Introduction

Sarcoidosis is a multisystem disorder marked by non-caseating granulomas, primarily affecting the lungs but capable of involving almost any organ system. Hepatic involvement is reported in 10-65%, ranging from asymptomatic presentations to severe complications such as chronic cholestasis, portal hypertension, or cirrhosis. Its broad spectrum of clinical presentations makes diagnosis challenging; therefore our hypothesis was that hepatic sarcoidosis is underdiagnosed.

Aims & Methods

This study aims to evaluate the prevalence and clinical characteristics of hepatic sarcoidosis by analyzing two distinct cohorts – a hepatology cohort and a pneumology cohort.
The hepatology cohort included 37 patients from a university hepatology center with clinically and/or histologically confirmed hepatic involvement in sarcoidosis. Clinical characteristics were recorded at initial diagnosis, and at 3- and 12-month follow-up.
In parallel, a pneumology cohort of 346 patients with biopsy-proven sarcoidosis from a pneumology center was examined for abnormal liver values or imaging findings. Regarding this cohort, statistical comparisons between sarcoidosis patients with and without hepatic abnormalities were conducted.

Results

In the hepatology cohort, 43.2% of patients (n = 16) were male and 56.8% (n = 21) female. At initial presentation, the mean BMI was 27.7 ± 7.3 kg/m² (median 25.8; range 19.0–50.5). The number of organ manifestations per patient ranged from 1 to 6, with a median of 3 and a mean of 2.97 ± 1.5; notably, 18.9% of patients (n = 7) presented with isolated hepatic involvement. Liver involvement was biopsy-confirmed in 62.9% of patients (n = 22), whereas only 40% (n = 15) showed corresponding morphological findings on imaging. Laboratory results predominantly showed a cholestatic pattern with elevated ALP and gamma-GT. Mean levels of elevated liver enzymes decreased over the follow-up period. The most common symptoms were fever (27.0%) and weight loss (24.3%), while 16.2% of patients (n = 6) were asymptomatic. 51.3% of patients (n = 19) were treated with glucocorticoids, 43.2% (n = 16) received no therapy.
In the pneumology cohort, 172 (49.7%) sarcoidosis patients showed abnormal liver values or imaging. In the cohort, 139 (40.2%) patients were female, and 207 patients (59.8%) were male. Hepatic abnormalities were observed significantly more frequent in males than females (54% vs. 43%, p = 0.046). Patients with hepatic involvement had a mean age of 52.9 ± 12.0 years (range 20–83) at the time of inpatient stay (n = 172). BMI was significantly higher in patients with hepatic involvement (median 29.8 vs. 27.1 kg/m², p < 0.001), while no significant age difference was observed. Splenic abnormalities were more common in those with hepatic involvement (23.4% vs. 7.7%, p < 0.001).

Conclusion

Analysis of the hepatology cohort highlights that biopsy-confirmed hepatic sarcoidosis can occur even in the absence of corresponding imaging findings. The clinical course of hepatic sarcoidosis is often self-limiting. In selected cases, treatment with glucocorticoids, other immunosuppressants, or ursodeoxycholic acid (UDCA) in patients with cholestatic symptoms is required.
The high number of liver abnormalities in the pneumology cohort suggests that hepatic sarcoidosis is underdiagnosed. Sarcoidosis patients should be assessed for potential hepatic involvement. Screening via ALP levels is recommended. The need to screen for hepatic involvement applies regardless of patient age.

Disclosure

There are no conflict of interest.

Introduction

EoE is a debilitating disease with physical, behavioral, and psychosocial impacts, resulting in substantial impairment in quality of life for patients and caregivers. Children with EoE can present with nonspecific symptoms such as food refusal or feeding difficulties, gastroesophageal reflux disease (GERD), nausea, and vomiting. Dupilumab is approved in the USA and EU for patients with EoE aged ≥1 year, weighing ≥15 kg. In the phase 3 randomized placebo-controlled EoE KIDS study (NCT04394351), in children aged 1 to 11 years, dupilumab significantly improved symptoms of EoE vs placebo, as measured by the Pediatric Eosinophilic Esophagitis Symptom Score version 2.0 (caregiver version; PEESSv2.0) after 16 weeks of treatment.

