Abstract:
INTRODUCTION:Guselkumab is a fully human monoclonal IgG1λ antibody for the treatment of plaque psoriasis that inhibits interleukin (IL)-23p19 subunit, reducing the proliferation of type 17 helper T (Th-17) cells and thus production of Th-17-derived pro-inflammatory cytokines, especially IL-17 and IL-22. Areas covered: In the following article, the mechanism of action and mainly the efficacy and safety profile of guselkumab available from results of trials will be discussed. We summarized these data after a literature review including PubMed search, relating proceedings and abstracts from relevant international conferences, assessment reports from European and United States regulatory agencies and treatment guidelines up to April 2018. Expert opinion: The central role of IL-23 in psoriasis pathogenesis is supported by genetic links of IL-23 and IL-23R alleles to psoriasis susceptibility; early clinical trials have demonstrated that sufficient inhibition of IL-23p19 results in rapid resolution of the disease. Targeting IL-23, may be responsible for the high efficacy and durable responses of guselkumab, avoiding some adverse effects of IL-17A blockade, like mucocutaneous candida infections or triggering/worsening of inflammatory bowel disease, experienced with agents acting selectively against this molecule and that seem to be class related.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Galluzzo M,D'Adamio S,Campione E,Bianchi L,Talamonti Mdoi
10.1080/14740338.2018.1488963subject
Has Abstractpub_date
2018-07-01 00:00:00pages
741-751issue
7eissn
1474-0338issn
1744-764Xjournal_volume
17pub_type
杂志文章,评审abstract:OBJECTIVE:To analyze the extent to which Spanish leaflets and drug information on the Net met quality criteria. RESEARCH DESIGN AND METHODS:A descriptive study was conducted comparing readability (REA) and comprehensibility (COM) criteria of a random sample of 77 marketed products of the 12 active ingredients most fre...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2013.744965
更新日期:2013-01-01 00:00:00
abstract::Gemcitabine-associated thrombotic thrombocytopenic purpura is a rare complication of gemcitabine treatment with an incidence ranging from 0.015 to 1.4%. Clinically, this disease manifests as haemolytic anaemia, thrombocytopenia and renal insufficiency; hypertension and neurological and pulmonary symptoms are also know...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740330902942299
更新日期:2009-05-01 00:00:00
abstract:OBJECTIVE:To investigate whether the use of statins was associated with kidney cancer risk. METHODS:We conducted a population-based case-control study in Taiwan. Cases consisted of all patients who were aged 50 years and older, and had a first-time diagnosis of kidney cancer for the period between 2005 and 2009. The c...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2012.678831
更新日期:2012-07-01 00:00:00
abstract:BACKGROUND:Gallstone disease is common in Western countries. Statins reduce biliary cholesterol secretion and have anti-inflammatory effects, suggesting that they may play a role in reducing the incidence of surgically treated gallstone disease. AIM:To examine a potential association between statin administration and ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2010.485190
更新日期:2010-07-01 00:00:00
abstract:INTRODUCTION:Niacin is one of the oldest drugs used in the treatment of dyslipidemia. Previously its use has been limited because of excessive flushing. Now an agent laropiprant (LRP) has been developed, which blocks the flushing pathway. Therefore, it is time to collate available information to assess the safety and t...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.638281
更新日期:2012-01-01 00:00:00
abstract:INTRODUCTION:The emergence of multidrug-resistant (MDR) infections has been extensively observed worldwide and has become a priority issue over past decade. Tigecycline , a broad spectrum antibiotic covering against many MDR organisms, has been widely used. However, recent meta-analysis studies have raised a concern fo...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.997206
更新日期:2015-02-01 00:00:00
abstract::Sjögren's syndrome dry eye is an inflammatory disease accompanied by an impairment of the autonomous nervous system of the ocular surface. The therapy for this condition is shifting from the mere tear replacement to a more complex approach including an anti-inflammatory treatment. Clinical trials have evidenced that t...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.1.33
更新日期:2007-01-01 00:00:00
abstract:INTRODUCTION:The antimalarial drug hydroxychloroquine (HCQ) is widely used to treat various rheumatic diseases. Many autoimmune diseases occur in women of child-bearing age who may become pregnant while on therapy, which raises concerns regarding the teratogenicity of HCQ and its effect on the outcome of the pregnancy....
