Evaluating the Impact of Black Box Warning Updates on the Reporting of Drug-Related Adverse Events: a Cross Sectional Study of the FAERS Database.

Background: The Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS) is a post-marketing surveillance system which relies on spontaneous reports of adverse drug reactions (ADRs). Our objective was to evaluate how black box warning (BBW) updates impact ADR reporting rates.

Research Design And Methods: We searched MEDWATCH for all BBW updates issued between January 2014 and December 2016 and categorized them as new, major, and minor.

Twenty Years of Targeted and Biologic Immunomodulatory Drugs: Postmarketing Modifications of Drug Labels Approved by the US Food and Drug Administration.

Objective: To determine the extent and characteristics of postmarketing safety issues associated with targeted and biologic immunomodulatory drugs.

Methods: We searched Drugs@FDA to identify immunomodulatory drugs approved between January 1, 1998, and December 31, 2017. Supporting studies characteristics, regulatory pathways, and label modifications from approval to May 2020 were collected from drug labels.

Quality evaluation of the underlying evidence in the updated treatment recommendations for systemic lupus erythematosus.

Objectives: SLE is a multisystem autoimmune disorder known for its broad clinical spectrum. Recently, the European, British and Latin American rheumatology professional societies [EULAR, British Society for Rheumatology (BSR) and Pan-American League of Associations of Rheumatology (PANLAR)] published updated recommendations for SLE management. The objective of this study was to characterize the data supporting the updated recommendations, with the goal of highlighting areas that could benefit from additional high-quality research.

The impact of tocilizumab on anxiety and depression in patients with rheumatoid arthritis.

Background: Mood disorders, such as anxiety and depression, are extremely prevalent among patients with rheumatoid arthritis (RA). In this study, we assessed the impact of treatment with tocilizumab (TCZ), an IL-6 antagonist, upon anxiety and depressive symptoms in a cohort of RA patients.

Materials And Methods: Study participants were adults diagnosed with RA who received a weekly subcutaneous injection of tocilizumab for 24 weeks.

Venous thromboembolism events among RA patients.

Background: Rheumatoid arthritis (RA) is associated with an increased risk for venous thromboembolism. However, so far, relatively few and small size-based studies have been conducted. We aimed to investigate the link between RA and venous thromboembolism utilizing a large sample of subjects originating from a large data base.

The Powers of Flowers: Evaluating the Impact of Floral Therapy on Pain and Psychiatric Symptoms in Fibromyalgia.

Background: Fibromyalgia is a syndrome of unknown etiology that is characterized by widespread pain, which severely impairs quality of life. Several forms of occupational and alternative therapy have demonstrated beneficial effects in fibromyalgia patients.

Objectives: To assess the effects of participation in a floral design course on physical and psychiatric symptoms in a cohort of fibromyalgia patients.

The long-term prognostic significance of sarcoidosis-associated pulmonary hypertension - A cohort study.

Background: Sarcoidosis is a multisystem, chronic, progressive, granulomatous disease. Sarcoidosis-associated pulmonary hypertension is a well described, but not common, complication of sarcoidosis. In small scale studies, it has been previously described as manifestation of advanced disease and was found to be associated increased morbidity and mortality.

Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis.

Objectives: Several epidemiological studies have investigated the link between silicone breast implants (SBIs) and autoimmune/rheumatic disorders, reporting inconsistent results. We aimed to evaluate the association between SBIs and the most clinically relevant autoimmune/rheumatic disorders using a large, population-based database.

Methods: In this cross-sectional study, we used the computerized databases of Maccabi Healthcare Services (MHS), which include up to 20 years of data on 2 million members.

Giant cell arteritis and inflammatory bowel disease - Is there a connection? Results from a population-based study.

Background: Giant cell arteritis (GCA) is an autoimmune disorder which primarily affects large vessels, whilst inflammatory bowel diseases (IBD) mainly target the gut. Co-existence of the two maladies has been reported sporadically in the literature; therefore the purpose of this study was to assess the authenticity of such an association in a large, cross-sectional study.

Methods: Utilizing data derived from the Clalit Health Services' registry, the largest health maintenance organization in Israel, we compared the proportion of CD and UC in GCA patients with age- and gender-matched controls.

Alzheimer's Disease in Systemic Sclerosis Patients: A Nationwide Population-Based Cohort Study.

Background: Neurological features are often overlooked in systemic sclerosis (SSc) patients and little is known about the link between dementia and SSc.

Objectives: We sought to investigate whether an association exists between Alzheimer's disease (AD) and SSc, as well as assess the impact of a dual diagnosis on mortality rates, by performing an extensive data analysis on a large subject sample.

Methods: We utilized the medical database of the Clalit-Health-Services in a case-control study.

Vitamin D, autoimmunity and recurrent pregnancy loss: More than an association.

Recurrent pregnancy loss (RPL) affects close to 1% of couples; however, the etiology is known in only about 50% of the cases. Recent studies show that autoimmune dysregulation is a probable cause of RPL, which in some cases may be overlooked. In order for a pregnancy to proceed to term, early modulation of immunologic response is required to induce tolerance to the semi-allogenic fetus.

