TY - JOUR
T1 - The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response
AU - Broessner, Gregor
AU - Reuter, Uwe
AU - Bonner, Jo H.
AU - Dodick, David W.
AU - Hallström, Yngve
AU - Picard, Hernan
AU - Zhang, Feng
AU - Lenz, Robert A.
AU - Klatt, Jan
AU - Mikol, Daniel D.
N1 - Funding Information:
We thank the study investigators and patients for their participation and commitment to this work. The authors thank Joan Smyth (PhD) and Vanesa Martinez Lopez (PhD) of Novartis Ireland Limited, Dublin, Ireland for providing medical writing support.
Funding Information:
The study was funded by Amgen Inc. Erenumab is co‐developed by Amgen and Novartis. Funding:
Funding Information:
Gregor Broessner, MD, has received unrestricted grants, honoraria, personal fees, and travel grants from Allergan, Amgen, AstraZeneca, European Headache Foundation (EHF), Fresenius, Grünenthal, Janssen Cilag, Lilly, Linde AG, Menarini, Novartis, Österreichische Akademie der Wissenschaften (ÖAW), Österreichische Gesellschaft für Neurologie (ÖGN), Österreichische Kopfschmerzgesellschaft (ÖKSG), Pfizer, Reckitt Benkiser, St. Jude Medical, and Teva. Uwe Reuter, MD, has acted as a consultant for Allergan, Amgen, Eli Lilly, Novartis, Teva, has served on advisory boards for Allergan, Amgen, Autonomic Technologies, Eli Lilly, Medscape, Novartis, Teva, is a member of speakers' bureaus for Allergan, Amgen, Eli Lilly, Medscape, Novartis, StreamedUp, Teva, and has received research support from the German Federal Ministry of Education and Research (BMBF) and Novartis. Jo H. Bonner, MD, has nothing to disclose. David W. Dodick, MD, has received personal fees from AEON, Alder BioPharmaceuticals, Allergan, Amgen, Amzak Health, Association of Translational Medicine, Autonomic Technologies, Axsome, Biohaven, Charleston Laboratories, Clexio, Daniel Edelman Inc., Dr Reddy's Laboratories/Promius, Electrocore LLC, Eli Lilly, eNeura, Equinox, Foresite Capital, Impel, Ipsen, Neurolief, Nocira, Novartis, Oppenheimer, Pieris, PSL Group Services, Revance, Salvia, Satsuma, Sun Pharma (India), Supernus, Teva, Theranica, University Health Network, Upjohn (Division of Pfizer), Vedanta, WL Gore, XoC, Zosano, ZP Opco; has received speaking fees from Amgen, Eli Lilly, Lundbeck, Novartis Canada; has received CME fees or royalty payments from Academy for Continued Healthcare Learning, Cambridge University Press, Catamount, Chameleon, Global Access Meetings, Global Life Sciences, Global Scientific Communications, Haymarket, HealthLogix, Medicom Worldwide, MedLogix Communications, Mednet, Miller Medical, Oxford University Press, PeerView, Universal Meeting Management, UpToDate (Elsevier), WebMD Health/Medscape, Wolters Kluwer Health; owns stock options for Aural Analytics, Epien, Healint, King‐Devick Technologies, Matterhorn, Nocira, Ontologics, Precon Health, Second Opinion/Mobile Health, Theranica; has acted as consultant without fee for Aural Analytics, Epien, Healint, Second Opinion/Mobile Health; is a member of the board of Directors of Epien, King‐Devick Technologies, Matterhorn, Ontologics, Precon Health; owns the patent 17189376.1‐1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis without fee; has received research funding from American Migraine Foundation, Henry Jackson Foundation, PCORI, US Department of Defense; has received professional society fees or reimbursement for travel from American Academy of Neurology, American Brain Foundation, American Headache Society, American Migraine Foundation, Canadian Headache Society, International Headache Society. Yngve Hallström, MD, has served on advisory boards for Amgen, Novartis and Teva. Hernan Picard, MD, is an employee of and stockholder in Amgen. Feng Zhang, MS, is an employee of and stockholder in Amgen. Robert A. Lenz, MD, PhD, is an employee of and stockholder in Amgen. Jan Klatt, MD, is an employee of and stockholder in Novartis. Daniel D. Mikol, MD, PhD, is an employee of and stockholder in Amgen. Conflict of Interests:
Publisher Copyright:
© 2020 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society
PY - 2020/10/1
Y1 - 2020/10/1
