bluuebunny/crossref_metadata_2025 huggingface dataset:
P0968 Comparison of two oral iron formulations for iron deficiency and iron deficiency anemia in inflamatory bowel disease: a multicentric prospective study
Authors: Guimaraes A , Leal T , Carvalho T , Mendes S , Gonçalves A , Leal C , Santos A , Soares J , Arroja B , Rebelo A , Damasceno J , Neves J , Gonçalves B , Rodrigues Â , Vasconcelos H , Gonçalves R
Published: January 2025

Background

The use of oral iron in iron deficiency (ID) and ID anemia in IBD is controversial. Its lower costs and ease of application have to be weighed against the fear of side effects and questions about its efficacy. The aim of this study was to assess the efficacy and tolerability of Sucrosomial® iron in correcting ID and ID anemia in IBD. As a secondary objective we aimed to assess the efficacy and impact of oral iron in correcting ID, ID anemia and disability in IBD.

Methods

This was a prospective and bicentric study. IBD patients diagnosed with ID or ID anemia between november 2022 and november 2023 treated with oral iron were included. Half of the physicians were instructed to prescribe ferric hydroxide-polymaltose complex - Ferrum Hausmann®(FH) - and the others Sucrosomial® iron – Fisiogen Ferro Forte®(FF). The primary endpoint was change in haemoglobin levels and correction of iron studies at 12 weeks after starting therapy, and secondary endpoints were assessing tolerability and disability (IBD-Disk).

Results

Fifty-six patients were included in the study (FH group – 33; FF group – 23). A total of 46 had ID and 10 had ID anemia. Thirteen patients had side effects - FF 13,0% vs FH 30,3% (p=0,132) - leading to iron discontinuation in 6. There was no difference in terms of efficacy between the two iron formulations. After 12 weeks, serum iron (p=0,017) and transferrin saturation index (p<0,001) improved. There was no change in ferritin levels (p=0,804) but there was an improvement in Hb levels (p=0,041) in patients with anemia. IBD-disk scores improved (p=0,004) after treatment and this improvement correlated with increasing serum iron (rs=-0,43; p=0,010) and Hb (rs=-0,50; p=0,002) levels.

Conclusion

Both iron formulations had similar efficacy. There was a trend to fewer side effects in the FF group but this was non-significant. Oral iron replacement improved Hb levels, iron studies and disability after 12 weeks of treatment.
P0970 Associations between diet, faecal and flatulence odour perception and disease activity in patients with inflammatory bowel disease and healthy controls
Authors: Pueschel L , Nothacker S , Kuhn L , Wedemeyer H , Lenzen H , Wiestler M
Published: January 2025

Background

Inflammatory bowel disease (IBD) affects gastrointestinal function and may alter faecal odour due to changes in the gut microbiome and metabolism. Given the relationship between diet, gut health and microbiome diversity, exploring the link between dietary habits and faecal odour in IBD seems crucial. This study investigates the associations between dietary behaviour, flatulence and faecal odour perception and disease activity in IBD patients compared to healthy controls (HC).

Methods

From October 2023 to October 2024, a total of 238 IBD (women: 51.3%; CD: 59.7%; remission: 33.5%) patients and 97 HC (women:70.1%) were enrolled at the IBD outpatient clinic of the Hannover Medical School. In addition to a short screening questionnaire for highly processed foods (sQ-HPF), dietary behaviour (Food Frequency Questionnaire (FFQ)), clinical (HBI, PMS) and biochemical (CRP, faecal calprotectin) parameters of disease activity were assessed as well as adherence to a mediterranean diet and changes in bowel movement odour (faecal and flatulence) were collected.

Results

Significant differences in flatulence (p<0.001) and faecal odour perception (p<0.001) were found between IBD patients and HC. Further associations with dietary habits revealed differences between HC and IBD individuals exhibiting strong flatulence odour demonstrating significant associations with the daily intake of carbohydrates (p = 0.007), sugar (p = 0.049), vegetables (p = 0.033), legumes (p = 0.010), and the daily energy intake (kJ) from highly- and ultra-processed foods (p = 0.002 and p = 0.007, respectively). However, the differences between HC and IBD individuals with strong faecal odour were only significant for the daily intake of legumes (p = 0.002).

Further analyses revealed significant associations between flatulence and faecal odour perception and IBD activity (p < 0.001). Subgroup analyses showed significant differences between Crohn’s disease (CD) and ulcerative colitis (UC) patients with and without strong faecal odour, particularly in those with moderate disease activity (p = 0.006 and p = 0.017). Additionally, significant differences in flatulence odour were found between CD and UC patients with moderate (p = 0.008) and severe disease activity (p = 0.041).

Conclusion

In conclusion, significant differences in flatulence and faecal odour perception were found between IBD patients and healthy controls, with dietary associations noted for strong flatulence and faecal odour. Disease activity was strongly associated with both flatulence and faecal odour perception, with notable differences between CD and UC, particularly in moderate and severe disease activity.
P0974 Risk factors for anti-TNFα induced paradoxical psoriasis in Inflammatory Bowel Disease and association with an IL-23 receptor polymorphism: A retrospective study
Authors: Natt N , Gindi M , Gregor J , Ponich T , Chande N , Kim R , Wilson A
Published: January 2025

Background

Anti-tumor necrosis factor (TNF)-α therapy is frequently used to treat inflammatory bowel disease (IBD). Paradoxical psoriasis (PP) is a known adverse effect of this drug class resulting in disfiguring skin lesions that may impact quality of life and lead to treatment cessation. To date, there are no tools to identify individuals who are susceptible to developing PP. Variations in the IL-23 receptor (IL23R) gene have been linked to psoriasis onset and may be implicated in PP. The aims of this study are 1. to study the incidence and outcomes of PP in anti-TNFα treated IBD patients at an academic centre in London, Ontario, Canada and 2. to examine risk factors associated with PP including the IL23R variant (IL23R1142G>A).

