Effect of a 2-week interruption in methotrexate treatment versus continued treatment on COVID-19 booster vaccine immunity in adults with inflammatory conditions (VROOM study): a randomised, open label, superiority trial

Interrupting methotrexate to improve immunity after COVID-19 booster vaccination: is it really worth it?

“…However, such a subjective sense of less controlled disease is also to be expected in real-world clinical practice. In the present study, 1 slightly more patients in the suspended methotrexate group sought medical assistance because of flares than did individuals in the continued methotrexate group (six [4·7%] of 127 vs three [2·4%] of 127); however, in real life, this could mean an additional burden on the health-care system, which would be a counterproductive effect during the pandemic.…”

“…However, antibody concentrations are ultimately a surrogate parameter of uncertain clinical significance. The Article 1 refers to the dose–response association between RBD antibody titres following vaccination and protection against COVID-19, 2 , 3 but this non-linear correlation was shown for RBD antibody concentrations up to 6000 binding antibody units per mL, which is far below the magnitudes observed in the VROOM study. Presumably, the correlation curves plateau at higher antibody titres.…”

“…Abhishek and colleagues 1 conducted an important clinical trial (the VROOM study), examining the effect of a 2-week interruption of methotrexate on the antibody response to the COVID-19 booster vaccination. The rigorous study design yielded insightful findings regarding the effects of this intervention on vaccine immunogenicity.…”

Suspending methotrexate for 2 weeks after COVID-19 vaccination

“…Withholding methotrexate only after the second vaccine dose rather than after both doses appeared to be as effective, and did not increase the risk of arthritis flares (withholding methotrexate after both doses did show a significant association with disease flare). A positive effect of a temporary hold in methotrexate on vaccine-induced immunity has been shown with three different COVID-19 vaccine technologies 4 , 5 and the influenza vaccine. 6 , 7 However, these studies were relatively small, with short follow-up periods, and were not designed to assess the effect of withholding methotrexate on the risk of infections or their complications.…”

“…This strategy differs from a previous study that included all patients regardless of previous COVID-19 status to provide more real-world evidence. 4 The two MIVAC trials addressed slightly different interventions but are complementary. The population in these studies was heterogeneous but reflective of the clinical population with well-controlled rheumatoid arthritis (>90% patients in the studies) and psoriatic arthritis with low disease activity.…”