Last Updated December 15, 2020 at 03:51PM ET

Patients on Biologic Agents for Dermatological Conditions and COVID-19

Saakshi Khattri, MB BS, MD


May 27, 2020

Dr Saakshi Khattri, assistant professor in dermatology and rheumatology (internal medicine) at the Icahn School of Medicine at Mount Sinai in New York, US, helps us make sense of emerging evidence about how COVID-19 affects dermatology patients taking biologic therapies.

Is there any data on how COVID-19 affect patients on biologics for dermatology conditions?

There are registries started by ACR (American College of Rheumatology), SECURE-PSO (in Dermatology), that have started collecting data on COVID-19 infection but so far there is very limited data on COVID-19 in patients that are on biologics. It’s still a new virus, so research is underway to see how being on a biologic has any bearing to being either more susceptible to COVID-19 or having more symptoms of COVID-19.

What we can do is look at past data from pivotal trials conducted on biologics where any adverse event is documented, including upper respiratory tract infection (URTI) and nasopharyngitis. We can look at that data and make an intelligent or an educated decision on what the risk could be from COVID-19 on patients who are currently on biologics. That being said SARS-CoV-2, the causative virus behind COVID-19, may behave differently than viral infections that were included in pivotal trials so hopefully data from these new registries that have been started should prove to be helpful.

It is important to note that biologics used in dermatology for the treatment of psoriasis fall into three main categories:

Anti-TNF Agents

The first category is anti-TNF agents: adalimumab, etanercept, certolizumab [pegol], infliximab to name a few. In pivotal trial data the percentage of patients with upper respiratory tract infections (URTI) in the anti-TNF group ranged from 7% to 15% and these numbers were not statistically different from the placebo group.

However, all anti-TNF agents do have a black boxed warning of increased risk of infection, such as viral infections. Based on that, one can surmise that there is a theoretical possibility of an increased risk of COVID-19 infection with anti-TNF agents, if COVID-19 behaves similarly to other viruses causing URTI.

IL-12/23 Blockers

The second type of biologics are IL-12/23 blockers or IL-23 blockers and they include ustekinumab, guselkumab, tildrakizumab, and risankizumab.

There is some data on the role of IL-12 in boosting anti-viral immunity. However, the data is from mice models and not from human genetic studies. In pivotal trials the risk of having a URTI in IL-12/23 and the IL-23 group ranged from 2% to 5%. This risk was similar to the placebo group.

The PSOLAR registry, with almost 8000 patients who were followed for 8 years, showed that the incidence of any URTI with patients on ustekinumab was lower than patients on anti-TNF agents. Probably the risk of URTI with anti-TNFs is a little bit more compared with more specific or more targeted biologics like IL-12/23 (since patients on ustekinumab were included in this registry, other IL-23 blockers were not included as this data was before their inclusion).

Furthermore, IL-12/23 and IL-23 blockers do not have any black box warning about an increased risk of infection, which is different when compared to anti-TNF agents.

IL-17 Blockers

Then, we have the IL-17 blockers: secukinumab, ixekizumab, and brodalumab. In the pivotal trials looking at these medications, compared to placebo the risk of URTI was similar between the biologic group compared to placebo group. The only infections that IL-17 blockers had which was more than the placebo group was yeast infections.

Are patients taking these agents at a higher risk of COVID-19 complications and if so why is that?

We don’t know whether being on biologics places patients at a higher risk of COVID-19 complications. The data is just not there right now.

Patients need to understand that they are on a biologic medication that is suppressing their immune system. It does place them theoretically at an increased risk of infections. So social distancing, washing hands, wearing a mask, or just not stepping outside unnecessarily are recommended. We are telling all our patients to follow the CDC or WHO guidelines.

The risk with anti-TNFs could be perceived to be slightly higher than the IL-12/23, IL-23s and the IL-17s. So, if patients are concerned about that we have a discussion with them and give them the opportunity to switch to an IL-12/23, IL-23 or an IL-17, depending on underlying conditions.

Some of my patients have switched from an anti-TNF to an IL-23 or IL-17 blocker. Others have been reluctant to switch if their psoriasis is well controlled. So it really comes down to the patient, how the patient feels about what he or she is on, how they feel about switching, and if their disease is under control. There is no data on COVID-19 risk on switching between different biologics at present.

If a patient has psoriasis that warranted a biologic in the first place, then he or she probably had moderate-to-severe psoriasis which failed to respond to other treatment modalities. So, if the disease is under control with a biologic, why would we want to risk stopping a medication that’s working and the possibility of having a psoriasis flare-up? But again, this is a decision best made between the patient and their treating physician.

Should biologic treatment be modified if a patient develops COVID-19?

If there is any concern that a patient on a biologic has COVID-19 then they should stop the biologic as soon as possible. That is something that the National Psoriasis Foundation (NPF) and the American Academy of Dermatology (AAD) have clearly stated.

Should blood monitoring be delayed during the COVID-19 pandemic?

The good thing about these biologics is that we only need annual testing just to make sure that patients don’t have tuberculosis. This annual testing (if due during this pandemic) can certainly be delayed.

Should biologic therapy for dermatological conditions be modified during the pandemic?

There is some research looking at what happens to patients if they stop their biologic (which was working for them) and restart it. Those trials have shown that when they are re-challenged with a biologic once their psoriasis starts flaring up, the recapture rate is not 100%. 10% to 20% of patients who responded to a biologic previously fail to respond upon re-challenge. This is a bigger issue with anti-TNFs because patients can develop antibodies.

The second issue is with regards to severity of the flare of their underlying disease. There is a real danger that stopping the biologic that is controlling psoriasis may result in a flare-up. In the worst-case scenario a patient may become erythrodermic, which means that they have psoriasis covering 100% of their body surface area. They then would have to be admitted to hospital or put on immunosuppressive medications that are more suppressive, like oral cyclosporine, to control the disease. Obviously, this is worst case scenario.

At the end of the day, everything is on a case-by-case basis and the whole risk/benefit discussion that we, as providers, have with patients cannot be done in a vacuum. How their psoriasis was before they were put on a therapy has to play a role in determining whether they want to continue their existing therapy or whether they want to switch it to something else, because we don’t want our patients to go back to how severe their disease was, when they were first put on a biologic medication.



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