Gilead and Galapagos Report Results of Filgotinib in P-llb/lll SELECTION Study for Ulcerative Colitis
Shots:
- The P-llb/lll SELECTION study comprises two induction trials and a maintenance trial. Both induction studies involve assessing of filgotinib (200/100 mg) vs PBO in a ratio (2:2:1) in adult patients with moderately to severely active UC
- Induction study result: In biologic-naïve patients (200mg dose), clinical remission @10wks. (26.1% vs 15.3%); MCS remission (24.5% vs 12.4%); endoscopic remission (12.2% vs 3.6%) and histologic remission (35.1% vs 16.1%). In biologic experienced patients, clinical remission @10wks. (11.5% vs 4.2%)
- Patients who achieved CR/ remission @10wks. were re-randomized to their induction dose of filgotinib vs PBO in a ratio (2:1) and treated @58wks. Maintaince trail results: CR (37.2% vs 11.2%); sustained clinical remission (18.1% vs 5.1%); MCS remission (34.7% vs 9.2%); endoscopic remission (15.6% vs 6.1%); histologic remission (38.2% vs 13.3%); patients achieved 6mos.corticosteroid-free clinical remission (27.2% vs 6.4%)
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