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Migraine Disorders: HELP
Articles by Fengwei Zhang
Based on 12 articles published since 2010
(Why 12 articles?)
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Between 2010 and 2020, Feng Zhang wrote the following 12 articles about Migraine Disorders.
 
+ Citations + Abstracts
1 Clinical Trial Early onset of efficacy with erenumab in patients with episodic and chronic migraine. 2018

Schwedt, Todd / Reuter, Uwe / Tepper, Stewart / Ashina, Messoud / Kudrow, David / Broessner, Gregor / Boudreau, Guy P / McAllister, Peter / Vu, Thuy / Zhang, Feng / Cheng, Sunfa / Picard, Hernan / Wen, Shihua / Kahn, Joseph / Klatt, Jan / Mikol, Daniel. ·Department of Neurology, Mayo Clinic, 5777 E Mayo Blvd, Phoenix, AZ, 85054, USA. Schwedt.Todd@mayo.edu. · Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany. · Geisel School of Medicine at Dartmouth, Hanover, NH, USA. · Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Medical and Health Sciences, University of Copenhagen, Copenhagen, Denmark. · California Medical Clinic for Headache, Santa Monica, CA, USA. · Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria. · Clinique de la Migraine et Céphalées, Département de Neurologie, Centre Hospitalier de L'Université de Montréal, Hôpital Notre-Dame, Montréal, QC, Canada. · New England Institute for Neurology & Headache, Stamford, CT, USA. · Amgen Inc., Thousand Oaks, CA, USA. · Novartis Pharmaceuticals Corp., East Hanover, NJ, USA. · Novartis Pharma AG, Basel, Switzerland. ·J Headache Pain · Pubmed #30276500.

ABSTRACT: BACKGROUND: Subcutaneous erenumab reduced monthly migraine days and increased the likelihood of achieving a ≥ 50% reduction at all monthly assessment points tested in 2 pivotal trials in episodic migraine (EM) and chronic migraine (CM). Early efficacy of migraine preventive medications is an important treatment characteristic to patients. Delays in achievement of efficacy can result in failed adherence. The objective of these post-hoc analyses were to evaluate efficacy in the first 4 weeks after initial subcutaneous administration of erenumab 70 mg, erenumab 140 mg, or placebo. METHODS: There is no generally accepted methodology to measure onset of action for migraine preventive medications. We used a comprehensive approach with data from both studies to evaluate change from baseline in weekly migraine days (WMD), achievement of ≥ 50% reduction in WMD, and proportion of patients experiencing migraine measured on a daily basis. The 7-day moving averages were overlaid with observed data. RESULTS: In both studies (EM: N = 955; CM: N = 667), there was evidence of onset of efficacy of erenumab vs. placebo during the first week of treatment, which in some cases reached nominal significance. For EM the changes in WMD were (least squares mean [LSM] [95% CI]): placebo, - 0.1 (- 0.3, 0.0); erenumab 70 mg, - 0.3 (- 0.5, - 0.2) p = 0.130; erenumab 140 mg, - 0.6 (- 0.7, - 0.4) p < 0.001. For CM the changes were: placebo, - 0.5 (- 0.8, - 0.3); erenumab 70 mg, - 0.9 (- 1.2, - 0.7) p = 0.047; erenumab 140 mg, - 0.8 (- 1.1, - 0.5) p = 0.18. Achievement of ≥ 50% reduction in WMD was observed as early as Week 1 (adjusted OR [95% CI] erenumab vs placebo) in EM: erenumab 70 mg, 1.3 (1.0, 1.9) p = 0.097; erenumab 140 mg, 2.0 (1.4, 2.7) p < 0.001. A similar outcome was observed for CM: erenumab 70 mg, 1.8 (1.1, 2.8) p = 0.011; erenumab 140 mg, 1.9 (1.2, 2.9) p = 0.009. Seven-day moving averages of observed data showed each treatment arm differed from placebo by Week 1 (OR [95% CI]): in EM Day 3 for erenumab 140 mg, 0.7 (0.5, 1.0) p = 0.031 and at Day 7 for 70 mg, 0.6 (0.4, 0.8) p = 0.002; in CM: Day 6 for erenumab 70 mg, 0.6 (0.4, 0.9) p = 0.022 and at Day 7 for 140 mg, 0.7 (0.4, 1.0); p = 0.038. CONCLUSION: Erenumab showed early onset of efficacy with separation from placebo within the first week of treatment in both chronic and episodic migraine patients.

