New post-hoc analyses of data from SELECTION Phase 3 program presented at European Crohn’s and Colitis Organisation (ECCO) virtual congress
A post-hoc analysis of the induction study data from SELECTION showed significant improvements in patient-reported outcomes (PROs) of stool frequency (SF) and of rectal bleeding (RB), that were observed as early as the first week of therapy in patients on 200mg of filgotinib daily versus placebo in patients with moderately to severely active UC. These findings were observed in both biologic-naïve and biologic-experienced patients. More patients receiving filgotinib 200mg versus placebo achieved a composite score of RB=0 and SF≤1 as early as day 9 in Induction study A (biologic-naïve; filgotinib 200mg 18.8%, placebo 9.5%, p<0.05) and as early as day 7 in Induction study B (biologic-experienced; filgotinib 200mg 10.7%; placebo 4.2%, p<0.05).1
A further post-hoc analysis of the SELECTION maintenance study reported the proportion of patients who were steroid-free at different timepoints, before achieving remission at Week 58. These data indicated that filgotinib 200mg reduced and eliminated corticosteroid (CS) use versus placebo at Week 58 in patients with moderately to severely active UC. Compared with placebo, a significantly higher proportion of patients who demonstrated CS-free remission at Week 58 with filgotinib 200mg had been CS-free in the previous six months (27% filgotinib 200mg vs 6% placebo, 95% CI 21 (8, 34), with a difference seen from as early as the previous eight months (22% filgotinib 200mg vs 6% placebo, 95% CI 15 (3, 28)).2
Additional safety analysis from SELECTION, combining induction, maintenance and the long-term extension study data, with a cumulative treatment exposure of 1,207 patient years for filgotinib 200mg versus 318 patient years for placebo, showed results consistent with the original induction and maintenance trials, where filgotinib was well tolerated in patients with moderately to severely active UC.3
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic type of inflammatory bowel disease (IBD) that occurs as a result of an abnormal immune system response. Across
About the SELECTION Phase 3 Trial
The SELECTION Phase 3 trial is a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the preferential JAK1 inhibitor filgotinib in adult patients with moderately to severely active UC. The SELECTION trial comprises two induction trials and a maintenance trial. The Induction Study A enrolled biologic-naïve patients, and the Induction Study B enrolled biologic-experienced patients.
Across both induction studies, 1348 patients with moderately to severely active UC were randomized to receive either filgotinib 200mg, filgotinib 100mg or placebo in a 2:2:1 ratio. Moderately to severely active UC was defined as a centrally read endoscopy score ≥ 2, a rectal bleeding score ≥ 1, a stool frequency score ≥ 1 and Physician Global Assessment (PGA) of ≥ 2 based on the Mayo Clinic Score (MCS). 644 patients with clinical remission or response at Week 10 of induction were subsequently re-randomized to the induction dose of filgotinib or placebo in a 2:1 ratio and treated through Week 58.
The primary objectives of SELECTION were to evaluate the efficacy of filgotinib compared with placebo in establishing clinical remission as determined by the Mayo endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥ 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1 at Week 10 in the induction studies and Week 58 in the maintenance study. Eligible patients who were enrolled in the SELECTION trial were enrolled in the ongoing SELECTION long-term extension trial to evaluate the long-term safety of filgotinib in patients with moderately to severely active UC. A majority of patients included in the trials had a MCS of 9 or higher at baseline, and 43% of biologic experienced patients had insufficient response to a TNF antagonist and vedolizumab as well.
For SELECTION study information visit: https://clinicaltrials.gov/ct2/show/NCT02914522
About filgotinib
Filgotinib is approved and marketed as Jyseleca (200mg and 100mg tablets) in the
About the filgotinib collaboration
About Galapagos
- Danese. S, et al. Rapidity of symptom improvements during filgotinib induction therapy in patients with Ulcerative Colitis: post hoc analysis of the phase 2b/3 SELECTION study. OP37,
ECCO Congress 2021 - Loftus, E, et al. Corticosteroid-free remission of Ulcerative Colitis with filgotinib maintenance therapy: post hoc analysis of the phase 2b/3 SELECTION study DOP82,
ECCO Congress 2021 - Schreiber. S, et al. Safety analysis of filgotinib for Ulcerative Colitis: results from the phase 2b/3 SELECTION study and phase 3 SELECTIONLTE long-term extension study. OP04,
ECCO Congress 2021 - Burisch J. et al. The burden of inflammatory bowel disease in
Europe . Journal of Crohn’s and Colitis (2013) 7, 322-337
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Forward Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, including the SELECTION study, competitive developments, and regulatory approval requirements, including the risk that the results of the SELECTION study may not support continued approval of Jyseleca for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent due to safety, efficacy or other reasons , the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for UC or any other indications, such regulatory authorities requiring additional studies, Galapagos’ reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, Galapagos’ estimations regarding its filgotinib development program and regarding the commercial potential of filgotinib, risks related to the implementation of the transition of the European commercialization responsibility to us, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended
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