Abstract:
INTRODUCTION:Disease-modifying antirheumatic drugs (DMARDs) have significantly improved clinical symptoms and quality of life with reduced disease progression in many patients with rheumatoid arthritis (RA). Short-term glucocorticoid therapy is often used initially in combination with DMARDs, but some patients still have difficulty reaching treatment goals. Repository corticotropin injection (RCI, Acthar® Gel) is approved as adjunctive therapy for short-term administration in patients with continued RA disease activity. AREAS COVERED:To determine the safety of RCI in the treatment of RA, adverse events (AEs) from a recent clinical trial of RCI as an adjunctive therapy along with DMARDs and glucocorticoids (ClinicalTrials.gov identifier NCT02919761) were compared with AEs reported in randomized clinical trials of DMARDs and glucocorticoids alone. A systematic review of the literature yielded 4 articles describing the detailed safety results of DMARD/glucocorticoid combination therapy used in the treatment of RA for comparison. EXPERT OPINION:There were no clinically significant differences between the AE profiles of RCI/DMARD/glucocorticoid treatment in the RCI clinical trial and those in the DMARD/glucocorticoid safety profile compiled from the reviewed clinical trials; this was supported by pharmacovigilance data. These results support the short-term safety of RCI as an adjunctive therapy for patients with persistently active RA.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Fleischmann R,Furst DEdoi
10.1080/14740338.2020.1779219subject
Has Abstractpub_date
2020-08-01 00:00:00pages
935-944issue
8eissn
1474-0338issn
1744-764Xjournal_volume
19pub_type
杂志文章abstract:OBJECTIVE:Attention deficit hyperactivity disorder (ADHD) is the most common psychiatric childhood disorder. The most commonly used drugs in the treatment of ADHD are methylphenidate (MPH) and atomoxetine (ATX); the former of the two is prescribed in USA more than it is in Western Europe. Some of the most important saf...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2014.941804
更新日期:2014-09-01 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
abstract:INTRODUCTION:Over 39,000 diabetic patients are surgically treated for trauma and orthopaedic injuries annually in the UK, yet the effects of diabetic medications on the skeletal system is an under researched and under acknowledged field. AREAS COVERED:This review covers all English language novel experimental data rep...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.639359
更新日期:2012-03-01 00:00:00
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: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:IMPORTANCE OF THE FIELD:Clopidogrel is an antiplatelet prodrug widely used in acute coronary syndromes and after intravascular stent placement. Acute or chronic use can cause bleeding, a major adverse effect, which can lead to drug discontinuation or noncompliance with therapy. AREAS COVERED IN THIS REVIEW:The mechani...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.532485
更新日期:2011-01-01 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: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: ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1488963
更新日期:2018-07-01 00:00:00
abstract:INTRODUCTION:Various limitations of unfractionated heparin (UFH) have triggered a search for new antithrombotic therapies for patients with coronary artery disease (CAD). Bivalirudin is a direct thrombin inhibitor with several pharmacological advantages over UFH and is currently endorsed by practice guidelines, particu...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.628312
更新日期:2012-01-01 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:INTRODUCTION:Sulfasalazine (SASP) is a drug commonly used in the treatment of inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease (CD) and rheumatoid arthritis (RA). A high incidence of side effects limits therapy with this drug. Getting a wider knowledge of drug pharmacology, indications a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2011.529898
更新日期:2011-03-01 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:The prevalence of depression in pregnancy is over 10% and a significant proportion of pregnant women use antidepressant medication. The safety of antidepressants in pregnancy is controversial, partly due to methodological challenges. The conflicting results in the literature may, however, also be due to di...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1341872
更新日期:2017-08-01 00:00:00
abstract:INTRODUCTION:The MAPK pathway is a signaling network that plays a key role in many normal cellular processes and in a large number of human malignancies. One of its effectors, MEK, is essential for the carcinogenesis of different tumors. In recent years, several drugs able to inhibit MEK have been assessed in clinical ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.892578
更新日期:2014-04-01 00:00:00
abstract:INTRODUCTION:ACE inhibitors are first-line therapy in patients with chronic kidney disease (CKD). The main adverse effects of ACE inhibitors are hypotension, renal function impairment and hyperkalemia. AREAS COVERED:This paper reviews evidence from clinical studies regarding adverse effects of ACE inhibitors in patien...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.951328
