The graph shows the percentage of patients with newly positive IgG COVID spike protein antibodies 2-4 weeks after their 2nd Pfizer mRNA vaccine shot

New Research: Antibody Levels After COVID Vaccine on Immunosuppressants

Some Immunosuppressant Drugs Cause Lower Antibody Levels after COVID Vaccine than do Other Drugs

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A large study was published in the Annals of Rheumatic Diseases showing antibody levels after COVID vaccine in patients on immunosuppressants. These drugs were taken by patients with systemic autoimmune diseases (such as rheumatoid arthritis, lupus, spondyloarthropathies, and vasculitis).

Since these drugs decrease immune system activity, it is not surprising that some of them appeared to lower the chances of someone responding to the COVID-19 vaccine. However, they varied a lot in how much they suppressed antibody responses. The investigators measured the most important antibody response called the SARS-CoV-2 spike S1/S2 proteins. Antibody levels were measured two to four weeks after the second vaccine dose of the Pfizer mRNA vaccine.

Remember that infections are in the top 3 causes of death in systemic lupus. It is important to get all vaccines as per “The Lupus Secrets.”

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The Pfizer COVID-19 RNA virus vaccine booster shot was studied in immunosuppressed patients: could a COVID booster vaccine for lupus patients be beneficial?

Immunosuppressed Patients Respond to Booster Shots: Hope for a COVID Booster Vaccine for Lupus and Other Autoimmune Disease Patients? [Updated 8/12/21]

 

Will a COVID Booster Vaccine for Lupus Patients Increase Response Rates?

We do not know, yet. However, the August 12, 2021 edition of the New England Journal of Medicine reported significant responses in immunosuppressed organ transplant patients. This provides hope that a COVID booster vaccine for lupus patients, and other autoimmune disease patients, who are immunosuppressed may also respond well.

The Problem: Early reports from COVID vaccine studies suggest that patients on immunosuppressants have lower response rates. The Johns Hopkins Hospital study has already suggested that patients on mycophenolate mofetil, rituximab, and steroids (when combined with another immunosuppressants) have high rates of nonresponse.

This leaves immunosuppressed patients, such as lupus patients, unsure of how well they responded to their COVID vaccines and they must remain vigilant with social distancing, mask wearing, etc. Unfortunately, the usual COVID antibody tests available to most doctors do not test for antibodies to the SARS-Cov-2 spike protein, which is essential to test for vaccine responses, so few patients know if they responded or not.

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Moderna and Pfizer Vaccines: How Effective is One COVID shot?

CDC Study answers this question

COVID-19 vaccine for lupus patients: One COVID shot effective?
Is just one COVID shot effective?

Please get your COVID-19 vaccine! We all would like life to go back to normal. The unvaccinated will be our major obstacle in reaching that goal. (and yes, that is my, and many others, unapologetic opinion)
QUESTION: How effective is just one COVID Shot if you did not get the second?
ANSWER: 82%

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“Do I need a mask after vaccination?” Now here is the truth

Male lupus patient with a mask

Please continue to protect yourself as you did before if you have lupus or another systemic autoimmune disease and are vaccinated against COVID-19

QUESTION OF THE DAY:

Dr. T. I have lupus. I got both of my Moderna COVID vaccines. Can I take off my mask like the CDC recommends?

ANSWER:

I am so glad you asked this question!

NO! (generally, see exceptions below)

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COVID Vaccine and Lupus: Join in a Research Study Now to See if it Worked

How the COVID Vaccine and Lupus Interact is Important to Figure Out: Consider Joining this NIH Research Study

The NIH is studying how the COVID vaccine and lupus interact. Please consider participating in this important research.

You can also click on this link to read more about the study and what in entails.

We also need healthy volunteers and patients who have other autoimmune diseases as well. Share this information with your friends, family, and loved ones. You must live close enough to the NIH in Bethesda, Maryland in order to participate as you need to travel there for the study.

Note that they will reimburse you for your participation. You will also find out what your SARS spike protein antibody result is (how well you responded to the vaccine).

Join the NIH study to learn about the COVID vaccine and lupus
Join the NIH study to learn about the COVID vaccine and lupus

Author

Don Thomas, MD, author of “The Lupus Encyclopedia” and “The Lupus Secrets

Provocative Advice: Lupus Patients need COVID Vaccines [2021]

Evaluation and recommendations by noted lupus experts: Lupus patients need COVID vaccines

Newspaper on fire about lupus patients and COVID-19 vaccines

Hot off the press from Lupus Science & Medicine
revised 6/13/21: Added mycophenolate, NSAIDs, and Tylenol to the list of drugs that should be held for vaccines

SARS-CoV-2 vaccines in patients with SLE
Link and reference below to the research studiesSummary of some main points (but I encourage you to read the article):

– This article is written by some of the world’s experts in lupus
– Dr. Joan Merrill, Dr. Anca Askanase, Dr. Wei Tang, and Dr. Leila Khalili

“… the risks of not receiving the vaccine are far greater at the present time.”

