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Phase III SELECTION trial data for Jyseleca demonstrates clinical benefits in ulcerative colitis.

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Last updated:8th Oct 2021
Published:6th Oct 2021
Galapagos announced results of two post-hoc analyses from the SELECTION and SELECTION LTE studies, which are part of the Phase III clinical program for Jyseleca (filgotinib), for the treatment of patients with moderately to severely active Ulcerative Colitis.

These analyses showed clinical benefits of continued dosing with filgotinib 200mg, an oral once-daily JAK1 preferential inhibitor, in patients who did not respond at week 10. Separately, health-related quality of life (HRQoL) benefits of filgotinib 200mg treatment versus placebo, in patients with UC were shown.

In SELECTION, patients who did not respond to induction therapy at week 10 could receive open-label filgotinib in the LTE. In a post-hoc analysis, it was shown that continuing filgotinib 200mg among those non-responders resulted in 65.7% biologic-naïve and 62.2% biologic-experienced patients achieving partial Mayo Clinic Score (pMCS) response by Week 12, with 17.1% biologic-naïve and 16.7% biologic-experienced patients in pMCS remission (Presentation MP082).

In addition, a post-hoc analysis of HRQoL data from the SELECTION study shows that patients treated with filgotinib 200mg achieved clinically meaningful improvements in their quality of life, versus placebo. These included Inflammatory Bowel Disease Questionnaire remission and measurements of productivity, physical, and mental components, assessed by 36-item Short Form Survey (SF-36), EuroQol 5-dimension (EQ-5D) visual analogue scale and Work Productivity and Activity Impairment questionnaire (Poster PO457).

Other posters included: "A Matching-Adjusted Indirect Comparison of Maintenance Oral Filgotinib versus Intravenous Vedolizumab for Moderately to Severely Active Ulcerative Colitis" and "Relationship between histo-endoscopic mucosal healing and baseline characteristics in patients with moderately to severely active ulcerative colitis receiving filgotinib in the phase IIb/III SELECTION study". These data will be presented at the UEGW virtual 2021 congress (3 – 5 October).

Condition: Ulcerative Colitis
Type: drug

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