Risk for 'more severe, critical' COVID-19 higher in RA vs. PsA, ulcerative colitis
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Patients with rheumatoid arthritis, but not psoriatic arthritis or ulcerative colitis, are at a greater risk for severe or critical COVID-19 versus those with COVID-19 alone, according to data published in The Journal of Rheumatology.
The researchers added that systemic therapies do not appear to increase the risk for severe COVID-19, with a possible exception for non-TNF-inhibitor biologics.
“Patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ulcerative colitis (UC) usually require treatment with immunomodulatory medications, which may increase the risk of SARS-CoV-2 and other infections,” Jeffrey R. Curtis, MD, of the University of Alabama at Birmingham, and colleagues wrote. “Moreover, these patients may be at higher risk for more severe coronavirus disease 2019 (COVID-19), including hospitalization, complications, and death.”
“The American College of Rheumatology (ACR) asserts that patients with autoimmune and inflammatory diseases treated with immunomodulatory therapies seem to be at higher risk for more severe COVID-19, but the lack of evidence from large, population-based studies is noted,” they added. “The effect of immunomodulation on the severity of COVID-19 remains unclear, and whether interruption of immunomodulatory therapies prevents severe complications of COVID-19 lacks high-quality evidence.”
To examine the characteristics and COVID-19 outcomes of patients with RA, PsA or ulcerative colitis receiving systemic therapies, compared with the general population, Curtis and colleagues conducted a descriptive, retrospective cohort study of data from the U.S. Optum deidentified COVID-19 electronic health record dataset. The analysis additionally served as a voluntary post-authorization safety study of tofacitinib (Xeljanz) conducted by Pfizer.
The Optum COVID-19 EHR dataset includes longitudinal information from 2007 to 2020 on patients tested for, or diagnosed with, COVID-19, and is a subset of the nationally representative Optum EHR database. For this analysis, Curtis and colleagues included 315,101 adults with COVID-19, stratified into three disease cohorts — those with RA, PsA or ulcerative colitis who had received systemic therapy — as well as a comparator cohort of those without RA, PsA or ulcerative colitis or systemic therapy use. Included systemic therapies were conventional synthetic disease-modifying antirheumatic drugs, JAK inhibitors — including tofacitinib — TNF inhibitors and non-TNF-inhibitor biologics.
The primary endpoints were hospitalization and ICU admission within 30 days of COVID-19 diagnosis. The researchers calculated incidence proportions of hospitalization and clinical manifestations, and estimated endpoint risk using logistic regression analysis, adjusting for demographics as well as demographics alongside comorbidities. Among the patients in the analysis, 2,306 had RA, 421 had PsA and 811 had ulcerative colitis. The comparator cohort included 311,563 patients.
According to the researchers, after adjusting for demographics, patients with RA demonstrated an increased risk for hospitalization (OR = 1.54; 95% CI, 1.39-1.7) and in-hospital death (OR = 1.61; 95% CI, 1.3-2) versus the comparators. Increased risks for hospitalization (OR = 1.25; 95% CI, 1.13-1.39) and in-hospital death (OR = 1.35; 95% CI, 1.09-1.68) were similarly observed after adjusting for demographics plus comorbidities.
Meanwhile, the risk for hospitalization was lower among COVID-19 patients with RA who received TNF inhibitors, compared with non-TNF-inhibitor biologics (OR = 0.32; 95% CI, 0.2-0.53), and versus the comparator cohort (OR = 0.77; 95% CI, 0.51-1.17). Hospitalization risk due to COVID-19 was similar between patients receiving tofacitinib and the comparators.
“The data reported here add evidence to the current literature that patients with RA, but not PsA or UC, are at higher risk for more severe or critical COVID-19,” Curtis and colleagues wrote. “Patients treated with systemic therapies did not appear to be at increased risk of severe COVID-19 compared to the comparator cohort, with the possible exception of non-TNFi biologics.”
“However, more data are needed to further understand the risk and outcome of COVID-19 in these patient populations,” they added. “Collectively, these data from patients with immune-mediated inflammatory conditions are important for informing medical management strategies, as well as COVID-19 vaccine priority decisions.”
Perspective
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The conclusion of the study from Curtis and colleagues was that, compared with the comparator cohort, patients with rheumatoid arthritis were at a higher risk of developing more severe or critical COVID-19 infections independent of which therapies were used to treat their RA. The exception was the non-TNF biologics that were associated with a greater risk presumably due to the fact that rituximab was included in this group. Other systemic therapies did not increase the risk further.
This conclusion differs from that of the COVID-19 Global Rheumatology Alliance (GRA) registry, which relies on members reporting their cases, whereas the current date was derived from a voluntary post-authorization safety study for tofacitinib embedded within the Optum deidentified COVID-19 electronic health record database. The GRA database found that the comorbidities of hypertension, cardiovascular disease and diabetes increase the risk of developing severe COVID-19.
Although the use of glucocorticoids was collected for the RA cohort and was found in 32.4% of patients, this therapy – known to increase the risk of developing severe COVID-19 – was not addressed separately from “systemic therapies” in this article. Additionally, another known predictor for more severe COVID-19, BMI was not included as a covariate in the analysis due to unavailable data.
I agree with the conclusion of the article that more data are needed to further understand the risk and outcomes of COVID-19 infections in our RA patients. I would be very interested to see the rituximab treated patients separated out from the non-TNF therapy group and exposure to glucocorticoids separated out from systemic therapies. Until then, I will use the data from this study to inform my RA patients of their risk of developing COVID-19 infections.
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