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1.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009559

ABSTRACT

Background: As the number of patients with a cancer diagnosis grows in the United States, there is an increasing need for physician scientists with oncology-related research training to develop new approaches to screening, diagnosis, therapy, and survivorship. A single US medical school developed the National Cancer Institute-funded Scholars in Oncology-Associated Research (SOAR) cancer research education program. Due to the COVID-19 pandemic, SOAR transitioned from fully in-person in 2019 to virtual in 2020 and hybrid in 2021. This study examines whether the in-person, virtual, or hybrid formats provide better educational experiences as rated by participants. Methods: SOAR includes a seminar series, an 11-week full-time cancer research experience, weekly research cluster group meetings, and tumor board and interprofessional shadowing experiences. In 2019 all program activities were in-person. In 2020 all activities were virtual with the shadowing suspended. In 2021, seminars and tumor boards were virtual, shadowing was in-person, and all other activities were hybrid. Pre- and post-surveys were collected from all participants to assess understanding of oncology and associated medical specialties. How participant understanding of oncology and related specialties changed within each year's program was analyzed with a Wilcoxon rank-sum test. The Kruskal-Wallis test was used to examine change in understanding between the cohorts. Results: 37 students participated in SOAR (2019 n = 11, 2020 n = 14, 2021 n = 12). Self-reported understanding of oncology as a clinical (p < 0.01 for all) and research discipline (p < 0.01 for all) improved within all three cohorts. There was no significant difference between each cohort's improvement in research understanding (p = 0.6158). However, there was a trend towards more of an improvement in the in-person cohort (p = 0.0796) for clinical understanding. There was no significant difference between each cohort's improvement in understanding of oncology-related disciplines such as medical oncology, radiation oncology, pediatric oncology, surgical oncology, and survivorship as both clinical and research disciplines (p > 0.1 for all). Conclusions: A virtual cancer research education program can be as effective as an in-person or hybrid program for research education although it may be suboptimal for learning about clinical oncology. Given the ongoing challenges presented by the COVID-19 pandemic, flexibility is needed in delivering cancer research education programs such as SOAR. With modern research methodology and communications technology, cancer research is becoming increasingly diverse and flexible in terms of research environment. If program leaders are steadfast in their adaptation of research education programs to a virtual or hybrid environment, participant understanding of oncology as a clinical and research discipline remains robust.

2.
Annals of the Rheumatic Diseases ; 81:314-315, 2022.
Article in English | EMBASE | ID: covidwho-2008921

ABSTRACT

Background: Although the risk for severe COVID-19 progression in children is low, this may be aggravated by the underlying disease and/or immunosuppres-sive drugs. Objectives: We analyzed clinical data of COVID-19 cases among paediatric patients with rheumatic diseases reported to the BIKER registry. Methods: The main task of the German BIKER (Biologics in Pediatric Rheumatology) registry is to monitor the safety of biologics therapies in JIA. After the onset of the COVID-19 pandemic, the survey was expanded with a standardized form to proactively interview all participating centers about the occurrence, presentation, and outcome of SARS-CoV-2-infections in children with rheumatic diseases. Interviews were conducted with 68 centers initially weekly and later biweekly. Results: A total of 68 centres participated in the survey. Clinical data from 194 COVID-19 cases reported to the BIKER registry from 41 German and 1 Austrian pediatric rheumatology institutions between February 2020 and December 2021 were analyzed. Juvenile idiopathic arthritis (JIA, n=144) was the most common diagnosis followed by genetic autoinflammation (n=18;i.e. FMF, TRAPS, CAPS, HIDS, DADA2), systemic autoimmune diseases (n=11;i.e. SLE, dermatomyositis, vasculitis) and 16 with other rheumatic diseases (i.e. CRMO, Uveitis). 5 patients with no rheumatic disease were excluded. 104 (54%) patients were receiving conventional DMARDs, 81 (43%) received biologics, mainly TNF inhibitors (n=66 (35%)). Of the 189 rheumatic patients with SARS-CoV2 infection, 123 (63%) were female. The mean age was 12.4+/-4.4 years in females and 13.2+/-4.1 in males. The duration of SARS-Co2 infection associated symptoms was 13.8+/-15.3 days (max. 113 days), in 35 (43%) patients they lasted for > 12 days. 46 (24%) were asymptomatic. Patients with autoinflammation and systemic autoimmunopathies reported more symptoms such as fever, head and throat ache. 4 patients only complained about dyspnea. Only 3 patients were hospitalized and received Oxygen-supplementation. The only patients admitted to ICU, received ventilation but succumbed. This 3/-year-old patient, initially diagnosed with systemic JIA, developed fatal disease with intracranial edema and respiratory failure, as well as typical pulmonary texture changes. Prior to her SARS-CoV-2 infection, the patient was treated with MTX and low-dose steroids. Genetic testing revealed a so far unrecognized congenital immunodeficiency. In the total JIA cohort, treatment with corticosteroids, conventional DMARDs, biologics or combinations did not influence the number of reported symptoms or the favorable outcome of the cohort. However, the duration of symptoms was lower in the TNF-treated cohort (10.4+/-6.4 days vs. 15.7 +/-19.7 days). In the cohort with autoinflammation, fever was observed in 11 (61%). Those 6 who received IL-1-inhibitors did not show a different outcome than those 12 who did not. No case of PIMS/MISC in children with rheumatic diseases was reported. Conclusion: Except for one patient with congenital immunodefciency who died from her COVID-19 infection, no case of severe COVID-19 was reported in our cohort. At the time of infection, over 80% of patients in our cohort had been treated with conventional DMARDs and/or biologics. This did not appear to have a negative impact on the severity or outcome of SARS-CoV2 infection. Interestingly, no case of PIMS/MISC was observed.

