ABSTRACT
Background Immunosuppressive and biological medications are a mainstay in the treatment of immune-mediated diseases, such as inflammatory bowel diseases (IBD), rheumatic diseases, and psoriasis. However, the COVID-19 pandemic caused concerns over the safety of these drugs pertaining to risk and severity of infection with SARS-CoV2. Moreover, pandemic mitigation strategies may negatively impacted treatment start with immunosuppressive and biological treatment fostering worse long-term disease outcomes. The aim of this study was to examine the impact of the COVID-19 pandemic on new starts of immunosuppressive and biological treatment in Austria. Methods We conducted a retrospective analysis with a 4-year observation period from 2017 to 2020 on real-world data on prescriptions for immune-mediated diseases of the Austrian health insurance funds covering 98% of the Austrian population. Data from all patients with incident biologic or conventional immunosuppressive treatment (Table 1) were included. Incidence of biologic (including small molecules) and immunosuppressive therapy was defined as all first prescriptions of one of the listed substances from 2017. The incidence rate for biologic and immunosuppressive treatments was recorded monthly in 2020 and compared with the three previous years (2017 – 2019). Results During the first lockdown in Austria in spring 2020 (week 12 – week 20), there was a significant decrease in the overall starts of biologic (including small molecules) and immunosuppressive treatments (both p<0.0001), especially in April (Figure 1 and 2). After that lockdown, new starts of immunosuppressive and biological treatments rapidly re-achieved pre-lockdown levels despite higher infection rates with SARS-CoV-2 and subsequent lockdown periods (Figure 3). Independent from the COVID-19 pandemic, we observed a continuous increase of biological medication (bDMARDs) and small molecules (p<0.0001) and a decrease of conventional immunosuppressive medications (cDMARDS) (p<0.0120) during all observed years (Figure 1 and 2) Conclusion In patients with immune-mediated diseases in Austria the COVID-19 pandemic led to a significant decrease of newly started immunosuppressive and biological treatments only during the first lock-down. Over the last four years, we can observe a continuous increase of small molecules and biological medication as well as a continuous decrease of conventional immunosuppressive medication.
ABSTRACT
BACKGROUND: Broad and decentralised testing of SARS-CoV-2 RNA genomes is a WHO-recommended strategy to contain the SARS-CoV-2 pandemic by identifying infected cases in order to minimize onward transmission. With the need to increase the test capacities in Austria, nation-wide numerous laboratories rapidly implemented assays for molecular detection of SARS-CoV-2 based on real-time RT-PCR assays. The objective of this study was to monitor reliability of the laboratory results for SARS-CoV-2 RNA detection through an external quality assessment (EQA) scheme. METHODS: For this, the Center for Virology, Medical University of Vienna was tasked by the Federal Ministry of Social Affairs, Health, Care and Consumer Protection to perform the first Austrian EQA on SARS-CoV-2 which was organised in cooperation with the Austrian Association for Quality Assurance and Standardization of Medical and Diagnostic Tests (ÖQUASTA). Data were analysed on the basis of qualitative outcome of testing in relation to the nucleic acid (NA) extraction and detection methods used. RESULTS AND CONCLUSION: A total of 52 laboratories participated, contributing results from 67 test panels comprising 42 distinct combinations of NA extraction and PCR reagents. By testing 3 positive (CT values: S1, 28.4; S2, 33.6; S3, 38.5) and 1 negative sample, no false-positive results were obtained by any of the laboratories. Otherwise, 40/67 tests (60 %) detected all positive samples correctly as positive, but 25/67 tests (37 %) did not detect the weakest positive sample (S3), and 3 % reported S2 and S3 as false-negative. Improvement in test sensitivity by focusing on NA extraction and/or PCR-based detection is recommended.