2 Clinical Trial Migraine-related disability, impact, and health-related quality of life among patients with episodic migraine receiving preventive treatment with erenumab. 2018

Buse, Dawn C / Lipton, Richard B / Hallström, Yngve / Reuter, Uwe / Tepper, Stewart J / Zhang, Feng / Sapra, Sandhya / Picard, Hernan / Mikol, Daniel D / Lenz, Robert A. ·1 Department of Neurology, Albert Einstein College of Medicine and Montefiore Medical Center, New York, NY, USA. · 2 Stockholm Neuro Center, Stockholm, Sweden. · 3 Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany. · 4 Geisel School of Medicine at Dartmouth College, Hanover, NH, USA. · 5 Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA. · 6 Global Health Economics, Amgen Inc., Thousand Oaks, CA, USA. · 7 Global Development, Amgen Inc., Thousand Oaks, CA, USA. ·Cephalalgia · Pubmed #30086681.

ABSTRACT: Background We evaluated the effect of erenumab, a fully human monoclonal antibody that inhibits the canonical calcitonin gene-related peptide receptor, on migraine-related disability, impact, and health-related quality of life among patients with episodic migraine. Methods Patients enrolled in a phase 3, 6-month, double-blind, placebo-controlled study of once-monthly erenumab 70 and 140 mg for migraine prevention (STRIVE) used an eDiary during the baseline and double-blind treatment phases to complete validated, specific questionnaires, including the modified (monthly) Migraine Disability Assessment Questionnaire; Headache Impact Test; and Migraine-Specific Quality of Life Questionnaire-role function-restrictive (MSQ-RFR), -role function-preventive (MSQ-RFP), and -emotional function (MSQ-EF). Results A total of 955 patients were randomized to receive erenumab 70 mg (n = 317), erenumab 140 mg (n = 319), or placebo (n = 319). Erenumab versus placebo resulted in significantly greater improvements in all patient-reported outcomes; changes from baseline were numerically higher with 140 mg erenumab. Improvements occurred rapidly and were maintained over 6 months of treatment. Between-group differences from placebo over months 4-6 for the 70- and 140-mg dose groups were, respectively, -2.1 and -2.8 for modified (monthly) Migraine Disability Assessment Questionnaire, -2.1 and -2.3 for Headache Impact Test, 5.1 and 6.5 for MSQ-RFR, 4.2 and 5.4 for MSQ-RFP, and 5.2 and 6.7 for MSQ-EF ( p < 0.001 for all). Erenumab also significantly reduced the proportion of patients with severe and very severe migraine-related disability and increased the proportion of patients with clinically meaningful improvements in migraine-related impact and health-related quality of life. Conclusion Erenumab reduced migraine disability and impact and improved patients' health-related quality of life, reinforcing its role as a promising new therapy for migraine prevention.

3 Clinical Trial A Controlled Trial of Erenumab for Episodic Migraine. 2017

Goadsby, Peter J / Reuter, Uwe / Hallström, Yngve / Broessner, Gregor / Bonner, Jo H / Zhang, Feng / Sapra, Sandhya / Picard, Hernan / Mikol, Daniel D / Lenz, Robert A. ·From the National Institute for Health Research-Wellcome Trust King's Clinical Research Facility, King's College Hospital, London (P.J.G.) · the Department of Neurology, Charité Universitätsmedizin Berlin, Berlin (U.R.) · the Neuro Center, St. Göran Hospital, Stockholm (Y.H.) · the Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria (G.B.) · Mercy Research, St. Louis (J.H.B.) · and the Departments of Global Biostatistical Science (F.Z.), Global Health Economics (S.S.), and Global Development (H.P., D.D.M., R.A.L.), Amgen, Thousand Oaks, CA. ·N Engl J Med · Pubmed #29171821.