3.
JACC: Case Reports ; 4(17):1090-1093, 2022.
Article in English | EMBASE | ID: covidwho-2004170

ABSTRACT

A 32-year-old professional athlete developed chronic recurrent pericarditis despite standard medical therapy. Etiology included postpericardiotomy syndrome, viral, or COVID-19 vaccine related, all potentially exacerbated by intense exercise. Treatment and return-to-play decisions were complicated by potential side-effect profile of therapies and ability to limit exercise as a professional athlete. (Level of Difficulty: Intermediate.)

4.
PubMed; 2021.
Preprint in English | PubMed | ID: ppcovidwho-333808

ABSTRACT

BACKGROUND: A feed-forward pathological signaling loop generated by TNFalpha and IFN-gamma in inflamed lung tissue, driving CXCL-10 (IP-10) and CXCL-9 chemokine-mediated activated T-cell and monocyte/macrophage tissue recruitment, may define, sustain and amplify the inflammatory biology of lethal COVID-19 respiratory failure. METHODS: To assess TNFalpha-antagonist therapy, 18 hospitalized adults with hypoxic respiratory failure and COVID-19 pneumonia received single-dose infliximab-abda therapy 5mg/kg intravenously between April and December 2020. The primary endpoint was time to increase in oxygen saturation to fraction of inspired oxygen ratio (SpO2/FiO2) by >= 50 compared to baseline and sustained for 48 hours. Secondary endpoints included 28-day mortality, dynamic cytokine profiles (Human Cytokine 48-Plex Discovery Assay, Eve Technologies), secondary infections, duration of supplemental oxygen support and hospitalization. FINDINGS: Patients were predominantly in critical respiratory failure (15/18, 83%), male (14/18, 78%), above 60 years (median 63 yrs, range 31-80), race-ethnic minorities (13/18, 72%), lymphopenic (13/18, 72%), steroid-treated (17/18, 94%), with a median ferritin of 1953ng/ml. Sixteen patients (89%) met the primary endpoint within a median of 4 days, 15/18 (83%) recovered from respiratory failure, and 14/18 (78%) were discharged in a median of 8 days and were alive at 28-day follow-up. Deaths among three patients >= 65yrs age with pre-existing lung disease or multiple comorbidities were attributed to secondary lung infection. Mean plasma IP-10 levels declined sharply from 9183 pg/ml to 483 pg/ml at Day 3 and further to 146 pg/ml at Day 14/discharge. Significant declines in IFN- gamma , TNFalpha, IL-27, CRP and ferritin were specifically observed at Day 3 whereas other cytokines were unmodified. IL-6 levels declined sharply among patients with baseline levels >10 pg/ml. Among 13 lymphopenic patients, six (46%) had resolution of lymphopenia by day 3, and 11 by day 14. CXCR3-ligand (IP-10 and CXCL-9) declines were strongly correlated among patients with lymphopenia reversal (Day 3, Pearson r: 0.98, p-value: 0.0006). INTERPRETATION: Consistent with a pathophysiological role of TNFalpha, the clinical and cytokine data indicate that infliximab-abda may rapidly abrogate pathological inflammatory signaling to facilitate clinical recovery in severe and critical COVID-19. Randomized studies are required to formally assess mortality outcomes. Funding: National Center for Advancing Translational Sciences.

