The study had been scheduled to enroll 560 patients but recruitment was stopped early by independent study oversight committees when interim results from the first 254 participants showed a clear finding.
Although methotrexate is effective in controlling autoimmune conditions and has become first-line therapy for many other conditions, it reduces the body’s ability to fight infection and produce a response. strong response to influenza and pneumonia vaccines, including those against COVID-19.
Patients over 18 years of age were recruited from dermatology and rheumatology outpatients at 26 NHS hospitals across England and Wales. The trial evaluated temporary discontinuation of treatment versus continuation of methotrexate immediately following the third main dose or booster dose of the COVID-19 vaccine.
127 participants were asked to take a two-week break from methotrexate, and 127 continued to use it as usual. Deciding who to stop or continue treatment with methotrexate is made by a computer program – similar to a coin toss or a roll of dice.
The team compared the spike in antibody levels between the two groups between 4 weeks and 12 weeks after they received a dose of the COVID-19 vaccine. The spike in antibodies prevents the virus from infecting cells inside the body.
Effects of stopping Methotrexate:
At 4 weeks and 12 weeks, the spike in antibody levels was more than two times higher in the group that discontinued methotrexate for two weeks after vaccination, compared with the group that continued it.
Disease control worsened at week 4 in the pause group, but that was back to normal by week 12. No impact on quality of life or general well-being.
The Independent Research Steering Committee advised against further recruitment to the VROOM trial. VROOM study participants will be invited for an additional visit six months after their immunization date.
The spike in antibody levels reflects the strength of the antibody response. The team is now testing the quality of the antibody response by measuring its ability to kill live SARS-CoV-2 virus and other variants of interest such as Omicron.
Lead investigator Professor Abhishek said: “We are extremely pleased with the initial results of the VROOM trial.
The antibody response doubled in patients who stopped taking methotrexate for two weeks. Improvement in antibody response was maintained for a period of 3 months.
There is a short-term increase in the risk of flare-ups of inflammatory conditions. However, most can be self-managed.
“We also did not see any adverse impact on patients’ quality of life after stopping the drug. However, the study did not evaluate whether this strategy resulted in fewer COVID-19 cases or fewer hospitalizations. due to COVID-19 is large enough to detect these differences.
“Implementing these results could significantly improve the protection that boosters against COVID-19 provide to millions of people living with these conditions.
Professor Andy Ustianowski said: “While the majority of the UK population is now vaccinated, it is more important than ever to continue with ongoing research to ensure we can get a vaccine. effectively in different patient groups.
“These landmark results provide high-quality evidence to help best protect millions of people with compromised immune systems, making them safer from viruses and existing chronic diseases.” surname.”
Professor Rosemary Boyton, who led the application, said: “This study is the first to report the effectiveness of a two-week interruption of an immunosuppressive drug called methotrexate immediately following vaccination. enhance COVID-19 to enhance antibody-associated immunity against SAR-CoV-2.
Our results showed a doubling of antibody levels, an increase that was maintained after 12 weeks. This has important implications for future vaccination strategies in this group of immunosuppressed patients. “
OCTRU Academic Lead, Jonathan Cook, said: “It is exciting to see the difference a simple, inexpensive and modest adjustment to treatment can make.
Clinical trials like VROOM are needed to help us understand how best to give vaccines such as COVID-19 boosters to different patient populations. “
Professor John Iredale, Executive Chairman of the Medical Research Council, which partially funded the trial, said: “This important finding means that many people who need to take immunosuppressive drugs now have one. safe and effective way to improve their immune response in life – save the COVID-19 vaccine.
This study shows once again that the ability of the world’s leading UK research community to quickly set up well-designed clinical trials can provide the evidence needed to optimize interventions. health and save lives during a pandemic. “