Methods

We performed a retrospective study of adult IBD patients treated with anti-TNFα therapies at London Health Sciences Centre between 2012 and 2024. Patient charts were reviewed for clinical variables and disease outcomes from the time of anti-TNFα exposure until treatment discontinuation or last follow-up. Patients’ serum was retrospectively genotyped for the IL23R1142G>A variant.

Results

We identified 496 IBD patients with 570 unique anti-TNFα exposures between 2012 and 2024. 26 patients developed 29 cases of PP while the remaining 473 patients did not develop PP after exposure to 542 anti-TNFα therapies, corresponding to a PP incidence rate of 5.1% in the study population. There was an increased proportion of patients with PP who had a positive family and personal history of psoriasis, though the latter was not significant (Table 1). The IL23R variant was more common in patients who developed PP compared to those who did not (46.2% vs. 5.1%, OR 16.04, 95% CI 6.69-38.41, Figure 1). The average time to develop PP was 9.5 months, with 55% of patients on high-dose anti-TNFα maintenance regimens. Majority of patients had moderate-to-severe disease (72.4%) based on body surface area (BSA) involvement and required treatment cessation (69.0%). All participants had complete resolution of PP following discontinuation of anti-TNFα therapy.

Conclusion

We identified an increased frequency of the IL23R1142G>A variant in patients who developed PP following anti-TNFα exposure compared to those who did not. Personal and family history of psoriasis were also more common in those who developed PP. Future studies should investigate other drug and disease characteristics that may predict those at highest risk for this anti-TNFα drug effect.
P0984 Treatment with allopurinol and low-dose azathioprine during pregnancy in patients with Inflammatory Bowel Disease. A Danish single center experience
Authors: Sivananthan K , Wildt S , Kiszka-Kanowitz M , Pedersen G , Vind I , Nordgaard-Lassen I , Munk Petersen A , Burisch J , Kristensen H , Theede K
Published: January 2025

Background

Low-dose azathioprine in combination with allopurinol (LD-AZA/ALLO) is a widely used treatment option in inflammatory bowel disease (IBD). Data on pregnancy and birth outcomes from exposure to combination therapy are sparse. The aim of this study was to provide data on safety and risk for adverse pregnancy and birth outcomes in women with IBD treated with LD-AZA/ALLO at the Gastrounit, Hvidovre Hospital, Copenhagen.

Methods

The study was a retrospective single center study. Inclusion criteria were established IBD diagnosis and treatment with LD-AZA/ALLO (AZA 50-75 mg/ ALLO 100 mg) during conception and pregnancy between 2013-2023. Data was collected from electronic medical charts and by questionnaire to all included women. Data registered was; demographics, diagnosis, disease characteristics, disease activity, IBD medications and number of pregnancies. Pregnancy outcomes were neonatal characteristics, obstetric complications, lactation and congenital malformations, disease, infections and admission to the hospital during the first year of life.

Results

In all, 44 women with 62 pregnancies (one twin pregnancy) and 59 live births were included. There were 1 spontaneous and 3 provoked abortions due to genetic disorders (1 trisomy 21 and 2 spinocerebellar ataxia). Obstetric complications were present in 8 (13%) pregnancies, (1 pre-eclampsia, 1 HELLP syndrome, 6 hypertension and/or gestational diabetes mellitus). 7 (11%) women had an IBD flare during pregnancy, none resulting in obstetrical complications. 5 (9 %) children were born prematurely, 4 (7 %) had low birth weight. No congenital malformations were reported. One child was born with facial nerve paralysis and later diagnosed with hyper-IgD syndrome. 8 (14 %) were admitted to neonatal ward (hours to days), mainly due to immature lungs.

During the first year of life, one child was admitted to the hospital due to COVID. One child was suspected to have an immune defect, but all symptoms and biochemical abnormalities resolved and interpreted as side effect to LD-AZA/ALLO. 5 children (9%) were treated with antibiotics due to minor infections. In total 84 % of the children were breastfed during LD-AZA/ALLO treatment.

Conclusion

In this large single center experience with 62 pregnancies in women treated with LD- AZA/ALLO, no malformations or indications of increased risk of complications of pregnancy and birth were observed. The majority of children were breastfed and no serious signals or complications were reported first year of life. Treatment with LD-AZA/ALLO during pregnancy and breastfeeding seems safe.
P0988 Dose-Dependent Incidence of Acne in Korean Patients Treated with Upadacitinib
Authors: Lee J , Kim S J , Lee M H
Published: January 2025

Background

Janus kinase inhibitors, like upadacitinib, are associated with drug-induced acne, typically showing a dose-dependent occurrence. While registrational trials reported acne in 3-7% of subjects, real-world data suggest higher rates, especially in non-Western populations. This study assesses the incidence, severity, and management of acne among Korean patients using upadacitinib.

Methods

We conducted a retrospective review of medical records from patients treated with upadacitinib for Inflammatory bowel disease (IBD), Rhematic arthritis (RA) and Atopic dermatitis (AD) at a single academic hospital from October 2021 to October 2024. Data were analyzed to determine the incidence and severity of acne and the effectiveness of various treatment approaches, with a focus on differences among patient groups.

