Introduction
Filgotinib (FIL) is an oral, once-daily Janus kinase 1 preferential inhibitor approved for the treatment of adults with moderately to severely active ulcerative colitis (UC), based on the results of the phase 2b/3 SELECTION trial1; however, real-world data are limited.
Aims & Methods
Here, we report baseline (BL) characteristics of enrolled patients with UC and early effectiveness and safety data for those who reached week 10 (W10) of FIL treatment in GALOCEAN (NCT05817942), an ongoing, European, multi-site, prospective, observational study to investigate the real-world effectiveness and safety of FIL. Data collected up to 15 Jan 2025 were included. BL characteristics were reported for the full analysis set and effectiveness outcomes were reported for the response evaluable set (RES). At W10, mean changes from BL (CFBs) in the partial Mayo Clinic Score (pMCS) and the 2-item patient-reported outcome (PRO2) score, and the proportions of patients in pMCS or PRO2 remission were assessed. Mean CFBs and the proportion of patients reaching the minimal clinically important difference at W10 in patient-reported outcomes (Short Inflammatory Bowel Disease Questionnaire, Urgency Numeric Rating Scale and Functional Assessment of Chronic Illness Therapy-Fatigue scores) were also calculated. Safety was assessed by documenting adverse events.
Results
As of 15 Jan 2025, 353 patients starting FIL ≤200mg were enrolled and had BL data available (female: 48.7%; age, median [min–max]: 36.0 [18–86] years; time since UC diagnosis, median [min–max]: 6.3 [0–35] years). The mean (SD) duration of follow-up was 23.9 (17.2) weeks. At BL, pMCS-defined UC severity rates were inactive (pMCS 0–1; 5.8% [n=20]), or mildly (pMCS 2–4; 28.3% [n=97]), moderately (pMCS 5–6; 35.9% [n=123]) or severely (pMCS 7–9; 30% [n=103]) active; 10 patients did not have BL pMCS. Most patients had left-sided colitis (38.2% [n=135]) or pancolitis (39.4% [n=139]). Overall, 21.2% (n=75) of patients were naive to conventional therapies (excluding corticosteroids [CS]), and 26.9% (n=95), 27.8% (n=98) or 45.3% (n=160) had previously received 0, 1 or ≥2 advanced therapies, respectively. At BL, FIL was used without concomitant therapy in 55.8% (n=197) of patients; CS were used as concomitant therapy by 26.3% (n=93) of patients. The most reported cardiovascular risk factor was current or former smoker (31.7% [n=112]). Overall, 75.9% (n=268) of patients had post-BL effectiveness data (RES). At W10, patients had improved clinical symptoms and health-related quality of life (HRQoL) vs BL (Table). A total of 123 (34.8%) patients discontinued FIL, mostly due to lack of effectiveness. No new safety signals were observed.
Conclusion
In this interim analysis of GALOCEAN, patients with UC had improved clinical outcomes (vs BL in symptoms and HRQoL) at W10 of FIL treatment in real-world clinical practice. FIL was generally well tolerated. This is consistent with previous data.2–4 GALOCEAN is ongoing, and results with higher patient numbers with longer exposure to FIL will be analysed to further characterize the real-world effectiveness and safety of FIL for UC.
Table. Effectiveness outcomes at BL and W10 after FIL initiation in the RES.
| | BL | W10 |
| Outcome measure | Mean score (SD) | Patients with moderately active disease, % (n/N) | Patients with severely active disease, % (n/N) | Mean score (SD) | Mean CFB (SD) | Patients with moderately active disease, % (n/N) | Patients with severely active disease, % (n/N) | Patients in remission,a % (n/N) | Patients with MCIDb vs BL, % (n/N) |
| pMCS | 5.2 (2.0)
n=262 | 38.5
(101/262) | 27.9
(73/262) | 2.4 (2.5)
n=232 | –2.9 (2.7)
n=228 | 10.3
(24/232) | 9.9
(23/232) | 41.5
(98/236) | – |
| PRO2 score | 3.2 (1.6)
n=265 | 59.6
(158/265) | 22.6
(60/265) | 1.4 (1.7)
n=248 | –1.8 (1.9)
n=247 | 26.6
(66/248) | 8.1
(20/248) | 43.1
(107/248) | – |
| SIBDQ score | 39.4 (11.7)
n=249 | – | – | 49.0 (12.9)
n=222 | 9.3 (11.3)
n=211 | – | – | – | 54.0
(114/211) |
| Urgency NRS score | 4.3 (2.7)
n=237 | – | – | 2.9 (2.8)
n=212 | –1.5 (3.0)
n=190 | – | – | – | 33.7
(64/190) |
| FACIT-Fatigue score | 28.7 (11.6)
n=249 | – | – | 34.0 (11.8)
n=222 | 5.3 (9.6)
n=211 | – | – | – | 55.5
(117/211) |
Data are reported for patients with available data. Analysis sets are defined as follows: the RES comprised patients who had BL and valid effectiveness data for ≥1 time point after FIL initiation, and the FAS comprised all patients with available BL data.
aDefinitions of remission were as follows: pMCS remission (RB ≤1, SF ≤1, PGA ≤1, pMCS ≤1); PRO2 remission (SF=0, RB=0).
bDefinitions of MCIDs were as follows: SIBDQ MCID (increase from BL ≥9); Urgency NRS MCID (decrease from BL ≥3); FACIT-Fatigue MCID (increase from BL ≥4).
