Benefit-Risk Assessment of Blinatumomab in the Treatment of Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia.

Abstract:

:Blinatumomab is the first-and-only Food and Drug Administration (FDA)-approved cluster of differentiation (CD) 19-directed CD3 bispecific T-cell engager (BiTE®) immunotherapy. It is currently FDA approved for the treatment of adults and children with Philadelphia chromosome-positive (Ph+) and Philadelphia chromosome-negative (Ph-) relapsed/refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL) and B-cell precursor ALL with minimal residual disease. Similarly, initial marketing authorization for blinatumomab in the European Union was granted for the treatment of adults with Ph- R/R B-cell precursor ALL. The benefits of treating R/R B-cell precursor ALL patients with blinatumomab include increased overall survival, more favorable hematologic remission and molecular response rates, and a lower incidence rate of selected adverse events when compared with standard-of-care chemotherapy. The key risks associated with blinatumomab treatment include cytokine release syndrome, neurotoxicity, and medication errors. Here, we review the benefits and risks of blinatumomab treatment and describe how these risks can be mitigated.

journal_name

Drug Saf

journal_title

Drug safety

authors

Stein A,Franklin JL,Chia VM,Arrindell D,Kormany W,Wright J,Parson M,Amouzadeh HR,Choudhry J,Joseph G

doi

10.1007/s40264-018-0760-1

subject

Has Abstract

pub_date

2019-05-01 00:00:00

pages

587-601

issue

5

eissn

0114-5916

issn

1179-1942

pii

10.1007/s40264-018-0760-1

journal_volume

42

pub_type

杂志文章,评审
  • Safety aspects of parenteral iron in patients with end-stage renal disease.

    abstract::Absolute and functional iron deficiency is the most common cause of epoetin (recombinant human erythropoietin) hyporesponsiveness in renal failure patients. Diagnostic procedures for determining iron deficiency include measurement of serum iron levels, serum ferritin levels, saturation of transferrin and percentage of...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199717040-00004

    authors: Sunder-Plassmann G,Hörl WH

    更新日期:1997-10-01 00:00:00

  • Skin sensitivity and transdermal drug delivery. A review of the problem.

    abstract::Transdermal devices are now marketed for the delivery of systemic medication through the skin. Advantages associated with transdermal drug delivery include avoidance of first-pass metabolism and improved patient compliance. Drugs currently available by this route include scopolamine (hyoscine), nitroglycerin (glyceryl...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199410020-00004

    authors: Carmichael AJ

    更新日期:1994-02-01 00:00:00

  • Discourse on safe drug use: symbolic logics and ethical aspects.

    abstract::Drug safety is not a matter for healthcare professionals alone. Patients are also involved, at three different levels: (i) in the behaviours patients adopt to reduce the adverse effects of the drugs; (ii) in regard to what some doctors say to their patients about drug risks; and (iii) in what the pharmaceutical indust...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/11538320-000000000-00000

    authors: Fainzang S

    更新日期:2010-08-01 00:00:00

  • Detection of adverse drug events and other treatment outcomes using an electronic prescribing system.

    abstract:BACKGROUND:Current pharmacosurveillance methods do not provide timely information on drug safety and effectiveness. Real-time surveillance using electronic prescribing systems could address this problem; however, the data collected using these systems has not been validated. We investigated the accuracy of using orders...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200831110-00005

    authors: Eguale T,Tamblyn R,Winslade N,Buckeridge D

    更新日期:2008-01-01 00:00:00

  • Fetal risks with dextrans during delivery.

    abstract::Epidural analgesia for caesarean section is increasingly used and is gradually replacing general anaesthesia. Hypotension is one of the main risks: preloading of the maternal circulation is used to prevent maternal hypotension and its consequences. For this, various colloid and crystalloid solutions are used. We repor...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-199207010-00008

    authors: Barbier P,Jonville AP,Autret E,Coureau C

    更新日期:1992-01-01 00:00:00

  • Serious events with infliximab in patients with inflammatory bowel disease: a 9-year cohort study in the Netherlands.