5.
Rechtsmedizin (Berl) ; 30(5): 325-331, 2020.
Article in German | MEDLINE | ID: covidwho-1797657

ABSTRACT

Background: Coronavirus disease 2019 (COVID-19), a disease caused by the new coronavirus (SARS-CoV-2), is a particular threat to old people. At the end of March 2020, the first and so far largest outbreak of the disease occurred in a retirement home in Hamburg. Methods: Analysis of procedures in dealing with a residential unit affected by SARS-CoV­2, accommodating a risk group of 60 seniors with dementia is presented as well as a detailed presentation of post-mortem examination results of all 8 deceased tested positive for SARS-CoV­2. Results: Out of 60 residents, 39 were infected by SARS-CoV­2. Due to preventive procedures it was possible to stop further spreading of the infection to other residential areas. In all 8 fatal cases, the autopsy diagnosis was death due to COVID-19. Autopsies revealed all COVID-19 patients to have a fatal (broncho)pneumonia and signs of relevant pre-existing cardiac, renal and pulmonary conditions in all cases. In 75% (n = 6) of the cases a fresh venous thrombosis was found. In 66.7% (n = 4) of the cases thrombotic events were combined with peripheral pulmonary artery thromboembolisms. Conclusion: The cohort of SARS-CoV­2 infected residents of a nursing home is characteristic for clinical and epidemiological features of the new coronavirus disease. Due to a centralized evaluation of all fatalities at the Institute of Legal Medicine in Hamburg, a detailed examination of all deceased positive for SARS-CoV­2 was possible. Thereby, increased case fatality rates of approximately 20% could in all cases be assigned to a relevant number of pre-existing comorbidities of multiple organ systems, which was consistent with the clinical data available.

6.
IEEE High Performance Extreme Computing Conference (HPEC) ; 2021.
Article in English | Web of Science | ID: covidwho-1764818

ABSTRACT

The Internet has never been more important to our society, and understanding the behavior of the Internet is essential. The Center for Applied Internet Data Analysis (CAIDA) Telescope observes a continuous stream of packets from an unsolicited darkspace representing 1/256 of the Internet. During 2019 and 2020 over 40,000,000,000,000 unique packets were collected representing the largest ever assembled public corpus of Internet traffic. Using the combined resources of the Supercomputing Centers at UC San Diego, Lawrence Berkeley National Laboratory, and MIT, the spatial temporal structure of anonymized source-destination pairs from the CAIDA Telescope data has been analyzed with GraphBLAS hierarchical hypersparse matrices. These analyses provide unique insight on this unsolicited Internet darkspace traffic with the discovery of many previously unseen scaling relations. The data show a significant sustained increase in unsolicited traffic corresponding to the start of the COVID19 pandemic, but relatively little change in the underlying scaling relations associated with unique sources, source fan-outs, unique links, destination fan-ins, and unique destinations. This work provides a demonstration of the practical feasibility and benefit of the safe collection and analysis of significant quantities of anonymized Internet traffic.

7.
Zeitschrift f..r Tourismuswissenschaft ; 13(3):387-404, 2021.
Article in German | CAB Abstracts | ID: covidwho-1759991

ABSTRACT

The COVID-19 pandemic not only affects many segments of the economy, especially the leisure and tourism industries, but also the education sector, i. H. schools, colleges and universities. In this respect, academic tourism training is doubly affected: on the one hand, courses in the previous form can no longer be carried out and require new teaching formats and concepts on the part of the teachers. On the other hand, there are increasing challenges for young academics to find jobs after completing their studies and/or (study-related) internships in the leisure and tourism industry. This project report is dedicated to the perspective of the teachers and analyzes the effects of the COVID-19 pandemic on the German-speaking tourism college and university landscape.