ABSTRACT: BACKGROUND: We tested erenumab, a fully human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, for the prevention of episodic migraine. METHODS: We randomly assigned patients to receive a subcutaneous injection of either erenumab, at a dose of 70 mg or 140 mg, or placebo monthly for 6 months. The primary end point was the change from baseline to months 4 through 6 in the mean number of migraine days per month. Secondary end points were a 50% or greater reduction in mean migraine days per month, change in the number of days of use of acute migraine-specific medication, and change in scores on the physical-impairment and everyday-activities domains of the Migraine Physical Function Impact Diary (scale transformed to 0 to 100, with higher scores representing greater migraine burden on functioning). RESULTS: A total of 955 patients underwent randomization: 317 were assigned to the 70-mg erenumab group, 319 to the 140-mg erenumab group, and 319 to the placebo group. The mean number of migraine days per month at baseline was 8.3 in the overall population; by months 4 through 6, the number of days was reduced by 3.2 in the 70-mg erenumab group and by 3.7 in the 140-mg erenumab group, as compared with 1.8 days in the placebo group (P<0.001 for each dose vs. placebo). A 50% or greater reduction in the mean number of migraine days per month was achieved for 43.3% of patients in the 70-mg erenumab group and 50.0% of patients in the 140-mg erenumab group, as compared with 26.6% in the placebo group (P<0.001 for each dose vs. placebo), and the number of days of use of acute migraine-specific medication was reduced by 1.1 days in the 70-mg erenumab group and by 1.6 days in the 140-mg erenumab group, as compared with 0.2 days in the placebo group (P<0.001 for each dose vs. placebo). Physical-impairment scores improved by 4.2 and 4.8 points in the 70-mg and 140-mg erenumab groups, respectively, as compared with 2.4 points in the placebo group (P<0.001 for each dose vs. placebo), and everyday-activities scores improved by 5.5 and 5.9 points in the 70-mg and 140-mg erenumab groups, respectively, as compared with 3.3 points in the placebo group (P<0.001 for each dose vs. placebo). The rates of adverse events were similar between erenumab and placebo. CONCLUSIONS: Erenumab administered subcutaneously at a monthly dose of 70 mg or 140 mg significantly reduced migraine frequency, the effects of migraines on daily activities, and the use of acute migraine-specific medication over a period of 6 months. The long-term safety and durability of the effect of erenumab require further study. (Funded by Amgen and Novartis; STRIVE ClinicalTrials.gov number, NCT02456740 .).

4 Clinical Trial Erenumab (AMG 334) in episodic migraine: Interim analysis of an ongoing open-label study. 2017

Ashina, Messoud / Dodick, David / Goadsby, Peter J / Reuter, Uwe / Silberstein, Stephen / Zhang, Feng / Gage, Julia R / Cheng, Sunfa / Mikol, Daniel D / Lenz, Robert A. ·From the Department of Neurology (M.A.), Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark · Department of Neurology (D.D.), Mayo Clinic, Scottsdale, AZ · NIHR-Wellcome Trust King's Clinical Research Facility (P.J.G.), Kings College London, UK · Department of Neurology (U.R.), Charité Universitätsmedizin Berlin, Germany · Jefferson Headache Center (S.S.), Thomas Jefferson University, Philadelphia, PA · Amgen Inc. (F.Z., S.C., D.D.M., R.A.L.), Thousand Oaks · and Gage Medical Writing, LLC (J.R.G.), Moorpark, CA. ·Neurology · Pubmed #28835404.

