Abstract:
BACKGROUND:Tumor necrosis factor (TNF)-α plays a critical role in psoriasis pathogenesis, and several anti-TNF agents have been developed as therapeutic drugs in this indication. SCOPE:To present the preclinical rationale and clinical data for onercept, a novel anti-TNF agent developed for the treatment of moderate-to-severe psoriasis, and to critically evaluate the onercept clinical development program. FINDINGS:Onercept was shown in preclinical studies to inhibit TNF-α and suppress clinical signs in several inflammatory conditions. In phase II studies onercept demonstrated a therapeutic benefit in psoriasis and psoriatic arthritis and no safety issues were identified. Based on these results, a phase III program comprising three multicenter, randomized, double-blind, placebo-controlled studies examining onercept in moderate-to-severe plaque psoriasis was initiated. Following the occurrence of two cases of systemic inflammatory response syndrome (SIRS) and lower than expected efficacy results, an independent Data Safety Monitoring Board (DSMB) determined that the risk-benefit ratio was not sufficiently favorable to justify continued development, and all clinical studies were promptly terminated. Although not initially diagnosed as such by the investigators, two further SIRS events were reported, one after study discontinuation. Although an increased incidence of infection and sepsis-like events has been associated with other anti-TNF therapies, an increased risk of infection was not observed with onercept treatment. Moreover, no infectious etiology was determined in the SIRS cases. The data suggest that the SIRS reactions were due to a systemic inflammatory response. CONCLUSIONS:Despite promising early clinical results, onercept showed many of the expected risks associated with other anti-TNF agents and proved not to have an exceptional efficacy and safety profile. The clinical development of onercept highlights the critical importance of DSMBs and closely monitoring patient safety and evaluating risk-benefit profiles in large clinical programs.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Papp Kdoi
10.1185/03007995.2010.507492subject
Has Abstractpub_date
2010-10-01 00:00:00pages
2287-300issue
10eissn
0300-7995issn
1473-4877journal_volume
26pub_type
杂志文章,评审abstract:OBJECTIVE:Abuse and misuse of prescription opioids is a significant public health concern. This review examines the strategies used to confer abuse-deterrent properties on opioid abuse-deterrent formulations (ADFs), the characteristics and supporting data for each of the available ADFs, and the role of opioid ADFs as p...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2017.1419171
更新日期:2018-04-01 00:00:00
abstract::Elevated serum cholesterol level is a key risk factor for cardiovascular morbidity and mortality. Cerivastatin is a highly effective lipid-lowering agent currently licensed at doses of 0.1, 0.2, 0.3 and 0.4 mg. This was a multicentre, randomised, double-blind, parallel-group study comparing the efficacy and safety of ...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/03007999909114095
更新日期:1999-01-01 00:00:00
abstract::Objective: This economic evaluation aims to provide a preliminary assessment of the cost-effectiveness of radiofrequency ablation (RFA) compared with argon plasma coagulation (APC) when used to treat APC-refractory gastric antral vascular ectasia (GAVE) in symptomatic patients.Methods: A Markov model was constructed t...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1747997
更新日期:2020-06-01 00:00:00
abstract:OBJECTIVE:To determine the effects of long-term atomoxetine treatment on sexual development in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) as compared with placebo and with a national US survey in non-Hispanic white children and adolescents. METHODS:This double-blind, placebo-controll...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2011.599372
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVE:To look into current evidence exploring the added value of rLH supplementation to rFSH in GnRH analogues cycles, to identify groups of women that still have no evidence for adjuvant rLH therapy and to discuss ways that may advance research on this topic. METHODS:Eight systematic reviews and meta-analyses exp...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1417827
更新日期:2018-05-01 00:00:00
abstract:OBJECTIVE:The objective of this study is to provide a comprehensive estimate of the cost of ADHD by consider ing the healthcare and work loss costs of persons with ADHD, as well as those costs imposed on their family members. METHODS:Excess per capita healthcare (medical and prescription drug) and work loss (disabilit...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079904X20303
更新日期:2005-02-01 00:00:00
