Filgotinib demonstrates promising results for various lines of therapy in UC

Both biologic-naïve and biologic-experienced patients with moderately to severely active ulcerative colitis (UC) achieved clinical remission more frequently when treated with filgotinib compared with placebo at weeks 10 and 58 of the phase 2b/3 SELECTION trial. In addition, the results at week 58 suggest that patients who had failed multiple biologics (of different mechanisms of action [MoA]) previously, could benefit from a treatment with high-dose filgotinib.

Filgotinib is an oral, once daily, JAK1 inhibitor that has demonstrated to induce and maintain clinical remission in UC patients with more efficacy than placebo in the phase 2b/3 SELECTION trial (NCT02914522). The current post-hoc analysis compared the efficacy of filgotinib in biologic-naïve and biologic-experienced patients with placebo at week 10 (induction) and at week 58 (maintenance) [1]. Furthermore, 4 subgroups of biologic-experienced patients were analysed, those who had not responded to: 1 biologic, ≥2 biologics, 1 MoA, or 2 agents with different MoAs. Primary endpoints were clinical remission and Mayo score response at week 10 and week 58. Prof. Iris Dotan (Rabin Medical Center, Israel) presented the findings.

At week 10, filgotinib 200 mg outperformed placebo regarding the proportion of patients in clinical remission in both biologic-naïve patients (26.1% vs 15.3%) and biologic-experienced patients (11.5% vs 4.2%). Clinical remission for patients on filgotinib 200 mg was achieved numerically more frequently in patients whose disease was not controlled after only 1 biologic (16.3%) or 1 MoA (15.1%) compared with subjects whose disease was not controlled after ≥2 biologics (7.4%) or 2 MoAs (6.7%). The Mayo score response showed a similar trend at week 10. At week 58, superior clinical remission rates were observed for filgotinib 200 mg versus placebo in both biologic-naïve patients (48.6% vs 16.7%) and biologic-experienced patients (23.9% vs 6.8%). Interestingly, filgotinib 200 mg demonstrated higher clinical remission rates than placebo in responders who had not responded to ≥2 biologics (27.9% vs 4.5%) or 2 MoAs (25.8% vs 0.0%) at the end of the maintenance study. However, this last result should be interpreted with caution due to low patient numbers.

1. Dotan I, et al. Efficacy of filgotinib in patients with ulcerative colitis by line of therapy in the phase 2b/3 SELECTION trial. OP191, UEG Week Virtual Congress 2021, 03–05 October.

 

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Posted on 27 October, 20218 April, 2024