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In the COVER randomized trial, 840 people with inflammatory arthritis either paused targeted DMARD treatment for two weeks around COVID vaccination or continued their usual schedule. The pause did not improve antibody responses and was associated with more arthritis worsening, supporting the researchers’ view that routine interruption for vaccine optimization is not warranted by these results.
A randomized trial of 840 people with inflammatory arthritis found that pausing targeted disease-modifying antirheumatic drugs (DMARDs) for two weeks around COVID-19 vaccination did not improve antibody responses, while arthritis worsening was more common among those who paused treatment. The results, reported in JAMA Internal Medicine, do not support routinely stopping these medicines to try to strengthen vaccine responses, the researchers said.
Participants were assigned in equal numbers either to hold their targeted DMARDs for two weeks or to continue treatment on their usual schedule. Six weeks after vaccination, the average rise in antibodies against the SARS-CoV-2 spike protein was 4.69-fold in the hold group and 4.86-fold in the group that continued medication. The ratio between the groups was 0.96, with a 95% confidence interval of 0.36 to 2.56, indicating no measured advantage for pausing treatment.
The trial’s secondary findings pointed to a downside. A clinically meaningful worsening on the OMERACT rheumatoid arthritis flare questionnaire, defined as a rise of at least 10 points, occurred in 21.1% of the hold group and 9.1% of the continue-treatment group. The odds of a new flare were more than twice as high with a temporary hold (odds ratio 2.27; 95% CI 1.41-3.65). Most of the questionnaire-measured events occurred in the first two weeks after vaccination and had resolved by the six-week follow-up.
The trial enrolled 602 people with rheumatoid arthritis, 198 with psoriatic arthritis and 40 with spondyloarthritis. Participants used several targeted drug classes, including TNF inhibitors, JAK inhibitors, interleukin-17 inhibitors and abatacept. The researchers found no difference in vaccine antibody response by treatment timing when results were examined across medication types. They also reported that people taking methotrexate, JAK inhibitors or abatacept had more muted responses than those taking some other DMARD classes, regardless of whether treatment was paused.
Pausing Treatment Added Flare Risk
The findings address a practical decision for people who rely on targeted medicines to control inflammatory arthritis: whether to interrupt treatment around vaccination in the hope of improving protection. In this trial, the measured antibody increase was virtually identical between the two strategies, while clinically meaningful disease worsening was more frequent after a hold. That balance weighs against a routine pause solely to optimize the vaccine response, though treatment decisions still need to account for an individual patient’s condition and medication.
The authors said the results do not establish that every DMARD pause is harmful or that the same findings apply to every vaccine or treatment schedule. They do, however, offer randomized evidence on a question that had prompted advice and discussion without strong trial data. People should not change prescribed medication based on the study alone; they can discuss vaccination timing and treatment plans with their rheumatology clinician.
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Why Researchers Tested a Two-Week Hold
Targeted DMARDs suppress parts of the immune system involved in inflammatory disease. Early in the COVID-19 vaccination rollout, clinicians and researchers raised the possibility that temporarily stopping such medicines might improve vaccine responses. That approach also carried a concern: reducing disease control could cause arthritis to worsen. The COVER trial was designed to measure both the antibody response and disease flares rather than assume that a temporary interruption would help.
Researchers began the formal trial in late 2021. Its primary outcome was the change in immunoglobulin G antibodies against the virus’s spike protein. Disease worsening was assessed through patients’ reports and the OMERACT questionnaire. Participants were not blinded to whether they paused their medication. The trial examined antibody levels, not whether the groups experienced different rates of COVID-19 infection, severe illness or hospitalization.
“Given the increased flare risk and absence of humoral immunogenicity benefit, these findings do not support routine temporary interruption for COVID-19 vaccine optimization.”
— Jeffrey R. Curtis and colleagues
Limits on What the Trial Shows
The results have limitations. About 31% of participants were lost to follow-up for the analysis, and 509 of 840 completed the OMERACT assessment. The researchers also said a two-week pause might not provide enough washout time for some drugs, so the trial does not settle what a longer interruption would do. The study did not report absolute rates for responses to the simple yes-or-no question about having a flare; the published flare comparison cited here comes from the questionnaire measure.
Enrollment and vaccination took place over three years, during which participants received different vaccine formulations and may have had prior exposure to different SARS-CoV-2 strains. The researchers did not stratify their analyses by arthritis diagnosis. The study also did not establish whether the timing of flares meant they were caused by vaccination itself, or whether the antibody findings translate into differences in protection from infection or severe COVID-19.
Discuss Medication Timing With Clinicians
The report does not identify a further trial milestone or recommend a medication change for individuals. For now, its findings support discussing vaccination and DMARD timing with a rheumatology clinician rather than pausing treatment routinely on the assumption that doing so will boost antibodies. Further research could clarify how different medicines, pause durations, vaccine formulations and prior infections affect immune responses and disease control.
Key Questions
Did stopping DMARDs improve COVID vaccine antibody levels?
No. In the trial, the average antibody increase was 4.69-fold after a two-week hold and 4.86-fold among participants who continued their medication. Researchers found no measured benefit from pausing treatment.
Did pausing medication affect arthritis flares?
Yes. A clinically meaningful worsening on the OMERACT questionnaire was recorded in 21.1% of the hold group, compared with 9.1% of those who continued treatment. Most measured events occurred in the first two weeks and had resolved by six weeks.
Which patients took part in the trial?
The 840 participants had rheumatoid arthritis, psoriatic arthritis or spondyloarthritis and were receiving targeted DMARDs, including TNF inhibitors, JAK inhibitors, interleukin-17 inhibitors or abatacept.
Should patients stop their DMARD before a COVID vaccine?
The trial does not support a routine two-week pause solely to improve antibody response. Patients should speak with their rheumatology clinician before changing prescribed treatment, since the study does not answer every medication or individual-care question.
Source: rss
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