Results

Out of 140 patients (IBD: 17, RA: 17, AD: 106) treated, acne was observed in 31 (22.1%), with a significant dose-response relationship. High-dose recipients (45 mg for IBD) exhibited a 58.8% (10/17) incidence rate, compared to 17.1% (21/213) among those on lower doses (30 or 15 mg for RA or AD). Most acne cases were mild, manifesting as inflammatory papules, and managed effectively with topical therapies. The higher dose group also showed a greater prevalence of facial and truncal acne. Treatment discontinuation due to acne was rare and not dose-dependent, with no cases in the high-dose group. Logistic regression highlighted the 45 mg dose as a significant risk factor for acne.

Conclusion

Korean patients treated with upadacitinib experience higher rates of acne compared to Western populations, particularly with higher doses. Most cases are mild and respond well to treatment, allowing for continued therapy. These findings underline the need for proactive acne management in patients receiving higher doses of upadacitinib

References

1.Temido MJ, Honap S, Bursztejn AC, et al. Drug-Induced Acne in Inflammatory Bowel Disease: A Practical Guide for the Gastroenterologist. Am J Gastroenterol 2024.Online ahead of print.
P0989 Interventions for rheumatological extraintestinal manifestations in Inflammatory Bowel Disease: an umbrella review of systematic reviews
Authors: Nardone O M , Alajmi A , Yuan Y , Jairath V
Published: January 2025

Background

Inflammatory Bowel Disease (IBD) is associated with extraintestinal manifestations (EIMs), commonly affecting the joints, eyes, skin, and liver, and influences treatment selection. We aimed to synthesize evidence from systematic reviews (SRs) with or without meta-analyses on the efficacy of therapeutic options for rheumatological EIMs to better clarify their positioning in the management of IBD

Methods

We searched MEDLINE, Embase, and the Cochrane Database of Systematic inception to May 31 2024 to identify SRs addressing therapeutic interventions for rheumatological EIMs. The exclusion criteria ruled out studies that were not SRs, did not focus on patients with IBD patients, or were unrelated to articular interventions. Screening, selection, and data extraction were performed independently by two authors, with a third author consulted when necessary. Reporting was aligned with PRISMA standards. The quality of SRs was assessed using the AMSTAR-2 tool

Results

We screened 1,436 references and included 10 SRs (2 with meta-analyses) in our analysis. The rheumatological EIMs most commonly reported included arthralgia, peripheral arthropathy, axial arthropathy, spondyloarthritis, and sacroiliitis. Therapeutic interventions included in the SRs were anti-TNF agents, methotrexate (MTX), ustekinumab, (UST) vedolizumab (VDZ), and JAK inhibitors. Treatment efficacy was mainly reported through symptom reduction rates. Quality of the SRs rated from high to very low confidence, with most achieving moderate confidence due to some non-critical weaknesses.

In four SRs anti-TNF therapy showed high response rates for both axial (range 59.1% to 61.8% in a SR) and peripheral spondyloarthritis (range 73.4% to 81.2% in a SR). One SR reported MTX as effective for peripheral enteropathic arthritis. Data on VDZ, UST, and JAK inhibitors were more controversial. One SR reported that UST was effective for arthralgia and psoriatic arthritis. A more recent meta-analysis showed that the improvement of pre-existing joint manifestations was greater in UST-treated patients compared to VDZ-treated patients (54% vs 42%). For tofacitinib, no change in peripheral arthritis was reported by two SRs. Four SRs evaluated treatment-induced rheumatological EIMs, revealing heterogeneous results, particularly with VDZ. However, data from a recent SRs suggest similar rates of new-onset rheumatological EIMs with VDZ and UST (9% vs. 6%)

Conclusion

Anti-TNF therapy appears to be effective in managing both peripheral and axial spondyloarthritis. Given the lack of consistent data on new advanced therapies, prospective studies designed to assess the impact of other advances therapeutics on rheumatological EIMs ,with rigorous endpoint assessment, are needed
P0997 The Rectal Stump during and after subtotal colectomy for Ulcerative Colitis: A scoping review of surgical strategies, medical management options and cancer surveillance recommendations
Authors: Argyriou O , Ghersin I , Stravodimos G , Worley G , Tozer P , Hart A , Sahnan K
Published: January 2025

Background

There are multiple decision nodes, during or after a subtotal colectomy for UC, regarding the management of the rectal stump. Intra-operatively, the retained stump may be closed intraperitoneally in the pelvis, secured at the subcutaneous tissue, or exteriorised as a mucous fistula. Post-operatively, microscopic evidence of proctitis is present in the majority of UC patients.Given the increased risk of cancer in UC, the presence of a retained rectal stump necessitates endoscopic surveillance. The aim of this scoping review was to summarise all available evidence on these 3 aspects of the management of the rectal stump in UC.

Methods

A scoping review of the literature was performed. Relevant studies were identified through a systematic search of Ovid Medline and Embase. Inclusion criteria were adult population and diagnosis of UC. Cohort studies, review articles and guidelines were eligible for inclusion. Articles were screened and reviewed by 2 independent reviewers and conflicts resolved by a 3rd reviewer. The references were grouped according to the subject of interest.

Results

Initial search returned 1267 studies, and after title and abstract screening and full-text screening, 93 studies were found eligible for inclusion in the review. Surgical management of the rectal stump at subtotal colectomy remains controversial. Intra-peritoneal closure has been shown to have higher pelvic sepsis rates, whereas subcutaneous placement results in higher rates of wound infections. A mucous fistula has been shown to have the lowest overall complication rate. Microscopic findings compatible with diversion proctitis develop in most patients, with incidence ranging from 71.4% to 100%. However, only a minority of these patients (30-40%) develop symptoms. Suggested treatments for diversion proctitis include topical mesalamine, corticosteroids or short-chain fatty acids. The overall risk of rectal stump neoplasia in patients with UC after subtotal colectomy is as low as 0.7% (2021 systematic review), with prior colorectal neoplasia being a major risk factor. No universal standardized guidance exists regarding endoscopic surveillance in this patient population.