Pericarditis among giant cell arteritis patients: From myth to reality.

Background: Giant cell arteritis (GCA) is an inflammatory disease of unknown etiology affecting adults age > 50 years. GCA (also known as temporal arteritis) is a vasculitis of large and medium-size vessels that involves the extracranial branches of the carotid artery. Common manifestations include constitutional symptoms, headache, jaw claudication, scalp tenderness, and vision loss.

The link between COPD and ankylosing spondylitis: A population based study.

Background: Ankylosing spondylitis (AS) is one of the most common and severe subtypes of the spondyloarthropathies. Extra-articular involvement among AS patients, including lung disease, has been described widely. Chronic obstructive pulmonary disease (COPD) has been linked to several autoimmune diseases, however, very few studies have investigated the association between AS and COPD.

Folate and B12 Levels Correlate with Histological Severity in NASH Patients.

Background: The correlation between abnormal vitamin serum levels and chronic liver disease has been previously described in literature. However, the association between the severity of folate serum levels (B9), vitamin B12 and nonalcoholic steatohepatitis (NASH) has not been widely evaluated. Therefore, the aim of this study was to investigate the existence of such a correlation in a cohort of NASH patients.

A systematic review of precipitating physical and psychological traumatic events in the development of fibromyalgia.

The role of physical and psychological trauma precipitating fibromyalgia is often encountered by physicians, yet a proper systematical review of this association is lacking. Literature searches identified 51 studies which examined the association of fibromyalgia with a preceding traumatic event of physical or emotional nature. The overall quality of evidence of studies included, as assessed by the GRADE criteria, was low, however the majority of studies described a significant association between prior physically traumatic events and the onset of chronic widespread pain or fibromyalgia.

Borderline positive antineutrophil cytoplasmic antibodies (ANCA)-PR3/MPO detection in a large cohort tertiary center: lessons learnt from a real-life experience.

Background: Enzyme-linked immunosorbent assay (ELISA) and indirect immunofluorescence (IIF) are the best strategies for antineutrophil cytoplasmic antibodies (ANCA) detection. In a minority of subjects, ELISA-based ANCA testing may result in a borderline positive titre. Therefore, we assessed the clinical significance of such a result.

Stroke among Rheumatoid Arthritis Patients: Does Age Matter? A Real-Life Study.

Background/aims: Rheumatoid arthritis (RA) is a chronic, debilitating autoimmune disease that affects the joints and it is known to be associated with cardiovascular morbidity. However, the association between RA and stroke among different age groups has not been explored. The objective of our study was to evaluate the association between RA and stroke in different age strata.

Plasmodium malariae in Israeli Travelers: A Nationwide Study.

Background: Little is known about Plasmodium malariae, a relatively rare cause of malaria in returned travelers. Recently, polymerase chain reaction (PCR) use for malaria diagnosis has enhanced specificity of P. malariae detection.

Patients With Vasculitides Admitted to the Intensive Care Unit: Implications From a Single-Center Retrospective Study.

Background: Vasculitides are a group of disorders characterized by inflammation of vessels. Vasculitides may have life-threatening complications with significant morbidity and mortality; however, information regarding the outcome and prognosis of patients with vasculitides requiring intensive care unit (ICU) is scarce.

Methods: Data of patients with vasculitides admitted to the ICU of the Sheba Medical Center between the years 2000 and 2014 were retrieved retrospectively.

Association between giant cell arteritis and thyroid dysfunction in a "real life" population.

Purpose: Giant cell arteritis is a systemic autoimmune disorder which involves inflammation of medium to large vessels. The association between giant cell arteritis and autoimmune thyroid disorders has been investigated numerous times in the literature with inconsistent results. Our objective was to evaluate whether a genuine association exists between giant cell arteritis and thyroid dysfunction, which is often due to immune-mediated thyroid disease.

Investigating the link between ischemic heart disease and Behcet's disease: A cross-sectional analysis.

Background: Behcet's disease (BD) is a multi-systemic chronic inflammatory disorder which involves the vasculature tree of all sizes. The current study's aim was to examine the association between BD and the development of ischemic heart disease (IHD) and its potential impact as a cardiovascular risk factor.

Methods: This study was conducted as a case-control study utilizing the database of Clalit Health Services.

Optimizing Anti-TNF-α Therapy: Serum Levels of Infliximab and Adalimumab Are Associated With Mucosal Healing in Patients With Inflammatory Bowel Diseases.

Background & Aims: It is not clear what serum levels of anti-tumor necrosis factor are associated with reduced intestinal inflammation in patients with inflammatory bowel disease (IBD). We aimed to identify serum levels of infliximab and adalimumab associated with mucosal healing in patients with IBD and to evaluate the putative gain in control of inflammation by incremental increases in drug levels.

Methods: We performed a retrospective cross-sectional study of 145 patients with IBD treated with infliximab (n = 78) or adalimumab (n = 67) at a medical center in Israel from 2009 through 2014.