Infectious Disease

What to say to your patients

April 02, 2021

5 min read

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Disclosure:
Calabrese reports that he has advised AbbVie and Sanofi-Genzyme and was in the speaker’s office.

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Working with minimal data and pressure from the pandemic, the American College of Rheumatology compiled guidelines for COVID-19 vaccination for people with rheumatic and autoimmune diseases.

The document published in Arthritis & Rheumatology contains 76 guidelines, 74 of which were agreed and two were not agreed. Of the agreed group, 16 statements had a “strong” consensus, while the rest were offered with a “moderate” consensus.

“The overriding principle is that this document should serve as the basis for a collaborative and informed discussion between rheumatology providers and their patients,” Cassandra Calabrese, DO, told Healio Rheumatology. “This is not the law.”

Some of the most important considerations involved continuing or suspending medication at the time of vaccination.

The group acknowledged that vaccination can be challenging in patients treated with rituximab (Rituxan, Genentech). They recommended that people receiving this drug should primarily use preventive measures after COVID-19, such as self-isolation. However, if the vaccine is given, it should be given approximately 4 weeks before the next scheduled rituximab cycle. After vaccination, if the patient’s disease activity permits, doctors should wait 2 to 4 weeks before giving the next dose of rituximab.

Methotrexate should be withheld for 1 week after each dose in patients with poorly controlled disease. No changes are required in patients with well-controlled disease.

Subcutaneous doses of abatacept should be maintained for the week before and the week after the first COVID-19 vaccine dose without interruption for the second dose.

No modifications are required for therapies ranging from sulfasalazine, leflunomide and mycophenolate mofetil (MMF) to azathioprine, oral cyclophosphamide, TNF inhibitors, interleukin-6R, IL-1, IL-17 and IL-12/23 inhibitors.

Healio Rheumatology sat down with one of the authors of the document. Cassandra Calabrese, DO, who serves as Associate in the Rheumatic and Immunological Diseases Division of the Infectious Diseases Division of the Cleveland Clinic Foundation. She gave an insight into the policy development process and the dangers of working under pressure in a room with minimal data.

Healio Rheumatology: Could you talk a bit about the process of developing this policy?

Calabrian: It was a big job. First and foremost, I have to give credit J.eff Curtis ((MD, MS, MPH from the University of Alabama at Birmingham) who did most of the work. It is always a challenge to put together a guidance document, but especially without data and in a room where there is such a great unmet need.

Cassandra Calabrese

The task was to review all previous information on all COVID-19 vaccines. Then we also had to look at other data on existing vaccines – including flu and pneumonia – and how they behave in these immune-mediated diseases and in the context of immunosuppression. There was a lot of homework, there was a lot of group opinions as we tried to understand all of this. We had to put our heads together and extrapolate from studies on pre-existing vaccines because we had no data on immunosuppressants for our patients.

Healio Rheumatology: What does this mean for the usefulness of these guidelines since you had to extrapolate from other vaccines?

Calabrian: The overriding principle is that this document should serve as the basis for a joint and informed discussion between rheumatology providers and their patients. This is not the law. For example, withholding medication won’t necessarily be the right choice for everyone. You need to consider the risks of COVID-19, which is significantly more complicated and can kill you much more often than influenza.

Healio Rheumatology: Can you delve deeper into the drug withholding recommendations and discuss the decision to withhold methotrexate for a week after vaccination?

Calabrian: This is where the idea of ​​extrapolation comes into play. Park and colleagues’ study of the flu vaccine showed that withholding methotrexate for 2 weeks can make the vaccine more effective. Since two of the COVID-19 vaccines use a two-dose regimen, we decided to split the difference and recommend withholding methotrexate for 1 week after each dose so that patients would not withhold methotrexate for a total of 4 weeks after receiving a COVID -19 mRNA vaccine. We have settled in the middle of the street to make it easier for patients.

Healio Rheumatology: How was the decision-making process for rituximab?