 The lupus experts also state,
“Patients with autoimmune rheumatic diseases should receive the COVID-19 vaccines and should be prioritized before the general population.”
– Other vaccines have been shown to be safe in lupus patients.
– They recommend temporarily stopping or changing the dosing schedule on some drugs, such as cyclophosphamide, methotrexate, mycophenolate (CellCept, Myfortic), rituximab (Rituxan), abatacept (Orencia), JAK inhibitors (Xeljanz, Olumiant, Rinvoq), NSAIDs, and Tylenol.

They recommend following the recommendations of the American College of Rheumatology (click on link)

– They recommend that doctors may want to consider monitoring antibody levels after the vaccine.
– Since we do not know how well lupus patients, patients with other autoimmune diseases, and immunosuppressed patients will respond to the vaccines, they should continue strict social distancing.
– The above recommendations are made without research regarding specifically these RNA vaccines. However, after evaluating all the data, The American College of Rheumatology and these lupus experts recommend vaccination in patients with autoimmune rheumatic diseases. 

What are the risks of COVID-19 infection when lupus patients get infected?

– They are not at higher risk for infection from the novel SARS-CoV-2 Coronavirus.
– However, they are at higher risk of hospitalization than the general population.
– COVID-19 infection may even increase lupus flares.

Please get your vaccine.  I got mine and I recommend it to all my patients.
This is not a substitute for your doctor’s advice. Please check with your physician first. 

Author

Don Thomas, MD: author of “The Lupus Encyclopedia” and “The Lupus Secrets

References:
Tang W, Askanase AD, Khalili L, et al. SARS-CoV-2 vaccines in patients with SLE. Lupus Science & Medicine 2021;8:e000479. doi: 10.1136/lupus-2021-000479

​American College of Rheumatology (ACR) COVID-19 Vaccine Clinical Guidance Task Force. COVID-19 vaccine clinical guidance summary for patients with rheumatic and musculoskeletal diseases, 2021www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf. Available: https:///www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdfGoogle Scholar

Allergies and Itching after COVID vaccine? Announcing Research Here

Results from 64,900 vaccines: How often are allergies and itching after COVID vaccine?

Urticaria hives allergic reaction in systemic lupus erythematosus SLE

Hives (urticaria) photo credit: James Heilman, MD, Wikipedia, “Hives”

​Journal of the American Medical Association Research Study: March 2021

(reference and link to the study are at the bottom of the page)

Easy-to-Read Results Summary:

– Researchers did this study based on the fact that many are nervous to get the vaccines due to having allergies themselves and all the media-hype regarding allergic reactions causes some people to avoid the vaccines.

So… what is the truth?
– Study was done at Massachusetts General Brigham (the Original Harvard hospital!)
​- Studied what happened the 3 days after the first vaccine (the time of highest chances for allergy symptoms)
– 40% got Pfizer, 60% Moderna

Mild allergic reactions
– 1 out of every 50 vaccines caused mild allergic reactions (itch, hives, swelling)
– Moderna (2.2% of the shots caused mild allergy) vs Pfizer (2% of the shots): not much difference
– 98% of all people had no allergic reactions at all (that is a nice, safe number)

Significant allergic reactions (anaphylaxis)
– Occurred in 1 out of every 3700 Pfizer shots (i.e. .027% of the shots)
– Occurred in 1 out of every 4300 Moderna shots (i.e. .023% of the shots)
– In total, there were 5 anaphylactic reactions per 20,000 vaccines (that is a really safe number compared to many other drugs)

Moderna and Pfizer COVID-19 mRNA vaccines for lupus patients

Pfizer and Moderna were pretty similar in how often they caused allergic reactions: very low numbers
​Timing for significant allergic reaction (anaphylaxis)
– An average of 17 minutes after the shot
– The range was from immediately after the shot up to 2 hours later at the latest
Anaphylaxis severity
– 7 of the 16 patients had mild skin reactions
– 9 of the 16 patients had “measurable” but not life-threatening reactions
– 3 did not seek any medical attention
– 1 went to the ICU and recovered
– 9 out of 16 patients needed an epinephrine shot (EpiPen) and all recovered
– There were no severe anaphylactic reactions (having shock or requiring intubation)

Who was most likely to get anaphylaxis?
– Out of 16 patients in total, 5 (31%) had a history of anaphylaxis
– 10 out of 16 (61%) had a history of allergies (probably not significantly different than the usual population)