    abstract:BACKGROUND:The tumour necrosis factor-alpha inhibitor infliximab is incorporated in the treatment guidelines for patients with inflammatory bowel disease (IBD). However, concerns about serious adverse events such as infections, malignancies and death do exist. OBJECTIVE:To evaluate the occurrence of serious events of ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/0002018-200831120-00009

    authors: de Vries HS,van Oijen MG,de Jong DJ

    更新日期:2008-01-01 00:00:00

  • The WHO World Alliance for Patient Safety: a new challenge or an old one neglected?

    abstract::The WHO World Alliance on Patient Safety is a new, all encompassing project to improve medical care. Individual patients are the focus and all countries are encouraged to develop systems in which medical error, therapeutic accidents and failures are minimised. The potential for adverse events is present at all levels ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200528050-00002

    authors: Edwards IR

    更新日期:2005-01-01 00:00:00

  • Antidepressants and the Risk of Hemorrhagic Stroke in the Elderly: a Nested Case-Control Study.

    abstract:BACKGROUND AND PURPOSE:Selective serotonin reuptake inhibitors (SSRIs) are frequently prescribed in the elderly due to a more favorable risk profile than other antidepressants (ADs). However, SSRIs are associated with an increased risk of gastrointestinal bleeding, while evidence on the risk of hemorrhagic stroke (HS) ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-019-00837-y

    authors: Schäfer W,Princk C,Kollhorst B,Schink T

    更新日期:2019-09-01 00:00:00

  • Vancomycin-Induced Thrombocytopenia: A Narrative Review.

    abstract::Thrombocytopenia has been reported as an adverse reaction of numerous drugs. Vancomycin is often overlooked as a culprit but has been associated with several cases of thrombocytopenia that were not well described in the literature. A literature search was conducted to find reports of thrombocytopenia induced by vancom...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-016-0469-y

    authors: Mohammadi M,Jahangard-Rafsanjani Z,Sarayani A,Hadjibabaei M,Taghizadeh-Ghehi M

    更新日期:2017-01-01 00:00:00

  • Risk of diabetic ketoacidosis after exposure to risperidone or olanzapine.

    abstract:BACKGROUND:Atypical antipsychotics have been associated with metabolic abnormalities including impaired glucose metabolism, exacerbation of existing diabetes mellitus and new-onset type 2 diabetes. Not all atypical antipsychotic agents appear to have the same propensity to cause these complications. OBJECTIVE:To asses...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200730070-00004

    authors: Ramaswamy K,Kozma CM,Nasrallah H

    更新日期:2007-01-01 00:00:00

  • People's Understanding of Verbal Risk Descriptors in Patient Information Leaflets: A Cross-Sectional National Survey of 18- to 65-Year-Olds in England.

    abstract:INTRODUCTION:Evidence suggests the current verbal risk descriptors used to communicate side effect risk in patient information leaflets (PILs) are overestimated. OBJECTIVES:The aim was to establish how people understand the verbal risk descriptors recommended for use in PILs by the European Commission (EC), and altern...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-017-0542-1

    authors: Webster RK,Weinman J,Rubin GJ

    更新日期:2017-08-01 00:00:00

  • Drug treatment of depression in HIV-positive patients : safety considerations.

    abstract::Safe and effective treatment of major depression, one of the most common comorbid conditions in individuals infected with HIV, significantly lowers morbidity and mortality from HIV disease. However, optimal treatment of both conditions is complicated by interactions between the disease processes as well as the pharmac...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200528090-00002

    authors: Pieper AA,Treisman GJ

    更新日期:2005-01-01 00:00:00

  • Micro-electrode arrays in cardiac safety pharmacology: a novel tool to study QT interval prolongation.

    abstract::Drug-induced QT interval prolongation is now a major concern in safety pharmacology. Regulatory authorities such as the US FDA and the European Medicines Agency require in vitro testing of all drug candidates against the potential risk for QT interval prolongation prior to clinical trials. Common in vitro methods incl...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200427110-00002

    authors: Meyer T,Boven KH,Günther E,Fejtl M

    更新日期:2004-01-01 00:00:00

  • Safety of efalizumab therapy in patients with moderate to severe psoriasis: an open-label extension of a phase IIIb trial.

