PTH-092\u2005Early ‘Real World’ Experience with Tofacitinib for Moderate to Severe Ulcerative Colitis

Abstract

Introduction Tofacitinib is an oral, small molecule Janus kinase inhibitor, which recently received NICE approval for the treatment of moderate to severe treatment refractory ulcerative colitis. We present early clinical and biochemical outcome data for a small group of new starters in a tertiary IBD referral centre. Methods A retrospective cohort analysis of patients was undertaken using prospectively maintained records. Patients commenced on tofacitinib through the patient access scheme between October 2018 to February 2019 were included. Clinical disease activity was measured at baseline, at four and eight weeks using the Simple Clinical Colitis Activity Index (SCCAI). Faecal calprotectin and C-reactive protein were measured at baseline and eight weeks. Results At the time of submission, 16 patients had commenced tofacitinib, with outcome data available for 8 patients who had reached at least four weeks of treatment. All 8 patients (median age 46) with Mayo 2–3 colitis demonstrated on pre-induction endoscopy, were previously exposed to an anti-TNF agent, of which 6 had also failed vedolizumab. Median baseline SCCAI (n=8) fell from 8 (range 2–14) to 3 (1–5) after four weeks and remained stable at eight weeks. Median baseline faecal calprotectin (n=5) fell from 364 (131- 645) to 95(30–289). One patient reaching week 16 was in endoscopic remission. Tofacitinib was well tolerated with only one patient reporting a mild headache and diarrhoea, which self-resolved in under a week. No haematological or biochemical abnormalities were noted. Conclusions Our early experience with tofacitinib for moderate to severe ulcerative colitis is encouraging, with an improvement in SCCAI and faecal calprotectin in all our patients. Oral dosing and a quicker onset of action are other advantages, which may enable positioning above vedolizumab. Further real life data is necessary in this setting to demonstrate effectiveness and a longer term safety profile.