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Safety and healthcare utilization following COVID-19 vaccination among adults with rheumatoid arthritis – a population-based self-controlled case series analysis


Objective — To determine if COVID-19 vaccines were associated with adverse events of special interest (AESIs) and healthcare use among adults with rheumatoid arthritis (RA).

Methods — Among adults with RA who received at least 1 COVID-19 vaccine, a self-controlled case series (SCCS) analysis was conducted to evaluate relative incidence (RI) rates of AESIs (Bell’s Palsy, Idiopathic Thrombocytopenia, Acute Disseminated Encephalomyelitis, Pericarditis/Myocarditis, Guillain-Barre syndrome, Transverse Myelitis, Myocardial Infarction, Anaphylaxis, Stroke, Deep Vein Thrombosis, Pulmonary Embolism, Narcolepsy, Appendicitis, and Disseminated Intravascular Coagulation) in any 21-day period following vaccination compared to control periods. Secondary outcomes included emergency department (ED) visits, hospitalizations, and rheumatology visits. A matched non-RA comparator group was created and a separate SCCS analysis was conducted. Relative incidence ratios (RIR) were used to compare between RA and non-RA groups.

Results — Among 123,466 RA patients and 493,864 comparators, the majority received mRNA vaccines. For RA patients, relative to control periods, AESIs were not increased. ED visits increased after dose 2 [RI:1.06 (95%CI:1.03-1.10)] and decreased after dose 3 [RI:0.93 (95%CI:0.89-0.96)]. Hospitalizations were lower after the first [RI:0.83 (95%CI:0.78-0.88)], second [RI:0.86 (95%CI:0.81-0.92)], and third [RI:0.89 (95%CI:0.83-0.95)] doses. Rheumatology visits increased after dose 1 [RI:1.08 (95%CI:1.07-1.10)], and decreased after doses 2 and 3. Relative to comparators, RA patients had a higher AESI risk after dose 3 [RIR:1.28 (95%CI:1.1- 1.6)]. RA patients experienced fewer ED visits [RIR:0.73 (95%CI:0.58-0.90)] and hospitalizations [RIR:0.52 (95%CI:0.36-0.75)] after dose 4.

Conclusion — COVID-19 vaccines in RA patients was not associated with an increase in AESI risk or healthcare utilization after every dose.



Lee JJY, Bernatsky S, Kwong JC, Li Q, Kwok TSH, Widdifield J. J Rheumatol. 2023; Oct 1 [Epub ahead of print].

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