A post-hoc analysis from a Phase III clinical programme evaluating Galapagos’ filgotinib showed significant symptom improvements for patients with ulcerative colitis (UC).
The new data, presented at the European Crohn’s and Colitis Organisation (ECCO) annual congress, showed significant improvements in patient-reported outcomes of stool frequency and rectal bleeding – observed as early as the first weeks of filgotinib 200mg daily therapy versus placebo.
According to Galapagos, these findings were observed in both biologic-naïve and biologic-experienced UC patients.
A further post-hoc analysis of the SELECTION maintenance study suggested the proportion of patients who were steroid-free at different timepoints before achieving remission at week 58.
This data suggested that filgotinib 200mg reduced and eliminated corticosteroid (CS) use versus placebo at week 58 in patients with moderately to severely active UC.
A significantly higher proportion of patients who demonstrated CS-free remission at week 58 with filgotinib 200mg daily had been CS-free in the previous six months in comparison to placebo.
In addition, safety analysis from the SELECTION programme – combining induction, maintenance and the long-term extension study data – showed results consistent with the original induction and maintenance trials, where filgotinib was well tolerated in patients with moderately to severely active UC.
“Listening to the needs of patients living with moderately and severely active UC, and the healthcare professionals treating them, helps us understand the importance of finding treatments that address both clinical symptoms and patient reported outcomes,” said Walid Abi-Saab, chief medical officer of Galapagos.
“[This] new data from SELECTION and the long-term extension study suggest that patients with moderately to severely active UC have experienced rapid response, sustained steroid-free remission and long-term tolerability when taking filgotinib 200mg versus those on a placebo,” he added.