ABSTRACT: OBJECTIVE: To assess long-term safety and efficacy of anti-calcitonin gene-related peptide receptor erenumab in patients with episodic migraine (EM). METHODS: Patients enrolled in a 12-week, double-blind, placebo-controlled clinical trial (NCT01952574) who continued in an open-label extension (OLE) study will receive erenumab 70 mg every 4 weeks for up to 5 years. This preplanned interim analysis, conducted after all participants had completed the 1-year open-label follow-up, evaluated changes in monthly migraine days (MMD), achievement of ≥50%, ≥75%, and 100% reductions, Headache Impact Test (HIT-6) score, Migraine-Specific Quality of Life (MSQ), Migraine Disability Assessment (MIDAS), and safety. Data reported as observed without imputation for missing data. RESULTS: Of 472 patients enrolled in the parent study, 383 continued in the OLE with a median exposure to erenumab of 575 days (range 28-822 days). Mean (SD) MMD were 8.8 (2.6) at parent study baseline, 6.3 (4.2) at week 12 (beginning of OLE), and 3.7 (4.0) at week 64 (mean change from baseline [reduction] of 5.0 days). At week 64, 65%, 42%, and 26% achieved ≥50%, ≥75%, and 100% reduction in MMD, respectively. Mean HIT-6 scores were 60.2 (6.3) at baseline and 51.7 (9.2) at week 64. MSQ and MIDAS improvements from baseline were maintained through week 64. Safety profiles during the OLE were similar to those in the double-blind phase, which overall were similar to placebo. CONCLUSIONS: One-year efficacy, supported by functional improvements and favorable safety and tolerability profiles, supports further investigation of erenumab as a preventive treatment in patients with EM. CLINICALTRIALSGOV IDENTIFIER: NCT01952574. CLASSIFICATION OF EVIDENCE: This study provides Class IV evidence that for patients with episodic migraine, erenumab reduces long-term MMD and improves headache-related disability and migraine-specific quality of life.

5 Article Long-term safety and efficacy of erenumab in patients with chronic migraine: Results from a 52-week, open-label extension study. 2020

Tepper, Stewart J / Ashina, Messoud / Reuter, Uwe / Brandes, Jan Lewis / Doležil, David / Silberstein, Stephen D / Winner, Paul / Zhang, Feng / Cheng, Sunfa / Mikol, Daniel D. ·Geisel School of Medicine at Dartmouth, Hanover, NH, USA. · Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark. · Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany. · Nashville Neuroscience Group and Vanderbilt University Department of Neurology, Nashville, TN, USA. · Prague Headache Center DADO MEDICAL sro, Prague, Czech Republic. · Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA. · Premiere Research Institute, Nova Southeastern University, West Palm Beach, FL, USA. · Global Biostatistical Science, Amgen Inc, Thousand Oaks, CA, USA. · Global Development, Amgen Inc, Thousand Oaks, CA, USA. ·Cephalalgia · Pubmed #32216456.

ABSTRACT: BACKGROUND: This study reports the long-term safety and efficacy of erenumab in chronic migraine patients. METHODS: This was a 52-week open-label extension study of a 12-week double-blind treatment phase study. During the double-blind treatment phase, patients received placebo or once-monthly erenumab 70 mg or 140 mg. During the open-label treatment phase, the initial monthly dose was erenumab 70 mg. Following protocol amendment, patients continued to receive erenumab 70 mg if they had already completed their Week 28 visit, otherwise, patients switched from 70 mg to 140 mg; if enrolled after the amendment, patients received 140 mg monthly throughout. RESULTS: In all, 451/609 (74.1%) enrolled patients completed the study. The exposure-adjusted patient incidence rate for any adverse event was 126.3/100 patient-years for the overall erenumab group. Overall, the adverse event profile was similar to that observed in the double-blind treatment phase. Adverse event incidence rates did not increase with long-term erenumab treatment compared with the double-blind treatment phase, and no new serious or treatment-emergent events were seen. Efficacy was sustained throughout the 52 weeks. Clinically significant reductions from double-blind treatment phase baseline (about half) were observed for monthly migraine days and migraine-specific medication days. Achievement of ≥50%, ≥75% and 100% reductions from the double-blind treatment phase baseline in monthly migraine days at Week 52 were reported by 59.0%, 33.2% and 8.9% of patients, respectively, for the combined dose group. A numerically greater benefit was observed with 140 mg compared with 70 mg at Weeks 40 and 52. CONCLUSIONS: Sustained efficacy of long-term erenumab treatment in patients with chronic migraine is demonstrated, with safety results consistent with the known safety profile of erenumab and adverse event rates comparable to placebo adverse event rates in the double-blind treatment phase. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT02174861).

