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In the COVER randomized trial, pausing targeted DMARDs for two weeks around COVID-19 vaccination did not increase patients’ antibody response compared with continuing treatment. Clinically meaningful disease worsening was more common in the hold group, supporting the researchers’ view that routine pauses for vaccine optimization are not supported by these findings.
A randomized trial of 840 people with inflammatory arthritis found that pausing targeted disease-modifying antirheumatic drugs (DMARDs) for two weeks around a COVID-19 vaccination did not improve antibody responses, while the pause was associated with more disease worsening. The results challenge the rationale for routinely stopping these medicines to try to increase vaccine response, but do not establish what is best for every patient or medication.
The COVER trial assigned participants to either hold targeted DMARDs for two weeks or continue them on their usual schedule. Six weeks after vaccination, the average increase 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 treatment. The reported ratio of antibody rises was 0.96, with a 95% confidence interval of 0.36 to 2.56, indicating no observed advantage for pausing treatment.
By one measure of disease worsening, 21.1% of participants in the hold group had a clinically meaningful increase in their OMERACT rheumatoid arthritis flare questionnaire score, compared with 9.1% of those who continued treatment. The difference was 12 percentage points, with a 95% confidence interval of 5.9 to 18.1. The researchers also reported that the odds of a new flare were more than twice as high in the hold group (odds ratio 2.27, 95% CI 1.41 to 3.65).
Most of the reported worsening occurred in the first two weeks after vaccination and had resolved by the six-week follow-up, according to the study report. The trial included 602 people with rheumatoid arthritis, 198 with psoriatic arthritis and 40 with spondyloarthritis. The researchers reported muted antibody responses among people taking methotrexate, JAK inhibitors or abatacept in both study groups; the trial did not find that holding medication changed the response by drug class.
Why a Routine Drug Pause Is Uncertain
For patients and clinicians weighing vaccination against the risk of worsening arthritis, the trial provides direct evidence on a commonly proposed strategy: temporarily interrupting targeted treatment. In this study, the pause did not produce higher measured antibody rises, while a questionnaire-based measure of worsening was more frequent among those assigned to stop treatment.
The findings may help guide discussions about routine medication holds, but they are not a personalized treatment instruction. The study examined a specific two-week pause and antibody levels, not every possible schedule, vaccine outcome or individual risk. Decisions about medication around vaccination should be made with the treating clinician, who can account for the patient’s condition and treatment.
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How the COVER Trial Tested Pauses
Temporary DMARD interruption was proposed during the early rollout of COVID-19 vaccines because some immune-suppressing medicines can affect vaccine responses. Researchers said the suggestion had limited direct evidence for this setting, prompting the COVER trial, which was initiated in late 2021 to compare a planned hold with continuing therapy.
The primary outcome was the change in immunoglobulin G antibodies against the SARS-CoV-2 spike protein. Researchers assessed disease worsening through participants’ reports and the OMERACT questionnaire; a rise of at least 10 points on that questionnaire counted as clinically meaningful. Treatments represented in the study included TNF inhibitors, JAK inhibitors, interleukin-17 inhibitors and abatacept. The researchers said vaccination status should ideally be optimized before biologic therapy begins when feasible, but that observation is distinct from evidence that pausing an established treatment improves vaccine response.
“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, as quoted in the study report
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Limits on Applying the Findings
The results have several limitations. Thirty-one percent were lost to follow-up, and only 509 of the 840 participants completed the OMERACT assessment used for the reported questionnaire comparison. The authors also noted that two weeks may not have been long enough to clear some medicines fully, which could affect the test of whether a medication pause changes vaccine response.
Participants were enrolled and vaccinated over three years, during which vaccine formulations and prior exposure to different SARS-CoV-2 strains varied. The researchers did not report analyses separated by arthritis diagnosis. They also did not establish whether the timing of some flares meant they were caused by vaccination; the report says the study authors did not address that possibility. Absolute rates for responses to the simple yes-or-no flare question were not reported in the source material.
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Clinical Decisions Remain Individual
The study report does not specify a next trial milestone or a change to clinical guidance. Its results add evidence against routinely pausing targeted DMARDs solely to improve COVID-19 vaccine antibody response, while leaving questions about particular drugs, schedules and patient groups open. Patients should discuss any planned medication interruption with their rheumatology care team rather than stopping treatment on their own.
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Key Questions
Did stopping DMARDs improve COVID-19 vaccine antibody responses?
No benefit was observed in the trial. Average antibody rises were 4.69-fold with a two-week hold and 4.86-fold when participants continued treatment.
Were arthritis flares more common when treatment was paused?
Yes, by the study’s reported measures. A clinically meaningful OMERACT score increase occurred in 21.1% of the hold group and 9.1% of the continued-treatment group. The researchers also reported higher odds of a new flare with the hold strategy.
Which patients took part in the trial?
The 840 participants included 602 people with rheumatoid arthritis, 198 with psoriatic arthritis and 40 with spondyloarthritis. They were taking various targeted DMARDs.
Does the study mean nobody should pause a DMARD for vaccination?
The findings do not support a routine two-week pause solely to improve COVID-19 vaccine antibody response. They do not settle every medication or individual circumstance. Patients should ask their clinician before changing or stopping a prescribed treatment.
Source: rss
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