bluuebunny/crossref_metadata_2025 huggingface dataset:
P0685 Endoscopic severity at presentation and C-reactive protein predict immediate and twelve-month outcomes of second-line medical therapy in Acute Severe Ulcerative Colitis
Authors: Subhaharan D , Kakkadasam Ramaswamy P , Edwards J , White L , Patrick D , Shahzad A , Willmann L , Moattar H , Shukla D , Ishaq N , Bhullar M , Dorrington A , Satsangi J , Mohsen W
Published: January 2025

Background

Medical rescue therapy (MRT) is effective in intravenous corticosteroid refractory acute severe ulcerative colitis (ASUC). Our primary objective was to identify parameters which identify initial and sustained response to MRT.

Methods

Two cohorts were studied retrospectively. Analysis of 66 adult ASUC admissions receiving MRT between 2015-19 at Gold Coast University Hospital and Logan Hospital was first performed. Clinical, endoscopic and laboratory data were collected. Response was defined as avoiding colectomy during the same admission. Univariable and multivariable logistic regression were employed to identify predictors of response. The predictors were validated in 99 patients admitted to Gold Coast University Hospital and Sunshine Coast University Hospital between 2020-23.

Results

In the development cohort, 55/66 patients (83.3%) responded to MRT. On multivariable analysis, UCEIS score at admission [Coef - 0.105 (-0.19 to – 0.007), p=0.03] and CRP on day 3 of post commencement of MRT (CRP on day R+3) [Coef -0.004 (-0.0008 to -0.0004), p=0.03] identified response to MRT. All patients (n=20) with a UCEIS score < 6 [Sensitivity 41.7%, Specificity 100%, PPV 100%, NPV 26.3%] and 97.1 % (33/34) patients with a CRP on day R+3 < 22mg/L responded to MRT [Sensitivity 71.7%, Specificity 90%, PPV 97.1%, NPV 40.9%]. In the validation cohort, 93/99 (94%) patients responded to MRT; 92.6% (25/27) with a UCEIS score < 6 [Sensitivity 26.9%, Specificity 66.7%, PPV 92.6%, NPV 5.6%] and 100% (72/72) patients with CRP on day R+3 < 22mg/L responded to MRT [Sensitivity 85.7%, Specificity 100%, PPV 100%, NPV 33.3%]. In patients with both UCEIS <6 and CRP on day R+3 < 22mg/L, 15/15 (100%) and 18/18 (100%), in the development and validation cohorts respectively, responded to MRT.

At 12 months after hospitalisation, in the development cohort, 45 (68.1%) patients had avoided colectomy. Of the patients with a UCEIS score <6, 19 (95%) patients and 28/34 (82.4%) patients with CRP on day R+3 < 22mg/L avoided colectomy. In the validation cohort, at 12 months, 84 (84.9%) patients had avoided colectomy. Of the patients with a UCEIS score < 6, 24/27 (88.9%) and 66/72 (91.7%) patients with CRP on day R+3 < 22mg/L had avoided a colectomy at 12 months. In patients with both UCEIS <6 and CRP on day R+3 < 22mg/L, 14/15 (93.3%) and 17/18 (94.4%), in the development and validation cohorts respectively, had avoided colectomy at 12 months.

Conclusion

UCEIS score < 6 at admission and CRP on day R+3 < 22mg/L predict response to second-line MRT and colectomy is extremely unlikely either on the index admission or within 12 months.
P0687 Development and validation of a novel multimodal model based on histology of colonoscopic biopsy to predict primary non-response to infliximab in patients with Crohn’s disease
Authors: Wang Y , Wang H , Ye Z , Huang B , Mao R
Published: January 2025

Background

Crohn’s disease (CD) is a chronic inflammatory condition of the gastrointestinal tract, and while biologics like infliximab (IFX) offer significant benefits, 10-30% of patients remain non-responders initially. This study aims to refine the prediction of treatment responses using artificial intelligence to integrate multimodal information, potentially enhancing treatment precision.

Methods

We conducted a retrospective analysis of clinical data from Crohn’s disease patients treated at The First Affiliated Hospital of Sun Yat-sen University from October 2016 to October 2021. The endpoint event was defined as primary non-response within 14 weeks of treatment. This study included clinical, laboratory, endoscopic, imaging, and histological data from colonoscopic biopsies. The data were split into a test set and an internal validation set in a 7:3 ratio. A deep learning (DL) model was developed using a multi-instance learning framework to incorporate this multimodal information for predicting primary non-response to IFX. Finally, the multimodal model was validated in an independent external validation cohort.[Figure1]

Results

The study included 170 patients, with 93 in the internal training set, 38 in the test set, and 39 in the external validation set. The DL model utilizing pathological features achieved an area under the receiver operating characteristic (AUROC) of 0.79 in 5-fold cross-validation. When combining pathological and radiological features, the AUC was 0.76, and integrating clinical features raised the AUC to 0.82. External validation upheld the efficacy of model with the highest AUC at 0.73 for the multimodal model.

Conclusion

The study developed several DL models to predict primary non-response to IFX with high accuracy. The most effective model integrated pathology, radiomics, and clinical data, supporting targeted treatment strategies and advancing personalized medicine for CD.
P0688 Decisional conflict among patients with fistulizing perianal disease phenotype of Crohn’s disease at diagnosis
Authors: Ibrahim F A E , Sebastian S
Published: January 2025

Background

Crohn’s Disease peri-anal fistula (CD-pAF) is a disabling form of the disease affecting work, social and sexual function. Despite Current improvements in medical and surgical management, pCD remains a difficult entity to treat. Decisions about optimal treatment in CD perianal fistula is frequently associated with decisional conflict. We aimed to assess what levels of decisional conflict (DC) do patients with CD-pAF experience after discussing treatment option(s) while making treatment choices at baseline.

