Abstract:
:The introduction of targeted biological therapies has revolutionised the management of immune-mediated inflammatory diseases (IMIDs) such as rheumatoid arthritis, ankylosing spondylitis, psoriasis and inflammatory bowel disease. Following treatment with these therapies, many patients experience significant improvements in different aspects of their disease, including symptoms, work productivity and other outcomes relevant for individuals and society. However, due to the complexity of biological drug development and manufacturing processes, the costs of these therapies are relatively high. Indeed, the financial burden on healthcare systems due to biological therapies is considerable and lack of patient access to effective treatment remains a concern in many parts of the world. As many reference biological therapies have now reached or are near to patent expiry, a number of 'biosimilar' drugs have been developed for use in various clinical settings, and some of these drugs are already in use in several countries. While the potential pharmacoeconomic benefits of cost-effective biosimilars seem clear, several issues have been raised regarding, for example, the definition of biosimilarity and the validity of indication extrapolation, as well as the 'switchability' and relative immunogenicity of biosimilars and their reference drugs. In this review, these issues will be discussed with reference to CT-P13, a biosimilar of the anti-tumour necrosis factor monoclonal antibody infliximab, which is approved in Europe and elsewhere for the treatment of various IMIDs. Other important issues, including those related to data collection during nonclinical and clinical development of biosimilars, are also discussed.
journal_name
J Intern Medjournal_title
Journal of internal medicineauthors
Isaacs JD,Cutolo M,Keystone EC,Park W,Braun Jdoi
10.1111/joim.12432subject
Has Abstractpub_date
2016-01-01 00:00:00pages
41-59issue
1eissn
0954-6820issn
1365-2796journal_volume
279pub_type
杂志文章,评审abstract:OBJECTIVES:To evaluate beneficial effects of postmenopausal hormone replacement therapy (HRT) on endothelial function, measured as intraplatelet cyclic guanosine monophosphate (cGMP, mediator of nitric oxide), cyclic adenosine monophosphate (cAMP, mediator of prostacyclin) and plasma endothelin-1 (ET-1), and on monocyt...
journal_title:Journal of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2796.2000.00613.x
更新日期:2000-04-01 00:00:00
abstract:PURPOSE:Pseudoxanthoma elasticum (PXE) is a recessive disorder involving skin, eyes and arteries, mainly caused by ABCC6 pathogenic variants. However, almost one fifth of patients remain genetically unsolved despite extensive genetic screening of ABCC6, as illustrated in a large French PXE series of 220 cases. We searc...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/joim.13193
更新日期:2020-10-27 00:00:00
abstract:OBJECTIVES:to examine fatigue variability over time in chronic fatigue syndrome (CFS) and the effect of other symptoms on its predictability. DESIGN:longitudinal cohort study of patients with CFS (Fukuda criteria). SETTING:specialist CFS clinical service. SUBJECTS:phase 1: 100 patients who participated in a study of...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.2010.02306.x
更新日期:2011-02-01 00:00:00
abstract::Seventeen patients with mild to moderate hypertension, as indicated by a diastolic blood pressure (DPB) of 95-115 mmHg (WHO I), were treated in a randomized, double-blind, parallel study, with either 5 mg of fosinopril, a new phosphinic acid-containing angiotensin converting enzyme (ACE) inhibitor, or 25 mg of hydroch...
journal_title:Journal of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1365-2796.1991.tb00482.x
更新日期:1991-12-01 00:00:00
abstract::The success of antiretroviral therapy in treating HIV infection has greatly prolonged life expectancy in affected individuals, transforming the disease into a chronic condition. A number of HIV-associated non-AIDS comorbidities have emerged in the ageing HIV-infected population, including osteoporosis and increased ri...
journal_title:Journal of internal medicine
pub_type: 杂志文章,评审
doi:10.1111/joim.12520
更新日期:2016-10-01 00:00:00
abstract::The effects of resuscitation on patients who died suddenly out of hospital were evaluated after the introduction of early defibrillation performed by ambulance personnel using semi-automatic defibrillators. Resuscitation attempts were initiated in 548 patients during the 1-year study period. Mean ambulance delay was 7...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.1989.tb00085.x
更新日期:1989-05-01 00:00:00
abstract::In this article, we review the current knowledge of the inherited genetics of epithelial ovarian cancer (EOC) susceptibility and clinical outcome. We focus on recent developments in identifying low-penetrance susceptibility genes and the role of the Ovarian Cancer Association Consortium (OCAC) in these discoveries. Th...
