Introduction
Filgotinib (FIL) is an oral, JAK1 preferential inhibitor approved for the treatment of ulcerative colitis (UC). Although the clinical efficacy of FIL in UC has been demonstrated in the SELECTION trial,1 real-world data are limited.
Aims & Methods
In total, 600 adult patients with moderately to severely active UC who initiate FIL treatment in routine clinical care will be enrolled in GALOCEAN (NCT05817942), an ongoing, European, multi-site, prospective, observational study. Here, we report baseline characteristics of the first 100 enrolled patients and effectiveness data from patients who reached week 10. Baseline demographics, disease characteristics, prior UC-related treatment and reasons for starting FIL were collected. At week 10, mean changes from baseline (CFBs) in the partial Mayo Clinic Score (pMCS) and the PRO-2 score, and the proportions of patients in pMCS remission (pMCS of ≤2) or PRO-2 remission (rectal bleeding subscore of 0 and stool frequency subscore of ≤1) were assessed. Mean CFBs at week 10 in patient-reported outcomes (Short Inflammatory Bowel Disease Questionnaire [SIBDQ], Urgency Numerical Rating Scale [NRS] and Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue] scores) were also calculated. Safety was evaluated by documenting adverse events.
Results
As of January 2024, 100 patients (FIL 200 mg, 97% [97/100]; FIL 100 mg, 3% [3/100]) were enrolled, and had baseline data available; out of which 55 reached week 10. Baseline characteristics are shown in the Table. In total, 70% of patients (67/96) had up to moderate disease activity (pMCS of ≤6) and 30% (29/96) had severe disease activity (pMCS of ≥7) at baseline; 42% (42/100) were biologic-naive. The most common cardiovascular risk factor was active or prior smoking (37% [37/100]). FIL was used as monotherapy in 47% of patients (47/100). At week 10, the mean (standard deviation [SD]) CFB in the pMCS was –2.7 (2.5; n=43), and 58% of patients (25/43) achieved pMCS remission. The mean (SD) CFB in the PRO-2 score at week 10 was –1.8 (1.7; n=46), and 72% of patients (33/46) achieved PRO-2 remission. Mean (SD) CFBs in patient-reported outcomes at week 10 were 10.1 (12.4; n=42) for the SIBDQ score, –1.3 (2.8; n=38) for the Urgency NRS score and 4.0 (9.3; n=42) for the FACIT-Fatigue score. Overall, 10 patients discontinued FIL because of adverse events, lack of effectiveness or physician decision. No new safety signals were identified.
Conclusion
In this first interim report of GALOCEAN, week 10 data show that FIL improves symptoms in patients with UC in real-world clinical practice and has beneficial effects on health-related quality of life and fatigue. GALOCEAN is ongoing and long-term data with higher patient numbers will be evaluated to further characterize the real-world effectiveness of FIL in UC.
Table. Baseline characteristics.
Characteristic
| Totala
(N=100)
|
Age, years, median (min–max)
| 37.0 (19–67)
|
Female, n (%)
| 52 (52)
|
UC duration, years, median (min–max)
| 5.9 (0–26)
|
UC type, n (%)
Proctitis
Left-sided colitis
Pancolitis
Unknown
| 13 (13)
49 (49)
34 (34)
3 (3)
|
Disease activity and patient-reported outcomes, mean (SD)
pMCS
PRO-2 score
SIBDQ score
Urgency NRS score
FACIT-Fatigue score
| 5.3 (2.0)
3.3 (1.6)
38.0 (11.5)
4.5 (2.6)
28.6 (11.7)
|
CRP, mg/L, median (min–max)
| 3.3 (0–50)
|
Prior biologic therapy, n (%)
| 58 (58)
|
Number of prior biologic therapies, n (%)b
0
1
2
3
≥4
|
42 (42)
23 (23)
23 (23)
7 (7)
5 (5)
|
aThe number of patients with missing data was n=1 for UC duration and UC type,n=4 forpMCS and PRO-2 score, n=11 for SIBDQ score, n=16 for urgency NRS score, n=11 for FACIT-Fatigue score and n=43 for CRP.
bMultiple uses of the same therapy were counted once.
CRP, C-reactive protein; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; pMCS, partial Mayo Clinic Score; NRS, Numerical Rating Scale; PRO-2, patient-reported outcome-2; SIBDQ, Short Inflammatory Bowel Disease Questionnaire; UC, ulcerative colitis.
|
References
- Feagan BG et al. Lancet 2021;397:2372–84.
Disclosure
The GALOCEAN study was sponsored by Galapagos NV (Mechelen, Belgium), who funded these analyses.
Medical writing support for the development of this abstract was provided by Risha Bulusu, MBiochem, of PharmaGenesis London, London, UK, and was funded by Alfasigma S.p.A.
WS, AM, MZ are employees of Alfasigma S.p.A at the time of abstract submission.
AA reports consulting and/or advisory board fees from AbbVie, Allergan, Amgen, Arena Pharmaceuticals, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Janssen Pharmaceuticals, Lionhealth, MSD, Mylan, Nestlé, Pfizer, Roche, Samsung Bioepis, Sandoz and Takeda; lecture and/or speaker bureau fees from AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Janssen Pharmaceuticals, Mitsubishi Tanabe Pharma Corporation, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda and Teva Pharmaceuticals; and research grants from Biogen, MSD, Pfizer and Takeda.
CGdSJ reports speaker and/or consultancy fees from AbbVie, Alfasigma, Amgen, Celltrion, Janssen, Galapagos, MSD, Pfizer and Takeda.
ER reports speaker fees from AbbVie, Faes Farma, Ferring Pharmaceuticals, Galapagos, Janssen Pharmaceuticals, Kern Pharma, MSD, Pfizer and Takeda; and consulting fees from AbbVie, Eli Lilly, Fresenius Kabi, Galapagos, Janssen Pharmaceuticals, MSD and Pfizer.
GD reports research/educational grants from Abbott, AbbVie, Celltrion, Genuity, Janssen Pharmaceuticals, MSD, Pfizer, Takeda and Tillotts Pharma; and speaker/personal fees from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Dr Falk Pharma, Galapagos, Gilead Sciences, Janssen Pharmaceuticals, MSD, Pfizer, Takeda/Shire and Tillotts Pharma.
JPS reports speaker fees from AbbVie, Fresenius Kabi, Galapagos, Janssen-Cilag, 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, grants from
Galapagos and NFU and central reading services for Alimentiv.
MLH reports research grants from Ferring, Janssen, Pfizer, Tilllotts, and Takeda, speaker fees from AbbVie, Ferring, Galapagos, Meda, MSD, Tilllotts and Takeda; and advisory board fees from AbbVie, Eli Lilly, Galapagos, Janssen, MSD, Pfizer and Takeda.
RS reports no financial disclosures or conflicts of interest.
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, Bior 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 AG, VectivBio, Ventyx Biosciences and Zealand Pharma.
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.
WR reports speaker fees from AbbVie, Celltrion, Ferring Pharmaceuticals, Galapagos, Janssen Pharmaceuticals, MEDICE, MSD, Pfizer, Roche, Sobi and Takeda; consulting fees from AbbVie, Amgen, AOP Health (formerly AOP Orphan), Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Galapagos, Gilead Sciences, InDex Pharmaceuticals, Janssen Pharmaceuticals, MedAhead, Microbiotica, Pfizer 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.
AJ and WS were employees of Galapagos NV (former study sponsor), and are now employees of Alfasigma S.p.A (current study sponsor).
MZ was an employee and shareholder of Galapagos NV (former study sponsor), and is now an employee of Alfasigma S.p.A (current study sponsor).
