P0849 Real-world efficacy and safety of filgotinib in ulcerative colitis: results from the ENEIDA registry
Authors: Rodríguez-Lago I , Cudero L , Martínez Pascual C , Mínguez A , Ferreiro-Iglesias R , Arranz L , Royo A M , Martín-Rodríguez D , Mejías M D L Á , Calafat M , Calvo M , Gargallo-Puyuelo C J , Granja A , Santos-Fernández J , Ucha P , Ceballos D , Martín-Arranz M D , Ferrer I , Ramos L , Almela P , Fernández-Clotet A , García-Bosch O , Huguet J M , Lozano M L , Riestra S , Sese E , Torres G , Trapero A M , Varela P , Domènech E , Barreiro-de Acosta M 
Published: January 2025

Abstract

Background
Ulcerative colitis (UC) is a chronic inflammatory disorder characterized by periods of relapse and remission. Current treatment options aim to achieve mucosal healing and sustain long-term remission, yet many patients experience treatment failure. Filgotinib (FIL), a selective JAK1 inhibitor, has emerged as a promising therapeutic agent in UC management with favorable outcomes in clinical trials. This study aimed to evaluate the real-world efficacy and safety of FIL in patients with moderate-to-severe UC.

Methods
We conducted a multicenter, observational, retrospective study involving adult patients with moderate-to-severe UC who were treated with FIL within the ENEIDA registry, a nationwide prospectively-maintained database. Data were collected from 28 Spanish IBD units between 12/2021 and 10/2024. Patients were eligible if they had an established diagnosis of UC, had been initiated on FIL and without previous colectomy. The primary outcome was clinical remission (partial Mayo ≤2 with no subscore &gt;1 and no rectal bleeding) at week 12 and 52, along with its safety profile.

Results
A total of 91 patients were included (mean age of 37.5 years (SD 18), 63% male, and a median disease duration of 83 months [IQR, 35-148], 65% non-smokers, 15% extraintestinal manifestations). Most of them had extensive (49%) or left-sided colitis (42%). Prior exposure to anti-TNF was present in 89%, vedolizumab in 43%, and ustekinumab in 38%, with 18% also exposed to JAK inhibitors. The majority of patients had Mayo 2 or 3 endoscopic score (87%). All but 2 patients started FIL 200 mg bid (98%) and 27% received concomitant steroids or immunosuppressants (5%).
Steroid-free clinical remission was 42% and 48% after 12 and 52 weeks, respectively (Figure 1). FIL persistence was 64% with median treatment duration of 6 months (IQR, 3.8-9.7). Those previously exposed to JAK inhibitors showed a 80% and 40% persistence after 12 and 52 weeks, respectively. This subgroup showed similar steroid-free clinical remission rates of 33% and 17%, respectively. Overall, hospital admission was indicated in 7% and colectomy in 1%.
FIL was generally well-tolerated, with 18% of patients reporting at least one adverse event, 19% of them considered as serious, including herpes zoster infection in 2% (both vaccinated, 1 severe infection requiring FIL withdrawal), with no cardiovascular or thromboembolic events reported.

Conclusion
In this real-world, multicenter observational study, FIL demonstrated its efficacy in the induction and maintenance of clinical remission in patients with active UC. The real-world safety profile was consistent with previous data, with no unexpected adverse events. These findings support FIL as a valuable therapeutic option in the management of UC.