Erenumab in highly therapy-refractory migraine patients: First German Real-world evidence

Abstract Background: Calcitonin gene related peptide (CGRP) monoclonal antibodies (mAB) are the first specific migraine prophylactic medication. Erenumab is the only CGRP mAB targeting the CGRP receptor. Clinical data regarding efficacy and tolerability of erenumab in highly therapy-refractory patients are not available, yet, although many patients treated with CGRP mAB under real world conditions can be considered as highly therapy-refractory.Methods: Clinical routine data of highly therapy-refractory migraine patients treated with erenumab 70mg for three months between November 2018 and December 2019 in the West German Headache Center, University Hospital Essen, Germany, were analysed. Monthly migraine days (MMD), monthly headache days (MHD) and days of acute medication intake (AMD) were assessed. Statistical analysis was performed using the Wilcoxon test. Descriptive statistics were performed to evaluate changes of vegetative symptoms, acute medication response, side effects, as well as treatment satisfaction.Results: Complete clinical data were available for 26 episodic (EM) and 74 chronic (CM) migraineurs. Sixty-six % (n=49) of CM patients had an additional medication overuse headache (MOH). After three months 57.7 % of EM patients and 41.9 % of CM patients had a 50% or greater reduction of MMD. The mean number of MMD was reduced by 3.43 (SE 1.26) in EM, and by 4.72 (SE 0.87) in CM. Thirty-nine patients (52.7%) returned from chronic to episodic course of migraine. After three months, 23 patients (46.9%) were not suffering from a MOH anymore.Conclusions: Erenumab seems to be a promising therapeutic option in highly therapy-refractory migraine patients.Trial registration: Retrospective registered.

Download Full-text

Erenumab in highly therapy-refractory migraine patients: First German Real-world evidence

10.21203/rs.3.rs-19814/v3 ◽

2020 ◽

Author(s):

Armin Scheffler ◽

Olga Messel ◽

Sebastian Wurthmann ◽

Michael Nsaka ◽

Christoph Kleinschnitz ◽

...

Keyword(s):

Clinical Data ◽

Real World ◽

Therapeutic Option ◽

Medication Overuse Headache ◽

Routine Data ◽

Wilcoxon Test ◽

University Hospital ◽

Real World Evidence ◽

Acute Medication ◽

Refractory Migraine

Abstract Background: Calcitonin gene related peptide (CGRP) monoclonal antibodies (mAB) are the first specific migraine prophylactic medication. Erenumab is the only CGRP mAB targeting the CGRP receptor. Clinical data regarding efficacy and tolerability of erenumab in highly therapy-refractory patients are not available, yet, although many patients treated with CGRP mAB under real world conditions can be considered as highly therapy-refractory.Methods: Clinical routine data of highly therapy-refractory migraine patients treated with erenumab 70mg for three months between November 2018 and December 2019 in the West German Headache Center, University Hospital Essen, Germany, were analysed. Monthly migraine days (MMD), monthly headache days (MHD) and days of acute medication intake (AMD) were assessed. Statistical analysis was performed using the Wilcoxon test. Descriptive statistics were performed to evaluate changes of vegetative symptoms, acute medication response, side effects, as well as treatment satisfaction.Results: Complete clinical data were available for 26 episodic (EM) and 74 chronic (CM) migraineurs. Sixty-six % (n=49) of CM patients had an additional medication overuse headache (MOH). After three months 57.7 % of EM patients and 41.9 % of CM patients had a 50% or greater reduction of MMD. The mean number of MMD was reduced by 3.43 (SE 1.26) in EM, and by 4.72 (SE 0.87) in CM. Thirty-nine patients (52.7%) returned from chronic to episodic course of migraine. After three months, 23 patients (46.9%) were not suffering from a MOH anymore.Conclusions: Erenumab seems to be a promising therapeutic option in highly therapy-refractory migraine patients.Trial registration: Retrospective registered.