N2 - Objective: To assess the efficacy of erenumab at the ≥50%, ≥75%, and 100% reduction in monthly migraine days (MMD) response thresholds, using data from the 6-month double-blind treatment phase (DBTP) of the Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention (STRIVE) pivotal clinical trial. Methods: Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days) were randomized (1:1:1) to erenumab 70 mg (n = 312), erenumab 140 mg (n = 318), or placebo (n = 316) once monthly. We determined the proportions of patients with ≥50%, ≥75% and 100% reduction in MMD over the last 3 months of the STRIVE DBTP (months 4 through 6) and conducted post hoc analyses to contextualize the treatment benefit in patient subgroups achieving, and not achieving, these response thresholds. Outcome measures included changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes. Results: The proportions of patients with a reduction in MMD from baseline were greater for erenumab than for placebo at all response thresholds. As previously reported for the ≥50% response threshold, 135/312 (43.3%) of patients on erenumab 70 mg and 159/318 (50.0%) on erenumab 140 mg responded, vs 84/316 (26.6%) for placebo. At months 4 through 6, 65/312 (20.8%) and 70/318 (22.0%) of those on erenumab 70 mg and erenumab 140 mg, respectively, achieved ≥75% reductions vs 25/316 (7.9%) on placebo. A reduction of 100% response, which required no migraine days over 3 consecutive months based on observed data, was achieved by 10/312 (3.2%) of patients treated with erenumab 70 mg and 16/318 (5.0%) for erenumab 140 mg, vs 9/316 (2.8%) for placebo. At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early. Meanwhile, 60/312 (19.2%) and 53/318 (16.7%) patients on erenumab 70 and 140 mg, respectively, had no reduction in MMD from baseline in months 4 through 6, compared with 104/316 (32.9%) patients on placebo. Conclusions: The responses at the ≥50%, ≥75%, and 100% thresholds provide context for establishing realistic patient and physician expectations regarding the magnitude of treatment benefit that may be achieved by patients with EM responding to erenumab (STRIVE, NCT02456740).
AB - Objective: To assess the efficacy of erenumab at the ≥50%, ≥75%, and 100% reduction in monthly migraine days (MMD) response thresholds, using data from the 6-month double-blind treatment phase (DBTP) of the Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention (STRIVE) pivotal clinical trial. Methods: Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days) were randomized (1:1:1) to erenumab 70 mg (n = 312), erenumab 140 mg (n = 318), or placebo (n = 316) once monthly. We determined the proportions of patients with ≥50%, ≥75% and 100% reduction in MMD over the last 3 months of the STRIVE DBTP (months 4 through 6) and conducted post hoc analyses to contextualize the treatment benefit in patient subgroups achieving, and not achieving, these response thresholds. Outcome measures included changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes. Results: The proportions of patients with a reduction in MMD from baseline were greater for erenumab than for placebo at all response thresholds. As previously reported for the ≥50% response threshold, 135/312 (43.3%) of patients on erenumab 70 mg and 159/318 (50.0%) on erenumab 140 mg responded, vs 84/316 (26.6%) for placebo. At months 4 through 6, 65/312 (20.8%) and 70/318 (22.0%) of those on erenumab 70 mg and erenumab 140 mg, respectively, achieved ≥75% reductions vs 25/316 (7.9%) on placebo. A reduction of 100% response, which required no migraine days over 3 consecutive months based on observed data, was achieved by 10/312 (3.2%) of patients treated with erenumab 70 mg and 16/318 (5.0%) for erenumab 140 mg, vs 9/316 (2.8%) for placebo. At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early. Meanwhile, 60/312 (19.2%) and 53/318 (16.7%) patients on erenumab 70 and 140 mg, respectively, had no reduction in MMD from baseline in months 4 through 6, compared with 104/316 (32.9%) patients on placebo. Conclusions: The responses at the ≥50%, ≥75%, and 100% thresholds provide context for establishing realistic patient and physician expectations regarding the magnitude of treatment benefit that may be achieved by patients with EM responding to erenumab (STRIVE, NCT02456740).
KW - STRIVE double-blind treatment phase
KW - efficacy
KW - episodic migraine
KW - erenumab
KW - responder thresholds
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U2 - 10.1111/head.13929
DO - 10.1111/head.13929
M3 - Article
C2 - 32851644
AN - SCOPUS:85089909151
VL - 60
SP - 2026
EP - 2040
JO - Headache
JF - Headache
SN - 0017-8748
IS - 9
ER -