Methods

We used the 16 point decision conflict scale to evaluate patients’ understanding and approval of treatment decision at baseline defined as within 6 months of fistula diagnosis.

Results

67 patients with newly diagnosed CD-PAF provided a response to Decision Conflict Scale questionnaire. The median age at fistula diagnosis was 37(31, 48). 39/67 (58%) were females. Notably, 20-30% of patients reported as "unsure" across most of the questions. 32/67(48%) chose biologics to be their preferred treatment option while 9/67(13%) chose surgery. 64% of patients reported to have made an informed choice regarding their treatment. Only 54% reported they have enough information about their treatment options. (Figure1)

Conclusion

Due to persisting uncertainties in the optimal management of CD- pAF, making informed choices on treatment approaches remain a challenge for patients. Decisional conflict can be lowered with decision supporting interventions. This does not only involve offering better therapeutic choices but also improvement in information, education and shared decision making strategies
P0690 Purposeful design and integration of a pilot Inflammatory Bowel Disease (IBD) diet clinic into a multi-disciplinary IBD service demonstrates exemplar service utility and is of high value to patients
Authors: Day A , Chu M , Scinto T , Han S , Vinci I , Hatzi M , Bryant R ,   Inflammatory Bowel Disease Translational Research Group
Published: January 2025

Background

International guidelines recommend people with inflammatory bowel disease (IBD) have access to a dietitian who can undertake a comprehensive nutrition assessment and provide personalised dietary counselling. Few Australian tertiary IBD services offer dedicated and co-located IBD diet clinics (IBDDCs) to enable point of care, integrated dietary management. The value of IBDDCs to patients and IBD services is unknown. This study aimed to examine the utility and patient-reported value of an integrated IBDDC.

Methods

A 24-month prospective clinical service audit of a pilot IBDDC at The Queen Elizabeth Hospital, Adelaide, South Australia was conducted. Adults with IBD and nutrition-related issues identified during gastroenterology consultation were referred for specialist IBD dietetic consultation. IBD-diet referral criteria and clinic templates that included direct access appointments for patients requiring point of care dietary management were established. IBDDC service activity audit captured referral rates, wait times, mode of consult delivery, attendance and appointment outcomes. A subgroup of patients completed service evaluation questionnaires. Descriptive data is presented.

Results

Between February 2021–February 2023, 182 new referrals to IBDDC resulted in 133 new appointments accounting for closures during COVID lockdowns. Of these, 108/133 (81%) attended first consultation and 86/108 (64%) were point of care appointments. The ratio of new to review appointment utilisation was 1:2. Of 382 scheduled reviews, 329/382 (86%) attended and 34/329 (9%) utilised point of care consults. Overall, 19/515 (3.7%) failed to attend (FTA) IBDDC appointments over 24-months. In a subgroup of 55 patients, 89.1% reported future access to integrated IBDDCs as highly valuable.

Conclusion

A dedicated IBDDC demonstrates high service utility and exceptionally low FTA rates over 24-months. Direct access appointments are novel and were well utilised for patients requiring point of care dietary assessment and care planning. This is exemplar of how to purposely integrate dietetic services into high acuity multi-disciplinary IBD models of care and maximise patient attendance. The next steps are to complete a health economic cost consequence analysis of IBDDC to inform integration of dietetic services into Australian IBD models of care.
P0699 Comparative Effectiveness and Safety of Denosumab Versus Bisphosphonates in Osteoporosis Management Among Patients with Inflammatory Bowel Disease: A U.S. Propensity Matched Cohort Study
Authors: Khataniar H , Desai A , Kochhar G
Published: January 2025

Background

Denosumab, a fully monoclonal antibody, is approved for the treatment of osteoporosis, including glucocorticoid-induced osteoporosis. Denosumab is an alternative to bisphosphonate therapy and has been shown to improve bone mineral density, and reduce the incidence of new fractures, however there is limited data in patients with inflammatory bowel disease (IBD). Through this study we evaluate the effectiveness of denosumab versus bisphosphonates in reducing osteoporosis-related fractures and safety related to IBD-specific outcomes.

Methods

We conducted a retrospective cohort study using a U.S. multi-institutional database (TriNetX), examining patients with IBD with osteoporosis who were initiated on denosumab or bisphosphonates from 2013 to 2022. The primary aim of the study was to assess the 1- and 2-year risk of de-novo fractures (spine and/or hip) in the denosumab cohort compared to bisphosphonate cohort. Cox proportional hazard model was used to identify predictors of denosumab failure. The secondary aim was to evaluate the 2-year risk of IBD-related outcomes which included corticosteroid use, advanced therapy initiation, and surgery. 1:1 propensity score matching (PSM) was performed for demographics, comorbid conditions, BMI, hemoglobin, albumin, calcium/vitamin D supplementation, IBD medications including steroid use.

Results

Among 2,423 patients with IBD and osteoporosis (mean age 62.8, female sex 67.3%, Crohn’s disease 48.5%), 520 received denosumab and 1,903 received bisphosphonates. After PSM, there was no difference in the 1-year (2.33% vs 3.49%, aOR 0.65, 95% CI 0.31-1.38) and 2-year risk (4.65% vs 6.78%, aOR 0.65, 95% CI 0.39-1.14) of fractures between the denosumab cohort compared to the bisphosphonates cohort. In terms of IBD-related outcomes, denosumab was associated with a lower risk of prednisone use (aOR 0.73, 95% CI 0.56–0.96) but no significant difference in the risk of de-novo advanced therapy use (aOR: 0.76, 95% CI 0.442–1.334), IV steroid use (aOR 1.13, 95% CI 0.78–1.64) and surgery (aOR 0.79, 95% CI 0.49-1.27) [Table 1].