6 Article Auricular acupuncture for migraine: A systematic review protocol. 2020

Zhang, Feng / Shen, Yifeng / Fu, Hongjuan / Zhou, Hao / Wang, Chao. ·Sichuan Integrative Medicine Hospital. · Acupuncture and Tuina School. · Clinical Medicine School, Chengdu University of Chinese Medicine, Chengdu, China. ·Medicine (Baltimore) · Pubmed #32000394.

ABSTRACT: BACKGROUND: Previous reviews indicate that the effect of auricular acupuncture on migraine. However, a systematic review is not available. Therefore, this protocol was conducted to evaluate the efficacy and safety of auricular acupuncture on migraine, by conducting a systematic review and meta-analysis. METHODS: The following databases will be searched from their inception to October 2019: Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Wan Fang Database, the Chongqing VIP Chinese Science and Technology Periodical Database (VIP), Cochrane Library, EMBASE, EBSCO, PubMed. The randomized controlled trials (RCTs) in English or Chinese associated with auricular acupuncture for migraines will be included. Eligible study conference abstracts and reference lists of manuscripts will be searched. The data collection and analysis will be conducted independently by 2 reviewers. Meta-analysis will be performed using Rev Man V.5.3.5 statistical software. RESULTS: This systematic review will be conducted to evaluate the efficacy and safety of auricular acupuncture in the treatment of migraine. Therefore, auricular acupuncture in the treatment of migraine needs to be further clarified. CONCLUSIONS: In summary, this review will determine whether the impact of auricular acupuncture for intelligence on the treatment of migraines. A better approach may be established for migraine base on this review. It provides reliable evidence for its extensive application. ETHICS AND DISSEMINATION: The private information from individuals will not publish. This systematic review also will not involve endangering participant rights. Ethical approval is not available. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/7ZR8Q.

7 Article Patent foramen ovale closure by using transesophageal echocardiography for cryptogenic stroke: single center experience in 132 consecutive patients. 2020

Han, Yangyang / Zhang, Xiquan / Zhang, Fengwei. ·Department of Cardiovascular Surgery, Qilu Hospital of Shandong University, West Wenhua Road No.107, Lixia District, Jinan, 250012, Shandong Province, China. · Department of Cardiovascular Surgery, Linyi People's Hospital Affiliated to Shandong University, Jiefang Street No. 27, Linyi, 276000, Shandong Province, China. · Department of Cardiovascular Surgery, Linyi People's Hospital Affiliated to Shandong University, Jiefang Street No. 27, Linyi, 276000, Shandong Province, China. zhangxiquan2019@163.com. ·J Cardiothorac Surg · Pubmed #31918738.

