Dear Friends and Patients,
I hope this message finds you well. Please excuse the group nature of this message, but I did want to reach out with the latest update about COVID-19, and vaccinations. If you want to skip right to the booster info, scroll down to #5 below.
Some of you may have already seen my Twitter messages over the last weeks and months about our pandemic. Below I itemize updates for you about this unprecedented time in our lives.
1) Patients with IBD (Crohn’s disease and ulcerative colitis, ostomies and J pouches) are NOT at increased risk of getting infected with SARS-CoV-2 or developing COVID-19.
They are not at decreased risk either, meaning if you are over 65 years old, obese, have high blood pressure or diabetes or other co-morbidities, your risk of having bad outcomes from COVID-19 is the same as the general population.
Having active IBD (not being in remission) has been associated with worse outcomes in several studies- it is important to have the disease managed.
2) The medications for IBD are not associated with increased risk of getting SARS-CoV-2 or developing COVID or having bad outcomes from COVID. There are some specific details to know:
A) high dose steroids (prednisone of greater than or equal to 20 mg/day for more than 4 weeks) are associated with worse outcomes from COVID. Our goal in IBD management has been to avoid steroids anyway of course, but this is particularly important. Fortunately, a minority of our patients are on this dose of prednisone.
B) the anti-cytokine therapies (anti-TNF (Remicade, Renflexis, Inflectra, Humira, Cimzia, Simponi), anti-IL12/23 (Stelara), tofacitinib (Xeljanz)) therapies appear in multiple updates to be safe and if you develop COVID, they are associated with better outcomes (statistically this means less risk of bad outcomes) than folks who are not on these therapies.
C) Vedolizumab (Entyvio) is not associated with any risk or benefit of COVID- it is very safe, and as those who are on it know, works only on the gut.
D) 5-ASA therapies (mesalamine, Lialda, Pentasa, Asacol, Delzicol, Colazal, sulfasalazine, Canasa, Rowasa) are safe. In the early days, one study suggested that they might be associated with risks, but this has washed out completely with the larger analysis and not seen in any other studies that looked at it.
E) The budesonide steroids (Entocort, Uceris) are safe.
3) The authorized vaccines against SARS-CoV-2 are recommended for all IBD patients. There is no timing issue in regards of getting the vaccine and dosing the IBD therapies. The vaccines do not cause flares in IBD (this is now confirmed in multiple studies, but also has never been seen with any vaccines in all the years and prior studies before COVID).
A) Given a choice, my recommendation for you is the two dose mRNA vaccines by Pfizer or Moderna.
B) The one dose J&J/Janssen vaccine is just fine. It just wasn’t quite as effective in non-IBD folks who were studied. In the IBD population, the J&J recipients had slightly lower antibody titers compared with the mRNA vaccines.
4) We believe that the vaccines are working the same as the general population in the vast majority of our patients with IBD based on good data from three US studies and other evaluations around the world. The US studies are linked below.
How do we know the vaccination is working? There are several ways to know that the vaccine is working. First, the clinical trials that led to their authorization (and soon full approval) demonstrated an extremely high seroconversion rate – meaning triggering the body to make antibodies against the coronavirus. We measure active immunity in three ways: A) titers of the anti-spike protein IgG; B) cellular immunity related to how our immune cells react to make more antibodies; C) (and most important) whether people who are vaccinated get infected, sick, hospitalized, or die.
The current vaccines in our IBD patients are as effective in them by measures of titers and so far, clinical outcomes of health as in the general population. Measuring cellular immunity is harder to do, is research based (see our study below!), and arguably much more important than the antibody measures. In other words, you can have low levels of the antibody against SARS-CoV-2 but still have a fully protective immunity which would kick in if you were exposed to the virus.
Bottom line: the vaccines are working.
5) What is a booster and should you get it? A booster is another dose of vaccine to stimulate a robust immune response or memory immune response so it can act when you need it. The second dose of the Pfizer and Moderna vaccines is a booster dose!
