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.
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)
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).
Evaluation and recommendations by noted lupus experts: Lupus patients need COVID 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 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.
Results from 64,900 vaccines: How often are allergies and itching after COVID vaccine?
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)
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 latestAnaphylaxis 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
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 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.
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.”
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
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 activityso 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
Lupus and Bactrim: List sulfa antibiotics (like Bactrim) in your allergy list if you have lupus
Lupus patients are more likely to have allergies to antibiotics (plus, lupus and Bactrim are a bad combination)
While lupus and Bactrim are a bad combination, many systemic lupus erythematosus (SLE) patients also report numerous drug allergies. However, studies do not show an increased amount of allergies than non-lupus patients (other than antibiotics).
Lupus and antibiotics treatment:
SLE patients have higher rates of allergies and intolerances to penicillins, cephalosporins, sulfonamides, and the antibiotic erythromycin. The most important antibiotic intolerance is that of sulfonamide (often called “sulfa”) antibiotics. This most commonly refers to the antibiotic trimethoprim-sulfamethoxazole (Bactrim and Septra).
Sulfur versus sulfonamides versus other sulfa drugs and lupus
The element called sulfur exists in all of us, so none of us are allergic to sulfur. Many different molecules contain sulfur to include sulfates, sulfites, and sulfonamides. Lupus patients have an increased risk of antibiotic sulfonamides (specifically Bactrim, trimethoprim-sulfamethoxazole) flaring their lupus. Sulfonamide antibiotics are very different than sulfates, sulfites, and others. These are safe for lupus patients to take. There are some non-antibiotic sulfonamides (furosemide, hydrochlorothiazide, acetazolamide, sulfonylureas used for diabetes, and celecoxib). However, these do not appear to increase lupus flares and are safe for lupus patients to take (unless they just happen to have an allergy to that particular drug).
Sulfa antibiotics can cause significant lupus flares (list is as an allergy!)
Around one-third of lupus (SLE) patients have reactions to Bactrim, and it can cause lupus flares as well. These reactions are more common in Caucasians, those with low lymphocyte counts (lymphopenia), and anti-SSA positive patients. Still, they can occur in any lupus patient. They especially can cause flares of fever, sun-sensitive rashes, and low blood cell counts. Sometimes these flares can be severe. There are so many other antibiotics now available that sulfonamide antibiotics can usually be avoided in SLE patients.
I, and most lupus experts, recommend that all lupus patients always carry an up-to-date medication list (similar to the first image, above) and that it also includes an allergy list that includes “sulfa antibiotics.” This can protect you if you ever get sick and end up in the emergency room where it can be hard to remember to tell your entire medical history. While lupus patients are more likely to be intolerant of the antibiotics penicillin, cephalosporins, and erythromycin, these do not typically cause lupus flares, and the vast majority of SLE patients tolerate them well. Therefore, they do not need to be avoided in lupus patients who are not allergic to them.
Patient Question: “Can you take amoxicillin if you have lupus?”
“Yes!” The good news is that we have dozens of other safe antibiotics that lupus patients can take. Lupus and antibiotics treatment should not be complicated. As long as you list “sulfa antibiotics” on your drug intolerance list and show it to doctors, they can come up with safe alternatives. Although lupus and Bactrim are a bad idea, lupus patients can take many other medications safely.
A long time ago, I realized that most patients and most physicians were not familiar with all the important things that lupus patients can do themselves that improve their health and lives. So, I made a list and called them “The Lupus Secrets” that addresses these important things. I called them “The Lupus Secrets” not because I wanted them to be a secret, but because they appeared to be a secret since most people (and doctors) did not know about all of them.
I regularly update this list as our knowledge of lupus improves. The Lupus Secrets list is given to all my patients, and encourage them to follow it. Most of my SLE patients are in remission or low disease activity, and I care for many people with SLE. My patients’ utilization of “The Lupus Secrets” is an important tool in achieving this goal. Please download a copy. Each recommendation has medical literature to back it up (check out the references below for this “Secret”), though each varies in the strength of evidence.
10 Reasons Not to Get a Flu Shot: The Flu Shot is a Life-Saver for Lupus Patients, Other Autoimmune Disease Patients, and … well… Everyone!
It’s that time of year again. Time to get your flu shot! I already got mine, have you gotten yours. Here are some important facts about the flu shot, infections, and systemic lupus erythematosus (SLE):
10 Reasons Not to Get a Flu Shot. (Or should you go ahead and get one)?
3) Don’t get the flu shot if you are isolated and will never come into contact with another human for the next year: Fortunately, with the public practicing social distancing, hand-washing, mask-wearing, etc. due to COVID-19, hopefully we’ll see less influenza. However, we still need everyone to get the flu shot. Getting COVID-19 plus influenza would be deadly.
8) Don’t get the flu shot if your flu shot is made from eggs: You should still get the flu shot, even if you have an egg allergy. Most of today’s flu shots are safe for egg allergy sufferers. Ask your health care provider to ensure you receive the correct, safe vaccine.
9) Don’t get the flu shot if your flu shot contains live virus: However, flu shots do not contain live vaccine. You can get the flu shot on any of your immunosuppressant medications. However, prednisone greater than 40 mg a day will decrease your response to the vaccine. If you are on Rituxan, try to get it 4 weeks before your Rituxan dose.
10) Don’t get the flu shot if you don’t care about hurting or infecting those around you: If you do not believe in getting the flu shot, at least get it to protect the ones you love. This is one of the main reasons why we health care professionals get it. We want to lower the chances of spreading it to our patients.
Please get your flu shot. The life you save may be your own.