8.
Open Forum Infectious Diseases ; 8(SUPPL 1):S22-S23, 2021.
Article in English | EMBASE | ID: covidwho-1746807

ABSTRACT

Background. Accurately identifying COVID-19 patients at-risk to deteriorate remains challenging. Dysregulated immune responses impact disease progression and development of life-threatening complications. Tools integrating host immune-protein expression have proven useful in determining infection etiology and hold potential for prognosticating disease severity. Methods. Adults with COVID-19 were enrolled at medical centers in Israel, Germany, and the United States (Figure 1). Severe outcome was defined as intensive care unit admission, non-invasive or invasive ventilation, or death. Tumor necrosis factor related apoptosis inducing ligand (TRAIL), interferon gamma inducible protein-10 (IP-10) and C-reactive protein (CRP) were measured using an analyzer providing values within 15 minutes (MeMed Key®). A signature indicating the likelihood of severe outcome was derived generating a score (0-100). Description of derivation cohort RT-PCR, reverse transcription polymerase chain reaction. Results. Between March and November 2020, 518 COVID-19 patients were enrolled, of whom 394 were eligible, 29% meeting a severe outcome. Age ranged between 19-98 (median 61.5), with 59.1% male. Patients meeting severe outcomes exhibited higher levels of CRP and IP-10 and lower levels of TRAIL (Figure 2;p < 0.001). Likelihood of severe outcome increased significantly (p < 0.001) with higher scores. The signature's area under the receiver operating characteristic curve (AUC) was 0.86 (95% confidence interval: 0.81-0.91). Performance was not confounded by age, sex, or comorbidities and was superior to IL-6 (AUC 0.77;p = 0.033) and CRP (AUC 0.78;p < 0.001). Clinical deterioration proximal to blood draw was associated with higher signature score. Scores of patients meeting a first outcome over 3 days after blood draw were significantly (p < 0.001) higher than scores of non-severe patients (Figure 3). Moreover, the signature differentiated patients who further deteriorated after meeting a severe outcome from those who improved (p = 0.004) and projected 14-day survival probabilities (p < 0.001;Figure 4). TRAIL, IP-10, CRP and the severity signature score are differentially expressed in severe and non-severe COVID-19 infection Dots represent patients and boxes denote median and interquartile range (IQR) The signature score of patients meeting a severe outcome on or after the day of blood draw is significantly (p < 0.001) higher than the signature score of non-severe patients. Dots represents patients and boxes denote median and IQR Kaplan-Meier survival estimates for signature score bins Conclusion. The derived signature combined with a rapid measurement platform has potential to serve as an accurate predictive tool for early detection of COVID-19 patients at risk for severe outcome, facilitating timely care escalation and de-escalation and appropriate resource allocation.

9.
Open Forum Infectious Diseases ; 8(SUPPL 1):S351-S352, 2021.
Article in English | EMBASE | ID: covidwho-1746498

ABSTRACT

Background. TNFα and IFN-γ may synergize to induce cytokine-driven lethal hyperinflammation and immune exhaustion in COVID-19 illness. Methods. To assess TNFα-antagonist therapy, 18 hospitalized adults with hypoxic respiratory failure and COVID-19 pneumonia received single-dose infliximab-abda therapy 5mg/kg intravenously between April and December 2020. The primary endpoint was time to increase in oxygen saturation to fraction of inspired oxygen ratio (SpO2/FiO2) by ≥ 50 compared to baseline and sustained for 48 hours. Secondary endpoints included 28-day mortality, dynamic cytokine profiles (Human Cytokine 48-Plex Discovery Assay), secondary infections, duration of supplemental oxygen support and hospitalization. Hospitalized patients with SARS-COV2 infection and pneumonia that were referred to the infliximab-abda study team for evaluation. Results. Patients were predominantly in critical respiratory failure (15/18, 83%), male (14/18, 78%), above 60 years (median 63 yrs, range 31-80), race-ethnic minorities (13/18, 72%), lymphopenic (13/18, 72%), steroid-treated (17/18, 94%), with a median ferritin of 1953ng/ml. Sixteen patients (89%) met the primary endpoint within a median of 4 days, 15/18 (83%) recovered from respiratory failure, and 14/18 (78%) were discharged in a median of 8 days and were alive at 28-day follow-up. Deaths among three patients ≥ 65 years age with pre-existing lung disease or multiple comorbidities were attributed to secondary lung infections. Mean plasma IP-10 levels declined sharply from 9183 pg/ml to 483 pg/ml at Day 3 and 146 pg/ml at Day 14/discharge. Significant declines in IFN-γ, TNFα, IL-27, IL-6 (baseline above 10pg/ml), CRP and ferritin were specifically observed at Day 3 whereas other cytokines were unaffected. Among 13 lymphopenic patients, six (46%) had resolution of lymphopenia by day 3, and 11 by day 14. CXCR3-ligand (IP-10 and CXCL-9) declines were strongly correlated among patients with lymphopenia reversal (Day 3, Pearson r: 0.98, p-value: 0.0006). following treatment with infliximab-abda. The status of the patient at last follow-up (discharged, alive or dead) is indicated. ECMO: extracorporeal membrane oxygenation Control of inflammatory markers and cytokines following infliximab therapy Values from individuals are connected with solid lines, with deceased individuals indicated in red. Statistics: n=18, paired ratio t-test compared to baseline;∗: P<0.05, ∗∗: P<0.01, ∗∗∗: P<0.001, ∗∗∗∗: P<0.0001, n.s.: not significant. Conclusion. Consistent with a central role of TNFα, the clinical and cytokine data indicate that infliximab-abda may rapidly abrogate pathological inflammatory signaling to facilitate clinical recovery in severe and critical COVID-19. Randomized studies are formally evaluating infliximab therapy in this context. Funding: National Center for Advancing Translational Sciences.

