Effect of a 2-week interruption in methotrexate treatment on COVID-19 vaccine response in people with immune-mediated inflammatory diseases (VROOM study): a randomised, open label, superiority trial
Primary result · Geometric mean S1-RBD antibody titreResult — go to the resultGeometric mean ratio 2.08 95% CI 1.59–2.70- pre-planned interim analysis; recruitment stopped early
Authors' conclusion
2-week interruption of methotrexate treatment in people with immune-mediated inflammatory diseases enhanced antibody responses after COVID-19 booster vaccination that were sustained at 12 weeks and 26 weeks.
Study context
- Population
- Adults (≥18 years) with IMIDs taking MTX (≤25 mg per week) for ≥3 months, after two primary vaccine doses; rheumatology and dermatology clinics, 26 UK hospitals685 screened
- Participants
- 383 adults
- Comparison
- 2-week interruption of MTX immediately after COVID-19 booster vaccination vs continuing MTX as usual
- Suspend methotrexaten = 191
- Continue methotrexaten = 192reference
- Primary endpoint
- S1 receptor binding domain (S1-RBD) antibody titres, assessed masked to group assignment
- Follow-up
- 4 weeks after COVID-19 booster vaccination
Methodological detailsmulticentre, open-label, parallel-group, superiority
- Multicentre
- Open-label
- Parallel-group
- Superiority
Primary result
Geometric mean S1-RBD antibody titre · 4 weeks
Geometric mean ratio
2.08
95% CI 1.59–2.70
P < 0.0001
By group
Suspend methotrexatevs Continue methotrexate
geometric mean ratio 2.08 (95% CI 1.59–2.70); P < 0.0001
As reported in the abstract
Safety
- No intervention-related serious adverse events occurred
Original publication
Effect of a 2-week interruption in methotrexate treatment on COVID-19 vaccine response in people with immune-mediated inflammatory diseases (VROOM study): a randomised, open label, superiority trial. Lancet Rheumatol. Published 12 December 2023. doi:10.
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