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.566555
更新日期:2011-09-01 00:00:00
abstract:OBJECTIVE:Higher vancomycin concentrations are thought necessary for treatment of deep-seated methicillin-resistant Staphylococcus aureus (MRSA) infection, yet this may result in greater risk of nephrotoxicity. We evaluated the relationship of serum vancomycin trough concentration with clinical outcomes and nephrotoxic...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740330903413514
更新日期:2010-01-01 00:00:00
abstract::Introduction: Treatment for chronic pruritus ranges from use of topical formulations to newer biologic agents. Targeting treatment to the underlying etiology is key in reducing the burden of disease while avoiding systemic or adverse effects.Areas covered: This review details the effective medical treatments used in v...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2020.1728252
更新日期:2020-04-01 00:00:00
abstract::A water soluble derivative of camptothecin, irinotecan (CPT-11) is effective against small-cell lung cancer (SCLC), as well as non-SCLC and gastrointestinal cancers. This extended review of recently concluded and ongoing studies focuses on irinotecan in the treatment of limited (LD) and extensive (ED) SCLC specificall...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.5.2.303
更新日期:2006-03-01 00:00:00
abstract:INTRODUCTION:Apatinib is an orally administered small-molecule vascular endothelial growth factor receptor 2 inhibitor. It has been approved and indicated for advanced gastric cancer after the failure of two or more lines of systemic therapy in China. Areas covered: This review summarizes the mechanisms, clinical appli...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1535592
更新日期:2018-11-01 00:00:00
abstract::Medication-induced oesophageal distress and injury have become increasingly common conditions. First, smooth muscle relaxants may worsen or produce symptoms of pre-existing gastro-oesophageal reflux disease; notable examples include certain calcium antagonists (nifedipine), nitrates, sildenafil, nicotine, theophylline...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2.5.495
更新日期:2003-09-01 00:00:00
abstract:INTRODUCTION:Basiliximab is a chimeric monoclonal antibody directed against the alpha chain of interleukin-2 receptor (IL-2R). When administered intravenously at a dosage of 20 mg at the time of transplantation and 4 days later, basiliximab saturates the alpha chain of IL-2R for 4 weeks. AREAS COVERED:This review eval...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,随机对照试验
doi:10.1517/14740338.2014.861816
更新日期:2014-03-01 00:00:00
abstract:OBJECTIVE:Further understand the safety profile of celecoxib and provide safety information for important adverse events (AEs). METHODS:Analysis of randomized controlled trials from the Pfizer clinical trial repository (final study reports completed by 31 July 2011) in which celecoxib was compared with placebo or non-...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析
doi:10.1517/14740338.2013.780595
更新日期:2013-07-01 00:00:00
abstract:INTRODUCTION:Conjugated equine estrogens (CEE) are widely used for the treatment of menopausal symptoms, such as vasomotor symptoms and vulvovaginal atrophy, and for the prevention of bone loss, in postmenopausal women. The safety profile of CEE has been extensively published over the past 20 years. AREAS COVERED:Data...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2013.824965
更新日期:2014-01-01 00:00:00
abstract::Anthracyclines are among the most active chemotherapeutic agents in cancer treatment. Although infrequent, cumulative dose-dependent cardiotoxicity is nevertheless a significant side effect of this therapy resulting in reduced cardiac reserve or even frank cardiac failure. Although used in several types of malignancy,...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.3.315
更新日期:2007-05-01 00:00:00
abstract:INTRODUCTION:Osteoarthritis (OA) is the most common form of arthritis and is a major cause of disability, especially in people ≥ 45 years old. Several international societies recommend the use of both acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) to alleviate OA pain. However, patients with OA often ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.1056776
更新日期:2015-08-01 00:00:00
abstract::Most available antimalarial drugs induce cardiac side effects. These side effects include various mild heart rate changes (amodiaquine) to excessive prolongation of the QT interval (halofantrine) which may lead to lethal arrhythmias such as Torsade de Pointes (TdP). The cellular mechanism of such events during antimal...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.3.421