If you’ve had COVID, the FIRST dose of the Pfizer or Moderna vaccines or the single dose of J&J is a booster!
The discussion most recently is whether people need a third dose (Pfizer/Moderna) or second dose (J&J). The FDA has authorized a third dose of the Pfizer/Moderna but has not authorized a second dose of the J&J vaccine. The Advisory Committee on Immunization Practices (ACIP) of the CDC have further suggested that boosters be considered in patients who are “immunocompromised”.
The arguments for a booster:
A) immune titers may be dropping and were seen to be lower in some patients with organ transplants and immune suppressed people (not IBD!)
B) a study in the UK (Clarity IBD) shows that immune titers are falling in some patients over time
C) the booster, like the vaccines themselves, is safe, so what’s the harm?
The arguments against a booster:
A) the message that IBD patients are immune compromised or immune suppressed is wrong – You are not, unless you are on high dose steroids or our rare medications like cyclosporine or tacrolimus
B) falling titers does NOT mean lack of immunity (see #4 above)
C) there are no data to say that IBD patients are having more breakthrough infections or worse problems from COVID than the other people in society
My recommendations regarding the booster:
A) if you had the J&J vaccine (the one dose vaccine) or only got one of your Pfizer/Moderna shots, regardless of your therapies, you should get a booster of one of the mRNA vaccines (this is not based on data to mix and match the vaccines, but is reasonable).
B) if you are on cyclosporine/tacrolimus or prednisone higher than 20 mg/d, you should get a booster. And you should have a plan to be off these therapies going forward
C) If you are on anti-TNF therapy (Remicade, Renflexis, Inflectra, Humira, Cimzia, Simponi), the CDC Advisory Council for Immunization Practices suggests that you consider a booster, but they have only recommended this for the people who have had the two dose vaccines (Pfizer/Moderna) and that they receive the same vaccine for the booster as received for the original vaccination.
I am not opposed to doing this for you, especially if you are on combination of an anti-TNF with methotexate or azathioprine/6-MP. But the data are not clear, so do not be alarmed or overly worried. My great team will help you sort this out as we learn more.
How can you get a booster? (or a vaccine if you haven’t gotten one)
The University of Chicago Medicine is pivoting to provide these through our super efficient vaccine clinic and I am informed this will occur early next week. We will update you then.
It is possible that with proof of prior vaccination, you will be able to get a booster from Walgreens (or other pharmacies). I do not have more details about that right now.
6) PLEASE JOIN OUR STUDY OF COVID VACCINATION IN IBD. This study is specifically looking at what all this is about- durability of immunity with the vaccines. If you are interested and available for just two blood draws, please email: email@example.com
For more information, you can go to my website, and under Rubin’s Reflections, you will find my recent Tweetorials about this: https://rubinlab.uchicago.edu/blog/
You can also see and listen to my lecture from July 21 discussing delta variant and other related topics at: https://bcove.video/3l6clDX
Other ongoing clinical trials on COVID Vaccine and IBD:
ICARUS IBD: https://www.icarusibd.org/
PREVENT COVID: https://www.ibdpartners.org/preventcovid
CORALE-V (Vaccine) IBD: https://www.corale-study.org/participate
Publications of interest:
Effect of IBD medications on COVID-19 outcomes: results from an international registry https://pubmed.ncbi.nlm.nih.gov/33082265/
Corticosteroids, But Not TNF Antagonists, Are Associated With Adverse COVID-19 Outcomes in Patients With Inflammatory Bowel Diseases: Results From an International Registry https://pubmed.ncbi.nlm.nih.gov/32425234/
Anti-SARS-CoV-2 antibody responses are attenuated in patients with IBD treated with infliximab https://pubmed.ncbi.nlm.nih.gov/33753421/
Wishing everyone good health and safety,
David Rubin, MD