scholarly journals Totality of evidence for ABP 980, a trastuzumab biosimilar: results of chemo-synergy studies in combination with pertuzumab

The Breast ◽  
2021 ◽  
Vol 56 ◽  
pp. S83
Author(s):  
H.-C. Kolberg ◽  
T. Thway ◽  
V. Hanes
Keyword(s):  
Totality Of Evidence

Ibuprofen and risk of hypoglycemia in diabetic and non-diabetic consumers: analysis of international pharmacovigilance data

2021 ◽  
Vol 9 (1) ◽  
pp. 5
Author(s):  
Mulugeta Russom ◽  
Filipos Yohannes ◽  
Abel Tekle ◽  
Ruth Ghirmay
Keyword(s):  
Individual Case ◽  
Causal Link ◽  
Epidemiological Evidence ◽  
Global Database ◽  
Bradford Hill ◽  
Bradford Hill Criteria ◽  
History Of ◽  
Hill Criteria ◽  
Time To Onset ◽  
Totality Of Evidence

Introduction: Ibuprofen was associated with hypoglycemia in a single published case report in a diabetic patient. Ibuprofen, however, has never been associated so far with hypoglycemia in previously healthy non-diabetic individuals and thus, it is not listed as adverse effect in its summary of product characteristics approved by major regulatory authorities. Objective: This study was conducted to assess the causal relationship between ibuprofen and hypoglycemia in diabetic and non-diabetic individuals. Materials and Methods: Analysis of the literature and the WHO global database of individual case safety reports, VigiBase, was made to explore evidence on the association of ibuprofen and hypoglycemia. The unpublished data and the currently availablepublished toxicological, biological, clinical and epidemiological evidence, if any, was systematically organized using Austin Bradford Hill criteria, causality assessment framework, to assess the causal link between ibuprofen and hypoglycemia. Results: In VigiBase, there were 125 cases of hypoglycemia associated with ibuprofen, reported from 19 countries. About 50% had history of diabetes. Ibuprofen was reported as sole suspect in 36.8% of the cases and the only drug administered in18.4%. Hypoglycemia resolved following discontinuation of ibuprofen in 21.6% and recurred in three patients with rechallenge. Outcome was fatal in 10.5%. Where ibuprofen was solely administered, median time-to-onset of hypoglycemia was one-day following administration of the drug. In an experimental study, a significant decrease in blood glucose level was observed at a higher dose of ibuprofen compared to a low-dose. Conclusion: Currently available totality of evidence reflects a possible causal association between ibuprofen and hypoglycemia that need to be substantiated with further studies.

scholarly journals A Review of the Totality of Evidence Supporting the Development of the First Adalimumab Biosimilar ABP 501

2019 ◽  
Vol 36 (8) ◽  
pp. 1833-1850 ◽  
Author(s):  
Richard Markus ◽  
Helen J. McBride ◽  
Monica Ramchandani ◽  
Vincent Chow ◽  
Jennifer Liu ◽  
...  
Keyword(s):  
Abp 501 ◽  
Totality Of Evidence

Totality of evidence in development of the bevacizumab biosimilar ABP 215: Central and investigator evaluation of efficacy from the MAPLE study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20708-e20708
Author(s):  
Michael Thomas ◽  
Nick Thatcher ◽  
Jerome H Goldschmidt ◽  
Yuichiro Ohe ◽  
Helen McBride ◽  
...  
Keyword(s):  
Risk Ratio ◽  
Objective Response ◽  
Progression Free Survival ◽  
Clinical Results ◽  
Double Blind Study ◽  
Double Blind ◽  
Free Survival ◽  
The Us ◽  
Duration Of Response ◽  
Totality Of Evidence

e20708 Background: ABP 215 (MVASI™ [bevacizumab]) is the first biosimilar to Avastin (bevacizumab) approved in the US and EU. This phase 3, double-blind study compared efficacy of ABP 215 with bevacizumab reference product (RP) in patients with advanced non-squamous NSCLC. Here we report the totality of evidence supporting similarity between ABP 215 and RP, including preclinical VEGF-A isoform binding relevant to the mechanism of action across indications, and clinical results of central and investigator evaluation of tumor response. Methods: VEGF-A kinetic parameters were compared for common isoforms 121, 165 and 189. Patients were randomized 1:1 to ABP 215 or RP 15 mg/kg Q3Wx6 cycles. All patients received carboplatin and paclitaxel Q3W for up to 6 cycles. Disease assessments (CT/MRI) were performed at screening, weeks 7, 13, 19, and Q9W thereafter by the investigator and, independently, by central, blinded radiologists. Efficacy was based on objective tumor assessments according to RECIST 1.1. Copies of all radiographs were submitted for central analysis. The primary efficacy endpoint was risk ratio of objective response rate (ORR); clinical equivalence was confirmed if the 2-sided 90% CI of the risk ratio was within the margin of 0.67-1.5. Additional efficacy analyses included duration of response (DOR) and progression-free survival (PFS). Results: Binding to all 3 isoforms was similar for ABP 215 and RP. In the MAPLE study, 642 patients (ABP 215, 328; RP, 314) were randomized. Based on central analysis, ORR was achieved in 128 (39.0%) patients in the ABP 215 and 131 (41.7%) in the RP groups, (ORR risk ratio: 0.93 [90% CI: 0.80, 1.09]). Based on investigator analysis, ORR was achieved in 157 (47.9%) patients in the ABP 215 and 151 (48.1%) in the RP groups (ORR risk ratio: 1.01 [90% CI: 0.88, 1.16]). Hazard ratio (HR, ABP 215 vs RP) for DOR was 1.08 (95% CI, 0.76, 1.54) and 0.76 (95% CI, 0.48, 1.23) per investigator and central assessment. PFS HR was 1.10 (90% CI, 0.92, 1.33) and 1.03 (90% CI, 0.83, 1.29) per investigator and central assessment. Conclusions: These results further confirm the similarity of ABP 215 and RP and support extrapolation to all available bevacizumab indications. Clinical trial information: NCT01966003.