After cox regression analysis, chronic steroid use (HR 1.99, 95% CI 1.26-3.1), prednisone use (HR 1.71, 95% CI: 1.07–2.72) and history of falls (HR 3.00, 95% CI 1.34-4.09) as significant predictors of treatment failure with denosumab [Figure 1].

Conclusion

Our study highlights the comparable effectiveness of denosumab compared to bisphosphonates in reducing the risk of fractures in patients with IBD and osteoporosis. There were no IBD-related safety signals related to denosumab use compared to bisphosphonates. Further prospective studies are needed to optimize osteoporosis management in this high-risk population.
P0704 A Multicenter Study Evaluating the Persistence, Effectiveness, and Safety of Methotrexate in Patients with Inflammatory Bowel Disease: The MICI-METHO Study
Authors: Caron B , Kirchgesner J , Nachury M , Bouguen G , Uzzan M , Buisson A , Le Cosquer G , Vuitton L , Seksik P , Petit S , Wils P , Nancey S , Altwegg R , Hupe M , Fumery M , Roblin X , Laharie D , Hebuterne X , Baumann C , Vicaut E , Peyrin-Biroulet L
Published: January 2025

Background

Methotrexate has demonstrated efficacy in Crohn’s disease (CD) as monotherapy and is increasingly used in combination therapy. There is no consensus regarding its use in clinical practice, and it remains underused. The aims of this study were to describe the use of methotrexate in patients with inflammatory bowel disease (IBD) in France, and assess its persistence and safety.

Methods

This was an observational, retrospective, multicenter study involving adult patients with IBD treated with methotrexate in monotherapy or combination therapy between January 2015 and December 2022. All patients were followed for at least 6 months after the initiation of treatment.

Results

A total of 1115 patients were included from 15 French centers. Among them, 510 were men (45.7%). The median age at diagnosis was 24 [17.9–36.4] years, and the median age at initiation of methotrexate was 35.6 [24.8–50.3] years. The majority of patients had CD (77%), and 378 (34.5%) patients had at least one extra-intestinal manifestation (EIM). Regarding prior treatments, 45.8% of patients had been exposed to azathioprine and 78.2% to anti-TNF agents.

The median treatment duration was 12.3 [5.9–29.9] months. The primary indication for methotrexate was IBD (81.5%), followed by EIM (rheumatological (11.9%) or dermatological (3.9%)). The most frequently used induction doses were 15 mg/week (47.5%) and 25 mg/week (31%), while the most common maintenance dose was 15 mg/week (51.1%). The treatment was mainly administered by subcutaneous injection (57.8%) or orally (38%). Methotrexate was prescribed in combination therapy in 90.6% of cases.

The persistence rate of methotrexate was 27.7 months in CD and 22.4 months in ulcerative colitis (UC). For CD, factors associated with persistence were female sex (Hazard Ratio (HR) 1.258; 95% Confidence Interval (CI) 1.051–1.506) and the presence of EIM (HR 0.709; 95% CI 0.583–0.862). In UC, the presence of EIM (HR 0.629; 95% CI 0.420–0.944) was associated with treatment persistence.

The main reasons for discontinuation of methotrexate were inefficacy (32.5%), intolerance (29.6%), and cessation of combination therapy (20.4%). A total of 344 (31.7%) patients experienced an adverse event related to methotrexate, and 9 patients experienced a serious adverse event. After discontinuation of methotrexate, 53.8% of patients continued treatment as monotherapy, 40% required another treatment, and 6.1% underwent surgical intervention.

Conclusion

The French multicenter MICI-METHO study is the first to provide a comprehensive overview of the real-world use, effectiveness, and safety of methotrexate in patients with IBD. A better understanding of this treatment could improve its use in IBD management.
P0707 Impact of age of disease diagnosis on disease phenotype and severity in patients with Inflammatory Bowel Diseases
Authors: Panayiotou S , Orfanoudaki E , Papatzelou I , Foteinogiannopoulou K , Theodoraki E , Drygiannakis I , Koutroubakis I E
Published: January 2025

Background

Up to 15% of inflammatory bowel disease (IBD) patients are diagnosed after the age of 60 years. The aim of the study was to compare disease characteristics and management of IBD patients diagnosed before (adult onset-AO) or after the age of 60 years (elderly onset-EO).

Methods

Data of a prospective longitudinal registry of IBD patients followed in a tertiary center over a twelve-year period (2012-2024) were analyzed. Consecutive IBD patients with complete data at study entry were included. They were divided into two groups according to their age at disease diagnosis <60 (AO) and ≥ 60 (EΟ) years. The two groups were compared for their demographic and clinical characteristics, their treatment and outcomes (IBD related surgeries, development of malignancy, death).

Results

A total of 714 IBD patients were included in the study. EO had 109 (15.3%) and AO 605 (84.7%). Median (IQR) age at diagnosis was 31 (22.5-43) years in AO and 66 (62-71.2) years in EO (p<0.0001) while the median (IQR) disease duration was 13.5 (7-23) years in AO and 9 (4.25-13) years in EO respectively (p<0.0001).

From the comparison of the 2 groups (EO vs AO), no association between age at diagnosis and disease type or gender was found. Extraintestinal manifestations (p=0.0009) and positive family history (p=0.001) were more frequent in AO. Age at diagnosis was associated with disease phenotype (p=0.006), location of NC (p=0.008) as well as perianal disease (EO more often had ileal location and inflammatory phenotype), while there were no differences in UC extension.

