Background/Purpose: The best strategy for the prevention of SARS-CoV-2 infection is vaccination. Both mRNA and vector vaccines have demonstrated a satisfactory safety profile in general population but information about their utility in patients with immune-mediated rheumatic diseases (IMRD) is scarce. Both mRNA and viral vector vaccines have demonstrated a satisfactory safety profile in general population but information about their utility in patients with immune-mediated rheumatic diseases (IMRD) is scarce.

Methods: Observational prospective study conducted in a tertiary University center in Catalonia, Spain in patients with IMRD vaccinated between January to May 2021. Patient’s information was obtained during clinical visits and follow-up was made by telephonic interviews. Vaccination was confirmed using the electronic clinical records of the local health system. We considered as fully vaccinated those patients with 2 doses of mRNA vaccines and 1 for vector or patients with previous SARS-CoV-2 infection who received 1 dose. Descriptive analysis was done. This study was approved by our hospital’s Ethical Committee.

Results: At the end of May, 285 patients with IMRD were registered. Most of the patients were female 193 (67%) with a mean age of 53.2 ± 14.5 years (range 18-92). Main IMRD were rheumatoid arthritis in 126 (42%), followed by spondyloarthropathies in 61 (21%), psoriatic arthritis in 46 (16%) and systemic lupus erythematosus in 21 (7.4%) among others (See Table).

Eight percent of patients had previous SARS-CoV-2 infection before vaccination. At the moment of the first dose, 73% of patients were in remission, 17% with low disease activity, 3% with moderate activity and only 2% with high disease activity.

A total of 160 (57%) patients were under DMARD treatment and 65 (22%) with glucocorticoids (mean dose 6.0 ± 4.4 mg/d), 218 (76%) were under targeted therapies (207 bDMARD and 11 with JAK inhibitors). The main bDMARD used are described in detail in Table.

A total of 128 (45%) of patients were fully vaccinated. Vaccines received included: Moderna in 73%, Pfizer/BioNTech in 17.5%, Astra Zeneca in 9 % and Janssen in 0.4%. Eighteen and 8% of patients stop or delayed DMARD and bDMARD, respectively after vaccination.

Underlying IMRD flare was reported in 16 (5.6%) of patients all of them mild or moderate. Main symptoms included arthralgias (9), arthritis (4), inflammatory back pain (2), and psoriasis (1). Only 1 patient had COVID-19 infection 1 week after first vaccine dose. A total of 153 (53%) patients reported any symptom related to vaccination, basically injection site pain (48%), myalgias (11%), and fever (8%). One patient had oral herpes after vaccination.

Conclusion: Among patients with IMRD, the safety profile of vaccines for SARS-CoV-2 was satisfactory. Disease flares were uncommon (5%) and mostly mild. Vaccination side effects were similar to expected for the general population reassuring the importance of SARS-CoV2 vaccination in patients with IMRD.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-safety-profile-of-sars-cov-2-vaccines-among-patients-with-immune-mediated-rheumatic-diseases/