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Objective: Although the factors that trigger and exacerbate chronic spontaneous urticaria (CSU) are well known, there is still a lack of information about the effects of COVID-19 vaccines on CSU. This study aimed to investigate exacerbations/relapses triggered by COVID-19 vaccines in patients with CSU who are well controlled with treatment or in remission. Materials and Methods: The study included 350 CSU patients. Demographic and clinical characteristics were collected from patients' medical records. The seven-day urticaria activity score (UAS7) and urticaria control test (UCT) were evaluated separately during the onset of the disease, pre-vaccination, and post-vaccination periods. Results: The mean age was 39.89 +/- 13.30 years and 74.6% of the patients were female. A total of 227 patients were vaccinated with the Pfizer/BioNTech mRNA vaccine, 67 with the Sinovac/CoronaVac inactivated vaccine, and 54 with both vaccines. Urticaria exacerbations/ relapses were observed in a total of 76 patients, and most CSU exacerbations/relapses occurred after the first dose (n=46). Median UAS7 scores increased significantly in the post-vaccination period in patients who experienced urticaria exacerbation (p<0.0001). Median UCT scores were significantly decreased due to urticaria exacerbation with vaccination (p<0.0001). Conclusion: Both mRNA and inactivated COVID-19 vaccine may lead to exacerbations or relapses in patients with CSU. Even so, exacerbations/relapses associated with COVID-19 vaccines can be easily controlled with treatments and do not preclude subsequent doses.
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Purpose This paper aims to analyze the impact of price-limit hits by hit type and when such hits start and stop using intraday trades and quotes at a one-second frequency for firms included in the BIST-50 index during the 13-months starting with March 2008. Like the recent COVID-19 period, this period includes the heightened stress in global financial markets in September 2008. Design/methodology/approach Using intra-day trades and quotes at a one-second frequency, the authors examine the market effects of price limits for firms included in the BIST-50 index during the global financial crisis. The authors compare the values of various metrics for 60 min centered on price-limit hit periods. The authors conduct robustness tests using auto regressive integrated moving average (ARIMA) models with trade-by-trade and with 3-min returns. Findings The findings are supportive of the following hypotheses: magnet price effects, greater informational asymmetric effects of market quality and each version of price discovery. Results are robust using samples differentiated by cross-listed status, same-day quotes instead of transaction prices and equidistant and trade-by-trade returns. Originality/value The authors use intraday data to reduce measurement error that is particularly pronounced when daily data are used to assess price limits that start and/or stop during a trading session. The authors contribute to the micro-structure literature by using ARIMA models with trade-by-trade and 3-min returns to alleviate some bias due to the autocorrelations in returns around price-limit hits in the presence of a magnet effect. The authors include some recent regulation changes in various countries to illustrate the importance of circuit breakers using price limits during COVID-19.
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Introduction: Inebilizumab is approved in the USA and Japan for aquaporin 4 immunoglobulin (Ig)G seropositive neuromyelitis optica spectrum disorder (NMOSD). Objective: Report final safety and efficacy data from the N-MOmentum trial of inebilizumab in NMOSD. Methods: Participants with NMOSD (aged 18+, EDSS score of ≤8, recent history of attacks) were randomized 3:1 to inebilizumab or placebo monotherapy for 28 weeks or up to attack occurrence;the randomized controlled period (RCP). Primary outcome was time to adjudicated attack. Participants could then enter the inebilizumab open label period (OLP). Final study data are presented, including attack risk and safety outcomes. Results: Of the 230 participants randomized and dosed, 216 (93.9%) entered and 174 (80.6%) completed the OLP. In the RCP, 87.0% were attack free with inebilizumab and 59.9% with placebo (72.8% risk reduction, p<0.001). In the OLP, 87.7% were attackfree in those continuing inebilizumab and 83.4% in those switched from placebo. Regardless of randomization, 225 participants received inebilizumab. Mean (SD) treatment duration was 3.2 (1.4) years;36.8% were treated for >4 years (maximum of 5.5 years). Total exposure was 730.36 person-years (py) with an annualized attack rate of 0.092;40/63 (63.5%) attacks occurred in the first year. Treatment-emergent adverse events (AE) were reported by 89 (39.6%) participants, most frequently urinary tract infection (26.2%), nasopharyngitis (20.9%) and arthralgia (17.3%). Infusion-related reactions with inebilizumab occurred in 28 (12.9%) participants (rate per 100-py: whole study, 11.1;RCP, 37.6). The rate (95% confidence interval) of infections per 100-py did not increase with continued treatment: year 1, 116.3 (102.4-131.6);year 2, 68.1 (57.2-80.6);year 3, 61.9 (50.3-75.5);year 4, 55.1 (41.7-71.4). 105 participants had transient low IgG (<700 mg/dL) during treatment, but no correlations were found between the worst IgG, IgM or IgA levels recorded and the occurrence of any infection or an infection ≥ grade 3 (Fisher exact test, all p>0.05). Three trial participants died: one from complications of NMOSD attack, one from a CNS event of unclear etiology and one due to COVID-19, after 9, 224 and 1225 days of inebilizmab treatment, respectively. Conclusions. During the 5.5 years of N-MOmentum, the risk of attack in participants receiving inebilizumab remained low with no evidence of unexpected serious adverse events, including serious infection.
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Introduction: A pandemic emerged in 2020 in Wuhan, China because of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) virus infection. It rapidly disseminated all over the world in a short time. This study described the demographic and clinical features of 479 coronavirus disease-2019 patients admitted to a designated pandemic hospital in Izmir, Turkey, and it aimed to incorporate our experiences into current literature. Materials and Methods: Patients confirmed with symptomatic SARS-CoV-2 infection by real-time polymerase chain reaction or by typical chest computed tomography findings and rapid antibody test positivity were enrolled in the study. Demographic and clinical data of the patients were extracted from electronic medical recordings. The patients were categorized into three groups based on the severity of clinical and laboratory findings: group 1, uncomplicated disease;group 2, mild/moderate disease;and group 3, severe disease. Demographic and clinical findings were compared between groups. Results: The mean age of the patients was 50.7 +/- 19.3 years;50.5% of the patients were male. No significant difference was observed between gender distributions in groups. The most common symptoms on admission were cough (219, 45.7%), fever (187, 39%), fatigue (176, 36.7%), and dyspnea (63, 13.2%). The most frequently observed comorbidities were hypertension (129, 26.9%), diabetes (71, 14.8%), and chronic heart diseases (35, 7.3%). The patients in group 3 had shown significantly higer number of underlying diseases. On chest computed tomography, ground-glass opacity was the most common radiologic finding. C-reactive protein, D-dimer, ferritin, and procalcitonin were found to be in significantly increased levels in patients with severe disease. Conclusion: Our observations during the first three months of pandemic suggested that the patients can present with a varying degree of severity. Some prognostic markers can predict the progression of the disease. We emphasize that accumulating experiences in the management of the disease accompanied by up-to-date tracking of guidelines would enable us to face up against upcoming surges more effectively.