abstract:OBJECTIVE:To determine the economic impact of sustained non-remission of depression on the total annual all-cause healthcare costs of patients with a history of depression. METHODS:Adults with ≥2 claims with depression diagnosis codes from the HealthCore Integrated Research Database were invited to participate in this...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2015.1029893
更新日期:2015-06-01 00:00:00
abstract::Cardiac arrhythmias are the most common cardiac complication reported in pregnant women with and without structural heart disease (SHD); they are more frequent among women with SHD, such as cardiomyopathy and congenital heart disease (CHD). While older studies had indicated supraventricular tachycardia as the most com...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1762555
更新日期:2020-07-01 00:00:00
abstract:OBJECTIVE:To provide a commentary on recent studies with the new IOP-lowering fixed-combination product brinzolamide 1%/timolol 0.5%. METHODS:Medline was searched for brinzolamide/timolol fixed-combination clinical literature (up to May 18, 2010) and the current comprehensive brinzolamide/timolol literature was review...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2010.517718
更新日期:2010-11-01 00:00:00
abstract:OBJECTIVE:Pharmaceutical preparations of human menopausal gonadotrophin (hMG), urine-derived follicle-stimulating hormone (u-FSH) and highly purified u-FSH (u-FSH-HP) have been available since the early 1960s and the mid 1980s and 1990s, respectively. Another commercial preparation of u-FSH-HP, Folyrmon P, was launched...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079905X48410
更新日期:2005-06-01 00:00:00
abstract::A double-blind study was carried out to investigate the prophylactic use of single-dose cefuroxime in elective abdominal surgery. Twenty-three patients received 1.5 g cefuroxime by intravenous injection immediately prior to induction of anaesthesia; 24 patients received no antibiotics. In the cefuroxime group, there w...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998009109459
更新日期:1980-01-01 00:00:00
abstract:BACKGROUND:The literature on nonfulfillment of prescription medications spans over three decades of work. There is a wide variation in reported nonfulfillment rates, but no previous study has systematically reviewed this literature to explore the reasons behind this variation. OBJECTIVE:The objective of this study was...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990903550586
更新日期:2010-03-01 00:00:00
abstract:BACKGROUND:This survey assessed the impact of symptoms of COPD on patients' ability to perform activities throughout the day and the extent to which physicians provided advice including how medications may help maintain quality of life. METHODS:The survey had three inclusion criteria--physician's diagnosis of COPD, ag...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.857648
更新日期:2014-02-01 00:00:00
abstract:OBJECTIVE:To evaluate the efficacy and safety of percutaneous polidocanol injection (PPI) in treatment of predominantly cystic thyroid nodules. MATERIALS AND METHODS:This prospective study included 111 patients with 122 benign predominantly cystic thyroid nodules inducing pressure symptoms or cosmetic problems. The no...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1080/03007995.2017.1325732
更新日期:2017-08-01 00:00:00
abstract:OBJECTIVE:To conduct a preliminary evaluation of a new oral formulation of controlled-release (CR) oxybutynin tablet taken once-daily in patients with urinary urge incontinence. RESEARCH DESIGN AND METHODS:A single-centre, open-label, 8-week study was conducted. Patients with urodynamically-confirmed detrusor instabil...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/030079903125002955
更新日期:2004-01-01 00:00:00
abstract:OBJECTIVE:Osteoarthritis is one of the most common forms of arthritis seen in primary care. Non-steroidal anti-inflammatory drugs (NSAIDs) play an important role in the management of osteoarthritis. However, gastrointestinal (GI) side effects limit their use. Cyclooxygenase-2 (COX-2) selective inhibitors exhibit better...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/030079906X104722
更新日期:2006-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Reduction in total cholesterol (TC) and LDL-cholesterol (LDL-C) forms one of the principal objectives of most cardiovascular secondary prevention strategies. Many patients being treated with statins, however, have significant residual dyslipidaemia, with many having suboptimal HDL-cholesterol ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802374633
更新日期:2008-09-01 00:00:00
abstract:INTRODUCTION:Phenylketonuria (PKU) is a rare autosomal recessive disorder caused by a deficiency of phenylalanine hydroxylase (PAH). Its prevalence is estimated to be 1:10,000 in Europe. PKU is the commonest congenital inborn error of metabolism. The aim of our study was to investigate the characteristics of clinical p...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1847717
更新日期:2020-11-23 00:00:00