Calabrian: Of all the drugs we use, we know that rituximab has the greatest impact on the effectiveness of the vaccine. We know this from data on influenza and pneumococcal vaccines. The discussion was especially challenging given the two-dose schedule of the COVID mRNA vaccines and because so many patients on this drug have forms of vasculitis and other end-organ disease that they simply cannot miss or delay a dose. Because of this, it may be preferable for them to receive the Johnson & Johnson vaccine, which is a single dose. This allows doctors and patients to coordinate as well as possible.

Healio Rheumatology: How about talking about MMF?

Calabrian: This was also particularly difficult. We know there is a signal that it is making the vaccine less effective. However, patients who take MMF generally have severe organ disease, which is why we didn’t recommend messing with it. There is also no data showing that holding MMF after a vaccine increases the vaccine’s responsiveness. This is certainly cause for reflection, but there is currently a great deal of uncertainty about the benefits and the risk-benefit ratio of patients holding this drug in their hand after the COVID-19 vaccination.

Healio Rheumatology: Are patients enrolled in studies or registries for more definitive answers to these questions in order to keep track of the responses to the recommendations?

Calabrian: Many institutions are already investigating vaccine responses in patients with RMD who are receiving the COVID-19 vaccines. We’re doing a trial here at the Cleveland Clinic, and we’re doing a trial at Washington University in St. Louis. Jeff Curtis and Kevin Winthrop are doing trials, and another group is working on it at Johns Hopkins. We can expect some of this data to be released soon.

Healio Rheumatology: Are there recommendations / concerns for patients using over-the-counter NSAIDs about the effectiveness of the vaccine?

Calabrian: There was also a lot of discussion on this topic. There have been some older studies, mainly in infants, that suggested that prophylactic antipyretics could potentially make the vaccine less effective. Hence all of these questions come about Tylenol and NSAIDs. For this reason, it is recommended that you do not take these drugs preventively before receiving the vaccine to avoid side effects. However, if patients develop reactogenicity after vaccination – arm pain, fever, chills, etc. – that’s perfectly okay. Take acetaminophen or NSAIDs.

Healio Rheumatology: Is there a risk of activation of autoimmune diseases or immune manifestations after vaccination or after COVID-19 itself?

Calabrian: I am often asked this question. There is currently no solid data to support these trends. Of course, there have been case reports of unusual post-vaccination events, but these are anecdotes from one very big denominator. But I try to remind myself and my patients that vaccines have been around for a long time with no evidence that they cause flares of immune-mediated or rheumatic disease. We believe these vaccines are comparatively safe for our patients.

Healio Rheumatology: Can pregnant and breastfeeding women get the vaccine? Are there any risks?

Calabrian: We recommend that this group be vaccinated along with breastfeeding women. Of course, pregnant women were not included in the vaccine studies. However, our recommendation is supported by the CDC and the Society for Maternal Fetal Medicine, among others.

Healio Rheumatology: What is the procedure for patients who develop symptoms after vaccination? Should you wait for negative symptoms or continue with the second dose?

Calabrian: One reason many patients hesitate is because their friends and family developed symptoms after receiving the vaccine. I always explain to them that the immune system is up and producing antibodies. This can be accompanied by fever, chills, headache, and body aches, and there may be redness or swelling at the injection site. It seems that this happens more often after the second dose than after the first. I tell my patients, “If this happens to you, which it probably does, it’s a good thing.” I find it helpful to have these expectations.

Healio Rheumatology: Many guidelines today are “living” documents, which means that they should be updated as new data emerges and treatment paradigms develop. Is this the case with this policy?

Calabrian: Absolutely. We are already working on the next iteration.

For more informations:

Cassandra Calabrese, DO, can be reached at 9500 Euclid Ave., Desk A50, Cleveland, OH 44195; Email: calabrc@ccf.org.

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COVID-19 and rheumatology

COVID-19 and rheumatology

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