The PERISCOPE trial: PERI-operative biologic DMARD management: Stoppage or COntinuation during orthoPaEdic operations

Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are common forms of inflammatory arthritis. They are caused by an overactive immune system and are treated with medicines that reduce pain and inflammation. In recent years, special immune-suppressing medicines, called biologics, have been developed, which are very effective in controlling the arthritis disease process and symptoms but can increase the risk of some infections.

People with inflammatory arthritis often need orthopaedic surgery (e.g. joint replacement) to relieve pain and improve function due to the damage caused by arthritis. The potential for increased risk for surgical site infections is a particular concern for patients undergoing orthopaedic surgery as these can be associated with long-term pain and need for further surgery. Currently, biologics are usually stopped before any planned operation to try and reduce the risk of infection and other complications such as slow wound healing. However, stopping biologics increases the risk of the painful and debilitating flares and delay recovery from surgery. Flares are often treated with steroids, which can increase the infection risk and delay wound healing. There are no randomised trials to support current guidance of stopping biologics before surgery.

The PERISCOPE study will involve 394 people with inflammatory arthritis on biologics from NHS hospitals across the UK who require orthopaedic surgery. Participants will be randomly allocated to either stopping or continuing their biologics before undergoing orthopaedic surgery. We will conduct regular patient assessments for the first 12 weeks following surgery. This will give a complete picture during the recovery period after the operation. We are using PROMIS-29; a quality of life questionnaire as the main study outcome. We will also ask patients about their health and wellbeing periodically over the next 12 months. We will record complications (infections, flares), disease activity, medications, how often people seek care and who with. We will compare costs and interview participants and clinicians to understand their views and experiences.

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