Regarding therapy, there was a less frequent use of biological therapies, immunosuppressants and steroids (p<0.05) in EOs, while the use of budesonide was higher (p<0.0001) [Table 1].

During follow-up, more malignancies and deaths were recorded in EOs (p<0.0001), while IBD related surgeries were numerically more in AOs (16% vs 9%), but the difference was not statistically significant (p=0.059).

Conclusion

There are some distinct differences in clinical characteristics and therapeutic management between AO and EO patients with IBD. Further investigation on the role of age of diagnosis on disease phenotype is needed.
P0708 Advanced Therapies in Elderly Patients with Inflammatory Bowel Disease: A Comparative Retrospective Cohort Study in Taiwan
Authors: Lin S H , Chiu H Y , Kuo C J , Chen C M , Wu R C , Chiu C T , Su M Y , Chang C W , Pan Y B , Le P H
Published: January 2025

Background

Inflammatory bowel disease (IBD) primarily affects young people, but increasing evidence indicates a shift toward older age. Elderly-onset IBD has several unique features, including atypical presentations and a higher risk for infections and malignancies. However, no studies have compared the clinical outcomes and analyzed the persistence of different advanced therapies in elderly-onset IBD patients. This study aims to address this gap.

Methods

In this retrospective cohort study, we included all IBD patients receiving advanced therapies and regular follow-ups at the Chang Gung IBD Center from October 2017 and September 2023. Patients were divided into two groups: the elderly-onset group (diagnosed with IBD at age 60 or older) and the control group (diagnosed with IBD before age 60). We compared one- year drug persistence, opportunistic infections, IBD-related admissions, complications, surgeries, and the number of acute flare-ups between the two groups. Additionally, we compared the one-year persistence of different advanced therapies within the elderly-onset group.

Results

We enrolled 511 IBD patients, with 107 in the elderly-onset group and the remaining in the control group. The elderly-onset group had higher body mass index, more cases of ulcerative colitis, fewer smokers, lower white blood cell count, lower hemoglobin, lower albumin, and a lower proportion of Montreal L3, B2, but a higher proportion of Montreal E1 and E3 diseases, and more Vedolizumab users compared to the control group. In terms of clinical outcomes, both groups had similar steroid-free remission rates, one-year persistence of advanced therapies, opportunistic infections, IBD-related complications, surgeries, and flare-ups. In the elderly group, Infliximab and Ustekinumab showed higher one-year persistence in Crohn’s disease (CD), but there was no statistically significant difference in ulcerative colitis (UC) according to the Kaplan-Meier analysis. There were three independent predictors for one-year advanced therapies persistence, included Montreal L1 (OR:6.722; 95% CI: 1.296-34.852; P=0.023) , Ustekinumab user (OR: 5.672; 95% CI: 1.138-28.267; P=0.034) and hemoglobin (OR: 1.612; 95% CI: 1.210-2.147; P=0.001) with an optimal cutoff value of 11.65 g/dL.

Conclusion

Elderly-onset IBD patients have unique clinical characteristics. Different advanced therapies persist in elderly-onset CD, but not in UC.

References

1.Sturm A, Maaser C, Mendall M, et al. European Crohn’s and Colitis Organisation topical review on IBD in the elderly. J Crohns Colitis. 2017;11:263-273.

2.Sousaa P, Bertanib L, Rodrigues C. Management of inflammatory bowel disease in the elderly: A review. Dig Liver Dis. 2023;55(8):1001-1009.
P0710 Effectiveness and Safety of Filgotinib After One Year in Patients with Ulcerative Colitis: Preliminary Results from the Filguito Registry in Andalusia (Spain)
Authors: Caballero Mateos A M , Suárez-Toribio Á , Trigo-Salado C , Rodríguez-González F J , Silva-Albarellos E , Martín-Rodríguez M D M , Gijón-Villanova R , Gómez-Delgado E , Benítez J M , Trapero-Martínez A M , Hernández-Martínez Á , Olmedo-Martín R V ,   GATEII
Published: January 2025

Background

Filgotinib represents a novel therapeutic option for the treatment of moderate-to-severe ulcerative colitis. This observational study aims to evaluate the efficacy and safety of Filgotinib in real-world clinical practice.

Methods

A retrospective registry was conducted across 10 hospitals in Andalusia, Spain, collecting clinical and biochemical data from 76 patients treated with Filgotinib. The analysis was performed at various treatment time points (baseline, 8 and 16 weeks, 6 and 12 months), irrespective of the treatment initiation time. Clinical remission (CR) was defined as a partial Mayo score ≤ 2 points, Clinical-Biochemical Remission (CBR) as a partial Mayo score < 3 and Calprotectin < 250 μg/g, and Steroid-Free Remission (SFR) as a partial Mayo score < 3 with no corticosteroid use since week 8. An intention-to-treat analysis was performed.

Results

The 76 enrolled patients had a mean age of 39.5 years (range: 19–76), with 54% being male. Extensive involvement was present in 60.3%, left-sided colitis in 34.2%, and proctitis in 5.5%. The mean duration of disease was 9 years (range 1-17). 3% were active smokers, and 17% were former smokers. 25% had extraintestinal manifestations, mainly articular (20%). The mean number of previous failed advanced treatments was 2. At treatment initiation, 79% were on 5-ASA therapy, 11% on Azathioprine, and 44% were using corticosteroids. 54% of patients had prior vaccination against the Zoster virus (Table 1a)

The clinical and biochemical efficacy data are presented in Table 1b. At the time of the study, 19 patients had discontinued treatment before 6 months (27%), and 21 before 12 months (30%), primarily due to primary/secondary failure (85%), with two cases due to adverse effects (evening fever and intolerance), and one due to pregnancy. No serious adverse events were reported.

