Rheumatoid Arthritis

Interruption of DMARDs Not Linked to Higher Disease Activity in RA After COVID-19 Vaccination

Avatar photoSheila Jacobs
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It is unclear whether disease control prevents RA-related bone loss, but data suggest it does in patients with early RA and high disease activity.1 Two systemic analyses of RA studies concluded that biologic DMARDs reduce generalized and localized bone loss.2,19 However, few studies were phase 3 trials, and most measured markers of bone turnover.2,19 High-quality trials that measure BMD change or fracture risk are needed. Bisphosphonates, denosumab, and parathyroid hormone are agents approved for osteoporosis and glucocorticoid-induced osteoporosis. Bisphosphonates and denosumab appear to have similar efficacy at preserving BMD.1 In some RA studies, denosumab also prevented and repaired erosions.2 The ACR guidelines for glucocorticoid-induced osteoporosis categorize patients as having low, moderate, or high fracture risk.18 They recommend calcium (1000 to 1200 mg/d) and vitamin D (600 to 800 IU/d) supplements for all patients, plus an osteoporosis agent (preferably an oral bisphosphonate) for patients with moderate to high fracture risk.

It is unclear whether disease control prevents RA-related bone loss, but data suggest it does in patients with early RA and high disease activity.1 Two systemic analyses of RA studies concluded that biologic DMARDs reduce generalized and localized bone loss.2,19 However, few studies were phase 3 trials, and most measured markers of bone turnover.2,19 High-quality trials that measure BMD change or fracture risk are needed. Bisphosphonates, denosumab, and parathyroid hormone are agents approved for osteoporosis and glucocorticoid-induced osteoporosis. Bisphosphonates and denosumab appear to have similar efficacy at preserving BMD.1 In some RA studies, denosumab also prevented and repaired erosions.2

The ACR guidelines for glucocorticoid-induced osteoporosis categorize patients as having low, moderate, or high fracture risk.18 They recommend calcium (1000 to 1200 mg/d) and vitamin D (600 to 800 IU/d) supplements for all patients, plus an osteoporosis agent (preferably an oral bisphosphonate) for patients with moderate to high fracture risk.

The association between DMARD interruption and RA disease activity during COVID-19 vaccination was determined.

Disease activity, as measured weekly using a validated patient-reported outcome, was shown to be stable among patients with rheumatoid arthritis (RA) receiving an additional dose (AddDose) of the COVID-19 vaccine at least 28 days after an initial mRNA vaccine series or at least 2 months after a single adenovirus vector vaccine. Results of the analysis were published in Annals of the Rheumatic Diseases. Study authors also suggested that holding disease-modifying antirheumatic drugs (DMARDs) were not associated with higher RA disease activity after an additional COVID-19 vaccine dose.

Patients with RA receiving treatment with immunosuppressive agents, including DMARDs, are eligible for an additional COVID-19 vaccine dose.

 The aim of the analysis was to evaluate change in RA disease activity before and after vaccination against COVID-19, as well as to explore whether holding DMARDs would be associated with greater RA disease activity following receipt of the additional vaccine.

A prospective, observational study was conducted among patients who received treatment at the Brigham and Women’s Hospital in Boston, Massachusetts, who had been previously vaccinated against COVID-19 with 2 doses of an mRNA vaccine or 1 dose of an adenovirus vector vaccine.

Participants were enrolled in the current study between July and November 2021 and completed an online survey 2 days after receiving an additional COVID-19 vaccine dose. Participants provided also provided information regarding their vaccine reactogenicity and their DMARD treatment plan during vaccination. The validated patient-reported RA Disease Activity Index-5 (RADAI-5) was used to evaluate RA disease activity weekly from enrollment through 4 weeks after the COVID-19 vaccine.

A total of 71 participants were enrolled in the study. The mean patient age was 62.2±

11.8 years; 84.5% were women. The most common DMARDs used among patients were methotrexate (42.3%) and tumor necrosis factor inhibitors (TNFi; 38.0%). Overall, 49.3% of the participants stopping receiving treatment with at least 1 DMARD during this period.

Following additional COVID-19 vaccination, the most commonly reported symptoms included injection-site pain and swelling (72%) and fatigue (52%).

Mean RADAI-5 score was 3.20±0.23 before the additional dose compared with 3.25±0.23 after the additional dose (difference, 1.6%; P =.51). Mean RADAI-5 score did not differ significantly before and after the additional vaccine among individuals in whom DMARDs were “held”, as well as among those who continued receiving DMARDs. Mean change in RADAI-5 score before and after additional vaccination did not significantly differ based on DMARD use (P for interaction =.16).

In a subset of 27 individuals with seropositive RA, the use of flow cyotometry quantified the percentages of 4 lymphocyte populations — T peripheral helper cells, T follicular helper cells, age-associated B cells, and plasmablasts — in blood samples collected

pre-AddDose and at week 4 post-AddDose. The frequency of the lymphocyte populations did not differ significantly before and after receiving the additional vaccine dose in 16 participants in whom at least 1 DMARD was held or in the 11 participants who continued receiving DMARD treatment.

Limitations of the current study included the small number of participants, even though the study was adequately powered to detect a difference of 15% in RA disease activity before and after the additional dose. Further, only a small number of patients provided blood for the flow cytometry analyses.

The study authors concluded, “Holding DMARDs was not associated with greater RA disease activity following the AddDose.”

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. 

Reference

Tedeschi SK, Stratton J, Ellrodt JE, et al. Rheumatoid arthritis disease activity assessed by patient-reported outcomes and flow cytometry before and after an additional dose of COVID-19 vaccine. Ann Rheum Dis. Published online February 15, 2022. doi:10.1136/annrheumdis-2022-222232

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