10.
2021 IEEE International Conference on Big Data, Big Data 2021 ; : 4411-4420, 2021.
Article in English | Scopus | ID: covidwho-1730859

ABSTRACT

A key takeaway from the COVID-19 crisis is the need for scalable methods and systems for ingestion of big data related to the disease, such as models of the virus, health surveys, and social data, and the ability to integrate and analyze the ingested data rapidly. One specific example is the use of the Internet of Things and wearables (i.e., the Oura ring) to collect large-scale individualized data (e.g., temperature and heart rate) continuously and to create personalized baselines for detection of disease symptoms. Individualized data, when collected, has great potential to be linked with other datasets making it possible to combine individual and societal scale models for further understanding the disease. However, the volume and variability of such data require novel big data approaches to be developed as infrastructure for scalable use. This paper presents the data pipeline and big data infrastructure for the TemPredict project, which, to the best of our knowledge, is the largest public effort to gather continuous physiological data for time-series analysis. This effort unifies data ingestion with the development of a novel end-to-end cyberinfrastructure to enable the curation, cleaning, alignment, sketching, and passing of the data, in a secure manner, by the researchers making use of the ingested data for their COVID-19 detection algorithm development efforts. We present the challenges, the closed-loop data pipelines, and the secure infrastructure to support the development of time-sensitive algorithms for alerting individuals based on physiological predictors illness, enabling early intervention. © 2021 IEEE.

11.
2021 IEEE High Performance Extreme Computing Conference, HPEC 2021 ; 2021.
Article in English | Scopus | ID: covidwho-1672689

ABSTRACT

First responders and other forward deployed essential workers can benefit from advanced analytics. Limited network access and software security requirements prevent the usage of standard cloud based microservice analytic platforms that are typically used in industry. One solution is to precompute a wide range of analytics as files that can be used with standard preinstalled software that does not require network access or additional software and can run on a wide range of legacy hardware. In response to the COVID-19 pandemic, this approach was tested for providing geo-spatial census data to allow quick analysis of demographic data for better responding to emergencies. These data were processed using the MIT SuperCloud to create several thousand Google Earth and Microsoft Excel files representative of many advanced analytics. The fast mapping of census data using Google Earth and Microsoft Excel has the potential to give emergency responders a powerful tool to improve emergency preparedness. Our approach displays relevant census data (total population, population under 15, population over 65, median age) per census block, sorted by county, through a Microsoft Excel spreadsheet (xlsx file) and Google Earth map (kml file). The spreadsheet interface includes features that allow users to convert between different longitude and latitude coordinate units. For the Google Earth files, a variety of absolute and relative colors maps of population density have been explored to provide an intuitive and meaningful interface. Using several hundred cores on the MIT SuperCloud, new analytics can be generated in a few minutes. © 2021 IEEE.

12.
Zeitschrift Fur Tourismuswissenschaft ; 13(3):387-404, 2021.
Article in German | Web of Science | ID: covidwho-1666808
13.
Marketing, Zeitschrift fur Forschung und Praxis ; 43(1-2):95-108, 2021.
Article in English | Scopus | ID: covidwho-1632846

ABSTRACT

The issue currently permeating is how COVID- 19 affects our lives, including in terms of consumer behavior. For example, sales of men's suits have fallen sharply since March 2020, while there has been high demand for jogging pants. While German online retailing was able to increase sales by double digits in 2020, downtown retailers of non-food articles (e.g., textiles, shoes, etc.) had to accept a decrease of more than 20 % (HDE 2021). Our article focuses on the questions of whether consumer behavior has been fundamentally affected by the crisis, whether previously formed shopping patterns have dissipated and led to new shopping behavior, and whether old habits will return. Using two surveys at different timestamps of the pandemic, we analyze the impact on consumers' shopping styles and particularly discuss whether the pandemic has permanently changed online shopping tendencies and ethical behavior, and whether the desire for experience-oriented shopping has changed. © 2021 C.H.BECK oHG. All rights reserved.