Conclusion

In a real-world cohort of patients with multi-refractory ulcerative colitis, Filgotinib demonstrated favorable efficacy and safety outcomes.

References

-Van Rompaey L, Galien R, van der Aar EM, et al. Preclinical characterization of GLPG0634,a selective inhibitor of JAK1, for the treatment of inflammatory diseases. J Immunol 2013;191: 3568–77.

-Danese S, Argollo M, Le Berre C, Peyrin-Biroulet L. JAK selectivity for inflammatorybowel disease treatment: does it clinically matter? Gut 2019; 68:1893–99.

-Feagan BG, Danese S, Loftus EV Jr et al. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double- blind, randomised, placebo-controlled trial. Lancet. 2021 Jun19;397(10292):2372-2384. doi: 10.1016/S0140-6736(21)00666-8. Epub 2021Jun 3.
P0715 Experience with Ustekinumab and Vedolizumab in Inflammatory Bowel Disease Patients: Single-Center Data
Authors: Kandemir H , Karataş A , Moral K , Bilican G , Kekilli M , Cindoruk M , Karakan T
Published: January 2025

Background

Ustekinumab and vedolizumab are used for patients with moderate to severe inflammatory bowel disease (IBD) who do not respond to anti-TNF therapy. This study aims to evaluate the effectiveness of ustekinumab and vedolizumab in this patient group and to assess response rates in both drug groups.

Methods

The study included a total of 134 patients, 67 of whom were on vedolizumab and 67 on ustekinumab, who were followed at the Gazi University Faculty of Medicine Hospital between January 2017 and October 2024. Age, gender, previous treatments, pre-treatment Harvey-Bradshaw index, Mayo score/disease activity index, and CRP values were recorded. Patients who did not respond clinically, in laboratory results, or endoscopically within the first 24 weeks were considered primary non-responders, while those who did not respond within the first 52 weeks were classified as secondary non-responders.

Results

Of the 134 patients, 77 (57.5%) were female, and 57 (42.5%) were male. A total of 71 (53%) patients had Crohn’s disease. Among the patients, 85 (63.4%) had previously used Infliximab, and 48 (35.8%) had used Adalimumab as anti-TNF therapy. In patients continuing Vedolizumab treatment, the average duration of use was 22.8 months for those with ulcerative colitis (UC) and 25.5 months for those with Crohn’s disease (CD). For those on Ustekinumab, the average duration was 15 months for UC patients and 21.1 months for CD patients.

Response Rates

• Primary Non-Response (24 weeks): For Ustekinumab, 6.9% (1 UC, 3 CD patients) and for Vedolizumab, 10.1% (4 UC, 2 CD patients).

• Secondary Non-Response (52 weeks): For Ustekinumab, 3.4% (1 UC, 1 CD patient) and for Vedolizumab, 18.6% (5 UC, 6 CD patients).

No statistically significant difference in non-response rates was observed between the two drug groups.

Conclusion

Both Ustekinumab and Vedolizumab exhibit comparable efficacy in IBD patients who are resistant to prior anti-TNF therapies, with no statistically significant differences in primary and secondary non-response rates between the groups.
P0717 Real-world data of Mirikizumab in the induction and maintenance therapy for ulcerative colitis
Authors: Eleftheriadou A M , Juhran K S , Hegazy A N , Haag L M , Siegmund B , Sonnenberg E ,   Charité IBD Group
Published: January 2025

Background

Mirikizumab, a humanized IgG4 monoclonal antibody binding subunit p19 of interleukin 23, has been approved for the therapy of ulcerative colitis since May 2023. Phase 3 studies showed significant efficacy in both inducing and sustaining clinical remission in patients with moderate to severe active ulcerative colitis.

Methods

All patients with active ulcerative colitis who began induction therapy with Mirikizumab at our outpatient clinic between July 2023 and June 2024 were analyzed retrospectively with a follow-up period until October 2024. Patients with prednisolone therapy exceeding 20 mg, loperamide intake or deviation of standard clinical application period were excluded. The primary endpoints were defined as achieving clinical remission following the completion of intravenous induction (at weeks 12, 16 or 24) and the maintenance of clinical remission at any time between week 8 and week 49 following the initiation of subcutaneous application. Secondary endpoints included rates of clinical remission and relapse in patients previously treated with Ustekinumab, a monoclonal antibody targeting the p40 subunit of interleukin-12 and -23.

Results

A total of 40 patients started Mirikizumab induction therapy, with 23 meeting the inclusion criteria. Seventeen patients were observed in the maintenance period. After completion of induction, 20 out of 23 patients (87.0%) achieved clinical remission. Among these, 12 (60.0%) had previously been treated with Ustekinumab. During the maintenance period, 6 out of 17 patients (35.3%) experienced a relapse, of whom 5 (83.3%) had prior therapy with Ustekinumab. Within the Ustekinumab subgroup, 5 out of 10 patients (50.0%) suffered relapse after initially achieving clinical remission.