ABSTRACT: BACKGROUND: Percutaneous closure of patent foramen ovale (PFO) is routinely performed using plain fluoroscopy in the catheter room. This method results in inevitable radiation damage, adverse effects of contrast agents on kidneys, and high cost. We performed PFO closure with a simplified and economical transesophageal echocardiography (TEE)-only guided approach in the operating room. This study aimed to investigate the feasibility, safety, and effectiveness of the percutaneous closure of PFO by only using TEE. METHODS: We reviewed the medical records of patients who underwent percutaneous PFO closure at our center from December 2013 to December 2017. A total of 132 patients with PFO and cryptogenic strokes underwent PFO closure by using cardi-O-fix PFO device under TEE guidance. The participants comprised 64 and 68 male and female patients, respectively. The mean age and body weight of the patients were 39.40 ± 13.22 years old (12-68 years old) and 65.42 ± 9.70 kg (40-95 kg), respectively. All patients only received aspirin (3-5 mg/kg body weight, oral administration) for 6 months. Contrast-enhanced transthoracic echocardiography (c-TTE) with Valsalva maneuver was performed during follow-up, and questionnaire surveys were obtained at 3, 6, and 12 months after the procedure. RESULTS: All (100%) patients were successfully closed. Follow-ups were conducted for 13 months to 48 months, with an average of 27 months. No severe complications were found during the follow-up period. Paroxysmal atrial fibrillation occurred in 4 patients within 3 months after the procedure. No recurrent stroke or death occurred in all patients during the follow-up period. Transient ischemic attack occurred in one patient 6 months after the procedure. Ten (7.6%) patients had a right-to-left shunt, as demonstrated by c-TTE at 12 months of follow-up. Among the 57 patients suffering from migraine, significant relief or resolution was reported by 42 (73.7%) patients. CONCLUSION: TEE-only guided PFO closure was a safe, feasible, and effective method that did not require the use of X-rays and contrast agents.

8 Article The spectrum of response to erenumab in patients with chronic migraine and subgroup analysis of patients achieving ≥50%, ≥75%, and 100% response. 2020

Brandes, Jan Lewis / Diener, Hans-Christoph / Dolezil, David / Freeman, Marshall C / McAllister, Peter J / Winner, Paul / Klatt, Jan / Cheng, Sunfa / Zhang, Feng / Wen, Shihua / Ritter, Shannon / Lenz, Robert A / Mikol, Daniel D. ·Nashville Neuroscience Group, NUMC, Vanderbilt University, Department of Neurology, Nashville, TN, USA. · Faculty of Medicine, University Duisburg-Essen, Essen, Germany. · Prague Headache Center, DADO MEDICAL s.r.o., Prague, Czech Republic. · Headache Wellness Center, Greensboro, NC, USA. · New England Institute for Neurology and Headache, Stamford, CT, USA. · Palm Beach Headache Center, West Palm Beach, FL, USA. · Novartis Pharma AG, Basel, Switzerland. · Amgen Inc., Thousand Oaks, CA, USA. · Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. ·Cephalalgia · Pubmed #31816249.

ABSTRACT: OBJECTIVE: To assess the efficacy of erenumab across the spectrum of response thresholds (≥50%, ≥75%, 100%) based on monthly migraine days (MMD) reduction in patients with chronic migraine from a 12-week, randomized study (NCT02066415). METHODS: Patients (n = 667) received (3:2:2) placebo or erenumab 70/140 mg once-monthly. The proportion of patients achieving a given response threshold was assessed. A RESULTS: The proportion of patients responding to erenumab exceeded that of placebo at the ≥50% and ≥75% response thresholds. At month 3, 39.9% and 41.2% of patients on erenumab 70 and 140 mg, respectively, achieved ≥50% response versus placebo (23.5%). Similarly, at month 3, 17.0% and 20.9% of patients on erenumab 70 and 140 mg, respectively, achieved ≥75% response versus placebo (7.8%). Compared with the overall erenumab-treated population (change in MMD: -6.6 [both 70 and 140 mg]), ≥50% responders showed MMD reductions of -12.2/-12.5 for 70 mg/140 mg versus -2.6/-2.2 for those not achieving ≥50% response. ≥75% responders showed MMD reductions of -13.9/-14.8 for 70 mg/140 mg versus -5.0/-4.3 for those not achieving ≥75% response. Relative improvements in MSMD and disability were observed in responders versus overall erenumab-treated population. CONCLUSION: For erenumab-treated patients achieving ≥50% response, the actual reduction in MMD was almost twice that of the overall population. These findings provide context for setting realistic expectations regarding actual treatment benefit experienced by patients responding to treatment.

