4/30/2021
Pfizer COVID-19 Vaccine in those with Rheumatic Diseases Study
A new study released from Israel is reporting that a handful of Pfizer COVID-19 vaccine recipients with rheumatic conditions developed shingles after receiving the vaccine.
The observational study included 491 patients with immune mediated conditions (including rheumatoid arthritis, spondyloarthritis, connective tissue diseases, vasculitis, and myositis) and 99 control patients (who did not receive the vaccine). The study monitored patients 6-weeks post vaccination. Six (1.6%) of the patients from the vaccinated group reported an outbreak of shingles. None of the patients who developed shingles had spondyloarthritis. The cases included 4 women with rheumatoid arthritis, 1 woman with Sjogren’s syndrome, and 1 woman with connective tissue disease and antiphospholipid syndrome.
As the numbers are so low, researchers are unclear whether the vaccine triggered shingles, or if it was due to the patients having weakened immune systems. Further studies are needed on this potential increased risk.
It is important to note:
Johnson & Johnson Vaccine Update
The U.S. Centers for Disease Control and Prevention and the Food and Drug Administration have lifted the pause of the Johnson & Johnson vaccination that was in place since the beginning of this month and distribution can now resume.
The pause was based on 6 reported cases of patients developing a very rare condition called thrombosis with thrombocytopenia syndrome (a condition where abnormally low levels of blood platelets are observed), and blood clots. (As of April 21, 2021 there have been 15 confirmed cases of this kind of blood clots [all occurring in women] among the 7.9 million people who have received the J&J vaccine.) [3]
After careful review, officials from the Centers for Disease Control and Prevention and the Food and Drug Administration determined that the risks of COVID-19 outweigh the very small risk of developing blood clots, and that the J&J vaccine was found to be safe and effective in the vast majority of people. [2]
The FDA has updated the instructions for health care providers and information for patients, explaining the potential risk for this rare side effect. Those with thrombocytopenia syndrome should take extra caution with this specific vaccine, although side effects are still considered rare even in this population.
SpA Patients with IBD: Don’t Skip or Delay Second Dose of COVID-19 Vaccine
A new UK study found that in patients with inflammatory bowel disease (IBD), those taking infliximab (Remicade) had less immune response generated after a single dose of either the Pfizer-BioNTech vaccine or the AstraZeneca vaccine compared to the general population.[4]
This study was a follow-up to a large study conducted in 2020 by the same researchers which found that less than 50% of those with IBD taking infliximab who had been infected with COVID-19 mounted a protective immune response following COVID-19 infection.[5]
In the new study investigating vaccine efficacy, the researchers found that infliximab is associated with weaker immune response after the first dose of either the Pfizer or AstraZeneca vaccines, but a second dose of the vaccine led to antibody creation and protective immune response for most IBD patients taking infliximab.
“Delayed second dosing should be avoided in patients treated with infliximab,” the researchers concluded.[4]
Older age (greater than 60), Crohn’s disease (vs. ulcerative colitis or unclassified IBD), and smoking were associated with lower antibody concentrations. Non-white ethnicity was associated with higher antibody concentrations following a single dose of either vaccine.[6]
SAA reached out to rheumatologist James Rosenbaum, MD, a member of our Medical and Scientific Advisory Board, for context on what this might mean for those with spondyloarthritis taking a TNF inhibitor. Dr. Rosenbaum noted that Crohn’s and ulcerative colitis are diseases that could each potentially affect vaccine responses themselves, and those with more severe disease would be treated with TNF inhibitors (such as infliximab.) It could be that the combination of disease and infliximab treatment together lowered immune response in those patients. Therefore, data from IBD might not apply to patients with spondyloarthritis.
“We really need data specifically on spondyloarthritis and TNF inhibitor use,” Dr. Rosenbaum said.
References:
[1] Furer, V., Zisman, D., Kibari, A., Rimar, D., Paran, Y., & Elkayam, O. (2021). Herpes zoster following BNT162b2 mRNA Covid-19 vaccination in patients with autoimmune inflammatory rheumatic diseases: A case series. Rheumatology. doi:10.1093/rheumatology/keab345
[2] Simon, S., & Huang, P. (2021, April 24). Johnson & Johnson’s COVID-19 Vaccine Is Back In Use In The U.S. Retrieved from https://www.npr.org/2021/04/24/990447618/johnson-johnsons-covid-19-vaccine-is-back-in-use-in-the-u-s
[3] https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-04-23/03-COVID-Shimabukuro-508.pdf
[4] Kennedy, N., Simeng, L., Goodhand, J. et al. Gut. Infliximab is associated with attenuated immunogenicity to BNT162b2 and ChAdOx1 nCoV-19 SARS-CoV-2 vaccines. Infliximab is associated with attenuated immunogenicity to BNT162b2 and ChAdOx1 nCoV-19 SARS-CoV-2 vaccines in patients with IBD | Gut (bmj.com)
[5] Kennedy, N., Goodhand, J., Bewshea, C. et al. Gut. Anti-SARS-CoV-2 antibody responses are attenuated in patients with IBD treated with infliximab. https://gut.bmj.com/content/70/5/865
[6] IBD Patients: Don’t Skip That Second COVID Shot. Retrieved from https://www.medpagetoday.com/infectiousdisease/covid19vaccine/92313
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