Conclusion

This scoping review has appraised the latest evidence on 3 crucial stages of the management of the rectal stump in UC. There is still uncertainty about the optimal surgical management of the stump, with different complication profiles. Medical management of diversion proctitis remains a major unmet need, and there are no randomized trials addressing this issue. There are no universally accepted guidelines on endoscopic surveillance of the rectal stump.
P1000 A quasi-experimental study evaluating effectiveness of partial enteral nutrition combined with exclusion diet in patients with mild to moderately severe ulcerative colitis
Authors: Vuyyuru S , Madan D , Kante B , Goswami S , Kumar P , Kumar Ranjan M , Mundhra S , Golla R , Singh N , Ranjan Dash N , Sharma R , Das P , Makharia G , Shankar Ghosh T , Kedia S , Ahuja V
Published: January 2025

Background

We designed this trial to evaluate efficacy of partial enteral nutrition (PEN) combined with exclusion diet (ED) in patients with mild to moderately active ulcerative colitis (UC).

Methods

In this quasi-experimental study, patients with mild-to-moderate UC (SCCAI=3-11) were allowed to choose either PEN+ED along with standard of care (SOC) or SOC alone. Disease activity was measured using simple clinical colitis activity index (SCCAI). Primary outcome was clinical remission (SCCAI≤2) 4 weeks. In addition, fecal microbiota analysis was performed at baseline and after week 4 in ten responders and four non-responders in PEN+ED arm.

Results

Sixty UC patients were included (PEN+ED=30; SOC=30). In the intervention group, 23 patients completed 4 weeks of PEN, 3 took a lower than prescribed dose, and 4 stopped after one week but continued ED. At week 4, 66.7% (20/30) patients in the PEN+ED arm achieved clinical remission at week 4 compared to 83.3% (25/30) receiving SOC. The proportion of patients with stool frequency score≤1 was similar between the two arms (90% vs 93.3%, p>0.99), however proportion of patients with rectal bleeding score ‘0’ was lower in patients receiving PEN+ED (56.7% vs 86.7%, p=0.01) at week 4. A numerically higher number of patients required steroids in SOC arm compared to PEN+ED arm, but it was not significant (23.3% vs 16.7%, p=0.748). At the microbiome level, PEN+ED was associated with a significant enrichment of ‘healthy-gut’ associated taxa (Figure 1) at week 4 compared to baseline and a concomitant-significant reduction in median Kendall distance to reference healthy Indian controls (p-value ≤1e-5), indicating the treatment shifts the microbiomes of patients towards controls.

Conclusion

Although PEN+ED does not appear to have additional clinical benefit to SOC at week 4, it was associated with significant improvement in gut microbiota. Long-term benefits of this therapy should be explored in future trials.

Table 1: Baseline characteristics of included patients

Figure 1: Figure showing change in the composition of the top 20 taxa across baseline and week4 with parenteral nutrition and exclusion diet in ulcerative colitis patients
P1005 Comparative short-term effectiveness of tofacitinib and upadacitinib in refractory, moderate-to-severe ulcerative colitis – An international, multicenter cohort study
Authors: Farkas B , Resál T , Lakatos P L , Limdi J K , Armuzzi A , Bezzio C , Savarino E V , Saibeni S , Michalopoulos G , Attauabi M , Seidelin J B , Fousekis F S , Katsanos K , Bacsur P , Ivány E , Bálint A , Szepes Z , Farkas K , Molnár T
Published: January 2025

Background

Limited comparative data is available on the real-world effectiveness and safety of tofacitinib (TOFA) and upadacitinib (UPA) in ulcerative colitis (UC).

Methods

We conducted an international, multicenter, real-life retrospective cohort study to assess and compare the short-term effectiveness of TOFA and UPA in bio-experienced, moderate-to-severe UC. The primary outcome was week 12 corticosteroid-free remission (CSFR) defined as clinical remission (CR; partial Mayo score [pMayo]<2 with a rectal bleeding subscore of 0) and C-reactive protein (CRP) ≤5 mg/L, as well as not receiving local and systemic steroids ≥30 days. The secondary outcomes were CR and biochemical remission (defined as CRP ≤5 mg/L and fecal calprotectin [Fcal] ≤ 250 mg/g) assessed at week 8 and week 12. Data was handled by intention to treat analysis. We performed multivariable logistic regression models with backward stepwise elimination to control potential confounders and to reduce bias. The most reliable models were selected based on ROC analyzes with highest area under the curve (AUC). Statistical power was calculated on the primary outcome with the number of subjects involved, resulting in 1-β=0.97.

