P84 Effectiveness and persistence of filgotinib in ulcerative colitis: real-world experience

Introduction Filgotinib is an orally administered selective Janus Kinase inhibitor used in the treatment of moderate-to-severe ulcerative colitis (UC). It was licensed in the UK in January 2022 and early real-world data showed its effectiveness following induction therapy. Here we aim to describe the effectiveness after induction and persistence at 6 months. Methods The data for all patients commenced on filgotinib was reviewed and retrospective analysis conducted. Patients’ disease background, previous advanced therapies, and response at 10 weeks and 6 months compared to baseline was documented. Response was defined as a reduction of: Simple Clinical Colitis Activity Index (SCCAI) ≥3 (or maintained SCCAI <2), faecal calprotectin (FCP) ≥50%, and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) ≥2. Remission was defined as: SCCAI <2, FCP ≤200µg/g, and UCEIS ≤1. Corticosteroid use during induction and drug persistence over 6 months was reviewed. Results Of the 17 patients commenced on filgotinib the majority (82%) were male with a median age of 36 (39–40) and disease duration of 5 years (0–9). Disease extent as per Montreal classification was: E1–18%, E2–53%, and E3–29%. Prior advanced therapy failure was only seen in 3 patients. All patients had clinically or endoscopically active disease and 47% received steroids during induction. Clinical remission was achieved in 41% of patients at 10 weeks (figure 1A), all of whom were steroid free. This was reflected in the overall reduction of median SCCAI from 6 (5–9) to 1.5 (0–4) (p=0.001). Where paired data was available, 30% (n=13) and 72% (n=11) were in endoscopic and biochemical remission respectively. Median UCEIS improved significantly from 4 (3–5) to 2 (2–4) (p=0.037) and FCP from 289 µg/g (172–579) to 25 µg/g (17–74) (p=0.11) though this did not reach statistical significance. Of those in clinical remission, all were in biochemical remission and 40% were in endoscopic remission. At 6 months, persistence was 73% (n=15) (figure 1B), with drug withdrawal due to primary non-response in 4 patients. 6-month outcomes are available in 7 patients (figure 1A), and of the 5 who are in clinical remission, all were in clinical remission at 10 weeks. The remaining patients continue filgotinib and are awaiting follow-up. No significant adverse events have been noted and 41% had mild changes to their blood test results not requiring drug withdrawal. *Response includes remission and response. Conclusions Filgotinib was effective in inducing and maintaining remission in this cohort of UC patients. The overall complexity of disease was low with minimal prior advanced therapy failure. Further data is required to review clinical outcomes in more refractory disease and long-term maintenance of remission.

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