Aims & Methods

In this post-hoc analysis of the EoE KIDS study, we evaluated the effects of long-term dupilumab treatment on PEESSv2.0 scores during the Part C open-label extension. PEESSv2.0 is a validated observer-reported outcome measure that assesses the frequency and severity of EoE symptoms and adaptive behaviors, divided into four domains: GERD, dysphagia, pain, and nausea; each is scored 0–100, with higher scores indicating a greater symptom domain severity. Patients who completed Week 52 in Part B of EoE KIDS were eligible for Part C, where all patients received open-label dupilumab, using the weight-tiered regimen later approved by the FDA (similar to the Part A and B higher-exposure regimen). In patients who received placebo or dupilumab higher exposure during Parts A and B, changes from baseline of the EoE KIDS study (Part A baseline) in the PEESSv2.0 total, frequency, severity, and domain scores were assessed at Week 52 (Part C baseline), Week 76, and Week 100.

Results

At Week 52, the mean change from baseline (95% confidence interval) in PEESSv2.0 total score was –23.8 (–32.1, –15.6; Table), with further reductions observed at Week 100 (–31.5 [–41.5, –21.4]). Mean changes from baseline in PEESSv2.0 frequency and severity scores were further reduced from Week 52 (–25.1 [–34.2, –16.1] and –22.2 [–30.3, –14.1], respectively), to Week 100 (–33.8 [–44.9, –22.7] and –28.6 [–38.3, –19.0]). Similar patterns of reduction were observed for individual primary domain scores, namely, GERD, dysphagia, pain, and nausea. During the Part C open-label extension, dupilumab safety was consistent with the known dupilumab safety profile.

Conclusion

Children with EoE, treated with long-term dupilumab, experienced sustained improvements in the frequency and severity of symptoms of EoE up to Week 100, assessed by the PEESSv2.0. Reductions in GERD, dysphagia, pain, and nausea domain scores were also maintained or in some cases further improved, although interpretation of Part C symptom data is limited due to the open-label study design. Future studies should consider the correlation of symptoms with trends in both endoscopic and histologic outcomes.

Table. Mean change from Part A baseline in PEESSv2.0 total, frequency, and severity scores during the Part C open-label extension of EoE KIDS
aTotal, frequency, and severity scores are all scored 0–100. bPEESSv2.0 was not measured as a clinical endpoint in Part B of the EoE KIDS study; Week 52 data represent PEESSv2.0 scores at Part C baseline. CI, confidence interval; EoE, eosinophilic esophagitis; GERD, gastroesophageal reflux disease; n, number of patients; PEESSv2.0, Pediatric Eosinophilic Esophagitis Symptom Score version 2.0 (caregiver version).
PEESv2.0 element, mean change (95% CI)a	Week 52b (n = 32)	Week 76 (n = 30)	Week 100 (n = 23)
Total	–23.83 (–32.05, –15.60)	–31.08 (–39.38, –22.78)	–31.47 (–41.49, –21.44)
Frequency	–25.14 (–34.17, –16.11)	–34.17 (–43.07, –25.26)	–33.79 (–44.88, –22.71)
Severity	–22.22 (–30.31, –14.13)	–27.31 (–35.97, –18.66)	–28.62 (–38.29, –18.96)

Disclosure

Oliva S: Celgene/Receptos/Bristol Myers Squibb, Medtronic, Ocean Pharma, Sanofi/Regeneron Pharmaceuticals Inc – advisory board/consulting fees. Medtronic, Sanofi/Regeneron Pharmaceuticals Inc. – speaker fees.
Gold B: Diasorin Molecular, IQVIA/AstraZeneca, Ironwood Pharmaceuticals, Johnson&Johnson, Mead Johnson/Reckitt, Nutricia, Pfizer Inc, Sanofi/Regeneron Pharmaceuticals – advisory board/consultancy fees.
Ashok D: Alexion Pharma, LaunchitDTx, Mirum Pharma – advisory board/consulting fees. Sanofi – speaker fees.
Parrish C: Sanofi/Regeneron, Takeda – advisory board/consulting. Regeneron Pharmaceuticals Inc., Sanofi – speaker fees. DBV technologies, NIH/NIAID – research support.
Xia C, Raphael BP, Radwan A, Thomas RB: Regeneron Pharmaceuticals Inc. – employees and may hold stock or shares.
Cazeau C, Almansa C, Tilton ST: Sanofi – employees and may hold stock or shares.

