Introduction

Filgotinib was licensed for use in ulcerative colitis in the UK in January 2022 and NICE approved in June 2022. We reviewed our patients treated with filgotinib following the additional measures recommended by the EMA to identify those at increased risk of side effects with JAK inhibitors. The position of filgotinib in therapeutic pathways and the ideal sequence of medications needs defining. This is a description of the real-world experience of its effectiveness and patient reported outcomes in one IBD tertiary referral centre.

Methods

Patients, as part of clinical care, had blood safety monitoring, adverse event recording and effectiveness measured using faecal calprotectin (FC), SCCAI and IBD-Control. Endoscopy data, where available, was collected. A retrospective observational analysis was conducted.

Results

All 31 patients initiated on filgotinib are included in this analysis. The mean age was 43 (SD ± 16) years, 17 were male and median disease duration was 3 (IQR 2–10) years. Disease extent (as per Montreal classification) is: E1: 3, E2: 8 and E3: 20. Four patients had previously been exposed to tofacitinib, 21 to anti-TNFα agents, 16 to vedolizumab and 7 to ustekinumab. 6 patients had not received any prior cytokine modulator drugs. 5 patients had at least one risk factor included in the EMA warning. At baseline median FC was 1037, 22 patients had SCCAI ≥6 and 11 patients were taking oral corticosteroids. of 20 patients who had endoscopic assessment at baseline, 17 had a Mayo score of ≥2. Persistence at 120 days was 65% (figure 1A). Four patients had primary non-response, two secondary loss of response and two patients stopped due to adverse events. of the 10 patients who remained on treatment and received follow up (mean 103 days), all had a clinically significant reduction in SCCAI score of ≥3 (figure 1B) and 9 had an improvement in their IBD-Control-8 subscore. 13 patients are awaiting follow-up but continue on the medication. Filgotinib was generally well tolerated, other than minor side effects including headache, pruritis and nausea. There were no venous thromboembolisms reported. Two patients underwent colectomies, both patients had prior exposure to all classes of approved biological medicines. No other serious adverse events were reported.

Conclusions

In this small group, that included a proportion of complex patients, filgotinib appears to be efficacious and well tolerated.

Filgotinib in ulcerative colitis: early real-world experience in Southampton