Filgotinib demonstrates long-term corticosteroid-sparing effects in UC

Post-hoc analysis of the phase 2b/3 SELECTION trial showed that corticosteroid (CS)-free remission was reached in a greater proportion of patients receiving filgotinib in the maintenance phase than patients who were receiving placebo in the maintenance phase, in a population of patients with moderately to severely active ulcerative colitis (UC). Moreover, patients receiving filgotinib in the maintenance phase who achieved clinical remission at week 58 were mostly CS-free for at least 6 months.

Filgotinib is an oral, preferential JAK1 inhibitor in development. Efficacy of filgotinib in patients with moderately to severely active UC was demonstrated in the randomised, double-blind, placebo-controlled, phase 2b/3 SELECTION trial (NCT02914522). Since long-term use of CS is linked to significant adverse events [1], the current post-hoc analysis aimed to assess if filgotinib has CS-sparing effects [2]. For the maintenance study, responders of the original induction trial were re-randomised 2:1 to either the same dose of filgotinib they received in the induction study (100 mg or 200 mg once daily) or placebo. Prof. Séverine Vermeire (University Hospital Leuven, Belgium) presented the results.

Regarding the patients on CS at maintenance baseline, 30% of the patients who were re-randomised to the filgotinib 200 mg arm (n=202) reached CS-free remission of at least 1 month at week 58, compared with only 6% of the placebo receivers (n=99). In addition, 27% of the filgotinib 200 mg receivers showed a CS-free remission of 6 months at week 58. Similarly, daily CS dosing of CS receivers at maintenance baseline was lower in the filgotinib arm than in the placebo arm. Finally, 93% of the patients receiving filgotinib 200 mg during maintenance and reaching remission at week 58 were CS-free ≥6 months.

1. Selinger CP, et al. Aliment Pharmaco Ther. 2017;46:964-973
2. Loftus Jr EV, et al. Corticosteroid-free remission of ulcerative colitis with filgotinib maintenance therapy: post hoc analysis of the phase 2b/3 SELECTION study. OP042, UEG Week 2021 Virtual Congress, 03–05 October.

 

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Posted on 27 October 20218 April 2024