journal_title:Journal of internal medicine
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2796.2011.02509.x
更新日期:2012-04-01 00:00:00
abstract:BACKGROUND:Asymmetric dimethylarginine (ADMA) is an endogenous inhibitor of nitric oxide (NO) synthesis causing endothelial dysfunction, an early sign of atherogenesis. Symmetric dimethylarginine (SDMA) does not inhibit NO synthases. Peripheral arterial disease (PAD) is a systemic indication of atherosclerosis. METHOD...
journal_title:Journal of internal medicine
pub_type: 杂志文章,多中心研究
doi:10.1111/j.1365-2796.2010.02322.x
更新日期:2011-03-01 00:00:00
abstract:OBJECTIVES:Angiotensin II may play an important role in the progression of renal disease. Currently, angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists are commonly used for renoprotection. To our knowledge, there is no study investigating this effect of angiotensin II receptor antag...
journal_title:Journal of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2796.2003.01071.x
更新日期:2003-03-01 00:00:00
abstract::In healthy individuals, insulin resistance is associated with physiological conditions such as pregnancy or body weight gain and triggers an increase in beta cell number and insulin secretion capacity to preserve normoglycaemia. Failure of this beta cell compensation capacity is a fundamental cause of diabetic hypergl...
journal_title:Journal of internal medicine
pub_type: 杂志文章,评审
doi:10.1111/joim.12096
更新日期:2013-09-01 00:00:00
abstract:BACKGROUND:Patients with coronary artery disease (CAD) and left ventricular systolic dysfunction (LVSD) are often asymptomatic. Angiogenesis is implicated in the physiology of vascular repair and cardiac remodelling, and is one of many pathophysiological processes implicated in heart failure. We hypothesized that plasm...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.2008.02057.x
更新日期:2009-05-01 00:00:00
abstract:OBJECTIVES:Obesity has generally been associated with higher bone density and lower fracture risk. However, weight-related indices of obesity may be related differently to health end-points, compared with fat-related indices (such as body fat distribution and fat mass), as they may capture different dimensions of obesi...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.2011.02443.x
更新日期:2012-05-01 00:00:00
abstract:OBJECTIVES:In this study, we explore the associations of decreased thyroid hormone levels with inflammation, wasting and survival in biochemically euthyroid patients with end-stage renal disease (ESRD). DESIGN:After exclusion of 23 patients with thyroid-stimulating hormone (TSH) values outside the normal range (0.1-4....
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.2007.01865.x
更新日期:2007-12-01 00:00:00
abstract:OBJECTIVES:The effects of atorvastatin, a new synthetic HMG-CoA reductase inhibitor, were investigated in patients with familial hypercholesterolaemia (FH), with high LDLc levels whilst on standard treatment. DESIGN:Open treatment with 40 mg atorvastatin daily for 6 weeks, followed by another 6 weeks with 80 mg atorva...
journal_title:Journal of internal medicine
pub_type: 临床试验,杂志文章
doi:10.1046/j.1365-2796.1998.00352.x
更新日期:1998-08-01 00:00:00
abstract:OBJECTIVES:To examine the occurrence over time of the metabolic syndrome (MetS) according to different definitions and the relation to change during follow-up in carotid artery intima-media thickness (IMT), measured by ultrasound. DESIGN:A cohort of 316, originally 58-year-old men, initially free of diabetes and cardi...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.2005.01511.x
更新日期:2005-07-01 00:00:00
abstract::Lifibrol is a powerful cholesterol-lowering drug of unknown mechanism of action. This investigation was carried out to determine whether the major action of lifibrol is to enhance clearance of low density lipoproteins (LDL) through the LDL-receptor pathway, and if so, whether the drug exerts its action by altering the...
journal_title:Journal of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2796.1999.00536.x
更新日期:1999-07-01 00:00:00
abstract::Atherosclerosis is a silent chronic vascular pathology that is the cause of the majority of cardiovascular ischaemic events. The evolution of vascular disease involves a combination of endothelial dysfunction, extensive lipid deposition in the intima, exacerbated innate and adaptive immune responses, proliferation of ...