Conclusion

Mirikizumab is an effective therapy in patients with active ulcerative colitis, including those who had a prior loss of response to Ustekinumab therapy. Patients with prior Ustekinumab therapy exhibited a higher rate of relapse during the maintenance phase.
P0721 Anti-TNFs have similar safety profile to vedolizumab and ustekinumab as first line biologic treatment in elderly patients with Crohn’s disease
Authors: Thurm T , Javits L , Nachmias N , Cohen N A , Leibovitzh H , Hirsch A , Ron Y , Maharshak N
Published: January 2025

Background

The prevalence of Crohn’s disease (CD) in elderly patients is rising and is associated with aging-related challenges. Data on effectiveness and safety of first line biologic treatment (FLBT) in the elderly, are scarce. Our aim was to compare the safety, effectiveness, and drug persistence to FLBT in elderly patients with CD.

Methods

A retrospective, single tertiary center study, including all patients with CD who initiated their FLBT at age≥60 years, between 1/1/2010 to 31/12/2023. Clinical and demographic data were extracted and adverse events (AEs), treatment response and drug persistence were collected.

Results

A total of 214 patients with CD ≥60 years of age started FLBT, data were available for 168 (78.5%) patients. Anti-TNFs were initiated in 85 (50.6%) patients, and non anti-TNFs in 83 (49.4%) patients (71-vedolizumab, 12-ustekinumab). Patients starting anti-TNF were younger (67.3±6.1 vs 72.0±7.0 years, p<0.001), with lower Charlson comorbidity index (CCI: 3.6±1.7 vs 4.9±2.2, p<0.001), had higher rates of penetrating (31.8% vs 9.6%, p=0.002) and perianal (40.0% vs 18.1%, p=0.002) disease phenotype, and previous GI resections (37.6% vs 22.9%, p=0.038). Endoscopic disease severity was comparable [Table 1]. Drug persistence was calculated from 2014 (time of vedolizumabs’ approval for clinical use) and was similar between the groups (60 patients on anti-TNF: median 82.0 weeks [IQR 27.5-175.3] vs. 83 patients on non-anti-TNF median 89.7 weeks [IQR 41.0-183.9], p=0.765). Use of corticosteroids (CS) and immunomodulators (IMM) during 14-weeks of induction and 52-weeks of maintenance was comparable (p=NS). At 52-weeks, no difference was observed in clinical response and remission rates, nor in dose escalation and drug discontinuation rates (p=NS). Eighty-three AEs were recorded at 52-weeks: 50 (58.8%) in anti TNF vs. 33 (39.8%) in non-anti-TNF group. Serious infections: 7 (8.2%) patients in the anti-TNF group (3 hospitalized for sepsis: 1 urinary and 2 respiratory, 1 cellulitis, 1 pharyngitis, 1 systemic CMV and 1 clostridium difficile infection (CDI) vs 7 (8.2%) in the non-anti-TNF group (2 intra-abdominal abscess, 1 herpes zoster infection, 1 CDI, 1 cellulitis and 2 bronchitis, p=1). Hospitalization and surgery rates were 25.8% and 12.9% in anti-TNF vs 22.9% and 8.4% in non-anti-TNF groups respectively, (p=NS) [Table 2]. In a multivariate logistic regression analysis adjusted to type of FLBT, age, gender, CCI, dose escalation, and treatment with CS and IMM, no variable was significantly associated with the development of AEs (p=NS).

Conclusion

Anti-TNFs and vedolizumab/ustekinumab have similar safety and drug persistence as FLBT among elderly patients with CD. Larger prospective studies are needed to fortify our findings.
P0724 Endoscopic and radiological outcomes of strictureplasty in patients with small bowel stricturing Crohn’s disease
Authors: Zhang X , Li Y , Zhu W
Published: January 2025

Background

Strictureplasty has proven effective for alleviating clinical symptoms in patients with Crohn’s disease (CD). However, endoscopic and radiological results of strictureplasty remain largely unknown. This study aims to evaluate postoperative endoscopic and radiological outcomes of strictureplasty in patients with CD.

Methods

Patients who had symptomic small bowel CD undergoing strictureplasty, including Heineke-Mikulicz (H-M) and Finney techniques, at our center between October 2014 and January 2024 were included in this study. Endoscopic and radiological outcomes were studied, using postoperative computed tomography enterography (CTE) and enteroscopy. To evaluate endoscopic recurrence, we applied the Simplified Endoscopic Score for Crohn’s Disease (SES-CD), focusing solely on the ileum (score range: 0-12). Two independent radiologists with extensive experience reviewed CTE parameters, including mucosal enhancement, mural stratification, wall enhancement, comb sign, lymphadenopathy, thick non-enhancing wall, bowel wall thickness, luminal diameter, and the upstream lumen.

Results

A total of 59 patients were included in this study, with 30 patients having both preoperative and postoperative CTE performed at our center. The majority of patients (52/59) underwent simultaneous intestinal resection. The median hospital stay was 9 days (range: 5–28 days), with postoperative ileus being the primary cause of delayed discharge. Postoperative endoscopic examination showed mucosal healing at the primary strictureplasty site in 47 of 59 patients (Median follow-up 8 months). CTE showed a marked reduction in bowel wall thickness compared to preoperative measurements (8.25 mm vs. 5.6 mm, P < 0.001, Fig.1) (Median follow-up 7 months). Endoscopic recurrence (SES-CD>3), requiring adjustments to medical therapy, was observed in 26 patients (44%) after a median follow-up of 9 months (range: 4-17 months); notably, 16 (62%) of these recurrences involved new sites rather than the primary strictureplasty.

