 08
PY 2022
DI 10.17185/duepublico/76397
LA en
DE Migraine; CGRP; mandatory treatment break; calcitonin gene-related peptide antibodies (receptor) monoclonal antibodies
AB BACKGROUND: Current German and European guidelines recommend migraine patients undertake a treatment break after 9 to 12 months of treatment with calcitonin gene-related peptide monoclonal antibodies (receptor) antibodies (CGRP monoclonal antibodies). Data regarding the validity of this strategy are still rare. METHODS: Clinical routine data of highly therapy refractory migraine patients were analysed 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. Statistical analysis was performed using the Friedman Test. Post hoc analysis was conducted using Wilcoxon signed-rank test. Descriptive statistics were performed to evaluate changes in vegetative symptoms, acute medication response as well as treatment satisfaction during the treatment break. 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 analysed. The mean number of MMDs among EM and CM patients after 12 months of CGRP antibody treatment increased during the recommended 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 (receptor) monoclonal antibody after the mandatory treatment break. CONCLUSION: A mandatory break in calcitonin gene-related peptide monoclonal (receptor) antibody therapies had a negative short-term impact on migraine patients.
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