Results

With the participation of 13 tertiary IBD centres, a total of 350 UC patients (Table 1.; mean age: 38.6 ± 13.8 years; 58.6% male) were enrolled in the study. Patients receiving UPA were more likely (OR=4.01 [95%CI: 1.49-10.82]) to achieve CSFR by week 12 compared to the patients on TOFA (47.1% vs. 22.4%). Additionally, higher baseline pMayo (OR=0.76 [95%CI: 0.59-0.98]) and baseline concomitant steroid use (OR=0.17 [95%CI: 0.08-0.40]) decreased the probability of reaching the primary outcome (AUC=0.80). Furthermore, UPA-treated UC patients were more likely to achieve CR at week 8 (54.8% vs. 26.4%; OR=4.06 [95%CI: 1.66-9.93; AUC=0.76]), and at week 12 (69.2% vs. 45.1%; OR=2.3 [95%CI: 1.04-5.13]; AUC=0.80), as well as biochemical remission at week 12 (43.3% vs. 27.3%; OR=6.96 [95%CI: 2.59-18.7]) than patients receiving TOFA. IBD-related hospitalisation was needed in 6.1% (15/246) of the patients on TOFA, as compared to 1.9% (2/104) of patients receiving UPA. Near-significant difference was observed in colectomy rates between the two patient groups (UPA vs. TOFA: 0% vs. 3.7%; p=0.066). Herpes zoster infection was reported in 1.6% (4/246) of the TOFA-treated patients, and in 1.0% (1/104) of the UPA-treated patients. No venous thromboembolism was observed.

Conclusion

Based on our real-life data, UPA might be associated with better short-term clinical outcomes compared with TOFA in refractory, moderate-to-severe UC.
P1012 Systemic biologic therapies are associated with comparable safety outcomes to vedolizumab for the management of Inflammatory Bowel Disease following liver transplantation
Authors: Chin S , Con D , Hilley P , Corte C , Testro A , De Cruz P , Choy M , Srinivasan A
Published: January 2025

Background

Although the ‘gut-specific’ safety profile of vedolizumab may be considered advantageous in inflammatory bowel disease (IBD) patients on concomitant immunosuppression following liver transplant, the safety of vedolizumab has not been compared with ‘systemic’ biologic therapies in this context. This study aimed to compare the safety of ‘gut-specific’ and ‘systemic’ biologic therapies to manage IBD following liver transplantation (LTx).

Methods

A retrospective observational study of IBD patients exposed to biologic therapy following LTx was undertaken across two Australian LTx centers. The primary outcome was the incidence rate of safety events per patient-year of biologic exposure, while the secondary outcome was the impact of non-biologic immunosuppression on safety events. Safety events were defined as any documented infection whilst on biologic therapy, and were stratified accordingly to ‘gut-specific’ (vedolizumab) or ‘systemic’ (anti-TNF, ustekinumab) biologic exposure. A severe safety event was defined as one that required hospitalisation.

Results

Thirty-six patients were exposed to 59 (median 12 (IQR 6-27) months) biologic episodes for IBD following LTx. Most patients had co-existing primary sclerosing cholangitis (88.9%) and ulcerative colitis (72.2%) (Table 1). The cohort were collectively exposed to 44.5 and 44.4 patient-years of ‘gut-specific’ (n=27) and ‘systemic’ (anti-TNF, n=22; ustekinumab, n=10) biologic therapy, respectively. Twenty-seven (45%) biologic episodes were associated with 41 safety events a median of 8 months (IQR 4.5-13.5) following biologic initiation (Table 2A). The incidence rate of safety events were comparable between ‘gut-specific’ and ‘systemic’ biologic exposures (0.43 vs 0.50 per patient-year, p=0.79). Corticosteroid exposure at biologic initiation was the only non-biologic immunosuppressive exposure associated with more frequent severe safety events (incidence ratio 5.40 [95% CI 1.66-17.63, P<0.01]; Table 2B).

Conclusion

In this study of LTx recipients with IBD, incidence of safety events between those exposed to ‘gut specific’ and ‘systemic’ biologic therapies were comparable. These data suggest that choice of IBD biologic therapy should not be primarily influenced by concurrent transplant immunosuppression. However, corticosteroid co-therapy at biologic initiation may be associated with a higher incidence of severe safety events, highlighting the need to rationalise corticosteroid therapy following biologic initiation. These observations warrant validation in separate cohorts.
P1015 Upadacitinib as a Rescue Therapy in Patients with Steroid- and Infliximab-Refractory Acute Severe Ulcerative Colitis: Real-Life Multicentre Results
Authors: Ünal Gülsen N , Bakkaloglu O K , Kav T , Kani H T , Akpinar A , Akincioglu P , Eskazan T , Balamir M , Dagci G , Sendur I , Buyuktorun I , Barutcu S , Bengi G , Cavus B , Oruc N , Alabdah Y , Atug O , Dincer D , Hatemi I , Erzin Y Z , Tezel A , Toruner M , Akyuz F , Celik A F
Published: January 2025

Background

Ulcerative colitis (UC) is a chronic inflammatory bowel disease with remissions and flares. Approximately 20% of UC Patients develop acute severe ulcerative colitis (ASUC), a serious condition that is refractory to standard therapies and leads to morbidity and mortality. Rescue therapy (salvage therapy) with steroids, cyclosporine, and/or infliximab is recommended by guidelines.1 The colectomy rate in ASUC remains at around 36% even in the biological millennium.2 Upadacitinib (UPA) is a JAK1 selective inhibitor used effectively to treat UC. The role of UPA as a rescue therapy in ASUC is not clear. This study aims to evaluate the outcomes of UPA as a rescue therapy in ASUC patients.

Methods

A total of 31 steroid- and infliximab-refractory ASUC patients from 10 IBD centers from all over Türkiye were included between April 2023 and October 2024 in our study. Demographics of the patients and disease characteristics were recorded. Stool frequency (per day), rectal bleeding scores, and C reactive protein (CRP) were assessed from the electronic database at baseline (week 0), week 1, 4, 8, and 16 retrospectively. Complete clinical response was defined as stool frequency ≤3 per day and rectal bleeding score 0-1.

