Antibody response to COVID-19 booster doubles in patients who paused methotrexate
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Patients who suspended methotrexate for 2 weeks after a COVID-19 booster vaccine had a “twofold” increased antibody response, compared with those who remained on the drug, according to data published in The Lancet Respiratory Medicine.
“A key challenge at this stage in the COVID-19 pandemic is to improve the vaccine-induced immunity of immunosuppressed individuals,” Abhishek Abhishek, PhD, professor of rheumatology at the University of Nottingham, in the United Kingdom, and co-authors wrote. “Understanding the effectiveness and safety of this simple intervention would provide valuable and timely guidance to achieve enhanced, durable immunity following COVID-19 vaccination in this clinically susceptible population, informing clinical practice and public health policy when additional vaccinations are being considered globally.”
To investigate the impact of suspending methotrexate for 2 weeks after receiving a COVID-19 booster vaccine, Abhishek and colleagues conducted an open-label, prospective, two-arm, parallel-group, randomized, controlled superiority trial with adult participants from 26 sites across the United Kingdom.
Eligible participants were required to be diagnosed with an immune-mediate inflammatory disease, such as rheumatoid arthritis, psoriasis of any kind, axial spondyloarthritis, atopic dermatitis, polymyalgia rheumatica or systemic lupus erythematosus. Patients also must have been prescribed methotrexate — 25 mg or less for at least 3 months prior to enrollment — and willing to pause treatment for 2 weeks. In addition, they had to have received two COVID-19 vaccine doses and been eligible for a third.
Patients were not eligible if their disease did not allow for safe discontinuation of treatment, if they received glucocorticoid-sparing drugs other than methotrexate within 2 months, if prednisolone was used daily at a dose higher than 7.5 mg per day in the past month, or if they received radiotherapy or chemotherapy for cancer in the previous 6 months.
The primary outcome of the study was S1-RBD antibody titers at 4 weeks following administration of the booster dose. Secondary endpoints included antibody titers at 12 weeks; patient-reported disease activity at 2, 4 and 12 weeks; patient-reported flares and actions taken; patient-reported quality of life; and a patient-reported global assessment of disease activity.
The analysis included 340 participants enrolled between Sept. 30, 2021, and March 3, 2022, of whom 254 — with a mean age of 59 years — were included in the interim analysis. Participants were randomized 1:1 to suspend methotrexate treatment for 2 weeks after their COVID-19 booster or continue treatment as usual, with 127 patients in each group. Concomitant therapy was maintained and disease flares were treated. Patients were assessed at 4 and 12 weeks post-vaccination.
At 4 weeks, the geometric mean SA-RBD antibody titer was 22,750 U/mL (95% CI, 19,314-26,796) in the group that suspended methotrexate and 10,798 U/mL (95% CI, 8,970-12,997) among those who continued treatment. The elevated response was consistent across methotrexate dosages, administration route, type of disease, age, primary vaccination platform and SARS-CoV-2 infection history, according to the researchers.
“We observed a sustained increase that was more than twofold in S1-RBD antibody binding on interruption of methotrexate treatment for 2 weeks immediately after vaccination against COVID-19, with a short-term increase in risk of disease flare-ups that were mostly self-managed and without any adverse impact on quality of life,” Abhishek and colleagues wrote. “Further research is required to assess whether interruption in treatment with other similarly acting immunosuppressive drugs will also enhance vaccine-induced immunity.”
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