9 Article Long-term tolerability and nonvascular safety of erenumab, a novel calcitonin gene-related peptide receptor antagonist for prevention of migraine: A pooled analysis of four placebo-controlled trials with long-term extensions. 2019

Ashina, Messoud / Kudrow, David / Reuter, Uwe / Dolezil, David / Silberstein, Stephen / Tepper, Stewart J / Xue, Fei / Picard, Hernan / Zhang, Feng / Wang, Andrea / Zhou, Yanchen / Hong, Frank / Klatt, Jan / Mikol, Daniel D. ·Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark. · California Medical Clinic for Headache, Santa Monica, CA, USA. · Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany. · Dado Medical sro, Prague Headache Center, Prague, Czech Republic. · Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, PA, USA. · Geisel School of Medicine at Dartmouth, Hanover, NH, USA. · Amgen Inc, Thousand Oaks, CA, USA. · Amgen Inc, South San Francisco, CA, USA. · Novartis Pharma AG, Basel, Switzerland. ·Cephalalgia · Pubmed #31707815.

ABSTRACT: BACKGROUND: Efficacy and safety of erenumab have been evaluated in a comprehensive clinical development program resulting in approval for migraine prevention in over 40 countries to date. METHODS: This integrated safety analysis included four double-blind randomized trials and their extensions (up to three-plus years). Safety endpoints included exposure-adjusted patient incidences of adverse events, serious adverse events, and anti-erenumab antibodies. RESULTS: In all, 2375 of the patients randomized across the four studies received at least one dose of erenumab (70 mg or 140 mg), with cumulative exposure of 2641.2 patient-years. Exposure-adjusted adverse event rates during the double-blind treatment phase were similar to placebo, with the exception of injection-site reactions (17.1 vs. 10.8 per 100 patient-years), constipation (7.0 vs. 3.8 per 100 patient-years), and muscle spasm (2.3 vs. 1.2 per 100 patient-years). During the long-term extensions, adverse events reported were similar to those observed during the double-blind treatment phase, and rates of injection site reactions, constipation, and muscle spasm were reported at lower rates than in the double-blind treatment phase. There were two deaths reported, both confounded by pre-existing conditions. CONCLUSIONS: This pooled safety analysis revealed a favorable and stable adverse event profile over time for erenumab with more than three years of exposure. TRIAL REGISTRATION: ClinicalTrials.gov NCT01952574, NCT02483585, NCT02456740, NCT02066415, and NCT02174861.

10 Article Long-term safety and tolerability of erenumab: Three-plus year results from a five-year open-label extension study in episodic migraine. 2019

Ashina, Messoud / Goadsby, Peter J / Reuter, Uwe / Silberstein, Stephen / Dodick, David / Rippon, Gregory A / Klatt, Jan / Xue, Fei / Chia, Victoria / Zhang, Feng / Cheng, Sunfa / Mikol, Daniel D. ·Department of Neurology, Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. · NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK. · Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany. · Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA. · Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA. · Amgen Inc., Thousand Oaks, CA, USA. · Novartis Pharma AG, Basel, Switzerland. ·Cephalalgia · Pubmed #31146544.

