Eleonora De Matteis1, Giannapia Affaitati2, Ilaria Frattale1, Valeria Caponnetto1, Francesca Pistoia1, Maria Adele Giamberardino2, Simona Sacco3, Raffaele Ornello1. 1. Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio, 67100, L'Aquila, Italy. 2. Department of Medicine and Science of Aging, 'G. D'Annunzio' University, Chieti, Italy. 3. Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio, 67100, L'Aquila, Italy. simona.sacco@univaq.it.
Abstract
BACKGROUND: Monoclonal antibodies targeting the calcitonin gene-related peptide, including erenumab, are migraine-specific preventive treatments, whose long-term effectiveness has still to be evaluated in real-life settings. We assessed early outcomes of erenumab discontinuation after a 52-week treatment in patients with a continuous positive response to the drug. METHODS: We evaluated the early outcomes after treatment completion in migraineurs from a real-life multicenter register. All patients received monthly erenumab for 52 weeks and attended a 8-week follow-up after treatment completion. Primary outcomes were responder rates and changes in monthly migraine days (MMDs), acute medications days (AMDs), and pain intensity on a Numerical Rating Scale (NRS score) during weeks 1-4 after erenumab treatment completion. RESULTS: The 32 included patients reported a decrease in MMDs, AMDs, and NRS score during the last 4 weeks of treatment compared with baseline (P<0.001). During weeks 1-4 after treatment completion, all the outcome measures increased compared with the last 4 weeks of treatment (P < 0.001) despite staying lower than baseline (MMDs and AMDs P < 0.001, NRS score P = 0.005). Over the same time frame, 18 (56%) patients maintained a ≥ 50% reduction from baseline in MMDs. At week 4 after treatment completion, 10 (31%) patients restarted treatment due to disease rebound to baseline levels. CONCLUSIONS: More than half patients had an early disease worsening, while the remaining patients maintained their responder status during weeks 1-4 after treatment completion. Further studies might identify predictors of prolonged response to erenumab and define the optimal treatment duration according to patients' characteristics.
BACKGROUND: Monoclonal antibodies targeting the calcitonin gene-related peptide, including erenumab, are migraine-specific preventive treatments, whose long-term effectiveness has still to be evaluated in real-life settings. We assessed early outcomes of erenumab discontinuation after a 52-week treatment in patients with a continuous positive response to the drug. METHODS: We evaluated the early outcomes after treatment completion in migraineurs from a real-life multicenter register. All patients received monthly erenumab for 52 weeks and attended a 8-week follow-up after treatment completion. Primary outcomes were responder rates and changes in monthly migraine days (MMDs), acute medications days (AMDs), and pain intensity on a Numerical Rating Scale (NRS score) during weeks 1-4 after erenumab treatment completion. RESULTS: The 32 included patients reported a decrease in MMDs, AMDs, and NRS score during the last 4 weeks of treatment compared with baseline (P<0.001). During weeks 1-4 after treatment completion, all the outcome measures increased compared with the last 4 weeks of treatment (P < 0.001) despite staying lower than baseline (MMDs and AMDs P < 0.001, NRS score P = 0.005). Over the same time frame, 18 (56%) patients maintained a ≥ 50% reduction from baseline in MMDs. At week 4 after treatment completion, 10 (31%) patients restarted treatment due to disease rebound to baseline levels. CONCLUSIONS: More than half patients had an early disease worsening, while the remaining patients maintained their responder status during weeks 1-4 after treatment completion. Further studies might identify predictors of prolonged response to erenumab and define the optimal treatment duration according to patients' characteristics.