Results

Mean age was 36±13years; 16(51.6%) were female, mean disease duration was 6.9±5.4 years, 30(96.8%) had immunomodulator experience (Table1). A total of 10 patients had ≥ 3 biologics failures. Complete clinical response at weeks, 4, 8, and 16 were in 13 (42%), 16 (64%), 12 (67%), and 10 (77%) patients respectively.

Rescue therapy responses were not statistically significant between ≥3 and <3 biologics failure groups (p=0.580) at week1. CRP normalization (<3 mg/L) at week 4 was found in 9(36%) patients. By the end of the week, 6 (33%) patients had undergone colectomy. Clinical responses and surgery rates of UPA at week1,4,8, and 16 were detailed in Figure 1.

Conclusion

UPA provided a complete clinical response as a rescue therapy within the first week in 42% of cases in anti-TNF and steroid non-responders even with multiple biologics experience. Over half of the patients showed clinical remission by weeks 4 and 8.

References

1.Raine T, Bonovas S, Burisch J, et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis. 2022;16(1):2-17. doi:10.1093/ecco-jcc/jjab1782.

2.Moore AC, Bressler B. Acute Severe Ulcerative Colitis: The Oxford Criteria No Longer Predict In-Hospital Colectomy Rates. Dig Dis Sci. Feb 2020;65(2):576-80.
P1017 Real-world effectiveness and safety of filgotinib with and without concomitant therapies in patients with Ulcerative Colitis: an interim analysis of the prospective, observational GALOCEAN study
Authors: Høivik MD- PhD M , Vermeire S , Reinisch W , Seenan J P , Löwenberg M , Schreiber S , Armuzzi A , Ricart E , Doherty G , Saldaña R , Sawyer W , Rudolph C , Jus A , Gilletta de Saint Joseph C
Published: January 2025

Background

Filgotinib (FIL), a once-daily, oral Janus kinase 1 preferential inhibitor, was approved for the treatment of Ulcerative Colitis (UC) following the phase 2b/3, randomized SELECTION clinical trial.1 Real-world data on the effectiveness and safety of FIL are needed to complement the results of clinical trials for applicability in daily clinical practice.

Methods

GALOCEAN (NCT05817942) is a European, multicenter, prospective, observational study that will recruit ~600 adults with UC receiving FIL in clinical care. In this interim analysis, we report data for up to 24 weeks. Effectiveness outcomes were the Mayo Clinic Score (MCS), the partial MCS (pMCS) and the two-item patient-reported outcome (PRO2) score, as well as Short Inflammatory Bowel Disease Questionnaire (SIBDQ), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and Urgency Numerical Rating Scale (NRS) scores. Safety assessments included treatment-emergent adverse events (TEAEs) and adverse events of special interest (AESIs). Data were analyzed for the overall patient group, and for those receiving FIL without baseline concomitant therapies (FIL−ct) or FIL with baseline concomitant therapies (FIL+ct; including conventional therapies, biologics and synthetic targeted small molecules).

Results

As of June 2024, 277 patients had been enrolled in GALOCEAN. Of these, 223 had available baseline data; 139 and 83 completed 10 and 24 weeks of treatment, respectively. At baseline, 53% of patients (118/223) received FIL−ct and 47% (105/223) received FIL+ct, of whom 92.4% (97/105) received aminosalicylates. Baseline characteristics are shown in Table 1. MCS, pMCS, PRO2, SIBDQ, FACIT-Fatigue and Urgency NRS data are shown in Table 2. At week 24, remission was achieved by 30% of patients (FIL−ct, 29%; FIL+ct, 31%) for the MCS, 47% (FIL−ct, 47%; FIL+ct, 47%) for the pMCS and 50% (FIL−ct, 44%; FIL+ct, 55%) for the PRO2 score. At week 24, minimal clinically important differences (MCIDs) were achieved by 66% of patients (FIL−ct, 75%; FIL+ct, 58%) for the SIBDQ score, 64% (FIL−ct, 72%; FIL+ct, 57%) for the FACIT-Fatigue score and 43% (FIL−ct, 50%; FIL+ct, 36%) for the Urgency NRS score. Overall, 30% of patients (FIL−ct, 25%; FIL+ct, 36%) had ≥1 TEAE and 6% (6% in each subgroup) had ≥1 AESI.

Conclusion

This study highlights the overall effectiveness and safety profile of filgotinib up to 24 weeks in a real-world cohort, both when used alone or with concomitant therapy. The safety profiles were consistent with previous data. The GALOCEAN study is ongoing.

References

1.Feagan BG et al. Lancet 2021;397:2372–84.
P1020 Trends in Opioid Use among Patients with Inflammatory Bowel Disease and Changes Following Advanced Therapy Initiation: A Korean nationwide population-based study
Authors: Jun Y K , Ji E , Choi Y , Shin C M , Park Y S , Kim N , Lee D H , Yoon H
Published: January 2025

Background

Opioid use patterns among Asian patients with inflammatory bowel disease (IBD), and the impact of advanced therapy (AT) on opioid use, are not well understood. This study aimed to investigate trends in chronic opioid use and assess the impact of AT initiation on opioid use among Korean patients with IBD.

Methods

Data were extracted from the Korean Health Insurance Review and Assessment Service database for adult patients with IBD from 2010 to 2022. Chronic opioid use was defined as ≥90 days or ≥3 opioid prescriptions within a calendar year. Chronic opioid users were matched with non-chronic opioid users at a 1:3 ratio based on sex, age, and type of IBD. Analyses included Poisson regression, the McNemar test, and generalized estimating equation (GEE).