“I have a history of anaphylaxis, what is my risk?”
– Assuming there were 4000 individuals with severe food or drug allergies in this group (this is the expected #)
– Only 5 out of 4000 people with a history of anaphylaxis get an anaphylactic reaction (1 out of every 800)
– Knowing that this is a group of people who are used to planning for anaphylaxis and should have an EpiPen, and who know they have to use it when exposed to a known allergen (like me when I accidentally eat shrimp), that is an incredibly low number.
– I took my EpiPen with me when I got mine. No problems! Only 1 out of every 800 times would someone need to use it

Bottom lines
– Since the results were reported by the employees themselves, and not confirmed by doctors, we cannot ensure that these were truly anaphylactic reactions (people do tend to overestimate such responses = my opinion)
– The researchers, Harvard-famous allergy experts, stated, “… the overall risk of anaphylaxis to an mRNA COVID-19 vaccine remains extremely low”

If you have had an anaphylactic reaction in the past (like I have), I recommend:
– Just take your EpiPen and wait a while after your shot if you have had anaphylaxis before. However, don’t sweat it.

You have a higher chance of getting into a car accident on the way to the shot than you do of getting an anaphylactic reaction

Did you get your vaccine? How did you do?
COMMENT BY CLICKING ON “Comments” ABOVE

​​

Author

Don Thomas, MD author of “The Lupus Encyclopedia” and “The Lupus Secrets

More COVID-19 deaths in rheumatic diseases: Latest study results

Research Shows More COVID-19 Deaths in Rheumatic Diseases: 10.5% of lupus and rheumatic disease patients died

Much higher rate than infected people without rheumatic disease

People with lupus and rheumatic diseases are at risk…
​What is the bottom line? What should you do?

Lupus patient in ICU hospital with COVID-19

Lupus patients and other rheumatic disease patients shown to have higher death rates per a recent large research study
Results of a world-wide study of 3729 rheumatic disease patients and COVID-19

– Earlier reports in early 2020 suggested that lupus patients may not have been at higher risk of COVID-19 complications. This report (referenced below) questions this.
– This report looked at 3729 patient. It included patients with systemic lupus, but it did not specify how many lupus patients nor how they did compared to other patients. However, it looked at the risk for death in patients receiving various drugs, patients with certain comorbidities, disease activity risks, sex, and countries of residence. 

BAD NEWS FOR LUPUS PATIENTS

FIRST THE BAD NEWS
BAD FINDINGS FROM THE STUDY

Rheumatic disease patients at highest risk for death after infected with COVID-19 (listed in order)
(these results will be given in odds ratios.
To figure out how to word this (odds ratio findings):
Subtract 1 from the number, move the decimal point 2 to the right, then say “___ greater odds of dying from COVID-19.”
For example, for an 80 year old with a rheumatic disease, they have a 518% greater odds of dying from COVID-19. A man with a rheumatic disease has a 68% greater odds of dying from COVID-19 infection than a woman does.”)

     – Age >75 years old, OR 6.18
– Rituximab (Rituxan) treatment, OR 4.04
– Sulfasalazine treatment, OR 3.60 (see commentary below)
– Age 66-75, OR 3.00
– Immunosuppressant treatments listed below, OR 2.22
(tacrolimus, mycophenolate, cyclosporine, cyclophosphamide, azathioprine)
– Not on a disease modifying agent immunosuppressant, OR 2.11 (compared to patients on methotrexate)
– Moderate to high disease activity, OR 1.87 (compared to patients in remission and low disease activity)
– High blood pressure plus heart disease, history of stroke, or hardening of the arteries, OR 1.89
– Prednisone more than 10 mg daily (or more than 8 mg methylprednisolone), OR 1.69 (compared to no steroids)
– Chronic lung disease (like COPD, asthma, interstitial lung disease, pulmonary fibrosis), OR 1.68

     – Men, OR 1.46 (compared to women)

United Kingdom had the highest death rate followed by Germany

________________________________________________________________

Commentary about sulfasalazine (SSZ): Do not take away from this that SSZ increases deaths from COVID-19. SSZ is often prescribed by rheumatologists to sicker patients who are at higher risk for infections in the first place. For example, there were more smokers in the SSZ group. SSZ does not suppress the immune system. Also, SSZ is a weak drug (most often used to treat rheumatoid arthritis). Patients on just SSZ are less likely to be in remission or low disease activity (and therefore at higher risk of death from a COVID-19 infection). I suspect that this is an “association” and not a “causality.”

