Q&A: Steroids, not anti-TNF therapy increase risk for severe COVID-19 infection in IBD
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For patients with inflammatory bowel disease, risk factors associated with severe COVID-19 infection included increasing age, comorbidities and corticosteroid use, according to an initial analysis of a large, international registry.
The Surveillance Epidemiology of Coronavirus Under Research Exclusion-IBD (SECURE-IBD) registry was recently launched to monitor and report outcomes of COVID-19 in patients with IBD. The registry aimed to answer questions that patients with IBD and their caregivers may have. The Icahn School of Medicine at Mount Sinai collaborated with the University of North Carolina School of Medicine to launch the international registry.
Healio Gastroenterology and Liver Disease spoke with Ryan C. Ungaro, MD, a gastroenterologist with Mount Sinai Hospital’s Feinstein IBD Center, about the results from the first analysis of the SECURE-IBD registry, which included 525 cases from 33 countries
Ungaro and colleagues reported that 37 patients had severe COVID-19 infection, 161 were hospitalized and 16 died. Risk factors for severe COVID-19 infection included increasing age and use of systemic corticosteroids, sulfasalazine or 5-aminosalicylate. However, anti-tumor necrosis factor treatment was not correlated with severe illness. – by Monica Jaramillo
Healio: What were the results from this study?
Ungaro: The main take home points for this first analysis was that the risk factors in patients with IBD for severe COVID-19 are similar to the general population, which include age or increasing number of comorbidities in addition to IBD. There is a trend, though not significant, that obesity is associated with worse outcomes. The strongest risk factor for severe COVID-19 infection, in IBD specifically, was systemic corticosteroid use such as medications like prednisone. Those patients had at least a six-fold higher risk for developing severe COVID-19 if they were on steroids. In addition, we had a surprising result that patients on sulfasalazine and/or mesalamine were at a somewhat increased risk as well. However, we’re still doing more analysis to delve deeper into this and try to make sure there aren’t confounders so I wouldn’t, at this point, interpret this finding as patients should stop their sulfasalazine/mesalamine. Overall, our findings reiterate the importance of limiting and tapering down the use of steroids in IBD patients especially in the era of COVID-19.
One of the most interesting and reassuring findings was the our most commonly used biologic medication, anti-TNF, was not associated with an increased risk for COVID-19 infection. Going into the pandemic, we were not sure how the use of biologics might impact the clinical course of Covid-19. In general, we thought they should stay on them, but we didn’t really know if it was going to increase the severity of infection. These results are reassuring for anti-TNF medications that patients are not at a higher risk for getting severe illness if they were to get COVID-19. It reaffirms that patients should stay on their anti-TNF medications during this pandemic.
Healio: Will the results change how patients with IBD are treated, at least during this pandemic?
Ungaro: In general, in IBD care, we try to limit steroid use. But, particularly now during COVID-19, it’s important to limit the use and if we do have to use it, try to use less systemically absorbed formulations. Patients taking prednisone should ideally be taken off it and switched over to a steroid-sparing therapy like a biologic.
Healio: Will you continue to use the registry and allow people to enter their data?
Ungaro: This was just the first analysis, where we thought we had enough data to say something robust. It included 525 patients and, as of this week, we now have more than 1,000 patients in the registry. We are planning for another analysis to answer some other questions on whether steroid dosage matters and to look at the impact of other classes of biologics.
Healio: Did the registry accomplished what you wanted?
Ungaro: Yes; so far it has been an amazing outpouring of collaboration across the IBD community to really try to get as much information into this database as possible so we can better inform our clinical decision making in this era of COVID-19. We are accomplishing that; although observational registries have their limitations, we are supplying some of the best data out there, to my knowledge, that can offer some guidance on how to manage IBD patients during the pandemic.
Healio: What is the next step in the research?
Ungaro: Some of what we will analyze in the coming weeks include the impact of the non-TNF biologics, comparing combination therapy with monotherapy, as well as looking at doses of steroids to see if higher doses pose higher risks. We are also starting to plan our longitudinal long-term follow-up study where we can try to build upon the registry and see if there are long-term sequalae or long-term complications that patients may have experienced due to having COVID-19. We want to see if COVID-19 impacts the trajectory of IBD.
Disclosures: Ungaro reports he is a consultant for Eli Lilly, Janssen, Pfizer and Takeda.
Perspective
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The primary take-away here is the safety of medications we use in IBD patients, in particular anti-TNF medications. The number one concern when the pandemic started was whether patients should stay on their medications and if those medications put them at higher risk for contracting COVID-19 or a more severe course of the disease.
This study was a collaborative international effort among the IBD community to report COVID-19 cases. The main signal we see from the data is that anti-TNF does not seem to correlate with severe outcomes from COVID-19 so we can advise patients they can safely stay on their medications if they are on biologics. Secondly, steroids seem to be associated with potentially worse outcomes with COVID-19. We already try to avoid prolonged steroid use in patients with IBD because of the many side effects and this data serves as reinforcement of that practice. Thirdly, there was an interesting finding that 5-aminosalycilate medications such as sulfasalazine and/or mesalamine may be associated with worse outcomes in COVID-19. It is hard to interpret that data right now because these drugs are non-immune suppressing and generally have always been thought to be safe. Further research is needed to determine if this is a true finding or possibly a false signal due to the study design.
There are inherent flaws to the study that were likely unavoidable due to the circumstances around the pandemic including the fact that it is a self-reporting registry without longitudinal follow-up of the patients. Doctors reported on confirmed cases that they knew about at a single time point, and as we know one of the limitations with COVID-19 in particular in the United States is the lack of testing. So many patients who have probable COVID-19 are not getting diagnosed and therefore were not eligible for this registry. Also, outcomes that may have occurred outside the reporting period could be missed. This may lead to some bias and potential confounding factors. For example, it may skew more toward severe cases of COVID-19 while missing mild cases. Despite these limitations, the SECURE-IBD registry has been an incredible effort to give gastroenterologists quick guidance in how to manage IBD during the pandemic. Hopefully, the investigators will build off this registry further in a prospective longitudinal study of patients with COVID-19.
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