Thousands of people with inflammatory arthritis who need joint surgery face a difficult choice: stop their biologic drugs to reduce infection risk, or continue them and risk a disease flare. This trial will settle whether it is safer to pause or keep taking these medications during the perioperative period. The problem is a clinical blind spot. Current practice—withholding biologics before surgery—is based on infection fears, but it leaves patients vulnerable to painful flare-ups and loss of disease control. No randomised trial has ever tested which approach works better. This matters because the trade-off between infection and flare directly affects recovery, pain, and long-term joint function for a large patient group. If the trial shows that continuing biologics is safe and effective, it could change surgical guidelines worldwide. Patients would avoid unnecessary flares, reduce steroid use, and maintain disease control during a critical recovery window. The research also includes a cost-effectiveness analysis, so the NHS will know whether one approach saves money while improving outcomes. A co-developed patient decision aid will help surgeons and patients weigh risks in plain language, making shared decision-making routine rather than guesswork.
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Research Question: What are the benefits and harms of continuation versus stoppage of biologics in patients with inflammatory arthritis (IA) undergoing orthopaedic surgery? Background: Biologic disease-modifying anti-rheumatic drugs (bDMARDs) have revolutionised the treatment of IA. However, many people with IA still require planned orthopaedic surgery to reduce pain and improve function. Currently bDMARDs are withheld during the perioperative period due to potential infection risk. However, this predisposes patients to a risk of flares and loss of disease control. This issue has not been explored in an RCT. Aims/Objectives: To determine the clinical effectiveness, cost effectiveness and acceptability of continuation versus stoppage of bDMARDs in patients with IA undergoing planned orthopaedic surgery. Methods: We will conduct a multi-centre, superiority RCT with an internal pilot and nested qualitative study. This pragmatic study will be conducted across 20 NHS sites and include diverse populations. It will include adults with Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Juvenile Inflammatory Arthritis who are currently prescribed bDMARDs. 394 patients will be randomised 1:1, stratified by site, disease, surgery (soft tissue/metalwork/joint replacement) and sex. Patients will be followed for the first 12 months post-surgery. The primary outcome will be PROMIS-29 during the first 12 weeks after surgery. Secondary outcomes include assessment of physical function, disease activity, medications use (steroids, antibiotics, additional drugs), health care resource use and costs. Adverse events and patient satisfaction will be recorded. The primary and secondary outcomes will be compared using a covariance pattern mixed-effect linear regression model, incorporating post-randomisation time points. Delayed wound healing and surgical site infections will be compared using a generalised linear model; risk differences and relative risk will be reported. Cost-effectiveness will be evaluated using a within-trial cost-utility analysis from NHS and personal social services perspectives over 12 months. We will interview 30 patients and 20 clinicians to establish acceptability and experience of the potential trade-off between infection risk and disease control. We will explore ways in which information relating to risks and benefits could best be described in a clinical setting. This research has been co-produced at all stages by our PPI advisory group (PAG), including members from underserved populations. Timelines: An embedded pilot phase (9 months) will enable assessment of the recruitment strategy. The study will take 52 months in total. Dissemination: The qualitative study will inform how the evidence should be described to key stakeholders to facilitate patient and clinician decision making as part of high-quality patient-centred care. With the PAG, we will co-develop a patient information sheet and decision aid to inform future patients and explain the risks/benefits in an accessible pictorial format. We will publish our findings in high-impact journals, which will be used to develop national and international guidelines. We will present at professional society events and organise press releases through NHS organisations. We will engage with rheumatology/orthopaedic communities, patient advocacy groups and charities in all disease areas to ensure broad adoption and implementation of the research findings
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