Doctor giving good news to lupus patients about COVID-19

NOW, THE GOOD NEWS
POSITIVE FINDINGS FROM THE STUDY

– Hydroxychloroquine (Plaquenil) and belimumab (Benlysta) treatments were not associated with higher death
– TNF inhibitor, leflunomide, abatacept (Orencia), tocilizumab treatments were not associated with higher death
– The United States had the lowest death rate of all countries in the study
– After the US, countries (in order) of lowest death rates = Germany, then France, then Spain

Strategies to protect against COVID-19 when you have lupus

The Bottom Line: What you should do
BOTTOM LINE AND WHAT YOU SHOULD DO TO PROTECT YOURSELF:

It is most important to keep your lupus under control. Do NOT stop any medications.
Abide by all nondrug ways to lower lupus disease activity so you don’t need as many steroids.
– Work hard with your doctor to control your disease better so you can lower your steroid dose. 
– Get vaccinated against COVID-19!
– Ask everyone around you to get vaccinated (the cocoon strategy)
– Even after vaccination, abide by all isolation, separation, social distancing strategies

ReferenceStrangfeld A, Schäfer M, Gianfrancesco MA, et al. Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance physician-reported registry. Annals of the Rheumatic Diseases Published Online First: 27 January 2021. doi: 10.1136/annrheumdis-2020-219498

Author

Don Thomas, MD, author of “The Lupus Encyclopedia” and “The Lupus Secrets

Immunosuppressants and COVID Vaccine: Fundamentals in the new guidelines

Immunosuppressants and COVID vaccine: which you should stop and not stop

Immunosuppressants and COVID vaccine ACR guidelines and recommendations
Immunosuppressants and COVID vaccine ACR guidelines and recommendations

American College of Rheumatology Clinical Guidance Summary UPDATED AUG 2021
The above come from the ACR published guidelines. You can find the entire article here
Revised with new drugs to stop for vaccines 9/12/21. However, they were again updated in August 2021. The above photo

Bottom Line:
Now it is recommended to stop immunosuppressants after the booster shot. 
These recommendations are quite puzzling to me. Note how they recommend stopping immunosuppressants for two weeks after getting the COVID-19 booster shot. However, they state that immunosuppressants such as azathioprine do not need to be stopped for the initial shots. The committee that formed these has a meeting after this August publication and I hope that they change the recommendations to be more uniform. After seeing these recommendations, I am recommending that my patients stop their immunosuppressants for all vaccines to help them work better (if they are not at high risk of flaring).

How about having a sulfa drug allergy and COVID vaccine? I hope the reader is aware that everyone with systemic lupus should avoid sulfa (sulfonamide) drugs. They can flare lupus. However, it is completely safe to get your COVID-19 vaccines.

Please check with your doctor and ask before implementing these. Your medical condition may dictate otherwise

Resource: American College of Rheumatology ACR COVID-19 Vaccine Clinical Guidance Task Force (2/8/21). COVID-19 Vaccine Clinical Guidance Summary for Patients with Rheumatic and Musculoskeletal Diseases. Retrieved on 2/25/21 from ​https:///www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf

Author

Don Thomas, MD, author of “The Lupus Encyclopedia” and “The Lupus Secrets

Dr. Donald Thomas gets his extra COVID vaccines: It was easy!

UPDATED September 2021: I cannot wait to get my extra COVID vaccines … specifically my 3rd booster shot!

1/22/21 was a historical day for me! I got my 2nd Moderna vaccine!
​PLEASE… everyone… get yours as soon as you can!

Extra COVID vaccines are important for us to prevent infection
Extra COVID vaccines are important for us to prevent infection

The pandemic is at an all-time high. Get your extra COVID vaccines! Lupus patients on immunosuppressants should get their 3rd shot of Moderna or Pfizer now (September 2021).
Be proactive, educate yourself if you are uncertain about the vaccine (but read reputable sites and not the crazy anti-vaccine sites).

I know I’ll make enemies with that comment, but I don’t care. Speaking the truth and hopefully getting someone to save their life is more important than trying to appease those who disagree. As Dr. Anthony Fauci said on the news yesterday, speaking the truth is “Liberating” and “Let the science speak!”

And to Aldene, my vaccinator at United Medical Center, Washington DC, in the video … thank you for saving my life with this God-send!

I updated this post in September 2021. I am recommending the 3rd Moderna and Pfizer vaccines to all my patients who are on immunosuppressant drugs and to all my systemic lupus patients. Supposedly, I should be able to get mine on September 20, 2021, and I cannot wait! I have seen too much death and lingering effects from COVID-19. Dealing with the family members and loved ones who are devastated by the loss of loved ones is difficult. I wish all the vaccine nay-sayers had to care for COVID-19 patients and their families and see the devastation up close. It does not compare to the flu.

Here is my previous post about the vaccine and lupus patients:

Click here to read about lupus patients and the COVID vaccines

Click here to learn about how the COVID vaccine works

Don’t forget, getting vaccines to prevent deadly infections is part of the Lupus Secrets!

Let this be our motto:

“Fear COVID, Embrace the vaccine!”

Author

Don Thomas, MD, author of “The Lupus Encyclopedia” and “The Lupus Secrets