Two-week methotrexate pause helps COVID booster response without significant flares
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Key takeaways:
- Patients who paused methotrexate treatment upon receiving a COVID-19 vaccine booster had significantly greater antibody response.
- Those who paused had more disease flares at week 4, but were comparable to non-pausers by week 26.
In patients with immune-mediated inflammatory diseases, a 2-week pause of methotrexate after receiving a COVID-19 vaccine booster yielded a sustained, significantly increased antibody response, without serious flares, according to a study.
“The COVID-19 pandemic has not gone away, and with the emergence of new variants and vaccine hesitancy among clinically vulnerable patients, it is important to optimize durable protection in people who are susceptible to severe COVID-19,” Abhishek Abhishek, PhD, professor of rheumatology at the University of Nottingham, in the United Kingdom, told Healio. “Evidence from our trial will help patients and clinicians make informed choices about the risks and benefits of interrupting methotrexate treatment around the time of vaccination against COVID-19.”
To determine whether a 2-week suspension of methotrexate following a COVID-19 vaccine booster could improve antibody response without seriously impacting inflammatory disease, Abhishek and colleagues performed an open-label, parallel-group, randomized trial in rheumatology and dermatology clinics throughout 26 U.K. hospitals. The researchers examined 383 adults with immune-mediated inflammatory diseases who had been taking up to 25 mg of methotrexate per week for at least 3 months, had received at least two COVID-19 vaccine doses, and were eligible for a booster dose.
Participants received a COVID-19 booster through the U.K. vaccination program and were randomly assigned 1:1 either to immediately suspend their methotrexate doses for 2 weeks (n = 191; mean [SD] age = 58.8 [12.5]; 62% women) or continue with the same dose on the same day (n = 192; mean [SD] age = 59.3 [11.9]; 61% women). Vaccine response was measured at 4, 12 and 26 weeks via fully quantitative antibody titer of the S1 receptor binding domain (S1-RBD) of the SARS-CoV-2 spike protein.
According to the researchers, who published their results in The Lancet Rheumatology, patients who suspended methotrexate demonstrated a significantly greater geometric mean S1-RBD antibody titer (mean = 25,413 U/mL; 95% CI, 22,227-29,056) vs. those who continued (mean = 12,326 U/mL; 95% CI, 10,538-14,418) at 4 weeks. In addition, S1-RBD antibody titers remained higher among those who paused treatment at 12 and 26 weeks.
Meanwhile, 53% of patients who suspended methotrexate self-reported at least one disease flare by week 4, vs. 33% of those who continued (OR = 2.28; 95% CI, 1.72-3.66). However, this gap narrowed by week 26, with 69% and 61%, respectively, reporting flare (OR 1.37; 95% CI, 0.72-1.27). In addition, most flares were self-managed, the researchers wrote.
“We identified a sustained increase in binding S1-RBD antibodies on interruption of methotrexate treatment for 2 weeks immediately after vaccination against COVID-19 with a short-term increase in risk of inflammatory disease flares that were mostly self-managed,” Abhishek and colleagues wrote.
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