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FRI0196 Biosimilars in the uk: early real world data from the british society for rheumatology biologics registers for rheumatoid arthritis
  1. D De Cock1,
  2. K Watson1,
  3. KL Hyrich1,2,
  4. on behalf of BSRBR-RA Control Centre Consortium
  1. 1Arthritis Research UK Centre for Epidemiology, University of Manchester
  2. 2National Institute of Health Research Manchester Musculoskeletal Biomedical Research Unit, Central Manchester NHS Foundation Trust, Manchester Academic Health Science, Manchester, United Kingdom

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 research on RA biosimilars has been done in the context of clinical trials, but real world data are lacking. No national mandate exists in the UK to switch all patients from originator to biosimilars, but there are regional variations.

Objectives This analysis aims to describe 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 03/08/2015, 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 a tick box and free text). Follow-up data, including disease activity, occurrence of adverse events and changes to treatment is captured 6-monthly for 3 years and annually thereafter. Descriptive data are presented.

Results To 15/12/2016, 417 RA patients were recruited to the BSRBR-RA at point of starting a biosimilar for whom data were available for analysis on 414 participants: 47 (11%) Inflectra, 78 (19%) Remsima and 289 (70%) Benepali. Of these, 138 started a biosimilar as first biologic, 242 switched directly from the originator product and 34 switched from an alternative biologic (Table). Patients switching from the originator did so after a median (IQR) of 6.7 (3.0–9.5) years and the majority had low disease activity (median DAS28 2.7 (IQR 2.0–3.9)). The switch reason was reported in 33% of patients, with cost listed as the main reason and “trust policy” included in 63% of 30 free text comments. Six-month follow-up data were available in 41 patients. Three patients on Remsima and 1 patient on Inflectra reported drug hypersensitivity reactions (rash, pruritus, hyperpigmentation), and 18% (6/34) of patients experienced a deterioration in their DAS28 of >1.2 after 6 months.

Conclusions This preliminary study gives an early 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.

Disclosure of Interest None declared

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