A recent clinical trial conducted by the University of Nottingham has demonstrated that individuals with inflammatory conditions can significantly enhance their antibody response to a COVID-19 booster vaccination by temporarily interrupting their treatment for two weeks after receiving the vaccine. The study found that the antibody response to the jab was two times higher at four weeks and one and a half times greater at 26 weeks compared to those who continued with their regular treatment. These improved antibody response levels were sustained for a period of six months.
Although patients who interrupted their treatment reported experiencing more flare-ups of their inflammatory conditions in the following weeks, the majority of these flare-ups were self-managed and did not require medical intervention. The interim findings of the Vaccine Response On Off Methotrexate (VROOM) trial, which included 250 patients and followed up for 12 weeks, were initially published in Lancet Respiratory Medicine and have already influenced clinical guidelines in both the United Kingdom and the United States.
The full trial findings, encompassing 383 participants and published in Lancet Rheumatology, demonstrate that the enhanced protection from stopping methotrexate treatment lasts for a duration of six months. The trial also reveals that the blood of individuals who suspended methotrexate treatment showed greater efficacy in neutralizing both the Wuhan strain and the omicron BA.1 variant. Additionally, when considering the six-month follow-up period, there was no excess risk of disease flare-ups in patients who temporarily halted their treatment after receiving a COVID-19 booster vaccination.
These findings are expected to be valuable for national immunization advisory committees and other specialist societies involved in formulating recommendations regarding the timing of vaccinations for individuals receiving or starting medications that suppress the immune system.
The VROOM trial enrolled patients with various inflammatory conditions who were being treated with methotrexate. Methotrexate is the most commonly used immune-suppressing drug, with approximately 1.3 million individuals in the UK being prescribed this medication for conditions such as rheumatoid arthritis and psoriasis. Many of these individuals were among the 2.2 million clinically extremely vulnerable individuals advised to shield during the initial phase of the COVID-19 pandemic based on specialist advice and individual risk factors.
While methotrexate effectively controls these conditions and is considered first-line therapy for many illnesses, it does reduce the body’s ability to fight infections and generate a robust response to vaccines for diseases such as flu and pneumonia, including those targeting COVID-19.
Professor Abhishek, Chief Investigator at the University of Nottingham and Honorary Consultant Rheumatologist at Nottingham University Hospitals NHS Trust, stated, “COVID-19 has not disappeared, and with the emergence of new variants and vaccine hesitancy among patients, it is crucial to optimize long-lasting protection in individuals who are vulnerable to COVID-19. The evidence from our trial will assist patients and clinicians in making informed decisions regarding the risks and benefits of temporarily interrupting methotrexate treatment around the time of COVID-19 vaccination.”
Professor Danny McAuley, Scientific Director for NIHR Programs, emphasized the importance of this research, stating, “As winter approaches, millions of people with compromised immune systems remain susceptible to COVID-19, despite the disease’s decreased prevalence. This important research provides further high-quality evidence that by managing medications in relation to vaccinations, we can keep patients healthier while reducing strain on the healthcare system.”
The study was conducted in collaboration with researchers from the University of Manchester, Imperial College London, the University of Oxford, Queen Mary University London, the UK Health Security Agency (formerly Public Health England), and participating NHS hospitals. The Oxford Clinical Trials Research Unit (OCTRU) oversaw the management of the study.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
Ravina Pandya, Content Writer, has a strong foothold in the market research industry. She specializes in writing well-researched articles from different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. With an MBA in E-commerce, she has an expertise in SEO-optimized content that resonates with industry professionals.