14.
Heart International ; 15(1):20-25, 2021.
Article in English | EMBASE | ID: covidwho-1468864

ABSTRACT

Recurrent pericarditis is associated with significant morbidity and adverse impact on quality of life. Contemporary studies have emphasized the key role of autoinflammatory pathways in its pathophysiology, mainly through the activation of inflammasomes and the production of interleukin (IL)-1α and IL-1β. The IL-1 pathway has emerged as a promising target for the treatment of these patients. A novel IL-1 inhibitor, rilonacept, functions as an IL-1 trap binding to the circulating IL-1α and IL-1β mitigating their inflammatory response. Recently, the RHAPSODY phase III clinical trial evaluated the use of rilonacept in patients with recurrent pericarditis, who were refractory to colchicine, or steroid-dependent. Rilonacept significantly reduced symptoms, inflammatory markers and recurrent episodes, and increased successful withdrawal of steroids. The safety profile of the medication is favourable and well tolerated by patients, with local injection site reaction being the most common side effect described. These results have shifted the paradigm of the understanding of the disease and promise to become part of the armamentarium of medications for the standard of care of these patients, with potential use as monotherapy. The changing landscape of therapeutics and pathophysiology warrants increased recognition and understanding from the international cardiology community about this novel drug and its implication in managing these complex patients.The objective of this review is to describe the bio-action of rilonacept in the treatment of recurrent pericarditis.

15.
New Scientist ; 245(3281):11-11, 2020.
Article in English | Web of Science | ID: covidwho-1395950
16.
IEEE High Performance Extreme Computing Conference (HPEC) ; 2020.
Article in English | Web of Science | ID: covidwho-1395949

ABSTRACT

Pandemic measures such as social distancing and contact tracing can be enhanced by rapidly integrating dynamic location data and demographic data. Projecting billions of longitude and latitude locations onto hundreds of thousands of highly irregular demographic census block polygons is computationally challenging in both research and deployment contexts. This paper describes two approaches labeled "simple" and "fast". The simple approach can be implemented in any scripting language (Matlab/Octave, Python, Julia, R) and is easily integrated and customized to a variety of research goals. This simple approach uses a novel combination of hierarchy, sparse bounding boxes, polygon crossing-number, vectorization, and parallel processing to achieve 100,000,000+ projections per second on 100 servers. The simple approach is compact, does not increase data storage requirements, and is applicable to any country or region. The fast approach exploits the thread, vector, and memory optimizations that are possible using a low-level language (C++) and achieves similar performance on a single server. This paper details these approaches with the goal of enabling the broader community to quickly integrate location and demographic data.