更新日期:2005-05-01 00:00:00
abstract::Bone morphogenetic proteins (BMPs) have been extensively studied since the discovery of agents within bone that could induce bone formation at ectopic sites by Urist in the 1960s. Extensive preclinical research has been carried out showing the efficacy of these products in promoting bone healing. Clinical trials are e...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.1.75
更新日期:2005-01-01 00:00:00
abstract::Introduction: Patients living with schizophrenia have a marked risk of clinically significant weight gain and obesity compared to the general population. The risks have been highlighted following the introduction of second-generation antipsychotics. In turn, obesity is associated with a higher prevalence of cardiovasc...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1674809
更新日期:2019-12-01 00:00:00
abstract:INTRODUCTION:Gastrointestinal bleeding (GIB) is a major problem in patients on oral anticoagulation therapy. This issue has become even more pressing since the introduction of direct oral anticoagulants (DOACs) in 2009. Areas covered: Here we review current evidence related to GIB associated with oral anticoagulants, f...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1325870
更新日期:2017-06-01 00:00:00
abstract::Aerosolized delivery of a number of antimicrobial agents has been studied. Despite a theoretical soundness behind this strategy, full consideration of the potential toxicities associated with this mode of administration is imperative. Aerosolized amphotericin B, as both deoxycholate and lipid formulations, has been st...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.6.5.523
更新日期:2007-09-01 00:00:00
abstract:INTRODUCTION:The approval of sofosbuvir (SOF), a nucleotide analogue NS5B polymerase inhibitor, and ledipasvir (LDV), a NS5A inhibitor, marked a new chapter in IFN and ribavirin-free treatment of hepatitis C virus (HCV). This drug reduces adverse events associated with IFN therapy. AREAS COVERED:The purpose of this pa...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2015.1053868
更新日期:2015-08-01 00:00:00
abstract:INTRODUCTION:Clozapine was first introduced as an antipsychotic in the 1970's but a cluster of deaths, later linked to the drug's risk of agranulocytosis, led to its withdrawal in most countries. However, work in the 1980's established its unique efficacy in treatment resistant schizophrenia (TRS), which constitutes as...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1191468
更新日期:2016-09-01 00:00:00
abstract::In a very short time, COX-2 enzyme inhibitors have gone from the darlings to the pariahs of the pharmaceutical industry. These drugs were developed based on the hypothesis whereby selective inhibition of the COX enzyme would lead to reduction in pain and inflammation without associated gastrointestinal and bleeding ri...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.6.1005
更新日期:2005-11-01 00:00:00
abstract::Worldwide, women comprise > 50% of all people living with HIV and the vast majority of these women are of childbearing age. In fact, a significant proportion of these women are identified as HIV-infected during pregnancy. Preventing perinatal transmission has been one of the greatest prevention successes of the HIV ep...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740330903241584
更新日期:2009-11-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:Trastuzumab has become a mainstay in the treatment of women with human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer in the metastatic and adjuvant settings. Although trastuzumab is generally well tolerated, cardiac toxicity has emerged as a rare but potentially serious ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740331003627441
更新日期:2010-03-01 00:00:00
abstract:INTRODUCTION:Pain management has become a widely discussed topic throughout all medical subspecialties. Although pediatric pain management has evolved significantly in its recent history, there is continued interest in the adequacy of pain treatment, both in the acute inpatient setting as well as the postoperative and ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2013.834045
更新日期:2014-01-01 00:00:00
abstract:INTRODUCTION:Bone strength determinants such as bone mineral density and bone quality parameters are determined by life-long remodeling of skeletal tissue. Denosumab is a fully human mAb receptor activator of NF-κB ligand, which selectively inhibits osteoclastogenesis, the end product of a cascade interaction among num...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2010.516249
更新日期:2011-03-01 00:00:00