Gilead and Galapagos presented late-breaking data from the phase 2b/3 SELECTION trial at the 2020 United European Gastroenterology Week (UEGW) Virtual Meeting (Abstracts #LB19 and #LB20). The trial evaluated filgotinib versus placebo in patients with moderately to severely active ulcerative colitis (UC). The data showed that a significantly higher proportion of patients treated with filgotinib versus placebo, achieved clinical remission at Week 10 and maintained remission through Week 58.
SELECTION was a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of filgotinib in adult patients with moderately to severely active UC. The trial comprised two induction trials and a maintenance trial. The Induction Study A enrolled biologic-naïve patients, and the Induction Study B enrolled biologic-experienced patients. Overall, 1,348 patients were randomized and treated in the SELECTION study. Across both induction studies, patients were randomized to receive filgotinib 200 mg, filgotinib 100 mg or placebo in a 2:2:1 ratio. 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.
Among biologic-naïve patients treated with filgotinib 200 mg, a significantly higher proportion of patients achieved clinical remission at Week 10 compared with placebo (26.1% vs. 15.3%). Additionally, a significantly higher proportion of biologic-naïve patients treated with filgotinib 200 mg versus placebo achieved Mayo Clinic Score (MCS) remission (24.5% vs. 12.4%), endoscopic remission (12.2% vs. 3.6%) and histologic remission (35.1% vs. 16.1%). A significantly higher proportion of biologic-experienced patients treated with filgotinib 200mg achieved clinical remission at Week 10 compared with placebo (11.5% vs. 4.2%).
At Week 58 (Maintenance Trial, n=558) 37.2% of patients receiving filgotinib 200 mg achieved clinical remission, compared with 11.2% of patients treated with placebo. A significantly higher proportion of those treated with filgotinib 200 mg versus placebo achieved sustained clinical remission (18.1% vs. 5.1%), MCS remission (34.7% vs. 9.2%), endoscopic remission (15.6% vs. 6.1%) and histologic remission (38.2% vs. 13.3%). Additionally, a significantly higher proportion of patients treated with filgotinib 200 mg achieved six-month corticosteroid-free clinical remission at Week 58 compared with placebo (27.2% vs. 6.4%).
The SELECTION long-term extension trial is ongoing to evaluate the long-term safety of filgotinib in patients with moderately to severely active UC.
Filgotinib is an oral, selective JAK1 inhibitor.
UC is a longer-term condition characterized by inflammation of the mucosal lining of the colon and rectum. An increasingly prevalent disease, UC has a significant impact on the quality of life of more than 2 million people around the world. Despite current treatments, many patients experience fecal urgency, incontinence, recurring bloody diarrhea and the need to empty their bowels frequently, often accompanied by abdominal pain, poor sleep and fatigue.