Infectious Disease

No affect on threat outcomes

February 19, 2021

4 min read

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Disclosure:
Alexander is a past chairman and currently a member of the FDA Advisory Committee on the Peripheral and Central Nervous System. has served as a paid advisor to IQVIA; is a co-founder and shareholder of Monument Analytics; and is a past member of OptumRx’s National P&T Committee. This agreement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest guidelines. Andersen receives PhD training assistance from the National Heart, Lung and Blood Institute’s T32 Training Program for Pharmacoepidemiology (T32HL139426-03).

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It’s only natural that people taking immunosuppressive drugs would fear COVID-19.

However, recent evidence is adding to a growing body of data suggesting that immunosuppression may not increase the risk of worse outcomes in COVID-19 hospitalizations.

“This is a small amount of good news at a time in this pandemic, when we need it,” said Dr. med. G. Caleb Alexander opposite Healio Rheumatology. “Doctors and patients may have decided to stop taking these drugs by then. We are beginning to see that this is not necessary. “Source: Adobe Stock

The concerns about immunosuppression and COVID-19 are twofold. One concern is that these drugs would increase your risk of acquiring the virus. The other is that if infected, these drugs would cause more serious complications.

Kayte Andersen, MSc, A graduate student in the Epidemiology Department of the Johns Hopkins Bloomberg School and colleagues wanted to answer the second question.

Kayte Andersen

They conducted a retrospective cohort study of 2,121 consecutive adult patients enrolled in the Johns Hopkins Medicine healthcare system between March 4, 2020 and August 29, 2020 with a confirmed or suspected diagnosis of COVID-19.

The results published in Clinical Infectious Diseases showed that 5% of this group were immunosuppressed prior to the COVID-19 diagnosis. Prednisone, tacrolimus, and mycophenolate mofetil were the most commonly reported immunosuppressive drugs.

Adjusted analysis results showed no significant increase in hospital mortality in immunocompromised versus non-immunocompromised patients (HR = 0.66; 95% CI, 0.28–1.55). Similarly, immunosuppression did not increase the risk of mechanical ventilation (HR = 0.79; 95% CI, 0.46–1.35) or length of stay (HR = 1.16; 95% CI, 0.92–1, 47).

Healio Rheumatology sat down with Andersen and G. Caleb Alexander, MD, MS, from the Johns Hopkins Bloomberg School of Public Health and the Center for Drug Safety and Efficacy to discuss the rationale for the study, the encouraging nature of the results, and the next steps in research.

Healio: What prompted the study?

Andersen: This is a really important question. Immunosuppressed individuals have been identified by the CDC as being at high risk for COVID-19.

Alexander: At the beginning of the pandemic, there were some concerns that patients would stop taking immunosuppressive drugs because they feared receiving COVID-19 or having poorer results if they acquired the virus.

G. Caleb Alexander

Healio: Has the cohort been defined as having an immunocompromised condition due to illness or medication?

Andersen: The cohort consisted of all people hospitalized in the five Johns Hopkins Hospitals with COVID-19. We defined people as immunocompromised or not by their drugs, which were often drugs for patients with rheumatic or autoimmune diseases, as well as solid organ transplants. Overall, this group comprised 5% of our cohort.

Alexander: This was primarily a study for patients treated with immunosuppressive drugs. This is how we derived the cohort and that was the exposure of interest.

Healio: There was no difference in mechanical ventilation risk, hospital mortality, or length of stay. Did age, gender, or a specific illness affect the results?

Andersen: We were able to consider age, gender and health status before they were hospitalized with COVID-19. We still didn’t find any difference in the results which we found comforting. In this study, we were unable to examine certain drug classes or drugs. However, we plan to do this in a larger data set.

Healio: How and why are you encouraged by these results?

Alexander: The study adds to a growing body of evidence showing that individuals taking chronic immunosuppressive medication do no worse than their counterparts on COVID outcomes. Looking at the bigger picture, one of the most encouraging aspects of these results is that this is a small amount of good news at a time in this pandemic when we need it. Doctors and patients may have decided to stop taking these drugs by then. We are beginning to see that this is not necessary. Our work continues to be corroborated by other studies showing similar results.

Healio: In order not to undermine the encouraging nature of the data, we have seen during this pandemic that the evidence to support or disagree with any particular conclusion can change in a short period of time. Are there concerns that more evidence might show the picture is more complicated than it currently appears?

Andersen: For now, our evidence is consistent with what we see from other groups in the literature.

Alexander: Even so, I don’t think our results are a blank check to start immunosuppressive drugs without careful consideration. However, the fact remains that many people need these drugs because of an organ transplant or an autoimmune disease or rheumatic disease. Our results show that these drugs have not been linked to worse outcomes from COVID, which we consider to be an important conclusion.

Healio: Are there any concerns about the interactions between immunosuppressants and the antivirals used to treat COVID-19 or dexamethasone?

Andersen: We plan to look at this in the national dataset. We want to see if patients hospitalized for immunosuppression may be treated differently, as dexamethasone is currently one of the mainstays of treatment. That is a question that still lingers.

Healio: What are the next steps for your group?

Andersen: We worked on a national dataset called the N3C, or National COVID Cohort Collaborative, which is a national collaboration of more than 30 hospital systems in the US. We are examining the results for immunocompromised patients in a national cohort to see if we would get the same result.

We hope we can address the same clinical issues we addressed in this study and more. First and foremost, however, we will focus on these two main groups of patients taking immunosuppressive drugs: organ transplant recipients and those with autoimmune or rheumatic diseases.

Alexander: As with any study, ours raises as many questions as it answers. In our study we combined all immunosuppressive drugs. The sample size did not allow us to take a really detailed look at individual drugs or those that work with different mechanisms of action. The pharmacology of many immunosuppressants is very different. We therefore believe that it will be important in future work to examine some of these questions in the context of the COVID results.

Answering these questions is extremely urgent as the pandemic has never been this bad. We need to keep trying to generate fundamental new knowledge. Fortunately, there are legions of scientists around the world working on it.

For more informations:

G. Caleb Alexander, MD, MS, and Kayte Andersen, MSccan be reached at 615 N. Wolfe Street, W6035; Email: galexand@jhsph.edu.

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