scholarly journals Determining false-positives requires considering the totality of evidence

2015 ◽  
Vol 112 (48) ◽  
pp. E6591-E6591 ◽  
Author(s):  
Andrew Healy ◽  
Neil Malhotra ◽  
Cecilia Hyunjung Mo
Keyword(s):  
False Positives ◽  
Totality Of Evidence

scholarly journals Totality of evidence needed for nutrition recommendations

2014 ◽  
Vol 10 (5) ◽  
pp. 310-310 ◽  
Author(s):  
Arne Astrup ◽  
Jennie Brand-Miller
Keyword(s):  
Totality Of Evidence

scholarly journals Effectiveness of interventions to reduce adverse outcomes among older adults following emergency department discharge: Protocol for an overview of systematic reviews

2020 ◽  
Vol 3 ◽  
pp. 27
Author(s):  
Mairéad Conneely ◽  
Katie Robinson ◽  
Siobhán Leahy ◽  
Dominic Trépel ◽  
Fionnuala Jordan ◽  
...  
Keyword(s):  
Older Adults ◽  
Systematic Reviews ◽  
Treatment Options ◽  
Grey Literature ◽  
Adverse Outcomes ◽  
Healthcare Needs ◽  
Emergency Department Discharge ◽  
Randomised Controlled ◽  
Totality Of Evidence

Background: Older adults are frequent users of Emergency departments (ED) and this trend will continue due to population ageing and the associated increase in healthcare needs. Older adults are vulnerable to adverse outcomes following ED discharge. A number of heterogeneous interventions have been developed and implemented to improve clinical outcomes among this cohort. A growing number of systematic reviews have synthesised evidence regarding ED interventions using varying methodologies. This overview aims to synthesise the totality of evidence in order to evaluate the effectiveness of interventions to reduce adverse outcomes in older adults discharged from the ED. Methods: To identify relevant reviews, the following databases will be searched: Cochrane Database of Systematic reviews, Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, Databases of Abstracts of Reviews of Effects, PubMed, MEDLINE, Epistemonikos, Ageline, Embase, PEDro, Scopus, CINAHL and the PROSPERO register. The search for grey literature will include Open Grey and Grey Literature Reports. Systematic reviews of randomised controlled trials will be analysed to assess the effect of ED interventions on clinical and process outcomes in older adults. Methodological quality of the reviews will be assessed using the Assessment of Multiple Systematic Reviews 2 tool. The review will be reported in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Summary of findings will include a hierarchical rank of interventions based on estimates of effects and the quality of evidence. Discussion: This overview is required given the number of systematic reviews published regarding the effectiveness of various ED interventions for older adults at risk of adverse outcomes following discharge from the ED. There is a need to examine the totality of evidence using rigorous analytic techniques to inform best care and potentially develop a hierarchy of treatment options. PROSPERO registration: CRD42020145315 (28/04/2020)

scholarly journals Diet, nutrition and the ageing brain: current evidence and new directions

2018 ◽  
Vol 77 (2) ◽  
pp. 152-163 ◽  
Author(s):  
Katie Moore ◽  
Catherine F. Hughes ◽  
Mary Ward ◽  
Leane Hoey ◽  
Helene McNulty
Keyword(s):  
New Technologies ◽  
B Vitamins ◽  
Current Evidence ◽  
Vitamin B ◽  
Ageing Population ◽  
Brain Health ◽  
Nutrition Interventions ◽  
Ageing Brain ◽  
Totality Of Evidence

Globally populations are ageing. By 2050, it is estimated that there will be two billion people aged 60 years or over, of which 131 million are projected to be affected by dementia, while depression is predicted to be the second leading cause of disability worldwide by 2020. Preventing or delaying the onset of these disorders should therefore be a public health priority. There is some evidence linking certain dietary patterns, particularly the Mediterranean diet, with a reduced risk of dementia and depression. Specific dietary components have also been investigated in relation to brain health, with emerging evidence supporting protective roles forn-3 PUFA, polyphenols, vitamin D and B-vitamins. At this time, the totality of evidence is strongest in support of a role for folate and the metabolically related B-vitamins (vitamin B12, vitamin B6and riboflavin) in slowing the progression of cognitive decline and possibly reducing the risk of depression in ageing. Future studies incorporating new technologies, such as MRI and magnetoencephalography, offer much promise in identifying effective nutrition interventions that could reduce the risk of cognitive and mental disorders. This review will explore the ageing brain and the emerging evidence linking diet and specific nutrients with cognitive function and depression in ageing, with the potential to develop strategies that could improve quality of life in our ageing population.

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