Conclusion

Significant mucosal and trasmural healing occurred at the primary stricture site within approximately one year. The preserved diseased bowel resulting from strictureplasty does not appear to be the main site of recurrence.
P0729 Comparative clinical outcomes of advanced therapy in bio-naïve versus bio-experienced patients hospitalized with Acute Severe Ulcerative Colitis: A retrospective cohort study
Authors: Hwang S W , Kim S , Lee C H , Kim J W , Kim M K , Lee S , Hong S W , Park S H , Yang D H , Ye B D , Byeon J S , Myung S J , Yang S K
Published: January 2025

Background

The characteristics of patients with acute severe ulcerative colitis (ASUC) in East Asia differ from those in Western countries. However, the clinical outcomes of ASUC treated with advanced therapies (ATs; biologics or small molecule drugs) have rarely been investigated in East Asia. This study aimed to analyse the clinical characteristics and outcomes of Korean ASUC patients receiving ATs based on prior exposure to biologics.

Methods

We retrospectively analysed 184 hospitalized ASUC patients treated with ATs at Asan Medical Center between 2014 and 2024. The clinical outcomes, including AT persistence, intestinal surgery, and ASUC-related hospitalization, were compared between bio-naïve and bio-experienced ASUC patients. Additionally, factors associated with 1-year AT persistence in ASUC patients were identified using Cox proportional hazards analysis.

Results

Of the 184 hospitalized ASUC patients, 137 were bio-naïve, and 47 were bio-experienced. Bio-experienced ASUC patients had a lower AT persistence rate and a higher rate of intestinal resection compared to bio-naïve ASUC patients during the follow-up period (p<0.01, p<0.0001, respectively). Among the 178 patients followed for more than 1 year at our center, 96.3% of bio-naïve ASUC patients were treated with anti-TNF agents, with a 1-year AT persistence rate of 84.5%. In contrast, 59.1% of bio-experienced ASUC patients received anti-TNF agents, resulting in a 1-year AT persistence rate of 38.5%; the remaining 40.9% received non-anti-TNF biologics or small molecule drugs, with a 1-year AT persistence rate of 72.2%. Previous exposure to biologics (hazard ratio [HR], 3.166; 95% confidence interval [CI], 1.734-5.782; p<0.001), age greater than 40 years at diagnosis (HR, 2.909; 95% CI, 1.530-5.528; p=0.001), and disease duration less than 12 months (HR, 1.863; 95% CI, 1.009-3.441; p=0.047) were associated with a lower 1-year AT persistence rate in patients with ASUC.

Conclusion

This study suggests that bio-experienced ASUC patients have worse clinical outcomes with AT compared to bio-naïve ASUC patients.
P0733 REALASA: Real-world effectiveness assessment of first-line 5-ASA for the treatment of Ulcerative Colitis in Sweden
Authors: Christophersen B , Nielsen L , Landeira M , Guedes S
Published: January 2025

Background

Despite being a well-established therapy for patients with mild-to-moderate ulcerative colitis (UC), there is limited evidence on the effectiveness and patterns of use of 5-aminosalicylic acid (5-ASA) in routine clinical practice. The study objective was to understand the treatment patterns of 5-ASAs in UC using secondary data from Sweden.

Methods

A retrospective study was conducted using data from linked Swedish registries. Adult patients diagnosed with UC and a first prescription of 5-ASAs (index date) between 01/01/2008 and 31/12/2020 were included. The cut-off date was 31/12/2018, to allow for adequate data over a 2-year follow-up period. The main objective was to describe patients diagnosed with UC in Sweden by 1) the proportion of patients that stayed on initial 5-ASA treatment regimens at different follow-up duration after 5-ASA initiation (182, 365, and 730 days after index date) and to estimate the duration of continuous treatment with initial treatment regimens in different subgroups (overall, 5-ASA with no other UC medication, and 5-ASA + other UC medication) and formulations (oral + rectal, only rectal, and only oral). The proportion of patients who switched from initial 5-ASA treatment to another UC treatment during the 5-ASA continuous exposure period and the proportion of patients that were adherent to 5-ASA treatment at different time points was estimated.

Results

A total of 13,461 patients with UC who initiated 5-ASA during the selection period were included in the study. Most patients (99.18%) initiated 5-ASA without other UC medication; the most common formulation was only oral 5-ASA treatment (93.42%). Among patients starting any 5-ASA treatment, almost half stayed on the 5-ASA treatment at 182 days after initiation, while the median duration of continuous treatment was 138 days. Around 50% of the patients were adherent to the initial 5-ASA treatment at 182 days, but the proportion decreased to 30% at 730 days. The proportion of patients who initiated 5-ASA treatment at index with no other UC medication stayed on the initial treatment to a lesser extent than patients with 5-ASA + other UC treatment. Very few treatment switches from 5-ASA to other UC treatments were observed at the different time points.

Conclusion

In this real-world study, the median duration of continuous 5-ASA treatment was less than half a year, and only half of the patients were adherent to the initial treatment at 6 months, decreasing even more over time. Guidelines recommend that patients who achieve remission with induction therapy continue with the same medication as maintenance therapy. Treatment optimization and monitoring may allow optimal control of mild-to-moderate UC.
P0734 Real-World Experience of Curcumin+Qing Dai Reduces Biochemical and Intestinal Ultrasound Disease Markers in Patients with Inflammatory Bowel Disease
Authors: Krugliak Cleveland N , Duty C , Bhondwe K , Rubin D T
Published: January 2025

Background

Curcumin + Qing Dai (CurQD) is an herbal supplement previously demonstrated in a placebo controlled trial to induce response and remission in patients (pts) with active Ulcerative colitis (UC).1 We report the real-world experience from a tertiary Inflammatory Bowel Disease center of this nutraceutical in pts with UC or Crohn’s disease (CD).