    abstract:BACKGROUND:Psoriasis is a chronic autoimmune disease characterized by infiltration of the dermis and epidermis by activated T cells and the hyperproliferation and abnormal differentiation of keratinocytes. It is a life-long disease with alternating periods of remission and recurrence. Efalizumab is a humanized, recombi...

    journal_title:Drug safety

    pub_type: 杂志文章,随机对照试验

    doi:10.2165/00002018-200831080-00008

    authors: Hamilton T,Menter A,Caro I,Compton P,Sobell J,Papp KA

    更新日期:2008-01-01 00:00:00

  • Betahistine: a retrospective synopsis of safety data.

    abstract::Betahistine is a structural analogue of histamine that is prescribed for the treatment of vestibular disorders such as Ménière's disease and the symptomatic treatment of vertigo. It is estimated from sales information that >130 million patients have been exposed to the drug since its registration in 1968. In this revi...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200629110-00004

    authors: Jeck-Thole S,Wagner W

    更新日期:2006-01-01 00:00:00

  • The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients.

    abstract:BACKGROUND AND OBJECTIVE:Many drugs that are used to treat children are either not licensed for use in paediatric patients (unlicensed) or prescribed outside the terms of the product licence (off label). The incidence of adverse drug reactions (ADRs) associated with the use of such drugs is yet to be established. This ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200427130-00006

    authors: Neubert A,Dormann H,Weiss J,Egger T,Criegee-Rieck M,Rascher W,Brune K,Hinz B

    更新日期:2004-01-01 00:00:00

  • Empirical performance of LGPS and LEOPARD: lessons for developing a risk identification and analysis system.

    abstract:BACKGROUND:The availability of large-scale observational healthcare data allows for the active monitoring of safety of drugs, but research is needed to determine which statistical methods are best suited for this task. Recently, the Longitudinal Gamma Poisson Shrinker (LGPS) and Longitudinal Evaluation of Observational...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-013-0107-x

    authors: Schuemie MJ,Madigan D,Ryan PB

    更新日期:2013-10-01 00:00:00

  • Long-term treatment with atypical antipsychotics and the risk of weight gain : a literature analysis.

    abstract::The aim of this review is to analyse and summarise the literature data about the incidence of weight gain in patients exposed to atypical antipsychotics during long-term (>or=1 year) treatment regimens. Despite the clinical relevance of the topic, the vast majority of reviewed studies showed methodological limitations...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200629040-00002

    authors: Gentile S

    更新日期:2006-01-01 00:00:00

  • Age at First Rotavirus Vaccination and Risk of Intussusception in Infants: A Public Health Modeling Analysis.

    abstract:INTRODUCTION:The epidemiology of naturally occurring intussusception is known to increase significantly between the ages of 3 and 8 months. Post-licensure studies have reported a fivefold and twofold increase in intussusception in the first week after the first dose and second dose, respectively, of current rotavirus v...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-016-0424-y

    authors: Yung CF,Chong CY,Thoon KC

    更新日期:2016-08-01 00:00:00

  • Risks and benefits of drugs used in the management of the hyperactive child.

    abstract::Childhood hyperactivity is a common behavioural complaint. The therapeutic options for physicians caring for children with hyperactivity are considerable and varied; current recommendations call for a multidisciplinary approach, including when necessary the use of drug therapy. Central nervous system stimulants are th...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199309010-00004

    authors: Fox AM,Rieder MJ

    更新日期:1993-07-01 00:00:00

  • Correction to: vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues.

    abstract::The article vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues, written by Tomas Bergvall. G. Niklas Norén. Marie Lindquist, was originally published Online First without open access. ...

    journal_title:Drug safety

    pub_type: 已发布勘误

    doi:10.1007/s40264-019-00803-8

    authors: Bergvall T,Norén GN,Lindquist M

    更新日期:2019-06-01 00:00:00

  • Coronary Risks Associated with Diclofenac and Other NSAIDs: An Update.

    abstract::The risk of coronary events with non-steroidal anti-inflammatory drugs has been the subject of much debate since the original trial of rofecoxib raised the issue. Since then, over almost 20 years, such risks have been shown in clinical trials of long-term high-dose users, and in observational studies comparing users w...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-019-00900-8

    authors: Moore N

    更新日期:2020-04-01 00:00:00

  • All-Cause Mortality Associated with Tramadol Use: A Case-Crossover Study.

