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The American Journal of Gastroenterology ; 116, 2021.
Article in English | ProQuest Central | ID: covidwho-1478570


Endpoints presented here are the percentage of patients in clinical remission at wk 8, per Adapted Mayo score, and the percentage of patients with a clinical response at wk 2, per partial Adapted Mayo score (both defined in Table footnotes), respectively, in patients who were on concomitant CS at baseline, at a dose maintained to the end of induction and in those treated with UPA without concomitant CS. Similar results were found with the clinical response rate at wk 2, with no difference between UPA-treated patients who received baseline CS (U-ACHIEVE: 58.1%;U-ACCOMPLISH: 55.1%) and those that received UPA without CS (U-ACHIEVE: 61.4%;U-ACCOMPLISH: 67.7%). Subjects were considered "non-responder" for binary endpoints at and after the UC-related corticosteroids censoring time point through the end of the Induction Study. † Dosing for main corticosteroids were as follows: prednisone. 10-40 mg QD, budesonide, 9 mg QD;or beclomethasone, 5 mg QD. § 95% CI for response rate is the synthetic result based on Student's t-distribution from PROC MIANALYZE procedure if there were missing data due to COVID-19 or is based on the normal approximation to the binomial distribution if there are no missing data due to COVID-19. ‡ 95% CI for response rate difference was calculated based on normal approximation to the binomial distribution.

J Clin Invest ; 130(11): 5967-5975, 2020 11 02.
Article in English | MEDLINE | ID: covidwho-690425


BACKGROUNDInitial reports from the severe acute respiratory coronavirus 2 (SARS-CoV-2) pandemic described children as being less susceptible to coronavirus disease 2019 (COVID-19) than adults. Subsequently, a severe and novel pediatric disorder termed multisystem inflammatory syndrome in children (MIS-C) emerged. We report on unique hematologic and immunologic parameters that distinguish between COVID-19 and MIS-C and provide insight into pathophysiology.METHODSWe prospectively enrolled hospitalized patients with evidence of SARS-CoV-2 infection and classified them as having MIS-C or COVID-19. Patients with COVID-19 were classified as having either minimal or severe disease. Cytokine profiles, viral cycle thresholds (Cts), blood smears, and soluble C5b-9 values were analyzed with clinical data.RESULTSTwenty patients were enrolled (9 severe COVID-19, 5 minimal COVID-19, and 6 MIS-C). Five cytokines (IFN-γ, IL-10, IL-6, IL-8, and TNF-α) contributed to the analysis. TNF-α and IL-10 discriminated between patients with MIS-C and severe COVID-19. The presence of burr cells on blood smears, as well as Cts, differentiated between patients with severe COVID-19 and those with MIS-C.CONCLUSIONPediatric patients with SARS-CoV-2 are at risk for critical illness with severe COVID-19 and MIS-C. Cytokine profiling and examination of peripheral blood smears may distinguish between patients with MIS-C and those with severe COVID-19.FUNDINGFinancial support for this project was provided by CHOP Frontiers Program Immune Dysregulation Team; National Institute of Allergy and Infectious Diseases; National Cancer Institute; the Leukemia and Lymphoma Society; Cookies for Kids Cancer; Alex's Lemonade Stand Foundation for Childhood Cancer; Children's Oncology Group; Stand UP 2 Cancer; Team Connor; the Kate Amato Foundations; Burroughs Wellcome Fund CAMS; the Clinical Immunology Society; the American Academy of Allergy, Asthma, and Immunology; and the Institute for Translational Medicine and Therapeutics.

Betacoronavirus/metabolism , Complement Membrane Attack Complex/metabolism , Coronavirus Infections , Cytokines/blood , Pandemics , Pneumonia, Viral , Systemic Inflammatory Response Syndrome , Adolescent , COVID-19 , Child , Child, Preschool , Coronavirus Infections/blood , Coronavirus Infections/epidemiology , Female , Humans , Male , Pneumonia, Viral/blood , Pneumonia, Viral/epidemiology , Prospective Studies , SARS-CoV-2 , Severity of Illness Index , Systemic Inflammatory Response Syndrome/blood , Systemic Inflammatory Response Syndrome/epidemiology