Solid results for long-term therapy of UC with filgotinib

In the long-term extension of the phase 3 SELECTION trial, filgotinib led to maintained efficacy up to week 144 as treatment for ulcerative colitis (UC) in patients who responsed to induction. The safety profile was in line with the previous results.

SELECTIONLTE (NCT02914535) is an ongoing, open-label extension trial of the JAK inhibitor filgotinib which has already been approved as a treatment for UC [1]. “The aim of this interim analysis, based upon approximately 4 years of therapy, was to assess the safety and efficacy over the longer term,” Dr Brian Feagan (University of Western Ontario, Canada) outlined the topic of the presented investigation. The analysis included data up to week 144 from 148 participants who completed the SELECTION trial (NCT02914522) and who responded to induction therapy with filgotinib and entered SELECTIONLTE after completing the maintenance part. It also included results up to week 192 from 372 patients who did not respond to induction and were directly changed to open-label filgotinib.

Looking at safety first, overall treatment-emergent adverse events (TEAE) were reported at an exposure-adjusted incidence rate of 111.5 per 100 patient-years. TEAE of at least grade 3 happened at 9.8 per 100 patient-years. Special focus was placed on specific issues noted in association with JAK inhibitor therapy. This included herpes zoster, malignancies, major adverse cardiovascular events and, venous thromboembolisms with rates of 1.5, 0.5, 0.2, and 0.1 per 100 patient-years, respectively.

The efficacy results were more favourable in the subgroup of completers than in the induction non-responders. Dr Feagan highlighted that up to 144 weeks, preservation is seen of the absolute changes in the partial Mayo Clinic Score from approximately 6 to 2 in approximately 70–80% of patients over time (see Figure).

Figure: Mean change in the Mayo Clinic Score over time in SELECTION and SELECTIONLTE among completers treated with filgotinib 200 mg during both studies [1]



N, number of patients with available data; pMCS, partial Mayo Clinic Score defined as the sum of Mayo rectal bleeding, stool frequency, and physician’s global assessment subscores; FIL200, filgotinib 200 mg; IND, induction; LTE, long-term extension; MNT, maintenance.

Notably, in the initial non-responders, the scores continued to improve up to week 192. As for health-related quality-of-life, over 90% of responders and over 60% of non-responders achieved a minimal clinically important difference that was defined as an increase of ≥16 points on the inflammatory bowel disease questionnaire score. Clinical remission, represented by ≥170 points in the same score, was seen in more than 80% of completers at week 144 and in over 70% of primary non-responders at week 192.

“In the collective assessment of the data, this indicates that filgotinib as a long-term treatment shows a consistent and established safety profile and is effective for the management of these patients,” Dr Feagan summarised.

1. Feagan BG. Efficacy and safety outcomes up to ~4 years of treatment with filgotinib 200 mg among patients with Ulcerative Colitis: Results from the SELECTIONLTE study. OP35, ECCO 2023, 01–04 March, Copenhagen, Denmark.

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Posted on 4 May 20238 April 2024