Download Full-text

Erenumab in Highly Therapy-refractory Migraine Patients: First Real-world Evidence

10.21203/rs.3.rs-19814/v1 ◽

2020 ◽

Author(s):

Armin Scheffler ◽

Olga Messel ◽

Sebastian Wurthmann ◽

Michael Nsaka ◽

Christoph Kleinschnitz ◽

...

Keyword(s):

Clinical Data ◽

Real World ◽

Therapeutic Option ◽

Medication Overuse Headache ◽

Routine Data ◽

Wilcoxon Test ◽

University Hospital ◽

Real World Evidence ◽

Acute Medication ◽

Refractory Migraine

Abstract Background: Calcitonin gene related peptide (CGRP) monoclonal antibodies (mAB) are the first specific migraine prophylactic medication. Erenumab is the only CGRP mAB targeting the CGRP receptor. Clinical data regarding efficacy and tolerability of erenumab in highly therapy-refractory patients are not available, yet, although many patients treated with CGRP mAB under real world conditions can be considered as highly therapy-refractory.Methods: Clinical routine data of highly therapy-refractory migraine patients treated with erenumab 70mg for three months between November 2018 and December 2019 in the West German Headache Center, University Hospital Essen, Germany, were analysed. Monthly migraine days (MMD), monthly headache days (MHD) and days of acute medication intake (AMD) were assessed. Statistical analysis was performed using the Wilcoxon test. Descriptive statistics were performed to evaluate changes of vegetative symptoms, acute medication response, side effects, as well as treatment satisfaction.Results: Complete clinical data were available for 26 episodic (EM) and 74 chronic (CM) migraineurs. Sixty-six % (n=49) of CM patients had an additional medication overuse headache (MOH). After three months 57.7 % of EM patients and 41.9 % of CM patients had a 50% or greater reduction of MMD. The mean number of MMD was reduced by 3.43 (SE 1.26) in EM, and by 4.72 (SE 0.87) in CM. Thirty-nine patients (52.7%) returned from chronic to episodic course of migraine. After three months, 23 patients (46.9%) were not suffering from a MOH anymore.Conclusions: Erenumab seems to be a promising therapeutic option in highly therapy-refractory migraine patients.

Download Full-text

Developing a multi-center clinical data mart of ACEI and ARB for real-world evidence (RWE)

Clinical Hypertension ◽

10.1186/s40885-018-0103-7 ◽

2018 ◽

Vol 24 (1) ◽

Author(s):

Hun-Sung Kim ◽

Sue Hyun Lee ◽

Tong Min Kim ◽

Ju Han Kim

Keyword(s):

Clinical Data ◽

Real World ◽

Data Mart ◽

Real World Evidence

Download Full-text

Understanding the Medical Chemistry of the Cannabis Plant is Critical to Guiding Real World Clinical Evidence

Molecules ◽

10.3390/molecules25184042 ◽

2020 ◽

Vol 25 (18) ◽

pp. 4042 ◽

Cited By ~ 2

Author(s):

Karim S. Ladha ◽

Prabjit Ajrawat ◽

Yi Yang ◽

Hance Clarke

Keyword(s):

Real World ◽

Clinical Decision Making ◽

Therapeutic Option ◽

Clinical Decision ◽

Therapeutic Effects ◽

Medical Cannabis ◽

The Past ◽

Real World Evidence ◽

Medical Chemistry ◽

Chemical Inputs

While cannabis has been consumed for thousands of years, the medical-legal landscape surrounding its use has dramatically evolved over the past decades. Patients are turning to cannabis as a therapeutic option for several medical conditions. Given the surge in interest over the past decades there exists a major gap in the literature with respect to understanding the products that are currently being consumed by patients. The current perspective highlights the lack of relevance within the current literature towards understanding the medical chemistry of the products being consumed. The cannabis industry must rigorously invest into understanding what people are consuming from a chemical composition standpoint. This will inform what compounds in addition to Δ9-tetrahydrocannabinol and cannabidiol may be producing physiologic/therapeutic effects from plant based extracts. Only through real-world evidence and a formalized, granular data collection process within which we know the chemical inputs for patients already using or beginning to use medical cannabis, we can come closer to the ability to provide targeted clinical decision making and design future appropriate randomized controlled trials.