Introduction

The Pisa EoE Adaptation Questionnaire (PiEAQ) on adaptive behaviors at mealtime significantly improves the correlation between dysphagia scores and histological disease activity (HDA) in eosinophilic esophagitis (EoE) [Reference 1].

Aims & Methods

Whether longitudinal variations of PiEAQ scores (∆PiEAQ) can capture HDA trends following pharmacological treatment of EoE has not been investigated. Consecutive adults (>18 years) with histologically active EoE (i.e., ≥15 eos/high-power field) were prospectively enrolled. Clinical characteristics, HDA, a recall-modified dysphagia symptom questionnaire (mDSQ), esophageal hypervigilance and anxiety scale (EHAS), and PiEAQ (drinking water to push the bolus, lubricating food, chewing for long, and blending food) were recorded longitudinally at baseline (T0) and 12 weeks post-treatment using a 30-day recall period (T1). ROC curve analysis with DeLong test was used to calculate the diagnostic accuracy (AUC) of clinical scores for predicting HDA following treatment. Significance threshold was p<0.05.

Results

Thirty-seven histologically active EoE patients were included (Table 1). The mDSQ, PiEAQ, and EHAS score at baseline were 2.97 (IQR, 2-5), 2.00 (IQR, 1-3), and 21 (IQR, 14– 25), respectively. Following treatment with budesonide orodispersible tablets (72.2%), PPIs (19.6%), dupilumab (5.5%), or milk-free diet (2.7%), histological remission was achieved in 78.4% of patients, while 21.6% remained histologically active. Post-treatment (T1), mDSQ, PiEAQ, and EHAS scores decreased significantly only in patients who achieved histological remission (Table 2 and Figure1). ROC curve analysis showed that a post-treatment reduction of at least 2 adaptive behaviors compared to baseline (∆PiEAQ=-2) had AUC of 85.0%, with 100% specificity and 64% sensitivity for the identification of patients achieving histological remission following treatment. Similarly, a post-treatment reduction of at least 3 points in mDSQ scores compared to baseline (∆mDSQ=-3) had AUC of 81.1% with 100% specificity and 57.7% sensitivity. The non-inferiority analysis showed that the ∆PiEAQ had similar performance to ∆DSQ (DeLong p-value= 0.46). A combined score integrating both ∆PiEAQ and ∆DSQ scores increased the AUC of clinical scores for capturing variations of HDA post-treatment to 90%, with 100% specificity and 73.1% sensitivity for detecting patients achieving histological remission post-treatment (Figure 2).

Conclusion

The PiEAQ is the first questionnaire investigating adaptive behaviors as a standalone domain in EoE. We demonstrated that longitudinal variations in PiEAQ scores are sensitive to HDA variations over time and can monitor histological disease activity trends after treatment. This study confirms that, similar to dysphagia, adaptive behaviors contribute to disease burden in EoE and improve with treatment.

Group	PiEAQ baseline (median)	PiEAQ post-treatment (median)	∆PiEAQ (T1-T0)	p-value
Non-responder (n=8)	2	1.86	-0.14	0.3
Responder (n=29)	1.96	0.138	-1.83	<0.0001
Group	mDSQ baseline (median)	mDSQ post-treatment (median)	∆mDSQ (T1-T0)	p-value
Non-responder (n=8)	2.29	2	+0.16	0.8
Responder (n=29)	3.27	0.33	-2.92	<0.0001
Group	EHAS baseline (median)	EHAS post-treatment (median)	∆EHAS (T1-T0)	p-value
Non-responder (n=8)	17.7	15.8	-1.91	0.9
Responder (n=29)	21.4	10.2	-11.2	<0.0001

References

1. Visaggi P, Del Corso G, Solinas I, Ovidi F, Adamo G, Dulmin I, Baiano Svizzero F, Bellini M, Savarino EV, de Bortoli N. Adaptive Behaviors, Esophageal Anxiety, and Hypervigilance Modify the Association Between Dysphagia Perception and Histological Disease Activity in Eosinophilic Esophagitis. Am J Gastroenterol. 2024 Dec 30. doi: 10.14309/ajg.0000000000003272. Epub ahead of print. PMID: 39787341.

