Peter J Goadsby1,2, Koen Paemeleire3, Gregor Broessner4, Jan Brandes5, Jan Klatt6, Feng Zhang7, Hernan Picard7, Robert Lenz7, Daniel D Mikol7. 1. 1 NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, UK. 2. 2 SLaM Biomedical Research Centre, King's College London, UK. 3. 3 Department of Neurology, Ghent University Hospital, Ghent, Belgium. 4. 4 Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria. 5. 5 Nashville Neuroscience Group and Vanderbilt University School of Neurology, Nashville, TN, USA. 6. 6 Novartis Pharma AG, Basel, Switzerland. 7. 7 Amgen Inc., Thousand Oaks, CA, USA.
Abstract
BACKGROUND:Erenumab was effective and well tolerated in a pivotal clinical trial of episodic migraine that included subjects both naïve to, and those who had failed, previous preventives. Here we evaluated the efficacy and safety of erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s): ≥1 or ≥2 prior failed migraine preventive categories, and in patients who had never failed. METHODS: Prespecified subgroup analyses evaluated change from baseline to months 4-6 (the primary endpoint of the blinded study phase) in monthly migraine days, achievement of ≥50% and ≥75% reduction in monthly migraine days, and change from baseline in acute migraine-specific medication days. Adverse events were also evaluated. RESULTS: Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70 mg and -1.3 [-1.9, -0.7] for 140 mg; ≥1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70 mg and -2.5 [-3.4, -1.7] for 140 mg; ≥2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70 mg and -2.7 [-4.0, -1.4] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥50% and ≥75% reduction in monthly migraine days. For the ≥50% reduction in monthly migraine day endpoint, placebo response in the no prior treatment failed group was 32.6%, in the ≥1 failed treatment 17.5%, and in the ≥2 failed treatments 11.1%. CONCLUSION:Erenumab showed consistent efficacy in episodic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups. The data suggest prior patients with prior treatment failures have lower placebo response rates.
RCT Entities:
BACKGROUND:Erenumab was effective and well tolerated in a pivotal clinical trial of episodic migraine that included subjects both naïve to, and those who had failed, previous preventives. Here we evaluated the efficacy and safety of erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s): ≥1 or ≥2 prior failed migraine preventive categories, and in patients who had never failed. METHODS: Prespecified subgroup analyses evaluated change from baseline to months 4-6 (the primary endpoint of the blinded study phase) in monthly migraine days, achievement of ≥50% and ≥75% reduction in monthly migraine days, and change from baseline in acute migraine-specific medication days. Adverse events were also evaluated. RESULTS: Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70 mg and -1.3 [-1.9, -0.7] for 140 mg; ≥1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70 mg and -2.5 [-3.4, -1.7] for 140 mg; ≥2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70 mg and -2.7 [-4.0, -1.4] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥50% and ≥75% reduction in monthly migraine days. For the ≥50% reduction in monthly migraine day endpoint, placebo response in the no prior treatment failed group was 32.6%, in the ≥1 failed treatment 17.5%, and in the ≥2 failed treatments 11.1%. CONCLUSION:Erenumab showed consistent efficacy in episodic migrainepatients who had failed prior preventive treatments and was well tolerated across subgroups. The data suggest prior patients with prior treatment failures have lower placebo response rates.
Authors: Andrew M Blumenfeld; Peter J Goadsby; David W Dodick; Susan Hutchinson; Chengcheng Liu; Michelle Finnegan; Joel M Trugman; Armin Szegedi Journal: Headache Date: 2021-03-22 Impact factor: 5.887
Authors: D D Ruff; J H Ford; A Tockhorn-Heidenreich; V L Stauffer; S Govindan; S K Aurora; G M Terwindt; P J Goadsby Journal: Eur J Neurol Date: 2019-12-02 Impact factor: 6.089
Authors: Stewart J Tepper; Messoud Ashina; Uwe Reuter; Yngve Hallström; Gregor Broessner; Jo H Bonner; Hernan Picard; Sunfa Cheng; Denise E Chou; Feng Zhang; Jan Klatt; Daniel D Mikol Journal: J Headache Pain Date: 2021-07-23 Impact factor: 7.277