Autoimmune Disorder Lupus Flare Rate 'Higher in [COVID-19] Vaccinated Patients Than Unvaccinated Controls': Journal 'Immunological Medicine'

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect various parts of the body.

A study published Monday in Immunological Medicine found disease flares in patients with systemic lupus erythematosus (SLE), a chronic autoimmune disease that can affect various parts of the body, were higher among COVID-19 vaccinated individuals than unvaccinated ones.

Lupus is referenced more than two dozen times in Pfizer Inc.’s COVID vaccine safety data, meaning the company was aware of the risk before the jab rollout.

The new study, supported by the Japan Agency for Medical Research and Development, aimed to clarify the effectiveness and safety of SARS-CoV-2 mRNA vaccination in patients with SLE.

The researchers enrolled 90 SLE patients who received two vaccine doses (Pfizer’s BNT162b2 or Moderna Inc.’s mRNA-1273) recruited between June and October 2021.

The control group comprised 90 unvaccinated patients with systemic lupus erythematosus (SLE). These patients were selected from those in the maintenance phase, at least 6 months after induction therapy. They attended medical appointments between June and October 2020, during the same season as the vaccinated group a year earlier.

Adverse reactions to the vaccine occurred in 88.9% of vaccinated patients within three days of a second vaccination, including both local and systemic reactions.

“Sixty-four (88.9%) patients experienced adverse reactions within 3 d (mean ± SD: 0.7 ± 0.7 d) after the second dose of the vaccine (Supplementary Table 2), including local reactions in 73.6% and systemic reactions in 79.2%,” the study reads.

Moreover, 69.2% of vaccinated SLE patients experiencing flares required additional treatments, including increased glucocorticoids, immune suppressants, and biologics in eight cases.

One patient received a topical intervention with a vasodilator infusion, a medical procedure where vasodilator drugs are administered intravenously.

“Among the patients with flares, nine (69.2%) began additional treatments, including an increase and addition of glucocorticoids, immune suppressants, and biologics in eight and topical intervention with an infusion of vasodilator in one,” the study says.

Some of these patients terminated additional vaccinations.

Some experienced a severe flare of nephritis (inflammation of the kidneys), worsening of proteinuria (an unusually high amount of protein in the urine), haematuria (blood in the urine), and leukocytopenia (low white blood cell count).

On the other hand, in the unvaccinated control group, only “four (4.4%) patients experienced a flare and one (1.1%) patient experienced flares and a severe flare.”

The authors confirm the “flare rate was higher in vaccinated patients than unvaccinated controls.”

“This study indicated that the disease activity modestly but significantly increased after the second dose of the SARS-CoV-2 mRNA vaccine in patients with SLE,” they state.

Patients with SLE therefore “need to consider the possibility of underlying disease flares when receiving the vaccine.”

For patients with SLE considering mRNA vaccination, “careful follow-up is required if there is residual disease activity of critical organ damage.”

The study authors conclude by emphasizing the “risk” COVID vaccination poses to SLE patients: “[R]esidual disease activity and serological activity before vaccine administration can be risk factors for flares after vaccination. Careful follow-up is required after vaccine administration in patients susceptible to residual disease activity, particularly in critical organs.”

The study was approved by Keio University School of Medicine’s ethics committee and was conducted under the Declaration of Helsinki and Good Clinical Practice.

All participants provided written informed consent, the study notes.