Background and Aims Subcutaneous (SC) vedolizumab presents the opportunity for inflammatory bowel disease (IBD) patients to manage their treatment at home. There is currently no data on the process of transitioning patients established on intravenous (IV) to SC as part of routine clinical care. The aim of this programme is to evaluate the clinical and biochemical outcomes of switching a cohort of IBD patients established on IV vedolizumab to SC 12 weeks following the transition. Methods 178 adult patients were offered the opportunity to transition to SC vedolizumab. Patients who agreed were reviewed prior to switching and at week 12 (W12) after their first SC dose. Evaluation outcomes included disease activity scores, the IBD-Control patient-reported outcome measures (PROMs) and faecal calprotectin (FCP). Reasons for patients declining or accepting transitioning, pharmacokinetics, adverse drug reactions and risk factors for a poor outcome in SARS-CoV-2 infection were also assessed. Results 124 patients agreed to transition, of which 106 patients had been on IV vedolizumab for at least 4 months. There were no statistically significant differences in disease activity scores or IBD-Control PROMs between baseline and W12. A statistically significant increase in FCP was observed (31µg/g vs. 47µg/g; p=0.008), although this was unlikely to be clinically relevant. The most common adverse drug reaction reported was injection site reactions (15%). Based on this cohort of patients, an expected reduction of £572,000 per annum is likely to be achieved. Conclusions Transitioning patients established on IV vedolizumab to SC appears to be safe and effective, with high patient satisfaction and multiple benefits for the health service.

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IntroductionBiosimilar infliximab (CT-P13) has been licensed for the treatment of IBD in Europe for over a year with the potential for significant cost savings. However, uptake in the UK has been slow primarily due to concerns over the lack of safety and efficacy data particularly with regard to switching patients from the originator product. We present the preliminary data from a controlled switch programme in a cohort of adult IBD patients.MethodsA prospective study was undertaken to assess the safety and efficacy of switching patients receiving originator infliximab (Remicade) to its biosimilar (CT-P13). Patient demographic data was collected along with disease severity scores (HBI and SCCAI), biological markers of disease activity, drug and antibody levels and PROM data (IBD-Control questionnaire) prior to the switch and at each subsequent infusion visit. Evaluation of the efficacy of biosimilar infliximab at the time of the last infusion was compared with the originator at switch over. Means, medians, and ranges were calculated. Adverse events were prospectively collected.Results78 IBD patients were included in the cohort (63 CD and 15 UC). The average age for the CD and UC patients was 43 and 42 years respectively. The average length of therapy on Remicade prior to the switch was 46 months for CD and 25 months for UC. 66/78 (85%) patients were receiving the standard dosage of 5 mg/kg 8 weekly with 12/78 (15%) either on a shortened interval or a 10 mg/kg dose. 42/63 (67%) of CD patients were in remission at switch over compared to 43/60 (72%) at the most recent infusion (4–6 months). The number of patients with mild, moderate and severe disease remained stable throughout the study period (Mild 10/63 (16%) v 11/60 (18%): Moderate 10/63 (16%) v 5/60 (8%): Severe 1/63 (2%) v 1/60 (2%)). 9/15 (60%) of UC patients were in remission at switch over compared with 11/13 (85%) at the most recent infusion. There was no difference in the mean CRP before and after the switch in either CD patients (5.4 vs 5.6 p=0.32) or UC patients (3.1 vs 3.0 p=0.73). The mean patient questionnaire score data also remained unchanged before and after the switch (CD 4.4 vs 4.0 p=0.56, UC 4.9 vs 3.1 p=0.61). Five patients (3 CD, 2 UC) discontinued infliximab during the study period (3 switched biological class, 1 infusion reaction, 1 deep remission). There were no adverse safety signals with one infusion reaction (1/283 infusions) and the rate of mild adverse events unchanged from before and after the switch.ConclusionSwitching patients with IBD from originator infliximab to biosimilar infliximab appears both safe and effective. Wider uptake in the UK would result in considerable cost savings to the NHS.Disclosure of InterestNone Declared

IntroductionBiosimilar infliximab (CT-P5013) has been licensed in the UK for over a year with the potential for significant cost savings, though uptake to-date has been surprisingly slow. We report the introduction of biosimilar infliximab through a closely managed switching programme.MethodsFollowing the licensing of biosimilar infliximab we made a decision to instigate a closely managed switching programme encompassing all patients on maintenance treatment with Remicade and all new starters. A working party was set up with strong managerial support to deliver the project. We initially estimated savings of £400,000/year to the local health economy. Following meetings with the 3 local CCGs agreement was confirmed for a 50:50 gain share agreement between the CCGs and the Trust. To facilitate and monitor the switching programme a new Band 7 IBD Biological nurse, a Band 7 IBD Biological pharmacist, and an IBD administrator were recruited. All patients were informed by letter of the planned switch and the rationale for it. A variety of clinical and biological markers were also recorded at each visit along with PROM data.ResultsTo date since the start of the project on 16th September 2015 88 patients have been treated with biosimilar infliximab. 78 (63 CD/15 UC) patients on maintenance treatment with Remicade were switched to CT-P13 with unchanged efficacy and safety (the detailed results are the basis of a separate abstract); a further 10 patients received induction therapy (7 CD/3 UC). 3/88 patients requested further clarification from the IBD team with all patients subsequently agreeing to the switch. All patients were seen by either the IBD pharmacist or IBD specialist nurse and stated they felt well informed. Over the first six months the programme has generated total cost savings of £232,576.52 with projected year savings of £540,000. Staff costs totalled £90,000. PROM data from the cohort revealed very high satisfaction with treatment with a mean score of 7.3 (Range 3–10) for overall disease control. Patient feedback was universally positive.ConclusionThe introduction of biosimilar infliximab can be achieved through a closely managed programme with very significant cost savings to the local health economy. Engaged conversations between primary and secondary care facilitate realising these savings allowing investment in the local IBD service with direct impact on patient care. Patients were overwhelmingly supportive of the project. Wider uptake in the UK would result in considerable cost savings to the NHS.Disclosure of InterestNone Declared