Issue: July 2021
Source: Cohen MC. Clin Infect Dis. 2021; doi:10.1093/cid/ciab494.
Disclosures: Calabrese reports consulting relationships with AbbVie, Centecor Biopharmaceutical, Crescendo Bioscience, GlaxoSmithKline, Horizon Pharma, Janssen Pharmaceuticals, Pfizer, Regeneron Pharmaceuticals and UCB.
July 19, 2021
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COVID-19 in the eighth inning: Outpatient care of immunosuppressed patients

Issue: July 2021
Source: Cohen MC. Clin Infect Dis. 2021; doi:10.1093/cid/ciab494.
Disclosures: Calabrese reports consulting relationships with AbbVie, Centecor Biopharmaceutical, Crescendo Bioscience, GlaxoSmithKline, Horizon Pharma, Janssen Pharmaceuticals, Pfizer, Regeneron Pharmaceuticals and UCB.
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Last July, I wrote an editorial entitled “The rheumatologist, the third inning of COVID-19 and the importance of masks.” Thinking back and wondering where we are now, I would say the top of the eighth!

While the game is getting near the end, there is still a lot of time left to score more runs in prevention and treatment, as well as opportunities to blow the lead. We need to close this out for sure.

Leonard H. Calabrese, DO
Leonard H. Calabrese

One of the critical issues we are all wrestling with right now is still how to maximally protect our patients from severe COVID-19. Given my privilege of writing in editorial fashion, I will not cite the growing data that has informed us that our patients with inflammatory diseases — especially those on certain immunosuppressive regimens — are not responding as robustly to our vaccines as we had hoped. As a consequence, many of our patients are still vulnerable to severe and even fatal COVID-19. Nothing seems to be more tragic than to have patients who are fully vaccinated develop COVID-19 and have to fight for their life. While clinically rare, we have unfortunately already encountered this in our practice.

I commented in last month’s cover story that we would love to have a simple test to give us an accurate appraisal of post-vaccine degrees of clinical protection; in reality, we do not have a binary test to tell us for sure our degree of protection. While making no antibodies to the spike protein is not good news, such patients may still hopefully develop non-humoral immune responses to afford some degree of protection especially from severe forms of the disease. I will wager that in the next 6 to 8 weeks, we will have multiple studies (including one from the Cleveland Clinic) to provide some data to help better apprise this situation.

A second concern is that it has become abundantly clear that patients with inflammatory diseases, especially those on rituximab and other B-cell depleting therapies, as well as glucocorticoids, IV abatacept, anti-metabolites and possibly JAK inhibitors, are particularly vulnerable to severe COVID-19 and its sequela. Not coincidently, these same drugs are also capable of blunting the immune response to our current vaccines.

So, what should we be doing and telling our patients? First, I tell virtually all my patients who have been vaccinated to not cut loose with high-risk behavior until the case rate asymptotically approaches zero. For now, minimize travel and large group outings and wear a mask in public.

Some will say why bother getting vaccinated then? The answer is twofold. First, a vaccine may reduce the likelihood of severe/fatal COVID-19 even if the antibody response is not robust. As noted above, we cannot yet fully quantify this, but the majority of our patients will be afforded protection. Secondly, vaccinated immunosuppressed patients, in my opinion, can be allowed to meet in small groups of well-curated vaccinated friends/family without masks. This is a plus for sure.

Finally, ask yourself if you know how to get one of your immunosuppressed patients or even non-immunosuppressed patients with risk factors (aged >65 years, obesity, diabetes, heart disease, etc.) into a rapid treatment care path for monoclonal antibodies. These therapies are a major step in our treatment algorithms, and they are currently underutilized.

While several anti-spike monoclonals are approved in the United States and Europe, Regeneron made a huge leap ahead in early June with FDA approval of their monoclonal antibody cocktail in a more user-friendly preparation, allowing it to be administered by subcutaneous injection in addition to its original administration form of IV infusion. This is a game-changer in my opinion, and it has greatly simplified administration.

The data for benefits are clear. Early monoclonal antibody therapy can significantly improve outcomes in high-risk outpatient COVID-19, especially in those with poor antibody responses, but time is of the essence, as noted by Myron Cohen and colleagues in Clinical Infectious Diseases. If you can get your patient into a care path, the therapy is easy.

Our job is not over by a long shot, so let’s focus on the good things we can do: 1) Vaccinate! 2) Counsel some caution even to our vaccinated immunosuppressed patients until the case rate fades to near zero; and 3) For those patients at increased risk who develop COVID-19, get them treated with a monoclonal before the window closes.

That’s my take from the eighth inning. Share your own impressions on where we stand at calabrl@ccf.org or rheumatology@healio.com.