journal_title:Journal of internal medicine
pub_type: 杂志文章,评审
doi:10.1111/joim.12296
更新日期:2014-12-01 00:00:00
abstract:AIM:There is firm evidence of a relation between type 2 diabetes (T2DM) and increased risks of cancer at various sites, but it is still unclear how different antihyperglycaemic therapies modify site-specific cancer risks. The aim of this study was to provide a complete characterization of all possible associations betw...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/joim.12567
更新日期:2017-02-01 00:00:00
abstract::We describe a 48-year-old woman with recurrent severe hypoglycaemia apparently caused by a paraprotein with insulin-binding capacity. Very high fasting values were found for serum insulin (170 and > 250 mU l-1) as well as for proinsulin 125 pmol l-1 and an insulinoma was suspected. Hypoglycaemia developed after an ora...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.1993.tb00766.x
更新日期:1993-10-01 00:00:00
abstract:BACKGROUND:Structural remodelling of left ventricle is a common feature in the progression of congestive heart failure (CHF). Matrix metalloproteinases (MMPs) have been directly implicated as they degrade extracellular proteins. To test the hypothesis that MMP-and its inhibitor, tissue type inhibitor of matrix metallop...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.2007.01823.x
更新日期:2007-09-01 00:00:00
abstract::When and where did modern humans evolve? How did our ancestors spread over the world? Traditionally, answers to questions such as these have been sought in historical, archaeological, and fossil records. However, increasingly genetic data provide information about the evolution of our species. In this review, we focus...
journal_title:Journal of internal medicine
pub_type: 杂志文章,评审
doi:10.1046/j.1365-2796.2002.00907.x
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND:As reported by major clinical series in the literature, about 2% of patients receiving unfractionated heparin (UFH) develop immune-mediated (type II) heparin-induced thrombocytopenia (HIT) that may be complicated in 30-75% of cases by a paradoxical thrombotic syndrome (HITTS), either arterial or venous. HITT...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1046/j.1365-2796.2002.01021.x
更新日期:2002-08-01 00:00:00
abstract::A 61-year-old female patient, treated for hyperthyroidism with thiamazole, developed a severe maturation arrest in the granulocytic lineage and a total agranulocytosis. Subcutaneous GM-CSF was started immediately and given for 6 days. Bone marrow samples were taken before GM-CSF therapy and on days 3 and 8. An increas...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.1992.tb00612.x
更新日期:1992-11-01 00:00:00
abstract:OBJECTIVES:We evaluated mortality from cardiovascular disease (CVD), coronary heart disease (CHD) and all causes in relation to use of any hormone therapy (HT) and HT with oestradiol and norethisterone or levonorgestrel. DESIGN:Population-based cohort study. SETTING AND SUBJECTS:Women in three Norwegian counties were...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.2004.01396.x
更新日期:2004-11-01 00:00:00
abstract::We studied the effect of sleeping in the head-up tilt (HUT) position, alone and in combination with fludrocortisone, on orthostatic tolerance and blood pressure (BP) in six patients with hypoadrenergic orthostatic hypotension. A high salt diet of 150-200 mmol Na+ d-1 was also administered. Combined treatment reduced o...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.1992.tb00563.x
更新日期:1992-08-01 00:00:00
abstract:BACKGROUND:We aimed to study the effect of social containment mandates on ACS presentation during COVID-19 pandemic using location activity and mobility data from mobile phone map services. METHODS:We conducted a cross-sectional study using data from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) in...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/joim.13206
更新日期:2021-02-01 00:00:00
abstract:BACKGROUND:Heart failure is characterized by chronically increased adenosine levels, which are thought to express a protective anti-heart failure activation of the adenosinergic system. The aim of the study was to assess whether the activation of adenosinergic system in idiopathic dilated cardiomyopathy (IDC) can be mi...
journal_title:Journal of internal medicine
pub_type: 杂志文章
doi:10.1111/j.1365-2796.2003.01234.x
更新日期:2003-12-01 00:00:00
abstract:OBJECTIVES:The aim was to study the effect of a 5-year diet intervention on 24-year mortality in middle aged men with combined hyperlipidaemia. SETTING:We studied 104 initially healthy men (in 1972) aged 40-49 years with baseline values of total serum cholesterol >6.45 mmol L-1 and fasting triglycerides >2.55 mmol L-1...
journal_title:Journal of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.0954-6820.2003.01248.x
更新日期:2004-01-01 00:00:00
abstract::The objective was to review the current status of meta-analysis, the process of combining the results of similar investigations, which was described in 1976. It has evolved rapidly, and thousands have already been published. Meta-analysis may be performed in a narrative form or in the preferred statistical format, whi...
journal_title:Journal of internal medicine
pub_type: 杂志文章,评审
doi:10.1046/j.1365-2796.1997.118127000.x
更新日期:1997-03-01 00:00:00
abstract::Multiple sclerosis (MS), a chronic inflammatory demyelinating and neurodegenerative disease of the central nervous system, is today a leading cause of unpredictable lifelong disability in young adults. The treatment of patients in progressive stages remains highly challenging, alluding to our limited understanding of ...
journal_title:Journal of internal medicine
pub_type: 杂志文章,评审
doi:10.1111/joim.13045
更新日期:2020-07-01 00:00:00