ABSTRACT: BACKGROUND: Previously published three-month placebo-controlled and one-year open-label clinical trial data have provided information on the efficacy and safety of erenumab. METHODS: Interim analysis was undertaken from an ongoing five-year open-label treatment phase after all patients completed three years in the open-label treatment phase or discontinued the study. Adult patients with episodic migraine enrolled in the open-label treatment phase initially received 70 mg erenumab monthly. A protocol amendment increased the dosage to 140 mg monthly to assess long-term safety of the higher dose. Safety and tolerability were assessed by monitoring adverse events, electrocardiograms, laboratory assessments, and vital signs. RESULTS: Of 383 patients enrolled in the open-label treatment phase, at data cutoff 235 (61.3%) remained in the study, all received 140 mg for ≥1 year. Median (Q1, Q3) exposure (70 or 140 mg) for all patients enrolled was 3.2 (1.3, 3.4) years. The most frequent adverse events (≥4.0/100 patient-years) were reported as viral upper respiratory tract infection, sinusitis, influenza, and back pain. Exposure-adjusted serious adverse event rates were 4.2/100 patient-years. There was no increase in cardiovascular events over time. CONCLUSIONS: In this long-term study of a CGRP-receptor antibody, erenumab was found to be safe and well-tolerated with a spectrum and rate of adverse events consistent with shorter-term placebo-controlled studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT01952574.

11 Article Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study. 2019

Goadsby, Peter J / Paemeleire, Koen / Broessner, Gregor / Brandes, Jan / Klatt, Jan / Zhang, Feng / Picard, Hernan / Lenz, Robert / Mikol, Daniel D. ·1 NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, UK. · 2 SLaM Biomedical Research Centre, King's College London, UK. · 3 Department of Neurology, Ghent University Hospital, Ghent, Belgium. · 4 Department of Neurology, Headache Outpatient Clinic, Medical University of Innsbruck, Innsbruck, Austria. · 5 Nashville Neuroscience Group and Vanderbilt University School of Neurology, Nashville, TN, USA. · 6 Novartis Pharma AG, Basel, Switzerland. · 7 Amgen Inc., Thousand Oaks, CA, USA. ·Cephalalgia · Pubmed #30982348.

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.

12 Article Efficacy and safety of erenumab (AMG334) in chronic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study. 2018

Ashina, Messoud / Tepper, Stewart / Brandes, Jan Lewis / Reuter, Uwe / Boudreau, Guy / Dolezil, David / Cheng, Sunfa / Zhang, Feng / Lenz, Robert / Klatt, Jan / Mikol, Daniel D. ·1 Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Medical and Health Sciences, University of Copenhagen, Copenhagen, Denmark. · 2 Geisel School of Medicine at Dartmouth, Hanover, NH, USA. · 3 Nashville Neuroscience Group and Department of Neurology, Vanderbilt University, Nashville, TN, USA. · 4 Department of Neurology, Charité Universitätsmedizin Berlin, Berlin, Germany. · 5 Headache Unit, Neurology Department, University Hospital Center of Montreal, Montreal, QC, Canada. · 6 Prague Headache Center, DADO MEDICAL s.r.o., Prague, Czech Republic. · 7 Amgen Inc., Thousand Oaks, CA, USA. · 8 Novartis Pharma AG, Basel, Switzerland. ·Cephalalgia · Pubmed #29984601.

ABSTRACT: Background Erenumab was effective and well tolerated in a pivotal clinical trial of chronic migraine. Here, we evaluated efficacy and safety of monthly erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s) (≥ 1, ≥ 2 prior failed medication categories) and in patients who had never failed. Methods Subgroup analyses evaluated change from baseline in monthly migraine days; achievement of ≥ 50% and ≥ 75% reduction in monthly migraine days; and change in monthly acute migraine-specific medication days. Adverse events were evaluated for each subgroup. Results Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days (primary endpoint) at Month 3 (treatment difference [95% CI], never failed subgroup: -2.2 [-4.1, -0.3] for 70 mg and -0.5 [-2.4, 1.5] for 140 mg; ≥ 1 prior failed medication categories subgroup: -2.5 [-3.8, -1.2], for 70 mg and -3.3 [-4.6, -2.1] for 140 mg; ≥ 2 prior failed medication categories subgroup: -2.7 [-4.2, -1.2], for 70 mg and -4.3 [-5.8, -2.8] 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. There were no new or unexpected safety issues. Conclusion Erenumab showed consistent efficacy in chronic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups.