Peter J Goadsby1, Uwe Reuter2, Yngve Hallström3, Gregor Broessner4, Jo H Bonner5, Feng Zhang6, Ian K Wright7, Denise E Chou6, Jan Klatt8, Hernan Picard6, Robert A Lenz6, Daniel D Mikol6. 1. NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College Hospital, London, UK peter.goadsby@kcl.ac.uk. 2. Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany. 3. Neuro Center, St Görans Hospital, Stockholm, Sweden. 4. Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria. 5. Mercy Research, Saint Louis, MO, USA. 6. Amgen Inc., Thousand Oaks, CA, USA. 7. Novartis Product Irl Ltd, Dublin, Ireland. 8. Novartis Pharma AG, Basel, Switzerland.
Abstract
OBJECTIVE: To assess efficacy and tolerability of 1-year erenumab treatment in patients with episodic migraine. METHODS: Patients were randomized (n=955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo, erenumab 70 or 140mg. At Week 24, 845 patients were re-randomized (1:1) to erenumab 70 or 140mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly migraine days (MMD), achieving ≥50%, ≥75% and 100% reduction in MMD, and safety/tolerability were assessed. RESULTS:Mean MMD at DBTP baseline was 8.3. At Week 52, mean changes (SE) from pre-DBTP baseline/Week 24 (pre-ATP baseline) in MMD were -4.2 (0.2)/-1.1 (0.2) (70mg) and -4.6 (0.2)/-1.8 (0.2) (140mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70mg (ATP), change in MMD from Week 24 to 52 was -0.1 (0.3), and for those increasing from 70 (DBTP) to 140mg (ATP) was -1.8 (0.3). At Week 52, 61.0%, 38.5% and 19.8% of patients on erenumab 70mg, and 64.9%, 40.8% and 21.2% on erenumab 140mg, achieved ≥50%, ≥75% and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in the ATP was similar to the DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose. CONCLUSION: Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding. CLINICALTRIALSGOV IDENTIFIER: NCT02456740 CLASSIFICATION OF EVIDENCE: Class II evidence that 52 weeks of treatment with erenumab 70 and 140mg subcutaneously monthly results in sustained reductions in monthly migraine days and similar dose tolerability for patients with episodic migraine.
RCT Entities:
OBJECTIVE: To assess efficacy and tolerability of 1-year erenumab treatment in patients with episodic migraine. METHODS:Patients were randomized (n=955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo, erenumab 70 or 140mg. At Week 24, 845 patients were re-randomized (1:1) to erenumab 70 or 140mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly migraine days (MMD), achieving ≥50%, ≥75% and 100% reduction in MMD, and safety/tolerability were assessed. RESULTS: Mean MMD at DBTP baseline was 8.3. At Week 52, mean changes (SE) from pre-DBTP baseline/Week 24 (pre-ATP baseline) in MMD were -4.2 (0.2)/-1.1 (0.2) (70mg) and -4.6 (0.2)/-1.8 (0.2) (140mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70mg (ATP), change in MMD from Week 24 to 52 was -0.1 (0.3), and for those increasing from 70 (DBTP) to 140mg (ATP) was -1.8 (0.3). At Week 52, 61.0%, 38.5% and 19.8% of patients on erenumab 70mg, and 64.9%, 40.8% and 21.2% on erenumab 140mg, achieved ≥50%, ≥75% and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in the ATP was similar to the DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose. CONCLUSION: Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding. CLINICALTRIALSGOV IDENTIFIER: NCT02456740 CLASSIFICATION OF EVIDENCE: Class II evidence that 52 weeks of treatment with erenumab 70 and 140mg subcutaneously monthly results in sustained reductions in monthly migraine days and similar dose tolerability for patients with episodic migraine.
Authors: Peter J Goadsby; Uwe Reuter; Michel Lanteri-Minet; Gabriel Paiva da Silva Lima; Peggy Hours-Zesiger; Chrystel Fernandes; Shihua Wen; Nadia Tenenbaum; Aditi Kataria; Michel D Ferrari; Jan Klatt Journal: Neurology Date: 2021-04-28 Impact factor: 9.910