OBJECTIVES: Patients with immune mediated inflammatory diseases (IMIDs) receiving B cell depleting therapy (BCDT) are among the most vulnerable to severe COVID-19 as well as the most likely to respond sub-optimally to SARS-CoV-2 vaccines. However, little is known about the frequency or severity of breakthrough infection in this population. We retrospectively analyzed a large group of vaccinated IMIDs patients undergoing BCDT in order to identify the presence of breakthrough COVID-19 infections and assess their outcomes. METHODS: In this retrospective cohort study, the pharmacy records and COVID-19 registry at the Cleveland Clinic were searched using specific ICD-10 codes to identify IMIDs patients who (1) were treated with BCDT, (2) were vaccinated against SARS-CoV-2, and (3) experienced breakthrough infections. Each EMR was reviewed to extract clinical data and outcomes. Univariate and multivariable logistic/proportional-odds regression models were used to examine the risk factors for severe outcomes. RESULTS: Of 1696 IMIDs patients on BCDT, 74 developed breakthrough COVID-19 prior to December 16th, 2021. Outcomes were severe with 29(39.2%) hospitalized, 11(14.9%) requiring critical care, and 6(8.1%) deaths. Outpatient anti-SARS-CoV-2 monoclonal antibodies were used to treat 21 with 1 hospitalization and no deaths. A comparator analysis examining 1437 unvaccinated IMIDs patients on BCDT over the same time period identified 57(3.9%) COVID-19 cases with 28(49.1%) requiring hospitalization including 7(12.3%) deaths. CONCLUSIONS: IMIDs patients on BCDT regardless of vaccine status appear vulnerable to infection with SARS-CoV-2 and are frequently associated with severe outcomes. Outpatient use of anti-SARS-CoV-2 monoclonal antibody therapy appeared to be associated with enhanced clinical outcomes. This article is protected by copyright. All rights reserved.
OBJECTIVES: Patients with immune mediated inflammatory diseases (IMIDs) receiving B cell depleting therapy (BCDT) are among the most vulnerable to severe COVID-19 as well as the most likely to respond sub-optimally to SARS-CoV-2 vaccines. However, little is known about the frequency or severity of breakthrough infection in this population. We retrospectively analyzed a large group of vaccinated IMIDs patients undergoing BCDT in order to identify the presence of breakthrough COVID-19 infections and assess their outcomes. METHODS: In this retrospective cohort study, the pharmacy records and COVID-19 registry at the Cleveland Clinic were searched using specific ICD-10 codes to identify IMIDs patients who (1) were treated with BCDT, (2) were vaccinated against SARS-CoV-2, and (3) experienced breakthrough infections. Each EMR was reviewed to extract clinical data and outcomes. Univariate and multivariable logistic/proportional-odds regression models were used to examine the risk factors for severe outcomes. RESULTS: Of 1696 IMIDs patients on BCDT, 74 developed breakthrough COVID-19 prior to December 16th, 2021. Outcomes were severe with 29(39.2%) hospitalized, 11(14.9%) requiring critical care, and 6(8.1%) deaths. Outpatient anti-SARS-CoV-2 monoclonal antibodies were used to treat 21 with 1 hospitalization and no deaths. A comparator analysis examining 1437 unvaccinated IMIDs patients on BCDT over the same time period identified 57(3.9%) COVID-19 cases with 28(49.1%) requiring hospitalization including 7(12.3%) deaths. CONCLUSIONS: IMIDs patients on BCDT regardless of vaccine status appear vulnerable to infection with SARS-CoV-2 and are frequently associated with severe outcomes. Outpatient use of anti-SARS-CoV-2 monoclonal antibody therapy appeared to be associated with enhanced clinical outcomes. This article is protected by copyright. All rights reserved.
Authors: Melek Yalcin Mutlu; Jule Taubmann; Jochen Wacker; Koray Tascilar; Filippo Fagni; Maximilian Gerner; Daniel Klett; Georg Schett; Bernhard Manger; David Simon Journal: Front Med (Lausanne) Date: 2022-08-03
Authors: Cassandra Calabrese; Elizabeth Kirchner; Alexandra Villa-Forte; Rula A Hajj-Ali; Brandon P Moss; James P Fernandez; Leonard Calabrese Journal: RMD Open Date: 2022-09