228. BIOSIMILARS IN THE UNITED KINGDOM: FIRST REAL-WORLD DATA FROM THE BRITISH SOCIETY FOR RHEUMATOLOGY BIOLOGICS REGISTERS FOR RHEUMATOID ARTHRITIS

Abstract

Background: Biosimilars, biopharmaceuticals assessed by regulatory agencies to have efficacy and safety similar to their reference products, were introduced to the UK market in February 2015 for rheumatoid arthritis(RA). Most RA research on biosimilars has been done in the context of clinical trials, but real world data are lacking. This analysis describes the characteristics of the first UK patients starting RA biosimilars registered with the British Society for Rheumatology Biologics Register for RA(BSRBR-RA). Methods: Since 3 August 2015, the BSRBR-RA has captured data on patients starting biosimilars available in the UK: infliximab(Inflectra and Remsima) and etanercept(Benepali). At biosimilar start, information is captured from the hospital including demographic and clinical data, previous biologic exposure and if switching therapies, the reason for switch (as tick box and free text). Follow-up data, including disease activity, adverse events and treatment changes is captured 6-monthly for 3 years and annually thereafter. Descriptive data are presented. Results: To 4 October 2016, 218 patients were recruited to the BSRBR-RA starting a biosimilar for whom data was available for analysis on 173 participants: 40(23.1%) Inflectra, 51(29.5%) Remsima and 82(47.4%) Benepali). Of these, 45 started a biosimilar as first biologic, 116 switched directly from the originator product and 12 switched from an alternative biologic (Table 1). Patients switching from the originator did so after a median(IQR) of 6.4(3.0-10.0) years and the majority had low disease activity [median DAS28 2.9(IQR 2.2-3.9)]. The switch reason was reported in 55% of patients, with cost listed as the main reason in 83% and trust policy included in 50% of 16 free text comments. Six-month follow-up data was available in 25 patients(all switchers from originator). One patient reported a drug hypersensitivity reaction(rash) with Remsina and three patients experienced a deterioration in their DAS28 of>1.2. Conclusion: This preliminary study gives a first review of biosimilar use in the UK, showing that these drugs are used in patients with active disease as both first-line and subsequent-line biologics. Many patients with low disease activity are also being switched from originators primarily for cost reasons. Outcome data are limited but data capture will continue and updated reports from the BSRBR-RA will continue to be presented. (Table Presented).