Disclosure

Speaker or Consultancy for Apogee Therapeutics, Dr Falk Pharma, Malesci, JB Pharmaceuticals, Sanofi, Alfasigma

Introduction

Dutch society has witnessed significant societal and demographic changes over the decades. With 28% of the Dutch population having a migration background in 2023, understanding diversity within the gastroenterology workforce is imperative. This study examines the evolution of sex, ethnic, and socio-economic diversity among Dutch gastroenterologists from 2005-2023.

Aims & Methods

This repeated cross-sectional study utilized pseudonymized data from the BIG-register, paired with demographic variables from Statistics Netherlands (CBS), covering the years 2005, 2010, 2015, 2020, and 2023. The total population sample in each year consisted of all individuals registered as gastroenterologists for at least one day in a respective year. Variables such as sex, migration background, year of birth, and parental socio-economic status indicators were analyzed to assess trends and identify factors associated with being a
gastroenterologist. Descriptive and logistic regression analyses were employed to explore these trends and compare generational differences.

Results

The study revealed a narrowing sex gap with an increase in female gastroenterologists (28% to 43% from 2005-2023), particularly among the younger cohort (60% female). However, ethnic diversity has not kept pace, with a decline in the representation of gastroenterologists from migration backgrounds among younger professionals (27% to 18% for gastroenterologists < 1979 and ≥ 1980, respectively). Socio-economic analysis indicated that approximately 75% of gastroenterologists have parents from top-20% assets category.

Conclusion

The gastroenterology field in the Netherlands shows significant advancements in gender diversity, but lags in ethnic and socio-economic diversity. The increasing trend of gastroenterologists from medical families highlights the need for policy adjustments, to ensure access to candidates from more diverse socio-economic backgrounds. Policies should focus much more on promoting comprehensive diversity to enhance healthcare outcomes and reflect the demographic changes within society.

References

1. Stanford FC. The Importance of Diversity and Inclusion in the Healthcare Workforce.
J Natl Med Assoc. 2020;112(3):247-9.
2. Gomez LE, Bernet P. Diversity improves performance and outcomes. J Natl Med
Assoc. 2019;111(4):383-92.
3. Juch A. 100 jaar Maag-Darm-Leverarts in Nederland 1913-20132013. 336 p.
4. Brach C, Fraser I. Reducing disparities through culturally competent health care: an
analysis of the business case. Qual Manag Health Care. 2002;10(4):15-28.
5. Moberly T. Men outnumber women three to one in some specialties. Bmj.
2018;363:k4098.
6. Subramaniam M, Azad N, Wasan SK, Long MT. Equal Opportunity: Women
Representation on Editorial Boards and Authorship of Editorials in Gastroenterology and
Hepatology Journals. Am J Gastroenterol. 2021;116(3):613-6.
7. Dossa F, Baxter NN. The place of women in gastrointestinal medicine and surgery:
the need for progress. Lancet Gastroenterol Hepatol. 2023;8(11):965-6.
8. Kesavarapu K, Schwartz J, Ikonomi E, Ahmad A. What's holding women back? A
review of gender inequality in gastroenterology in the USA. Lancet Gastroenterol Hepatol.
2019;4(12):898-900.
9. Esposito I, Simsek C, Nowak A, Tiniakos D, Equality UEG, Diversity G. United
European Gastroenterology Equality and Diversity Plan. United European Gastroenterol J.
2023;11(5):484-7.

Disclosure

OKB, ABB, PK and LM have no conflict of interests, CJJM is consultant for Douglas (New Zealand) and HLW (The Netherlands). All outside submitted work.