17.
Annals of the Rheumatic Diseases ; 80(SUPPL 1):883, 2021.
Article in English | EMBASE | ID: covidwho-1358753

ABSTRACT

Background: COVID-19 is a major challenge worldwide. Although the risk for a severe disease course is low among children with COVID-19, symptoms may be exacerbated by underlying disease and/or immunosuppressive medication. We analysed clinical data from COVID-19 cases in among pediatric patients with juvenile idiopathic arthritis (JIA) in Germany reported to the BIKER registry. Objectives: This is an analysis of clinical data for 56 COVID-19 cases reported to the German BIKER registry from 29 German pediatric rheumatology centers and clinics from February 2020 to January 2021. Methods: The major task of the German BIKER (Biologics in Paediatric Rheumatology) Registry is surveillance of biologics used in pediatric rheumatology patients. Following the start of the COVID-19 pandemic in Germany, a survey was established to proactively interview all participating centers regarding the occurrence, presentation and outcome of SARS-CoV-2-infected children with rheumatic diseases. Initially, the interviews were conducted in weekly intervals, later bi-weekly. A standardized Adverse Event of Special Interest form was developed requesting biographic data, pre-treatment, current medication, data on clinical presentation, course, treatment and outcome of COVID-19 pediatric rheumatology patients. Results: In all, 56 patients with JIA and SARS-CoV-2 infection were reported (Table 1). Of these patients, 71% were 12 or more years old. At the time of infection, 41% of the patients received conventional DMARDs and 52% received biologics (Table 1). Forty-four patients (79%) received either a conventional DMARD or a biologic. Most patients had a polyarticular course of their JIA (57%). In 49 of the 56 cases (88%) COVID-19 was detected directly by PCR (n=46), by antigen test only (n=1) or an undisclosed method (n= 2). Six patients had detectable SARS-CoV2 antibodies and reported to have had typical symptoms. One patient tested negative but developed typical symptoms at approximately the same time a positive SARS-CoV-2 test was returned for a family member. Symptoms were reported in 43 of the 56 patients (77%): fever n=15, rhinitis n=14, cough n=12, headache n=10, loss of sense of taste and/or smell n=9, pharyngitis n=8, fatigue n=5, musculoskeletal pain n=5, GI symptoms n=2 (abdominal pain n=1, diarrhoea n=1), dizziness n=3, encephalitis/seizure/respiratory failure/death n=1. Thirteen patients (23%) were asymptomatic. A 3-year-old female patient initially diagnosed with systemic JIA developed intracranial oedema and respiratory failure. Her SARS-CoV2 PCR test was positive and pulmonary imaging displayed typical changes in lung texture. Before her SARS-CoV-2 infection, the patient was treated with methotrexate and low-dose steroids. Unfortunately, she died three days following hospital admission. Genetic testing revealed an inborn immunodeficiency. Except for this one patient, all other cases were treated as outpatients and no deaths were reported. Conclusion: Apart from one patient with an inborn immunodeficiency who died from her COVID-19 infection, no case of hospitalization or severe COVID-19 was reported in our cohort of JIA patients. At the time of COVID-19 diagnosis, nearly 80% of patients in our cohort had been treated with conventional DMARD and/ or biologics. This seemed not to have a negative effect on severity or outcome of SARS-CoV2 infection.

18.
Annals of the Rheumatic Diseases ; 80(SUPPL 1):882, 2021.
Article in English | EMBASE | ID: covidwho-1358746

ABSTRACT

Background: Although children and adolescents are less likely to develop COVID-19 and generally show milder disease courses, it is unclear what impact the SARS-CoV2 infection has on children and adolescents with rheumatic and musculoskeletal disease (RMD). Due to their underlying disease as well as therapeutic immunosuppression these patients may be at higher risk of being more severely affected by SARS-CoV2. Furthermore, SARS-CoV2 infection might trigger a flare of the underlying disease. Objectives: To evaluate clinical characteristics and disease course of COVID-19 in children and adolescents with RMD and to analyze possible effects of SARSCoV2 infection on the underlying disease under different therapeutic regimens. Methods: Data from juvenile patients with RMD recorded via the SARS-CoV2 questionnaire within the National Pediatric Rheumatology Database and the registry for hospitalized children and adolescents with COVID-19 of the German Society for Pediatric Infectious Diseases were analyzed. In addition to age, sex and diagnosis, information was collected about the date and method of a positive SARS-CoV2 testing, reason for testing, on clinical manifestations, disease course, treatment and outcome of COVID-19, on drug therapy at the time of virus detection, on disease activity (NRS 0 -10, 0 = best) of the underlying disease at the last visit before and after the SARS-CoV2 infection. Results: From April 17th 2020 until January 25th 2021, data of 67 patients with RMD and confirmed SARS-CoV2 infection were collected. Mean age was 13.5 ± 3.9 years with equal sex distribution. The majority of patients were diagnosed with juvenile idiopathic arthritis (JIA, 64%), 12 (18%) patients had an autoinflammatory disease (FMF, CAPS, PFAPA, TRAPS) and 5 (7%) a connective tissue disease. Fifty-two patients (78%) were treated with a disease modifying antirheumatic drug (DMARD), 39% with a biological DMARD and 9% systemic glucocorticoids at the time of SARS-CoV-2 infection. Nineteen patients (28%) were tested for SARS-CoV-2 because of typical symptoms, the majority (67%) because of contact to an infected person. PCR was used most often (in 60 %). 52 patients (78%) developed symptoms of COVID-19, 15 patients remained asymptomatic. The most common symptom of COVID-19 was rhinitis (42%) and fever (38%), followed by fatigue (34%), taste/smell disorder (33%), sore throat (27%) and cough (23%). Disease severity was graded as mild in 44 of 52 (85%) symptomatic patients, only two patients were hospitalized, one of whom required intensive care and died of cardiorespiratory failure 3 days after symptom onset. In 22 of 26 (85%) SARS-CoV2-positive patients, no relevant increase in disease activity (difference in NRS ≤ 1 before/after infection) of the underlying disease was observed 31 days after symptom onset (median, IQR 17-52 days). One patient, who had paused tocilizumab for 2 doses, experienced a flare of his seronegative polyarthritis 2 months after asymptomatic SARS-CoV-2 infection. Conclusion: In our cohort, the clinical picture of COVID-19 in children and adolescents with RMD was similar to that of healthy peers. The majority of patients showed mild disease course with good outcome under various medications, however, one patient with a severe course of COVID-19 died. In addition, SARSCoV2 infection does not appear to have a relevant impact on the underlying disease activity, whereas discontinuation of therapy might pose a risk of flare.

