Abstract:
:Objectives: Bullous pemphigoid, an autoimmune dermatological disease, may be associated with the use of a relatively new anti-cancer drug class, PD-1 inhibitors, which includes pembrolizumab and nivolumab. This paper analyzes the signals between PD-1 inhibitors and bullous pemphigoid based upon the reported real-world data. Methods: A pharmacovigilance analysis was performed on the publicly available Adverse Event Reporting System database of Food and Drug Administration. Disproportionality ratios were used to examine a signal between PD-1 inhibitors and bullous pemphigoid. A heat map was generated to depict the signal between PD -1 inhibitor use and skin toxicity adverse events. Results: The analysis indicated that there is a significant signal (PRR = 13.82 [95% CI: 9.99-19.11], Chi-squared with Yates' correction = 420.48) between pembrolizumab use and bullous pemphigoid and that there is a significant signal (PRR = 13.19 [95% CI: 10.57-16.46], Chi-squared with Yates' correction = 869.71) between nivolumab use and bullous pemphigoid. The signals remained statistically significant after stratifying for sex and age for both pembrolizumab and nivolumab. The signal is supported by 35 case reports in which there was evidence of PD-1 inhibitor use and a pemphigoid adverse event. Conclusion: When prescribing PD-1 inhibitors, physicians should monitor closely for symptoms of bullous pemphigoid.
journal_name
Expert Opin Drug Safjournal_title
Expert opinion on drug safetyauthors
Aggarwal Pdoi
10.1080/14740338.2019.1619693subject
Has Abstractpub_date
2019-07-01 00:00:00pages
623-633issue
7eissn
1474-0338issn
1744-764Xjournal_volume
18pub_type
杂志文章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:INTRODUCTION:Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a novel solvent-free formulation of paclitaxel, which was developed to avoid toxicities associated with Cremophor EL® vehicle used in solvent-based paclitaxel. It is approved as monotherapy for treatment of metastatic breast cancer (MBC) in Europe a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.893293
更新日期:2014-04-01 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:Acne is a common skin condition of the pilosebaceous units that affects the young and old, ranges from moderate to severe and can be treated with an array of options. Topical retinoids are the initial treatment for acne due to their ability to treat comedones, the starting point of acne. AREAS COVERED:Taz...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.2016.1117605
更新日期:2016-01-01 00:00:00
abstract:INTRODUCTION:In the past two decades, the number of women with autoimmune and inflammatory diseases experiencing a pregnancy has significantly increased in parallel with the enormous advances in the diagnosis and management of these disorders. However, information regarding the safety of immunosuppressive agents comes ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.951326
更新日期:2014-12-01 00:00:00
abstract::Background: Erenumab has recently been approved as a pharmacological treatment for the prevention of migraine. However, the incidence estimates of adverse drug reactions (ADRs) were not consistent among studies. Consequently, pooled measures of the incidences of ADRs that accounts for inter-study heterogeneity are des...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2021.1866537
更新日期:2020-12-29 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:BACKGROUND:Clinical data on the long-term safety and efficacy of infliximab on psoriatic patients who are older than 65 years are limited. OBJECTIVES:The aim is to report the long-term efficacy, safety and tolerance of infliximab in geriatric patients. METHODS:This was a retrospective study conducted at the Departmen...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2016.1226279
更新日期:2016-11-01 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:INTRODUCTION:Adult onset Still disease (AOSD) is a rare systemic inflammatory condition. The clinical spectrum of this disease ranges from self-limiting forms with mild symptoms to life-threatening cases. Glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) represent the first line of therapy for AOSD, wi...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2020.1839411
更新日期:2020-12-01 00:00:00
abstract:INTRODUCTION:Carbonic anhydrase (CA) inhibitors have an impressive safety record despite the multiple functions that CA isozymes serve because they are not fully inhibited with most dosing. While reducing the targeted CA-dependent process sufficiently for disease control, residual activity and uncatalyzed rates in comb...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.897328
更新日期:2014-04-01 00:00:00
abstract:INTRODUCTION:Maraviroc is the only C-chemokine receptor 5 (CCR5) antagonist approved for the treatment of infection with HIV. This article reviews the safety and efficacy of maraviroc in the treatment of HIV infection. AREAS COVERED:The PubMed database was searched using the keywords 'maraviroc' and 'HIV'. In addition...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.640670
更新日期:2012-01-01 00:00:00
abstract:BACKGROUND:The abuse and diversion of pharmacological agents with CNS mechanisms of action is an important concern from governmental, regulatory, public health and safety perspectives. In recent years, there have been an increased number of reports concerning the abuse and diversion of quetiapine in forensic population...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740330802496883
更新日期:2008-11-01 00:00:00
abstract:INTRODUCTION:Hydroxychloroquine (HCQ) is an alkalinizing lysosomatropic drug that accumulates in lysosomes where it inhibits some important functions by increasing the pH. HCQ has proved to be effective in a number of autoimmune diseases including systemic lupus erythematosus (SLE). Areas covered: In this review the me...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2017.1269168
更新日期:2017-03-01 00:00:00
abstract:IMPORTANCE OF THE FIELD:HIV-infection has become a chronic disease in paediatric patients with the potential for long-term survival and exposure to antiretroviral (ARV) therapies for 2 decades longer than HIV-infected adults. On the other hand, the administration of ARV to HIV-infected pregnant women has greatly increa...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740330903579991
更新日期:2010-05-01 00:00:00
abstract:INTRODUCTION:Lanreotide autogel is a synthetic somatostatin analogue which has been FDA and EMA approved for unresectable, well to moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumor. Its action is mediated by its affinity to somatostatin receptors, especially sst2 and ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1559294
更新日期:2019-01-01 00:00:00
abstract:BACKGROUND:Ximelagatran, the first oral agent in the new class of direct thrombin inhibitors, was withdrawn from the market due to increased rates of liver enzyme elevations in long-term treatments. Despite intensive pre clinical investigations the cellular mechanisms behind the observed hepatic effects remain unknown....
