COVID-19 research briefs: current treatment with biologics does not increase poor outcomes and convalescent plasma safe

Daily POEMs

Published: 2020-06-06 © 2020 John Wiley & Sons, Inc.

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Clinical question
Is risk of COVID-19-related mortality or morbidity higher in patients receiving biologic agents? Is convalescent plasma safe?

Bottom line
Patients taking biologic agents not at greater risk of poor outcomes. Patients receiving convalescent plasma have few transfusion-related serious adverse events. (LOE = 4)

Reference
Haberman R, Axelrad J, Chen A, et al. Covid-19 in Immune-Mediated Inflammatory Diseases - Case Series from New York [published online ahead of print, 2020 Apr 29]. N Engl J Med. 2020;NEJMc2009567. doi:10.1056/NEJMc2009567 Joyner MJ, Wright RS, Fairweather DL, et al. Early safety indicators of COVID-19 convalescent plasma in 5000 patients. MedRxIV.org https://doi.org/10.1101/2020.05.12.20099879

Study design: Other

Setting: Inpatient (any location)

Synopsis
Research Brief #30: An unanswered concern is whether patients taking immune modulating drugs for the treatment of an inflammatory arthritis or inflammatory bowel disease are at greater risk of poor outcomes than the general population. This is a case series from New York City of 86 such patients, of whom 14 were hospitalized and one died. Most (87%) were taking an immune modulating drug for their condition, with 72% taking any biologic or Janus kinase inhibitor, 44% a tumor necrosis factor inhibitor, and 20% methotrexate. The rate of hospitalization was slightly lower than that for NYC as a whole (16% vs 26%); patients who were hospitalized tended to be older and have other comorbidities such as chronic lung disease. Use of non-biologic agents such as methotrexate (43% vs 15%), glucocorticoids (29% vs 6%) and hydroxychloroquine (21% vs 7%) was more common in the hospitalized patients. Overall this supports that chronic use of biologic agents do not significantly increase risk of adverse outcomes with COVID-19. Haberman R, Axelrad J, Chen A, et al. Covid-19 in Immune-Mediated Inflammatory Diseases - Case Series from New York [published online ahead of print, 2020 Apr 29]. N Engl J Med. 2020;NEJMc2009567. doi:10.1056/NEJMc2009567 Research brief #31: Many new treatments are being proposed for COVID-19, but safety assessment is often lacking. This report from the Mayo Clinic on a preprint server describes the safety outcomes for 5000 consecutive patients from around the US with COVID-19 treated with convalescent plasma as part of an FDA approved Expanded Access Program that began in early April. The median age was 62 years, and 81% had current severe or life-threatening disease while the remainder were at risk for severe disease. There were 36 serious adverse events (SAEs) within 4 hours of transfusion, of which only 2 were felt to be definitely related to the transfusion by the treating physician. The SAEs included 15 deaths (0.3), of which 4 (0.08%) were thought to be related to the transfusion. Other SAEs included transfusion associated circulatory overload in 7 patients, transfusion related acute lung injury in 11 patients, and severe allergic transfusion reaction in 3. Mortality at 7 days was 14.9%, but without a randomized trial of convalescent plasma compared to usual care we do not know its effectiveness. At least it does appear to be safe. Primum non nocere. Joyner MJ, Wright RS, Fairweather DL, et al. Early safety indicators of COVID-19 convalescent plasma in 5000 patients. MedRxIV.org https://doi.org/10.1101/2020.05.12.20099879

Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA

Copyright © 2020 John Wiley & Sons, Inc.