- 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, 3-5 October.
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 analyses compared the efficacy of filgotinib in biologic-naïve and biologic-experienced patients to placebo at week 10 (induction) and at week 58 (maintenance)1. Furthermore, 4 subgroups of biologic-experienced patients were analysed: failure of 1 biologic, failure of ≥2 biologics, failure of 1 MoA, failure of 2 MoAs.
Primary endpoints were clinical remission and Mayo score response at week 10 and week 58. Dr 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 bio-naïve patients (26.1% vs 15.3%) and bio-experienced patients (11.5% vs 4.2%). Clinical remission for patients on filgotinib 200 mg was achieved numerically more frequently in patients who had failed only 1 biologic (16.3%) or 1 MoA (15.1%) compared with subjects who had failed ≥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 bio-naïve patients (48.6% vs 16.7%) and bio-experienced patients (23.9% vs 6.8%). Interestingly, filgotinib 200 mg demonstrated higher clinical remission rates than placebo in responders who had failed ≥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.