P34 Biosimilar use in children and young people with juvenile idiopathic arthritis in a real-world setting in the United Kingdom

Abstract

Background: Little to no data regarding the use of biosimilars in children and young people (CYP) with juvenile idiopathic arthritis (JIA) exist. Our aim was to describe the characteristics of CYP with JIA starting biosimilars in the United Kingdom (UK) following their approval in the UK with musculoskeletal diseases. Methods: The Biologics for Children with Rheumatic Diseases (BCRD) is an ongoing prospective UK study recruiting CYP with JIA starting biologic therapies other than enbrel (followed in a separate parallel study) from 2010 onwards. Baseline information is collected via questionnaires completed by the treating physician or affiliated clinical research nurse. Follow-up data including disease activity measures and changes in drug therapy are collected at six months, one year and annually thereafter. From 30 September 2015, data has been captured on infliximab and etanercept biosimilars available in the UK. Results: To 7 June 2018, 80 patients in total were identified in the BCRD study starting a biosimilar of which 59 (74%) starting an infliximab biosimilar and 21 (26%) an etanercept biosimilar (Table 1). Of these, 50 (63%) started a biosimilar as their first biologic therapy. Nine (11%) patients switched from their originator. The median (IQR) time on originator before switch was 1.6 (0.7-6.6) years. Twenty one (26%) switched to an infliximab biosimilar from a non-originator biologic with fourteen switching for efficacy reasons and seven for safety reasons. The majority (n=15) switched from adalimumab. Active uveitis was present in ten patients at the point of starting a (Table presented) biosimilar. Follow-up data out to two years were available in twenty six patients. Eleven patients switched to another biologic in this period: four infliximab biosimilar patients switched to tocilizumab and three infliximab and two etanercept biosimilar patients switched to adalimumab. One patient switched back from etanercept biosimilar to originator due to increased pain, one patient switched from an etanercept biosimilar to an unknown biologic at the time. Infliximab biosimilars were interchanged in eleven patients due to changes in hospital procurement. No serious adverse events were reported. Three cases of recurrent uveitis in patients on an infliximab biosimilar switching from a non-originator biologic were noted. Conclusion: Biosimilars in CYP with JIA are being used as both firstline and subsequent-line biologic therapy. Whether a move towards switching all children receiving originator products to biosimilar products, as has been seen in rheumatoid arthritis, will occur is currently unknown but it is imperative that the safety of these treatment decisions are captured in patient registers.