Results

Between 2010 and 2020, Chronic opioid use was more prevalent in patients with Crohn’s disease (CD) compared to those with ulcerative colitis (UC). The number and proportion of chronic opioid users among Korean patients with CD and UC increased significantly (p-values <0.0001 for both trends). In 2010, only 123 patients with CD (1.57%) and 113 patients with UC (0.54%) were classified as chronic opioid users. However, by 2020, these numbers rose sharply to 1,286 patients with CD (5.44%) and 1,087 patients with UC (1.97%). In the McNemar test, the number of opioid users significantly decreased following AT initiation (p-value <0.0001 for both CD and UC): a large number of patients discontinued opioids after initiating AT (1,639 patients with CD and 1,600 patients with UC), while only a small number of patients began opioids after initiating AT (681 patients with CD and 642 patients with UC). GEE analysis further demonstrated that AT was significantly effective in reducing the number of opioid users among patients with CD (odds ratio [OR] = 0.479, 95% confidence interval [95% CI] = 0.440–0.521, p-value <0.0001) and UC (OR = 0.844, 95% CI = 0.775–0.919, p-value = 0.0001).

Conclusion

Although opioid use among Korean patients with IBD has been on the rise, AT is effective in reducing the number of opioid users among patients with both CD and UC.
P1025 A mental health intervention can support increased capacity and revenue in the IBD outpatient setting
Authors: Avery P , Cervantes M L , Moulton C , Hart A
Published: January 2025

Background

A national reference centre for inflammatory bowel disease (IBD) in the UK supports around 10000 people with inflammatory bowel disease. A mental health service development in our centre has provided access to medical treatments for IBD that have traditionally been used to treat mental health conditions. Fatigue, affecting an estimated 40% of patients with IBD, predicts increased use of outpatient services. In a psychiatrist-led clinic, modafinil, a medication used to treat narcolepsy, produced a mean 58% improvement in fatigue in a case series of 10 patients. This snapshot of patients treated in this clinic looks at the potential for cost and efficiency improvements to reduce the waiting list for consultant-led care.

Methods

The electronic health records of 10 individuals treated with modafinil (dose 50-400mg/day based on clinical response) were analysed. Contacts were compared for 12 months before and 12 months after the intervention. The mean average of any saved appointments was calculated. All patients had severe fatigue, defined as an IBD Fatigue Assessment Score >10/20, for six months or more. Anonymous demographic data were collected, and potential savings in appointments between follow-ups charged at £87.00 and new appointments charged at £150.00; the possible increase in capacity was calculated.

Results

Of the 10 patients analysed, the mean age was 33.8; 40% were male and 60% female. Twenty per cent had comorbid irritable bowel syndrome, 10% had comorbid Ehlers-Danlos syndrome, 60% were prescribed advanced therapy (AT) and 30% had been on one or more previous ATs. IBD outpatient appointments for the combined cohort were reduced from 70 to 27 for the 12 months before modafinil commencement to the 12 months of treatment, a reduction of 43(61%) appointments and a mean average of 4.3 If clinic templates were altered to new from follow-up, for these appointments’ revenue would be increased from £3,741.00 to £6,450.00, representing an increase in revenue of £2,709.00. If just 10% of the 4000 patients estimated to have fatigue at our centre benefit from this treatment, 1,720 appointments in 12 months would be saved, representing a cost saving of £149,640.00. These appointments could also be made available for new patients with a revenue increase of £108,360.00. With 1,720 appointments made available, this also offers increased access to specialist opinions for patients with IBD who need it

Conclusion

In addition to improving patient quality of life, modafinil shows potential health-economic benefits in IBD, including reduced burden on outpatient services and potential for increased revenue for specialist services. Replication of these findings in larger cohorts and randomised trials is needed.
P1027 Assessment of body fat composition in patients with inflammatory bowel diseases by bioelectrical impendance analysis: a single-centre study
Authors: Vukovic J , Sundov Z , Sustic I , Ivana J , Ana K ,   J Vukovic Sustic I Jukic I Krizman A
Published: January 2025

Background

Body fat percentage (BF%) serves as a valuable indicator of nutritional status and associated health risks, particularly in patients with chronic inflammatory conditions such as inflammatory bowel disease (IBD). This study aimed to evaluate and compare BF% between healthy controls and individuals diagnosed with IBD to determine potential disparities in body composition linked to the disease.

Methods

A cross-sectional study design was employed, involving 76 IBD patients (34 with UC and 42 with CD disease) who are in clinical remission treated with biological therapy and 64 healthy controls. BF% was assessed using bioelectrical impedance analysis, providing a comparative analysis between these two groups. Statistical significance was evaluated using a two-sample t-test with a significance threshold of p < 0.05.

Results

The mean BF% was 22.54 for the IBD patient group and 23.59 for the healthy cohort. The observed difference was not statistically significant (p = 0.3765), suggesting that BF% in IBD patients may not differ substantially from that of healthy individuals within this sample.

Conclusion

Our findings indicate no significant deviation in BF% between IBD patients and healthy controls, suggesting that body fat levels might remain stable and indicate the quality for treatment of IBD. BIA related indices are effective tool for assessment of nutritional status, and indicate the quality for treatment of IBD. This study underscores the complexity of body composition in chronic inflammatory conditions and highlights the need for further research to assess the role of treatment on body composition in IBD populations.

References

1.Jabłońska B, Mrowiec S. Nutritional Status and Its Detection in Patients with Inflammatory Bowel Diseases. Nutrients. 2023;15(8).