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1517/14740338.7.4.351
更新日期:2008-07-01 00:00:00
abstract:INTRODUCTION:Fingolimod (Gilenya®, FTY720) is an oral sphingosine-1-phosphate analogue that was approved by the FDA in 2010 for the treatment of relapsing forms of multiple sclerosis (MS). Fingolimod's mechanism of action is primarily related to lymphocyte sequestration in primary and secondary lymphoid tissues. Phase ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2014.920820
更新日期:2014-07-01 00:00:00
abstract::Objectives: To assess the risk of adverse events (AEs) associated with brentuximab vedotin in lymphoma patients.Methods: Articles were retrieved from PubMed, Cochrane, and Clinicaltrials Databases to identify randomized controlled trials (RCTs) comparing brentuximab vedotin with non-brentuximab vedotin in lymphoma pat...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析
doi:10.1080/14740338.2020.1718103
更新日期:2020-05-01 00:00:00
abstract:INTRODUCTION:Secukinumab is a human monoclonal antibody that selectively targets and neutralizes interleukin (IL)-17A, a cytokine that is normally involved in mucocutaneous defense against extracellular organisms and is abnormally expressed in psoriasis. In 2015, secukinumab was the first IL-17A inhibitor approved for ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2016.1221923
更新日期:2016-10-01 00:00:00
abstract:INTRODUCTION:A number of new biological immune modulators have become available as treatments for inflammatory diseases over the past two decades. Most prominent among them are TNF-α inhibitors (TNFi) which have been available in the clinic since the late 1990s. TNFi have demonstrated efficacy in various rheumatologic ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2013.831403
更新日期:2014-01-01 00:00:00
abstract:INTRODUCTION:Cardiovascular (CV) diseases are the leading cause of death and disability in the developed countries. Lipid-lowering therapy is a cornerstone of the CV risk modification strategy. The first line treatment for hyperlipidemia is statins, which decrease low-density lipoprotein cholesterol (LDL-C) by 30-50% a...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1080/14740338.2019.1620730
更新日期:2019-07-01 00:00:00
abstract:BACKGROUND:To perform an international comparison and analysis of celecoxib spontaneous adverse event reports (AERs) from Canada, Australia and the United States, focusing on gastrointestinal, renal and cardiovascular events. This study also examined concomitant medicines use which may have potentiated the risk of the ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1589447
更新日期:2019-03-01 00:00:00
abstract::Folic acid supplementation has drawn much attention in recent years for the prevention of Alzheimer's disease and cognitive decline. In this review, the authors describe how current evidence does not support the use of folic acid supplements to protect against cognitive decline. Although a few studies suggest that fol...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析
doi:10.1517/14740338.5.4.511
更新日期:2006-07-01 00:00:00
abstract:INTRODUCTION:Nephrotoxicity is generally considered as the most clinically significant adverse reaction of amphotericin B, and has been reported in up to 80% of amphotericin B recipients during the first 2 weeks of treatment. Numerous experimental and clinical investigations have been performed over the past 4 decades,...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740338.2012.721775
更新日期:2012-11-01 00:00:00
abstract::Objectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved. In this study, the authors reviewed the Eudravigilance publicly accessible database to describe the volume and expectedness of...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章
doi:10.1080/14740338.2019.1676724
更新日期:2019-12-01 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:BACKGROUND:This meta-analysis has been conducted to determine the risk of elevated transaminases associated with immune checkpoint inhibitors use in patients with cancer. METHODS:Studies eligible for our analysis included randomized Phase II and III trials of patients with cancer on ipilimumab, nivolumab, pembrolizuma...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,meta分析,评审
doi:10.1517/14740338.2015.1085969
更新日期:2015-10-01 00:00:00
abstract::Osteonecrosis of the jaw is a new disease, partly caused by bisphosphonates. It is commonly assumed that the bisphosphonates somehow cause cell death (osteocyte necrosis) within the jawbone, which makes it prone to chronic infection. In this article, an alternative pathogenetic theory is suggested, based on the normal...
journal_title:Expert opinion on drug safety
pub_type: 社论
doi:10.1517/14740338.5.6.743
更新日期:2006-11-01 00:00:00
abstract::Stroke is a common cause for morbidity and mortality, causing substantial economic costs. Because thrombosis plays a key role in the pathogenesis of ischaemic stroke, heparins, platelet inhibitors and anticoagulants have been used in stroke management. There were high hopes that patients might benefit from the use of ...
journal_title:Expert opinion on drug safety
pub_type: 杂志文章,评审
doi:10.1517/14740330903150157
更新日期:2009-09-01 00:00:00