Safety and Health Care Utilization following COVID-19 Vaccination among Adults with Rheumatoid Arthritis - A population-based self-controlled case series analysis.

Abstract

To determine if COVID-19 vaccines were associated with adverse events of special interest (AESIs) and health care use among adults with rheumatoid arthritis (RA). 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. 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. COVID-19 vaccines in RA patients was not associated with an increase in AESI risk or health care utilization after every dose.