Clinical rheumatology
-
Clinical rheumatology · Feb 2020
Associated factors with interstitial lung disease and health-related quality of life in Chinese patients with primary Sjögren's syndrome.
The main purpose of this study was to investigate the current situation of primary Sjögren's syndrome (pSS) patients with interstitial lung disease (ILD) in China. The relationships between social demography, disease activity, psychological status, clinical variables, and ILD were analyzed. Besides that, the quality of life (QoL) in pSS with ILD was also analyzed. ⋯ ILD was very common in pSS. ILD had a significant negative impact on the QoL of patients. Therefore, it is of great significance to strengthen the early intervention and drug treatment of pSS patients to prevent ILD and improve their QoL.Key Points• This cross-sectional study finds that the incidence of ILD in patients with pSS is 30.1%.• The occurrence and development of ILD is associated with disease duration, fatigue, alanine aminotransferase (ALT), neutrophils, albumin, and use of hormone.•The study also finds that the QoL of pSS-ILD is significantly lower than in patients with non-ILD, especially the score in the dimension of role physical function.
-
Clinical rheumatology · Feb 2020
Comparison of signal detection of tumour necrosis factor-α inhibitors using the Korea Adverse Events Reporting System Database, 2005-2016.
There are no pharmacovigilance studies on adverse event (AE) data for tumour necrosis factor alpha (TNFα) inhibitors in South Korea. We analysed AEs induced by adalimumab, infliximab, and etanercept METHODS: We used data from the Korea Institute of Drug Safety and Risk Management-Korea Adverse Events Reporting System Database (KIDS-KD) collected between 2005 and 2016. We used three different signal detection methods: proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The drug was compared with drug labels in the USA and Korea. Logistic regression analysis identified AEs that are more likely to occur with drug use. ⋯ Seven new signals that were not included in the current label were identified for TNFα inhibitors and should be updated and monitored.Key Points• Large-scale spontaneous AE reporting data and data mining techniques are useful for detecting signals of rare AEs as well as common AEs induced by drugs.• Drug labels should be updated to reflect signals that are newly discovered by continuous monitoring.