Download Full-text

027 Will refractory patients respond to erenumab in the real world?

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2019-anzan.26 ◽

2019 ◽

Vol 90 (e7) ◽

pp. A10.1-A10 ◽

Cited By ~ 1

Author(s):

Bronwyn Jenkins ◽

Shuli Cheng ◽

Elspeth Hutton

Keyword(s):

Real World ◽

Medication Overuse ◽

Medication Overuse Headache ◽

Exclusion Criteria ◽

High Severity ◽

Severity Scores ◽

Daily Headache ◽

Refractory Migraine ◽

Randomised Controlled ◽

Headache Centres

IntroductionErenumab has been studied in Randomised Controlled Trials (RCT), with stricter exclusion criteria than real world populations.Methods65 patients from two Australian headache centres on Erenumab had primary outcomes of ≥ 50% response in monthly migraine days (MMD) and monthly headache days (MHD), compared to their demographics, frequency, duration of Chronic Migraine (CM), failed prophylactic medications, severity scores and medication overuse headache (MOH).Results35% (23/65) had daily headaches, with ≥ 50% MHD and MMD reduction in this subgroup of 17% (4/23) and 65% (13/20), respectively. Duration of CM was >10 years in 48% (29/61), with ≥ 50% MHD and MMD reduction in 28% (8/29) and 48% (13/27), respectively. 100% (64/64) had failed > 3 prophylactic medications with ≥50% MHD and MMD reduction in 30% (19/64) and 47% (27/58), respectively, with reducing rates of ≥ 50%MMD reduction if >5 (29%; 17/58) and >10 (22%;2/9). 95% had high severity scores (HIT-6 score >60), with a ≥ 50% MMD reduction in 43% (23/54). MOH occurred in 41% (24/58) for triptan and 29% (17/58) for codeine medications, with a ≥ 50% MMD reduction in 71% (17/24) and 41% (7/17), respectively (all groups p>0.05).ConclusionThis real world cohort treated with Erenumab included patients that would be excluded from RCT analysis- including more chronic, frequent, severe and refractory migraine. Despite this, there were still ≥50% responders in more severe subgroups, particularly daily headache, high severity scores and triptan MOH. Measuring MMD may be more sensitive for assessing improvement than MHD.

Download Full-text

Automating Electronic Clinical Data Capture for Quality Improvement and Research: The CERTAIN Validation Project of Real World Evidence

eGEMs (Generating Evidence & Methods to improve patient outcomes) ◽

10.5334/egems.211 ◽

2018 ◽

Vol 6 (1) ◽

pp. 8

Author(s):

Emily Beth Devine ◽

Erik Van Eaton ◽

Megan E. Zadworny ◽

Rebecca Symons ◽

Allison Devlin ◽

...

Keyword(s):

Quality Improvement ◽

Clinical Data ◽

Real World ◽

Data Capture ◽

Real World Evidence

Download Full-text

Real-world evidence of the effectiveness of adjuvant chemotherapy for early stage breast cancer from Scottish routine data.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.15_suppl.e12558 ◽

2018 ◽

Vol 36 (15_suppl) ◽

pp. e12558-e12558

Author(s):

Peter S Hall ◽

Ewan Gray ◽

Joachim Marti ◽

David Brewster ◽

Jeremy Wyatt

Keyword(s):

Breast Cancer ◽

Adjuvant Chemotherapy ◽

Real World ◽

Early Stage ◽

Routine Data ◽

Early Stage Breast Cancer ◽

Real World Evidence

Download Full-text

Generating real-world evidence: Using automated data extraction to replace manual chart review.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e18096 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e18096-e18096 ◽

Cited By ~ 1

Author(s):

Jennifer H. Law ◽

Christopher Pettengell ◽

Lisa W Le ◽

Steven Aviv ◽

Patricia DeMarco ◽

...