Methods

This is a retrospective study at the University of Chicago. We included adult pts with IBD who were recommended and then received CurQD. CurQD is administered as a daily dose ranging from 540-1300 mg of Qing Dai and 320-1200 mg of curcumin. We reviewed pt demographics, medication history, Simple Clinical Colitis Index (SCCAI), Harvey-Bradshaw Index (HBI), faecal calprotectin (FCP) levels, and International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) or Milan ultrasound criteria (MUC), and evaluated for remission at follow-up (f/u) 8 weeks ± 4 weeks. Remission was defined as SCCAI≤2, HBI<5, FCP<150 μg/g, IBUS-SAS<37.5 or MUC≤6.2.

Results

18 UC and 9 CD pts were included. Concomitant IBD therapy was continued at CurQD initiation. (Table 1). 14 (78%) UC pts and 7 (78%) CD pts were on advanced therapy. At baseline, median FCP and IBUS-SAS/MUC were elevated in both CD and UC cohorts. Median SCCAI was elevated in the UC group, but median HBI for the CD group was not. Median time to f/u was 54 days and 50 days for UC and CD cohorts, respectively. In the UC cohort, median SCCAI lowered from 3 to 1, FCP from 507 to 157, and MUC from 7.6 to 6.09. In the CD cohort, 6 pts had a decrease in HBI from a mean of 2 to 0.67, and 3 pts worsened from 1.3 to 9.67, one who changed therapies in f/u, one who underwent total colectomy 4 months after CurQD initiation, one who discontinued CurQD at f/u. FCP decreased from 254 to 54.6, and IBUS-SAS decreased from 54.6 to 26.2. At f/u, 13/20 (65%) pts (10/14 UC, 3/6 CD) were in clinical remission by SCCAI/HBI, 7/14 (50%) (4/9 UC, 3/5 CD) in biochemical remission by FCP, and 6/8 (75%) (4/5 UC, 2/3 CD) in sonographic remission by MUC/IBUS-SAS. Of the 6 UC pts on steroids at CurQD initiation, 4 (66.7%) were in steroid-free remission at f/u. No pts with CD required steroids. One patient with UC reported a headache, and two pts with UC discontinued CurQD due to non-specific intolerance. No AEs were reported among CD pts and no major or serious AEs were reported in either UC or CD pts.

Conclusion

This real world experience with CurQD as add-on therapy for adult pts with IBD in the U.S. demonstrated overall improvement in clinical, biochemical and sonographic disease markers within 8±4 weeks, as well as favorable safety and tolerability.

References

1.Ben-Horin S, Salomon N, Karampekos G, et al. Curcumin-QingDai Combination for Patients With Active Ulcerative Colitis: A Randomized, Double-Blinded, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2024;22(2):347-356.e6. doi:10.1016/j.cgh.2023.05.023
P0735 Early dietetic assessment predicts clinical efficacy of Exclusive Enteral Nutrition in adults with Crohn’s disease
Authors: Chu M , Day A S , Bogatic D , Hatzi M , Chu S K , Costello S P , Bryant R V
Published: January 2025

Background

Exclusive Enteral Nutrition (EEN) is an effective but underutilised therapy in adults with Crohn’s disease (CD). Key factors influencing patient adherence and clinical outcomes for EEN in adults remain poorly understood. This study aims to identify the determinants of adherence, therapy completion, and clinical outcomes in adults with CD.

Methods

This retrospective, multicentre study evaluated consecutive adult patients (≥18 years) prescribed EEN from February 1, 2019, to February 28, 2022, at two tertiary hospitals in Adelaide, South Australia, prior to EEN protocol implementation. Adherence was defined as complete exclusion of table food and fluids and meeting the minimum prescribed daily volume of EEN. Therapy completion was defined as completing the prescribed duration. The primary outcome was clinical remission (Harvey Bradshaw Index (HBI)≤4) or response (HBI change ≥3). The dietetic review frequency and adverse effects were recorded. Early review was defined as dietetic assessment during weeks 1–3 for courses ≥6 weeks. Statistical tests included Chi-squared, Fisher’s exact, and Mann-Whitney U tests, with significance at p<0.05. Multivariable logistic regression included significant covariates with age and sex as controls.

Results

Among 108 patients (50.0% female, mean age 41.8±16.1 years), most had ileocolonic (51/108, 47.2%) disease and stricturing phenotype (44/108, 40.7%). Baseline HBI was 8 (IQR 6-11) with 60.2% (65/108) on advanced therapies (Table 1). Full adherence to EEN was achieved by 68.2% (73/107). Of 94 patients (87.0%) prescribed EEN with a defined duration (median 6 weeks, range 2-8), completion rate was 71.8% (67/94). Among 67 patients treated for remission induction, remission and response rate was 59.7% (40/67) and 58.2% (39/67), respectively. Patients attended a median of 4 (IQR 3–6) dietetic visits. Constipation (19.2%, 20/104) was a common adverse effect. On multivariable analysis, active smoking reduced odds of remission (OR 0.028, 95% CI 0.001-0.709, p=0.030); while therapy completion (OR 23.0, 95% CI 1.8-683.5, p=0.019), early response (OR 35.2, 95% CI 1.8-683.5,p=0.019) and early remission (OR 20.4, 95% CI 1.5-273.3,p=0.019) improved odds. Number of dietetic visits predicted therapy completion (OR 2.43, 95% CI 1.53-3.85,p<0.001) and use of broth was linked to poorer adherence (OR 0.369, 95% CI 0.152-0.898,p=0.028).

Conclusion

EEN induced clinical response and remission in adults with CD. Clinical efficacy is enhanced by adherence and completion of therapy, which can be facilitated by increased dietetic support and avoiding non-nutritive items. Optimised EEN protocols to standardise and guide application of this effective nutrition therapy are required to determine if efficacy can be further improved.