BL, baseline; CFB, change from baseline; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; FIL, filgotinib; MCID, minimal clinically important difference; NRS, Numeric Rating Scale; PGA, Patient Global Assessment; pMCS, partial Mayo Clinic Score; PRO2, 2-item patient-reported outcome; RB, rectal bleeding subscore; RES, response evaluable set; SD, standard deviation; SF, stool frequency subscore; SIBDQ, Short Inflammatory Bowel Disease Questionnaire; W10, week 10. |
References
1. Feagan BG et al. Lancet 2021;397:2372–84.
2. Löwenberg M et al. United European Gastroenterol J 2024;12:406.
3. Seenan JP et al. J Crohns Colitis 2025;19 Suppl 1:i1881–2.
4. Høivik ML et al. J Crohns Colitis 2025;19 Suppl 1:i2083–4.
Disclosure
AA reports consultancy and/or advisory board fees from AbbVie, Alfasigma, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Giuliani, Janssen Pharmaceuticals, Lionhealth Benefit Society, Merck, Nestlé, Pfizer, Roche, Samsung Bioepis, Sandoz, Sanofi, Takeda and Tillotts Pharma; lecture and/or speaker bureau fees from AbbVie, AG Pharma, Alfasigma, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Janssen Pharmaceuticals, Lionhealth Benefit Society, Merck, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda and Teva Pharmaceuticals; and research grants from Biogen, MSD, Pfizer and Takeda.
ER reports speaker fees from AbbVie, Faes Farma, Ferring Pharmaceuticals, Galapagos, Janssen Pharmaceuticals, Kern Pharma, MSD, Pfizer and Takeda; and consultancy fees from AbbVie, Eli Lilly, Fresenius Kabi, Galapagos, Janssen Pharmaceuticals, MSD and Pfizer.
JPS reports speaker fees from AbbVie, Alfasigma, AstraZeneca, Fresenius Kabi, Galapagos, Janssen-Cilag, Pfizer, Pharmacosmos, Takeda and Tillotts Pharma; and advisory board fees from AbbVie, Bristol Myers Squibb, Dr Falk Pharma and Galapagos.
ML reports consultancy/lecture fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Galapagos, Janssen-Cilag, Johnson & Johnson, Medtronic, Pfizer, Takeda and Tillotts Pharma; grants from Galapagos and the Netherlands Federation of University Medical Centres; and central reading services for Alimentiv.
SV reports financial support for research from AbbVie, Galapagos, Johnson & Johnson, Pfizer and Takeda; speaker and/or consultancy fees from AbbVie, Abivax, AbolerIS Pharma, Agomab Therapeutics, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Biora Therapeutics (formerly Progenity), Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cytoki Pharma, Dr Falk Pharma, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Genentech-Roche, Gilead Sciences, GSK, Hospira, IMIDomics, Janssen Pharmaceuticals, Johnson & Johnson, Materia Prima, Mestag Therapeutics, MiroBio, Morphic Therapeutic, MRM Health, MSD, Mundipharma, Pfizer, ProDigest, Prometheus Biosciences, Robarts Clinical Trials, Surrozen, Takeda, Theravance Biopharma, Tillotts Pharma, VectivBio, Ventyx Biosciences and Zealand Pharma; and participation on a data safety monitoring board for Sanofi.
CGdSJ reports speaker and/or consultancy fees from AbbVie, Alfasigma, Amgen, Celltrion, Galapagos, Janssen Pharmaceuticals, MSD, Pfizer and Takeda.
MLH reports research grants, speaker and/or advisory board fees from AbbVie, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Janssen Pharmaceuticals, MSD, Pfizer, Takeda, Tillotts Pharma, and Viatris (formerly Meda).
SS reports personal fees from AbbVie, Amgen, Arena Pharmaceuticals, Biogen, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli Lilly, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos/Gilead Sciences, Hikma Pharmaceuticals, I-Mab, Janssen Pharmaceuticals, Morphic Therapeutic, MSD, Mylan, Pfizer, Protagonist Therapeutics, Provention Bio, Sandoz/Hexal, Takeda, Theravance Biopharma and Ventyx Biosciences.
GD reports research/educational grants and/or speaker/personal fees from Abbott, AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Dr Falk Pharma, Galapagos, Genuity Science, Gilead Sciences, Janssen Pharmaceuticals, MSD, Pfizer, Takeda/Shire, and Tillotts Pharma.
RS reports no financial disclosures or conflicts of interest.
WS was a consultant funded by Galapagos NV (former study sponsor) and is now a consultant funded by Alfasigma S.p.A. (current study sponsor).
CR was an employee of Galapagos NV (former study sponsor) and is now an employee of Alfasigma S.p.A. (current study sponsor).
VS is a consultant funded by Alfasigma S.p.A. (current study sponsor).
WR reports speaker and/or consultancy fees from AbbVie, Amgen, AOP Health (formerly AOP Orphan), Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, InDex Pharmaceuticals, Janssen Pharmaceuticals, MedAhead, MEDICE, Microbiotica, MSD, Pfizer, Roche, Sobi and Takeda; advisory board fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, Janssen Pharmaceuticals and Pfizer; and research funding from AbbVie, Janssen Pharmaceuticals, Sandoz, Sanofi and Takeda.
The GALOCEAN study is sponsored by Alfasigma S.p.A., who funded these analyses. Medical writing support for the development of this abstract was provided by Annika Pecchia-Bekkum, PhD, of PharmaGenesis London, London, UK, and was funded by Alfasigma S.p.A.