abstract:OBJECTIVE:Early involvement of specialists is associated with improved survival in ovarian cancer patients. However, only 33-60% of patients are currently being referred. A more effective strategy to get patients with an elevated risk of ovarian cancer to gynecologic oncologists is needed. The objective of this study w...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2016.1176014
更新日期:2016-06-01 00:00:00
abstract:OBJECTIVES:High-sensitivity C-reactive protein (hs-CRP) has been explored for use in predicting cardiovascular risk. The recent Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) study found that statin therapy reduced cardiovascular events in those with ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.516994
更新日期:2010-10-01 00:00:00
abstract:OBJECTIVE:Schizophrenia is one of the most debilitating diseases in the United Arab Emirates. Oral antipsychotics (OA) are commonly used in terms of pharmacotherapy; however, these treatments can be rendered ineffective by poor patient adherence. Paliperidone palmitate once monthly (PP1M) is a long acting antipsychotic...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1417246
更新日期:2018-04-01 00:00:00
abstract:INTRODUCTION AND OBJECTIVE:The management of hyponatremia has evolved in recent years, particularly with the introduction of tolvaptan for hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). This commentary presents a summary of recent international recommendations in the for...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2015.1072706
更新日期:2015-01-01 00:00:00
abstract::The effects of flurbiprofen on various coagulation and haemostasis parameters were studied in 19 patients adequately anticoagulated on a fixed dose of phenprocoumon. Laboratory controls were performed 5 times at weekly intervals. Flurbiprofen 50 mg 3-times daily was given for 2 weeks after an initial control period of...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997709108972
更新日期:1977-01-01 00:00:00
abstract:BACKGROUND:Small cell lung cancer (SCLC) patients, who have achieved complete or partial response after chemotherapy, should be followed with prophylactic cranial irradiation (PCI). PCI for extrapulmonary small cell carcinoma (EPSCC) is not routinely recommended. The purpose of this review is to discuss all aspects of ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2014.904771
更新日期:2014-07-01 00:00:00
abstract:BACKGROUND:Differences between interferons have been evaluated for over 20 years. While randomized controlled trial (RCT) data is mainly used for assessments and strong data for causal inferences, it does not necessarily reflect everyday practice. Real-world data may provide additional information. PURPOSE:To assess t...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1080/03007995.2016.1276895
更新日期:2017-03-01 00:00:00
abstract:OBJECTIVE:To assess the impact of the decision by Kela (The Social Insurance Institution) to adopt guidelines for the management of food allergies in children, developed by the Finnish Medical Society Duodecim, as the basis for reimbursing clinical nutrition preparations for the treatment of cow milk allergy (CMA) in F...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079908x280455
更新日期:2008-04-01 00:00:00
abstract:UNLABELLED:Therapeutic interventions that block the renin-angiotensin-aldosterone system (RAAS) have an important role in slowing the progression of cardiovascular risk actors to established cardiovascular diseases. In recent years, angiotensin receptor blockers (ARBs) have emerged as effective and well-tolerated alter...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079907x210723
更新日期:2007-07-01 00:00:00
abstract:BACKGROUND:Eribulin mesylate (eribulin) is indicated for patients with metastatic breast cancer (MBC) who have previously received at least two chemotherapies in the US and for patients with locally advanced breast cancer (LABC) or MBC who have progressed after at least one chemotherapy in the European Union (EU). In b...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1835853
更新日期:2020-12-01 00:00:00
abstract:OBJECTIVE:Although a reduced aflibercept (2.0 mg) injection frequency relative to the approved dosing posology is included in national treatment guidelines for wet age-related macular degeneration (AMD), there is limited evidence of its comparative efficacy. The objective was to compare the efficacy and safety of reduc...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析,评审
doi:10.1185/03007995.2015.1084909
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:Niacin is currently the most effective approved agent for raising high-density lipoprotein cholesterol. However, niacin-induced cutaneous flushing (redness, warmth, tingling and/or itching) significantly limits patient acceptance. To further characterize flushing, a patient-reported Flushing Symptom Question...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/030079907x199637
更新日期:2007-07-01 00:00:00