2-year outcomes of filgotinib in ulcerative colitis in a large real-world cohort
Clara Ramos-Belinchon, Magdalena Staworko, Beatriz Gros, Jack Nicholls, Marina Orti Cuerva, Eksha Gupta, Nathan Constantine-Cooke, Elliot Gemmell, Claire O'Hare, Ian D Arnott, Charlie W Lees, Nikolas PlevrisBackground and objective
While short-term real-world studies on filgotinib in ulcerative colitis support its effectiveness, long-term data are lacking. We aimed to assess the 2-year effectiveness and safety of filgotinib.
Methods
All patients with ulcerative colitis treated with filgotinib in National Health Service Lothian with a minimum of 12 months since filgotinib commencement were included. The primary outcome was drug persistence at 2 years. Secondary outcomes included steroid-free clinical remission at 1 and 2 years (partial Mayo score <2 in the absence of steroid treatment), C-reactive protein (≤5 mg/L) and faecal calprotectin (<250 µg/g) remission at 1 and 2 years.
Results
Of 193 patients receiving filgotinib, 170 were included in the effectiveness analysis, with a median follow-up of 735 days (487-937). Filgotinib persistence was 50.2% at 2 years. Proctitis (adjusted HR (aHR) 1.88 (95% CI 1.01 to 3.51)) and previous exposure to advanced therapies (aHR 1.91 (95% CI 1.08–3.37)) were associated with a greater risk of drug cessation. Steroid-free clinical remission was achieved in 40% (49/123) and 32% (25/77) at 1 and 2 years. C-reactive protein remission was achieved in 53% (62/116) and 45% (34/75) at 1 and 2 years. Faecal calprotectin remission was achieved in 46% (51/111) and 45% (34/76) at 1 and 2 years. Severe adverse events occurred in 4.7% (9/193) and 1% (2/193) were diagnosed with malignancies.
Conclusions
Our study, with the longest follow-up reported to date, demonstrates promising effectiveness in the long-term, especially in advanced-therapy-naïve patients. Proctitis was identified as a phenotype associated with poorer persistence.