The SARS-CoV-2 vaccines were well tolerated among a majority of patients with inflammatory or autoimmune rheumatic and musculoskeletal diseases (I-RMDs), with rare reports of flares and serious adverse events (AEs), according to study results published in Annals of the Rheumatic Diseases.
The exclusion of patients with I-RMDs from SARS-CoV-2 vaccine clinical development programs led to rising concerns among patients and health care providers about the safety of the vaccines in this patient population. Smaller studies had been conducted; however, the researchers sought to further address these concerns by creating the largest international case series of patients with I-RMDs vaccinated against SARS-CoV-2.
Patient-level data were derived from the European Alliance of Associations for Rheumatology (EULAR) Coronavirus Vaccine (COVAX) registry from February 5, 2021 to July 27 2021. The registry includes rheumatologist-reported data from patients with preexisting I-RMDs and noninflammatory rheumatic and musculoskeletal diseases (NI-RMDs) who had 1 or more doses of any vaccine against SARS-CoV-2.
A total of 5121 eligible participants from 30 countries were included in the current analysis. Of the total cohort, 90% had an I-RMD (n=4604; 68% women; mean age, 60.5 years), with primary diagnoses of inflammatory joint diseases (58%), connective tissue diseases (18%), and vasculitis (12%). A total of 10% of the study cohort had an NI-RMD (n=517; 77% women; mean age, 71.4 years). Treatment regimens among patients at the time of their COVID-19 vaccination included conventional synthetic disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, and immunosuppressants.
The majority of patients had received the Pfizer/BioNTech vaccine (70%), 17% received the AstraZeneca/Oxford vaccine, and 8% received the Moderna vaccine. Overall, 25% of patients had received at least 1 dose of the vaccine, 74% had received 2 doses, and 1% had received 3 doses. The mean time between the first vaccine dose and the case reporting was 66 days in the I-RMD group and 64 days in the NI-RMD group.
Researchers noted that vaccine-related adverse events (AEs) occurred in 37% of patients with I-RMDs and 40% of patients with NI-RMDs. Physicians were asked to report early AEs that occurred within 7 days of vaccination, as well as AEs of special interest involving an organ or organ system. The majority of AEs reported were nonserious transient reactions, such as fatigue, pain at the injection site, fever, and muscle pain. Breakthrough infections were reported in 0.7% of fully vaccinated patients with I-RMDs and in 1.1% of fully vaccinated patients with NI-RMDs. Flares of I-RMDs were reported in 4.4% of cases (0.6% severe), with 1.5% of flares resulting in medication changes.
Researchers highlighted that no causal conclusions regarding vaccination and the development of flares or AEs could be firmly be drawn from the dataset. The study had others limitations, including that the differences in flare risk among RMDs may have influenced the overall flare rate observed. Based on the varied time frames between vaccination and case reporting, only limited conclusions could be made regarding the long-term safety profiles of the vaccines. Moreover, the majority of the patients had received the Pfizer/BioNTech vaccine, mitigating the opportunity for comparison between the other SARS-CoV-2 vaccines. Finally, the analysis relied primarily on voluntary, physician-reported data, which may have introduced bias.
“In conclusion, our findings should provide reassurance to rheumatologists, other health professionals and vaccine recipients and promote confidence in SARS-CoV-2 vaccine safety in people with I-RMDs,” the researchers said. “Future studies should address the effectiveness and safety of vaccines against SARS-CoV-2 in patients with I-RMDs and/or patients taking immunosuppressive/immunomodulatory drugs, both in controlled and general surveillance settings.”
Disclosure: Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Machado PM, Lawson-Tovey S, Stangfeld A, et al. Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry. Ann Rheum Dis. Published online December 31, 2021. doi:10.1136/annrheumdis-2021-221490