更新日期:2014-10-01 00:00:00
abstract::This review examines current knowledge regarding the safety of probiotic bacteria in man. Tighter and more comprehensive standards and regulations will be developed as probiotic therapy moves from a limited number of products used in the food industry, into more defined therapeutic categories and more complex organism...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.4.6.1135
更新日期:2005-11-01 00:00:00
abstract:INTRODUCTION:Pomalidomide, a derivative of thalidomide and member of the immunomodulatory drugs is licenced for use in relapsed and refractory multiple myeloma (RRMM) in Europe, USA, Canada and Japan. AREAS COVERED:This review details all published trials in which pomalidomide has been used in the treatment of myeloma...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2016.1154039
更新日期:2016-01-01 00:00:00
abstract::Introduction: Botulinum toxin (BoNT) is a protein secreted by the anaerobic Gram-negative bacterium Clostridium botulinum. Among the seven known subtypes, type A is the most commonly used in women to treat diseases. It primarily blocks presynaptic release of acetylcholine at the neuromuscular junction, resulting in te...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2020.1707803
更新日期:2020-01-01 00:00:00
abstract:INTRODUCTION:There is now 16 years' worth of established results of various trials demonstrating the bortezomib efficiency in the treatment of multiple myeloma. Over this time, the introduction of bortezomib has been a major break through in the treatment of multiple myeloma. Bortezomib can be administered in the outpa...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2018.1513487
更新日期:2018-09-01 00:00:00
abstract:BACKGROUND:To evaluate the safety and tolerability of Polyquad-preserved Travoprost (PQ-Travoprost) in patients previously treated with benzalkonium chloride (BAK)-preserved Latanoprost. METHODS:Cohort 6-month study on open-angle glaucoma or ocular hypertension patients. Complete ophthalmic examination, intraocular pr...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2015.1017467
更新日期:2015-05-01 00:00:00
abstract::Self-medication, using non-prescription drugs, is beneficial to patients, healthcare professionals, the pharmaceutical industry and governments. Although many non-prescription medications are effective, misuse and abuse of these products can arise. Monitoring of specific populations and products, in addition to data r...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740338.2.1.1
更新日期:2003-01-01 00:00:00
abstract:INTRODUCTION:Emergency contraception (EC) is a way to significantly reduce the chance of becoming pregnant after an episode of unprotected intercourse. Considerable data support the safety of all available and emerging options for EC. Areas covered: This review presents a comprehensive summary of the literature regardi...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1354985
更新日期:2017-10-01 00:00:00
abstract::Given the fact that as many as 9% of all adverse drug reactions involve toxic effects on the liver and with upwards of 50% of all cases of fulminant hepatic failure being ascribed to acetaminophen and other agents, the safe use of medications takes on an even greater importance whenever the prescription of potentially...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.1.2.159
更新日期:2002-07-01 00:00:00
abstract::Background: The safety and effectiveness of vonoprazan-based Helicobacter pylori (H. pylori) eradication therapy in routine clinical practice, and patient characteristics that influence safety and effectiveness, have not been well investigated.Methods: H. pylori-positive patients with gastric ulcer, duodenal ulcer, id...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1676722
更新日期:2019-12-01 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::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::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:Acute bacterial skin and skin-structure infections (ABSSSI) may develop in both in-patients and out-patients, possibly with a severe clinical presentation. Since most phase 3 randomized clinical trials have shown non-inferiority in efficacy across different agents, considerations regarding their different ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1621288
更新日期:2019-08-01 00:00:00
abstract::The optimum anti-HIV drug has yet to be found. This paper will summarise some of the oral adverse effects associated with antiretroviral agents against HIV. The development of antiretroviral drugs for the treatment of HIV infection has been aimed at the inactivation of two HIV enzymes: reverse transcriptase and protea...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.1.4.307
更新日期:2002-11-01 00:00:00
abstract:INTRODUCTION:Cardiac injury is one of the most impairing side effects of anticancer treatment. The extension of the range of available drugs, the use of combination regimens and the association with radiation therapy have improved life expectancy; however, they have also caused a rising typology of cardiac toxicities, ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.705826
更新日期:2012-09-01 00:00:00