Objectives: This study aimed to assess the risk of tuberculosis (TB) in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) treated with any of the commercially available tumour necrosis factor inhibitors (TNFis) in Slovenia.
Design: This is a cohort, registry (biorx.si) cross-linked with the Slovenian National TB Registry.
Setting: National, involving all Slovenian rheumatology centres (six secondary and two secondary/tertiary).
Participants: 2429 patients with RA, AS or PsA exposed to at least one TNFi participated in the study.
Primary And Secondary Outcome Measures: The primary outcome measures were age-adjusted and sex-adjusted TB incidence rates (IRs) and the standardised incidence ratios (SIRs) compared with the general population exploring different TNFi exposure windows. The secondary outcome measures were a detailed characterisation of the national latent tuberculosis infection (LTBI) screening and TB chemoprophylaxis protocol implementation.
Results: Among the 2429 patients exposed to at least one TNFi for a total of 10 445 (49% RA, 33% AS and 18% PsA) person-years (PY), 99% completed LTBI screening and 6% required TB chemoprophylaxis. Six RA (three adalimumab, three certolizumab), two PsA (two golimumab) and zero AS patients developed TB. Five out of eight had miliary TB, three out of eight had pulmonary TB and two patients died. The age-standardised and sex-standardised TB IR (95% CI) per 100 000 PYs/SIRs (95% CI) compared with the general Slovenian population for the current TNFi exposure were 52 (0 to 110)/6.7 (0.6 to 80), 47 (0 to 110)/6.1 (0.3 to 105), 45 (0 to 109)/5.8 (0.3 to 112) overall, in RA and PsA, respectively.
Conclusions: The TB IR in the Slovenian patients with RA, AS and PsA treated with TNFi was comparable with TB IRs in TB non-endemic countries with less than a tenth of the patients requiring TB chemoprophylaxis.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7045120 | PMC |
| http://dx.doi.org/10.1136/bmjopen-2019-034356 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022.
Clin Trials
January 2025
Rare Diseases Team, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Background/aims: Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.
View Article and Find Full Text PDFHIF-1α and VEGF Immunophenotypes as Potential Biomarkers in the Prognosis and Evaluation of Treatment Efficacy of Atherosclerosis: A Systematic Review of the Literature.
Front Biosci (Landmark Ed)
January 2025
Department of Pathology, Faculty of Medicine, School of Health Sciences, University of Thessaly, 41500 Larissa, Greece.
Background: Hypoxia-inducible factor 1 alpha (HIF-1α) and its related vascular endothelial growth factor (VEGF) may play a significant role in atherosclerosis and their targeting is a strategic approach that may affect multiple pathways influencing disease progression. This study aimed to perform a systematic review to reveal current evidence on the role of HIF-1α and VEGF immunophenotypes with other prognostic markers as potential biomarkers of atherosclerosis prognosis and treatment efficacy.
Methods: We performed a systematic review of the current literature to explore the role of HIF-1α and VEGF protein expression along with the relation to the prognosis and therapeutic strategies of atherosclerosis.
Self-reported health status of patients with acute retinal ischemia and stroke related hemianopia.
Eur Stroke J
January 2025
Department of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Background: We aimed to assess impairments on health-related quality of life, and mental health resulting from Retinal artery occlusion (RAO) with monocular visual field loss and posterior circulation ischemic stroke (PCIS) with full or partial hemianopia using patient-reported outcome measures (PROMs).
Methods: In a prospective study, consecutive patients with acute RAO on fundoscopy and PCIS on imaging were recruited during their surveillance on a stroke unit over a period of 15 months. Baseline characteristics were determined from medical records and interviews.
Application of Cardiac Rehabilitation Aerobic Exercise in Patients with Stable Angina in Coronary Heart Disease.
Br J Hosp Med (Lond)
January 2025
Department of Sports Arts, Hebei Sport University, Shijiazhuang, Hebei, China.
A novel exercise protocol for cardiac rehabilitation aerobic (CRA) has been developed by Hebei Sport University, demonstrating efficacy in patients with coronary heart disease (CHD). The objective of this study was to evaluate the impact of CRA on precise cardiac rehabilitation (CR) for CHD patients presenting with stable angina pectoris. The study cohort comprised patients with stable angina who were categorized into three groups: the CRA group (n = 35), the power bicycles (PB) group (n = 34), and the control group (n = 43).
View Article and Find Full Text PDFEfficacy of General Magnetic Therapy and Motor-Evoked Potential-Guided Precision Magnetic Therapy in Patients with Overactive Bladder: A Randomized Controlled Trial.
Br J Hosp Med (Lond)
January 2025
Department of Urology, The Second Affiliated Hospital of Zhejiang Chinese Medicine University, Hangzhou, Zhejiang, China.
Overactive bladder (OAB) is a prevalent chronic condition affecting approximately 12% of adults, with incidence increasing with age. While pharmacological and behavioural therapies are standard treatments, their efficacy is often limited by side effects and poor adherence. This study aimed to compare the therapeutic effects of precision magnetic stimulation guided by motor-evoked potential with general magnetic therapy in patients with OAB.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!