Keyword(s):

Data Collection ◽

Clinical Data ◽

Real World ◽

Chart Review ◽

Clinical Decision Making ◽

Data Extraction ◽

Clinical Care ◽

Data Abstraction ◽

Real World Evidence

e18096 Background: Real world evidence is a valuable resource to help guide clinical care beyond evidence generated from clinical trials, for example safety and effectiveness of novel treatments in special populations. Administrative databases often lack sufficient clinical detail to address gaps in the improvement of patient management and quality of care. Detailed clinical data collection and curation are resource intensive, limiting the ability to generate and maintain large informative cancer databases. Darwen, novel technology developed by Pentavere, enables the automation of data abstraction from unstructured hospital electronic medical records and may eliminate the need for manual chart review. Methods: Health records were identified through an institutional cancer registry from patients with stage IIIB/IV lung cancer (NSCLC or SCLC) diagnosed and treated at the Princess Margaret Cancer Centre between 01/01/2015 and 31/12/2017. Cases underwent automated data extraction including demographics, comorbidities, treatment, concurrent medications and outcomes until 30/06/2018. Agreement with data fields extracted using manual data collection in an external validation set of patients is planned. Results: Of 1210 patients identified, 538 were eligible for analysis. From automated data abstraction, 9.9% were reported to have SCLC, 67.5% adenocarcinoma, 11.2% squamous carcinoma, 28% EGFR mutations, 5.8% ALK fusions and 9.3% tumour PDL1 > = 50%. Of the 304 (56.5%) that received systemic therapy, initial treatment was chemotherapy for 55.6%, targeted therapy in 34.2% and immunotherapy in 10.2%. Additional outcome data and agreement with manually curated data fields will be presented. Conclusions: Automated software to extract clinical data is a powerful new tool to generate and maintain databases that yield high quality real world clinical evidence. This is a critical next step to improve clinical decision making, inform evidence-based practice and improve quality of cancer care.

Download Full-text

The quality of research with real-world evidence

Colombia Medica ◽

10.25100/cm.v50i3.4259 ◽

2019 ◽

pp. 39-41

Author(s):

Mauricio Palacios Gómez

Keyword(s):

Clinical Trials ◽

Clinical Data ◽

Real World ◽

Clinical Care ◽

Medical Science ◽

Clinical Information ◽

Real World Data ◽

Real World Evidence ◽

Definition Of ◽

Time Required

Most of the medical practice has not been proven by controlled clinical trials, and there are no plans to conduct such trials in order to decrease clinician uncertainty. This happens partly due to the difficulty of making designs with scientific and ethical validity, the costs of this type of research and the time required to generate results, which can be several years. Clinical trials do not have the capability to generate information that allows to make decisions in some sectors of clinical care and public health, such as when an epidemic occurs. Therefore, medical science is based on observational studies, past practices and therapeutic tradition (1). Observation of clinical data that have defined a clinical behavior precedes the clinical trial. The knowledge about scurvy, the fact that this pathology is considered a nutritional deficiency and its treatment with citrus fruits, originated thanks to the collection of clinical data on sailors, soldiers and prisoners of the British Crown in the 18th and 19th centuries (2). This clinical information, which was collected uniformly and served to produce new knowledge, is what is now known as Real World Data (RWD). A modern definition of RWD would be one that talks about data obtained by any non-interventionist methodology that is collected prospectively and retrospectively from observations of routine clinical practice, and which comes from various sources including data from patients, doctors, hospitals, payers, social data, etc (3).

Download Full-text