In patients with systemic lupus erythematosus (SLE), SARS-CoV-2 mRNA vaccination is safe for individuals who have medium-term disease activity or flares, according to findings published in Lupus Science & Medicine.
Researchers conducted a matched-pair study to evaluate the medium-term impact of vaccination on disease activity among patients with SLE using physicians’ objective assessment of disease activity, a validated questionnaire, and laboratory tests.
Study inclusion criteria were as follows: (1) patients in the Kyoto Lupus Cohort who had visited Kyoto University Hospital (Kyoto, Japan), at least twice between January 1, 2021, and December 1, 2021 whose disease activity was being measured and; (2) patients who fulfilled the 1997 American College of Rheumatology, 2012 Systemic Lupus, and International Collaborating Clinics classification criteria for SLE.
A total of 150 patients with SLE were included in the current study. All individuals who had received 2 doses of the SARS-CoV-2 mRNA vaccine were matched in a 1:1 ratio with unvaccinated patients, according to the first vaccination date.
All disease activities were evaluated prior to initial vaccination and following the second vaccination using the following parameters:
- SLE Disease Activity Index-200 (SLEDAI-2K), which was an objective parameter;
- The Japanese version of the SLE Symptom Checklist Questionnaire (SSC-J), which was a subjective parameter;
- The physician-visual analogue scale (Ph-VAS);
- The patient-VAS (Pt-VAS); and
- Laboratory data.
Flares were evaluated using the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI flare index. All disease activities up to 3 months prior to the index date were defined as baseline.
The primary study outcome was SLEDAI-2K scores at 30 days following the second vaccination. Secondary outcomes included the following:
- SLEDAI-2K scores at 60 days and 90 days after the second vaccination;
- SSC-J scores at 30 days, 60 days, and 90 days after the second vaccination;
- SELENA-SLEDAI flare index at 30 days, 60 days, and 90 days after the second vaccination;
- Ph-VAS and Pt-VAS scores at 30 days, 60 days, and 90 days after the second vaccination;
- SLEDAI-2K arthritis categories and SSC-J arthralgia at 30 days after the second vaccination;
- Serologic activities at 30 days after the second vaccination; and
- SLEDAI-2K and SSC-J scores at 30 days, 60 days, and 90 days after the second vaccination in individuals with high disease activity (ie, with an SLEDAI-2K score of >10).
Results of the study showed that SLEDAI-2K levels did not differ significantly among vaccinated and unvaccinated patients with SLE at 30 days, 60 days, and 90 days after the second vaccination (adjusted estimate, 30 days: -0.46, 95% CI, -1.48 to 0.56, P =.39;
adjusted estimate, 60 days: 0.38, 95% CI, -0.64 to 1.40, P =.47; adjusted estimate,
90 days: 0.40, 95% CI, -0.54 to 1.34, P =.41).
The results were similar with respect to SSC-J score (adjusted estimate, 30 days: 0.05, 95% CI, -1.46 to 1.56, P =.95; adjusted estimate, 60 days: -0.63, 95% CI, -2.08 to 0.82,
P =.40; adjusted estimate, 90 days: 0.27, 95% CI, -1.04 to 1.58, P =.69), as well as flare index (adjusted estimate, 30 days: 0.81, 95% CI, 0.36-1.85, P =.62; adjusted estimate, 60 days: 1.13, 95% CI, 0.50-2.54, P =.77; adjusted estimate, 90 days: 0.85, 95% CI, 0.32-2.26, P =.74).
Limitations of the study include the fact that Kyoto Lupus Cohort comprised many individuals who had already been vaccinated and the 30-day observation period.
The study authors conclude, “[W]e observed that medium-term disease activities or flares of SLE did not worsen with the SARS-CoV-2 vaccination, which supports its use in patients with SLE. Further studies are needed to evaluate the long-term impact of vaccines over several years [in patients with SLE].”
Yoshida T, Tsuji H, Onishi A, et al. Medium-term impact of the SARS-CoV-2 mRNA vaccine against disease activity in patients with systemic lupus erythematosus. Lupus Sci Med. 2022;9(1):e000727. doi:10.1136/lupus-2022-000727