    abstract:INTRODUCTION:Although the mortality risk associated with tramadol use in children has triggered the revision of tramadol drug labeling, the mortality risk in adults has not been thoroughly explored. OBJECTIVE:The objective of this study was to evaluate whether tramadol use is associated with mortality in various risk ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-018-00786-y

    authors: Jeong S,Tchoe HJ,Li J,Shin JY

    更新日期:2019-06-01 00:00:00

  • What Future Healthcare Professionals Need to Know About Pharmacovigilance: Introduction of the WHO PV Core Curriculum for University Teaching with Focus on Clinical Aspects.

    abstract::Adverse drug reactions (ADRs) can cause serious health problems, as shown in studies about drug-related hospitalizations. To build knowledge of and raise awareness about ADRs among healthcare professionals, more education in the field of ADRs and pharmacovigilance (PV) is needed. No standard exists for teaching PV at ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-018-0681-z

    authors: van Eekeren R,Rolfes L,Koster AS,Magro L,Parthasarathi G,Al Ramimmy H,Schutte T,Tanaka D,van Puijenbroek E,Härmark L

    更新日期:2018-11-01 00:00:00

  • Clinical features and management of severe dermatological reactions to drugs.

    abstract::Cutaneous adverse drug reactions are a frequent occurrence and have been reported in more than 2% of hospitalised patients. Among the most commonly involved drugs are sulphonamides, penicillins, anticonvulsants and non-steroidal anti-inflammatory drugs. Two groups of mechanisms are involved in the pathogenesis of drug...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199005010-00005

    authors: Raviglione MC,Pablos-Mendez A,Battan R

    更新日期:1990-01-01 00:00:00

  • Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    abstract:INTRODUCTION:Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. METHODS:Three major types of EHDs in China (i.e., a regional commu...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-017-0589-z

    authors: Yang Y,Zhou X,Gao S,Lin H,Xie Y,Feng Y,Huang K,Zhan S

    更新日期:2018-01-01 00:00:00

  • Immunisation and type 1 diabetes mellitus: is there a link?

    abstract::Recent evidence from animal studies has raised the possibility that immunisation by vaccines can influence the pathogenesis of type I (insulin-dependent) diabetes mellitus. In non-obese diabetic mice and biobreeding rats, complete Freund's adjuvant and bacillus Calmette-Guérin (BCG) vaccine have successfully been used...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199920030-00001

    authors: Hiltunen M,Lönnrot M,Hyöty H

    更新日期:1999-03-01 00:00:00

  • Benefit and Risk of Tofacitinib in the Treatment of Rheumatoid Arthritis: A Focus on Herpes Zoster.

    abstract::The biologics have revolutionized the treatment of rheumatoid arthritis (RA). However, there are still patients that are difficult to control and a cure is still not achievable. Tofacitinib, a Janus kinase (JAK) inhibitor is an orally available, new-in-class, disease-modifying anti-rheumatic drug with similar efficacy...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-016-0430-0

    authors: Yamaoka K

    更新日期:2016-09-01 00:00:00

  • Safety and Tolerability of Histone Deacetylase (HDAC) Inhibitors in Oncology.

    abstract::Histone deacetylases (HDACs) are expressed at increased levels in cells of various malignancies, and the use of HDAC inhibitors has improved outcomes in patients with haematological malignancies (T-cell lymphomas and multiple myeloma). However, they are not as effective in solid tumours. Five agents are currently appr...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-018-0773-9

    authors: Shah RR

    更新日期:2019-02-01 00:00:00

  • Anticonvulsant-induced psychiatric disorders. The role of forced normalisation.

    abstract::With the introduction of several new anticonvulsant drugs into clinical practice in recent years, renewed attention has been paid to treatment-emergent effects, especially behavioural syndromes. In this review, the more severe psychiatric syndromes that may be associated with anticonvulsants are discussed, especially ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199615030-00001

    authors: Trimble MR

    更新日期:1996-09-01 00:00:00