P393 Effect of filgotinib on anaemia in patients with Ulcerative Colitis in SELECTION
Loveikyte, R.(1)*;de Haas, A.(2);Oortwijn, A.(3);Eskens, B.(3);Jamoul, C.(4);Muller, K.(4);van der Meulen-de Jong, A.(5);
(1)Leiden University Medical Center LUMC, Gastroenterology and Hepatology, Leiden, The Netherlands;(2)Galapagos NV, Clinical Development Department, Leiden, The Netherlands;(3)Galapagos NV, Medical Affairs Department, Leiden, The Netherlands;(4)Galapagos NV, Biostatistics Department, Mechelen, Belgium;(5)Leiden University Medical Center, Department of Gastroenterology and Hepatology, Leiden, The Netherlands;
Patients with ulcerative colitis (UC) often have anaemia owing to inflammation and/or blood loss.1 Filgotinib (FIL) is a once-daily, oral, Janus kinase (JAK) 1 preferential inhibitor approved for the treatment of UC, which may be associated with fewer haematological events than pan-JAK inhibitors. In the phase 2b/3 SELECTION trial (NCT02914522),2 FIL 200 mg (FIL200) was well tolerated and effective vs placebo (PBO) in patients with UC. This post hoc analysis of SELECTION data compared haematological events across the FIL and PBO treatment arms.
In SELECTION, adults with moderately to severely active UC were randomized 2:2:1 to receive FIL200, or FIL 100 mg, or PBO once daily for 11 weeks during induction. FIL responders (clinical remission or a Mayo Clinic Score response at week 10 [W10]) were rerandomized to continue their induction FIL dose or PBO in the 47-week Maintenance (MNT) Study. PBO responders continued PBO during MNT. This analysis evaluated the proportions of patients with haematological events (anaemia, leukopenia, lymphopenia, neutropenia and thrombocytopenia) at baseline (BL), W10 and W58. Haematological events were defined based on the relevant laboratory parameters being below the lower limit of normal. For anaemia at W10 and W58, patients were further stratified by rectal bleeding (RB) status (no: RB subscore=0; yes: RB subscore ≥1) at W10 and W58, respectively.
At BL, ~50% of patients had anaemia in all treatment arms. Among these patients, the proportion without anaemia at W10 was similar across the FIL and PBO arms (25.0–30.7%; Table 1). Among patients without BL anaemia, the proportion with anaemia at W10 was also similar across all arms (12.1–17.3%). Among patients without RB at W10, the proportion of patients with a change in anaemia status from BL to W10 was also similar across arms. At W58, the proportion of patients with anaemia was similar across all arms, although ~40% of patients overall had missing data (Table 2). At BL, <5% of patients had leukopenia across all treatment arms (Tables 3 and 4). Lymphopenia, neutropenia and thrombocytopenia were also uncommon at BL (<10%, <4%, and <1% of patients, respectively). Among patients without these four haematological events at BL, <5%, <6%, 4% and ~1%, respectively, had them at W10.
Treatment with JAK1-preferential FIL up to W58, was not associated with anaemia, thought to occur via JAK2 inhibition, in patients overall and in those without RB at W10, compared with PBO. The small numbers of patients with haematological events excluding anaemia at BL limit rigorous inter-arm comparison.
1. Malesza IJ et al. Nutrients 2022;14:3478. 2. Feagan BG et al. Lancet 2021;397:2372–84.