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IntroductionThe introduction of biosimilar infliximab with CT-P13 offers substantial potential cost savings. Data on switching from Remicade to CT-P13 is only just emerging and was not available in early 2016. Therapeutic drug monitoring (TDM) is increasingly recognised as an effective means to optimise patient outcomes on anti-TNF therapy, but is not widely adopted in the UK. Following discussions with hospital management, we took the opportunity to implement TDM whilst switching patients established on Remicade to biosimilar CT-P13.MethodA switch pathway was agreed and implemented, with all data collected prospectively. Routine blood tests, disease activity scores (Partial Mayo/HBI), faecal calprotectin (FC) and serum for infliximab trough levels (ITL) and antibodies to infliximab (ATI) were obtained. Results were reviewed in a virtual biologics clinic and decision made on further management as per NICE DG-22 TDM algorithm. Clinical remission was defined as HBI <5 and Partial Mayo<2.Results169/170 patients currently receiving Remicade agreed to our switch process. 95/169 (56%) patients were switched to CT-P13 with no dose change whilst 15/169 (9%) switched with dose escalation and 8/169 (5%) with dose de-escalation. 27/169 (16%) patients stopped biologic therapy altogether due to a combination of immunogenicity (ITL<3 µg/ml; ATI>8 µg/ml), clinical and biochemical remission. 24/169 (14%) patients had immunogenicity with infliximab but were not in remission and therefore switched to an alternative biologic (ADA n=18; VDZ n=6). Remission rates of patients switched with no dose change were 97% pre-switch, compared to 91%, 95%, and 96% at week 6–8, week 12–16 and week 18–24 respectively. In the patients with CD (n=91) median HBI remained unchanged pre-switch and at week 6–8 (HBI 0, p=0.5), week 12–16 (HBI 0, p=0.5) and week 18–24 post-switch (HBI 0, p=0.4). There was no significant difference between ITL and incidence of ATI pre-switch and at week 18–24 (4.2 µg/ml vs 3.7 µg/ml, p=0.4; 30% vs 26%, p=0.5). 100% of patients who switched with dose de-escalation (n=8) remained in remission at week 18–24. Data on patients who switched with dose escalation or who stopped treatment are presently being analysed. No infusion reactions were reported. Health-economic evaluation of the switch process/TDM implementation has projected a cost-saving of approximately £7 00 000 in year 1.ConclusionOur local experience further supports interchangeability between originator and biosimilar infliximab whilst also demonstrating the significant cost saving that can be achieved through the adoption of biosimilars and TDM.Disclosure of InterestNone Declared

IntroductionThe GEMINI clinical trials programme has demonstrated the efficacy and safety of vedolizumab in the induction and maintenance of Crohn’s disease and ulcerative colitis. 2 years after licensing and subsequent approvals (eg. NICE/SMC), there is great interest in real world effectiveness and safety data from early adopters. Here, we present the short and medium term outcomes from a single centre cohort of IBD patients treated with vedolizumab.MethodThe following were prospectively collected for all patients at each infusion: observations, routine haematology, biochemistry and inflammatory markers, clinical disease activity score, faecal calprotectin (FC) and adverse events. Clinical effectiveness was evaluated by assessing changes in HBI and SCCAI at 12–14 weeks and 26 weeks. Clinical remission was defined as a HBI <5 and SCCAI <3. Response was defined as a change in disease activity ≥3. Changes in CRP/FC were also analysed.ResultsBy the end of November 2016, 94 patients had received vedolizumab treatment. 63/94 (27 CD, 33 UC, 3 IBDU) had completed 12–14 week follow-up and are included in the primary analysis of clinical efficacy. Median disease duration was 7.9 years (IQR 4–15) with 36/63 (57%) patients previously exposed to anti-TNF therapy. Median HBI and SCCAI at baseline were 4 (IQR 2–7) and 5 (IQR 2–6) respectively. At 12–14 weeks median HBI was 3 (IQR 1–7) (p=0.37) with SCCAI dropping to 1 (IQR 1–3) (p=0.004). At 26 weeks median HBI fell to 2 (IQR 0.5–3, n=15) (p=0.02) and SCCAI remained at 1 (IQR 0–1, n=26) (p=0.0001). 23/63 (37%) patients were in clinical remission at baseline (59% on steroids) with 42/63 (67%) at 12–14 weeks (24% on steroids) and 35/41 (85%) at 26 weeks (12% on steroids). Clinical response and remission rates of those patients with clinically active disease at baseline were 61% and 53% at week 12–14 (n=36), and 78% for both at week 26 (n=24). Median FC was 730 µg/g (IQR 215–858, n=50) at baseline, 170 µg/g (IQR 60–465, n=36) at week 12–14 (p=0.00018) and 70 µg/g (IQR 30–180, n=29) at week 26 (p=0.00001). No significant drug related complications were observed. Arthralgia was the most commonly reported side effect (12/94). 7/94 (7%) patients underwent surgery within 30 weeks of starting vedolizumab. 2 pregnancies and 1 colorectal cancer were reported in our cohort.ConclusionOur experience further supports the clinical effectiveness and safety data for the use of vedolizumab. We demonstrate a clear benefit in clinical/biochemical disease activity in a cohort of IBD patients many of which had complex and previously refractory disease.Disclosure of InterestNone Declared