19.
Annals of the Rheumatic Diseases ; 80(SUPPL 1):933-934, 2021.
Article in English | EMBASE | ID: covidwho-1358724

ABSTRACT

Background: In 2017, Adalimumab Biosimilars became approved. Comparative studies to the originator have been performed in adult patients with rheumatoid arthritis, ankylosing spondylitis and psoriasis and extrapolation led to approval for juvenile idiopathic arthritis (JIA). Objectives: So far there is limited experience with biosimilars in JIA: The large national data base of the BIKER-registry was used to describe experience with Adalimumab biosimilars in clinical practice Methods: This retrospective analysis used data of the German BIKER-registry. The data basis war screened for patients exposed to Adalimumab. Subcohorts with initiation of treatment after 2017, use of the originator and of biosimilars were built. The course of JADAS10, Physician global assessment VAS 0-100-mm, Parent/patient global assessment VAS 0-100-cm, Active joint count 0-71, truncated at 10, ESR and CHAQ-DI was analyzed. Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESI). Results: Until 31.10.2020, 1173 JIA patients were reported to have received Adalimumab. 352 treatments have been started after January 1, 2017. A biosimilar was used first line in 44 patients. Further 55 patients switched for the originator to a biosimilar. 2 patient switched from a biosimilar to the originator. 3 patients switched to a second biosimilar while 5 patients who switched from the originator to a biosimilar reswitched back to the originator. After 2017, 33 pediatric rheumatology centres reported initiation of Adalimumab treatment. 17 have used a biosimilar. 15 centres have swichted at least 1 patient from the originator to a biosimilar and 14 have used first line a biosimilar in at least 1 patient. In a single centre, initiation of a biosimilar was used more frequently (8 versus 7). The patients' characteristics and disease activity parameters were brightly comparable. The JIA category rheumatoid factor (RF) negative polyarthritis was less frequent in the biosimilar first cohort while RF positive polyarthritis and psoriatic arthritis was more frequent. In patients with idiopathic uveitis the originator was used more often. In the switching cohort, more patients had RF negative polyarthritis, persistent oligoarthritis but less had psoriatic arthritis and no had RF positive polyarthritis. No difference in disease activity parameters between patients receiving the originator or biosimilars were noted, neither at baseline, during the course of treatment nor at last observation upon treatment (Figure 1). At the time of switching, 46 (92%) had JADAS minimal disease activity (MDA) and 30 (69%) were in JASDAS remission. At last observation, those numbers were comparable with 42 (86%) with JADAS MDA and 28 (57%) with JADAS remission. In total, 45 adverse events (AE) were reported in 45 patients upon biosimilar treatment. 26 patients had 1, 12 patients had 2 and 6 patients reported 3 and 1 reported 4 events. Adverse event of special interest were Infection associated leukopenia (n=1), COVID 19 infection (n=1), Uveitis flare (n=8), other disease deterioration (arthritis flare) (n=20), injection site reaction n=2. A single serious AE was reported. A 16 year old female adolescent was admitted for unexpected CK elevation. In 10 patients, Adalimumab was discontinued, in 2 it was temporarily paused. Conclusion: This article is the first attempt to present a large sample of data on JIA patients exposed to Adalimumab biosimilars. Since approval of Adalimumab-Biosimilars, limited experience from clinical practice is available. Biosimilars are used in a minority of patients and by a minority of centers although no difference in efficacy or safety was noted from our analysis.

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Journal of General Internal Medicine ; 36(SUPPL 1):S344-S345, 2021.
Article in English | Web of Science | ID: covidwho-1348922
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