Introduction

The Rutgeerts score, developed three decades ago, is used to assess postoperative endoscopic recurrence in patients with Crohn’s disease (CD) following ileocolonic resection with an end-to-end anastomosis.¹ However, contemporary surgical techniques have introduced new anatomical locations – the ileal body and ileal inlet – which were not accounted for in the original Rutgeerts score.² Additionally, the original Rutgeerts score has demonstrated limited inter-observer reliability.³ To address these limitations, an updated Rutgeerts score, incorporating new anatomical sites, has been proposed. According to the updated Rutgeerts score lesions restricted to the ileal inlet, or the ileal body can no longer be scored as i2a.² While the updated Rutgeerts score offers improved assessment of inflammation after an ileocolonic resection, its reproducibility has not yet been validated.

Aims & Methods

The aim of our study was to evaluate the inter- and intra-observer reliability of the updated Rutgeerts score.
We conducted a retrospective analysis of 183 patients with CD (48% male, median age 36.8 years) who underwent video-recorded ileocolonoscopy within 14 months of resection with ileocolonic anastomosis. An expert reader MF selected and scored videos of ileocolonoscopies, which were then used as the gold standard. After receiving a two-hour training with a set of ten videos eight expert gastroenterologists reviewed and scored the videos. Each reader assessed 92 videos, including 23 videos that were re-scored after at least one month. Based on the gold standard, inter- and intra-rater agreement was calculated across all score levels and for each score level. Inter-rater reliability was assessed using Fleiss' kappa, and intra-rater reliability using Cohen’s kappa, both with and without application of linear weights.

Results

The probability of perfect agreement between two readers across all scores was 0.604 (95% CI: 0.559-0.649). The chance-corrected inter-observer agreement based on Fleiss’ kappa with linear weights across all scores was 0.619 (95% CI: 0.562-0.676). The strongest inter-observer agreement was observed for the i2a score, with a value of 0.736 (95% CI: 0.647-0.826), while the weakest was seen for the i1 score (0.357, 95%CI: 0.225-0.489).
Intra-rater reliability with a Cohen’s kappa was 0.688 (0.609-0.767), and with weighted kappa was 0.831 (0.758-0.868). The overall agreement rate was 76.0% (69.1%-82.0%).

	Categorical		Ordinal
	Estimate	95%CI	Estimate	95%CI
All levels	0.604	(0.559;0.649)	0.882	(0.866;0.897)
i0	0.633	(0.467;0.800)	0.884	(0.824;0.945)
i1	0.357	(0.225;0.489)	0.829	(0.758;0.899)
i2a	0.736	(0.647;0.826)	0.925	(0.896;0.954)
i2b	0.502	(0.439;0.566)	0.856	(0.834;0.877)
i3	0.487	(0.351;0.623)	0.859	(0.798;0.920)
i4	0.715	(0.606;0.824)	0.894	(0.854;0.934)

Table 1. Summary of agreement across score levels: Agreement for all scores and by individual score levels, based on the gold standard (defined as the scores given by an expert reader MF). Categorical agreement reflects only perfect agreement. Ordinal agreement applies linear weights, assigning less weight to minor disagreements and more to larger ones.

Conclusion

The updated Rutgeerts score demonstrates good agreement and substantial inter- and intra-rater reliability in assessing postoperative endoscopic recurrence in CD, supporting its potential for broader adaptation in both clinical practice and research settings.

References

1. Rutgeerts P, Geboes K, Vantrappen G, Beyls J, Kerremans R, Hiele M. Predictability of the postoperative course of Crohn’s disease. Gastroenterology. 1990;99(4):956-963. doi:10.1016/0016-5085(90)90613-6
2. Rivière P, Bislenghi G, Vermeire S, et al. Postoperative Crohn’s Disease Recurrence: Time to Adapt Endoscopic Recurrence Scores to the Leading Surgical Techniques. Clin Gastroenterol Hepatol. 2022;20(6):1201-1204. doi:10.1016/j.cgh.2022.02.025
3. Marteau P, Laharie D, Colombel JF, et al. Interobserver Variation Study of the Rutgeerts Score to Assess Endoscopic Recurrence after Surgery for Crohn’s Disease. Journal of Crohn’s and Colitis. 2016;10(9):1001-1005. doi:10.1093/ecco-jcc/jjw082

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.