2.Bischoff SC, Escher J, et al. ESPEN practical guideline: Clinical Nutrition in inflammatory bowel disease. Clinical nutrition (Edinburgh, Scotland). 2020;39(3):632-53.
P1029 Janus Kinase Inhibitors for the Management of Acute Severe Ulcerative Colitis: A Multicentre Study
Authors: Gilmore R , Fernandes R , Chin S , Con D , De Cruz P , Demase K , Sparrow M , Thin L , Baker J , Venugopal K , Lucas S , Garg M , Loebenstein M , Nguyen A , Moore G , Tandon B , Bryant R , MacFarlane K , Lynch K , Abdul S , Subhaharan D , Mohsen W , Haig A , Day M , White L , Begun J , An Y K
Published: January 2025

Background

Acute Severe Ulcerative Colitis (ASUC) is a medical emergency, with limited therapeutic options available for medical management. Tofacitinib and Upadacitinib are novel Janus Kinase inhibitors (JAKi), with proven efficacy for ulcerative colitis (UC). This study aimed to examine the outcomes of patients treated with JAKi for ASUC in a real-world population.

Methods

A retrospective multi-centre study was conducted including patients (≥18 years) with ASUC commenced on Tofacitinib or Upadacitinib from April 2021 to April 2024. ASUC was defined according to Truelove and Witt’s criteria. Demographic and clinical data were recorded at admission, JAK induction, discharge, week 8, week 16 and 1 year post-induction. The primary outcome was need for colectomy. We further evaluated adverse events and drug-specific response.

Results

A total of 124 patients were included from 11 Australian Inflammatory Bowel Disease (IBD) centers. Tofacitinib was used in 49%, while Upadacitnib was used in the remainder. 58% of patients received JAKi as first line salvage therapy, while the remainder received JAKi sequentially after failure of first line infliximab therapy.

The rate of colectomy during admission was 17% and 40% by 1 year. There was no significant difference between rate of colectomy during index admission (p=0.38), or 1 year post induction (p=0.24) between Tofacitinib and Upadacitinib.

There was a significantly increased risk of inpatient colectomy for those receiving sequential salvage compared to initial JAKi salvage (p=<0.01). However, there was no significant difference in the rate of colectomy in either cohort up to 1 year post induction (p=0.19).

Clinical response was observed in 45% of patients by day 3 of induction and 65% by day 7. Clinical remission rates were 40% by week 8 and 65% by week 16. Biochemical remission was achieved in 51% by week 16. Mucosal healing was achieved in 47% of patients who underwent repeat endoscopy within 16 weeks of induction.

Adverse events occurred in 16% of patients, all of which were minor and did not require hospitalisation. The most common events noted were acne (7%) and nasopharyngitis (6%).

Conclusion

Jaki demonstrate effectiveness and safety for the management of ASUC. There was no significant difference in the inpatient colectomy rate between Tofacitinib and Upadacitinib. There was a significantly higher rate of inpatient colectomy for patients requiring sequential salvage therapy, but no significance when patients were followed up to 1 year. There is variability in prescribing practice between dosage of Tofacitinib and Upadacitinib, duration and dosage of corticosteroid wean, and the use of prophylactic PJP and VTE prophylaxis.
P1034 Prognostic value of short-term endo-histological outcomes in moderate-to severe ulcerative colitis patients on tofacitinib treatment – prospective cohort study
Authors: Resál T , Bacsur P , Farkas B , Ivány E , Bálint A , Bősze Z , Fábián A , Bor R , Tóth T , Szepes Z , Farkas K , Molnár T
Published: January 2025

Background

Data are scarce on the deep remission of tofacitinib (TOFA) in moderate-to severe ulcerative colitis (UC), however, it can fundamentally change disease course and behaviour.

Methods

This was a prospective cohort study, assessing the short-term effectiveness of TOFA in UC patients. Baseline was the day of induction of TOFA. Clinical, biochemical, endoscopic and histological activities were assessed at baseline and at week 8 and 12, and we collected one-year treatment persistence. Primary outcome was week 12 histological remission (HR), defined as Nancy score<1 and endoscopic Mayo score (eMayo)≤1. Secondary outcomes were week 12 corticosteroid-free remission (CSFR), defined as clinical remission (CR; partial Mayo score [pMayo]<2 with a rectal bleeding subscore of 0) and C-reactive protein (CRP) ≤5 mg/L and endoscopic remission (eMayo score ≤1), furthermore, one-year treatment persistence were assessed. Data was handled by intention to treat analysis. We performed multivariable logistic, Cox-regression and linear regression models to control potential confounders and to reduce bias. The most reliable models were selected based on ROC analyzes with highest area under the curve (AUC).

Results

A total of 75 moderate-to severe UC patients (mean age 38.4 ± 12.1; male/female ratio 32/44) were involved in our prospective cohort study. In total, 7 patients (9.2%) achieved histological remission, while 20 patients (26.7%) achieved endoscopic remission. We found, that one-year treatment persistence was strongly influenced by week 12 endoscopic remission (β=3.79 [95% CI: 1.21 – 6.37]), but not by HR (β=1.58 [95% CI: -0.74 – 3.89]). In total, 34 patients (44.7%) were in CSFR at week 12, and higher baseline pMayo score decreased (OR=0.64 [95% CI: 0.43 – 0.94]), while albumin increased (OR=1.33 [95% CI: 1.01 – 1.76]) the chance of achieving the outcome (AUC = 0.93).

Conclusion

Based on our prospective cohort study, short-term HR is still a hard-to-reach endpoint in moderate-to-severe UC on TOFA. We found, that one-year treatment persistence is influenced by endoscopic mucosal healing, but not by HR, however, it should be enhanced, that as only a few patients achieved HR, the necessary statistical power was lacking.