bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0681 Filgotinib for active Ulcerative Colitis in clinical practice - Effective treatment at week 8 is associated with higher clinical remission and persistence rates at Week 52 -
Authors: Yamada A , Yokoyama K , Harada Y , Ito T , Horii T , Kanazawa J , Ikehara H , Kusano C 
Published: January 2025

Abstract

Background
There are few reports on therapeutic outcomes one year after starting filgotinib (FIL), a novel JAK inhibitor for ulcerative colitis (UC) in clinical practice. We studied the therapeutic outcomes and safety of FIL at 52 weeks after its initiation.

Methods
This is a single-centre retrospective study including 60 patients whose partial Mayo Score (pMS) was ≥2 and whom we were able to follow up for eight weeks or more in our centre after the start of FIL. The primary endpoint was the clinical remission rate at Week 52, the secondary endpoints were the clinical response rate at Week 52, cumulative persistence rate of FIL at Week 52, clinical remission rate and response rate at Week 8 and adverse events. Treatment response and persistence were examined according to treatment history with biologics (BIO) and JAK, concomitant use of immunomodulators (IM), pMS at the start of FIL and clinical response at Week 8 after the start of FIL. Remission was defined as pMS≤1 and response as decrease of pMS≥2 from the start of FIL.

Results
Amongst the 60 patients who started FIL in our centre from Apr 2022 onwards, the median of pMS at the start of FIL was 5 (IQR 2-6), the mean treatment duration was 404±279 days. BIO/JAK naive cases were 48% (29/60), cases with concomitant use of prednisolone (PSL) were 23% (14/60), and the mean dosage was 8.5 mg/day. Cases with concomitant use of IM was 37% (22/60). The overall clinical remission rate at Week 52 was 56% (25/45), 72.2% in BIO/JAK naive cases and 44.4% in BIO/JAK experienced cases (p=0.07) (Fig 1a). It was 61.5% in pMS 2-6, and 16.7% in pMS≥7 (p=0.07) (Fig 1b), whereas there was no significant difference between concomitant use of IM and non-IM cases (Fig 1c). Compared to the non-response cases, the remission rate of clinical response cases at Week 8 after the start of FIL was significantly higher in the remission rate at Week 52 (70% vs 27%, p=0.01) (Fig 1d). The clinical response rate at Week 52 was 58% (26/45) and the remission rate and response rate at Week 8 were 42% (25/60) and 68% (41/60), respectively. The cumulative persistence rate of FIL at Week 52 was 74.4% (Figure 2a). The BIO/JAK naive cases showed a significantly higher persistence rate at Week 52 compared to the BIO/JAK experienced cases (86.8% vs 61.7%, p&lt;0.05) (Figure 2b). The persistence rate at Week 52 of the clinical response at Week 8 cases was significantly higher than the non-response cases (85.9% vs 40.0%, p&lt;0.05) (Figure 2c). There was one patient who discontinued FIL due to an adverse event of skin symptoms.

Conclusion
Both clinical remission rate at Week 52 and persistence rate of FIL were significantly higher in the cases that had response at week 8, compared to the non-response cases.
P0684 Real world experience with granulocyte and monocyte adsorptive apheresis (ADACOLUMN®) in patients with refractory inflammatory bowel disease: a retrospective observational multicenter cohort study
Authors: Hupé M , Bouguen G , Buisson A , Landman C , Uzzan M , Nancey S , Guillaume C , Cyrielle G , Charkaoui M , Serrero M , Wampach A , Collins M , Altwegg R , Cholet F , Amiot A 
Published: January 2025

Abstract

Background
Granulocyte and monocyte adsorptive apheresis (GMA) with ADACOLUMN® (JIMRO Takasaki Japan) is an effective and safe therapeutic option for patients with mild to moderate inflammatory bowel disease (IBD) refractory to pharmacological therapy, especially ulcerative colitis (UC). The aim of this study was to report effectiveness of GMA in patients with IBD.

Methods
All consecutive active, non-operated UC patients and Crohn’s disease (CD) patients treated with GMA in 15 French tertiary-care centres from 2007 to september 2024 were assessed. Patients received 4 to 8 weekly sessions of GMA alone or in combination with previously failing advanced therapy. Patients were assessed for effectiveness at week 14 and at week 54 for those continuing GMA as maintenance therapy and at every visit for safety. Clinical remission, steroid-free clinical remission, clinical response, colectomy as well as safety were ascertained.

Results
One hundred and twenty-nine patients with IBD (75 males, median age: 40.9 IQR[29.3-58.1] years, 102 with UC, IBD duration: 7.0 [2.9-13.1] years) were included. One hundred patients (77.5%) were previously treated with immunosuppressants and 97 (72.2%) with at least one anti-TNF. In patients with UC, baseline median total Mayo score was 7 [6-12] and mean CRP level was 23.3 ± 86.0 mg/L. In patients with CD, baseline median Harvey-Bradshaw index was 9 [7.25-10.75] and mean CRP level was 21.9 ± 27.3 mg/L. In patients with UC, week 14 clinical remission, steroid-free clinical remission and response rates were 33.3%, 27.5% and 52.0%, respectively. In patients with CD, week 14 clinical remission, steroid-free clinical remission and response rates were 33.3%, 29.6% and 66.7%, respectively. At week 14, nine patients with UC and 3 patients with CD required emergent surgery. At week 14, adverse events were reported in 26 (20.2%) and were mainly related to flare of IBD in 16 (12.4%). Other adverse events which were never classified as serious included headache in 3, arthromyalgia in 3 and abdominal pain, diarrhea, grade-1 increase in liver enzymes and mild hypotension in one. At week 54, 48 patients were still treated with maintenance GMA therapy including 13 with CD and 35 with UC. At week 54, steroid-free clinical remission rates were 38.5% (5/13) in patients with CD and 60% (21/35) in patients with UC.

Conclusion
In this real world cohort of patients with refractory IBD, GMA induced steroid-free clinical remission in one third of patients with CD and UC at W14. In patients continuing GMA maintenance therapy, steroid-free clinical remission was observed in one third of patients with CD and two thirds of patients with UC. Safety profile was favourable mostly related to relapse of IBD.
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

Abstract

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 &lt; 6 [Sensitivity 41.7%, Specificity 100%, PPV 100%, NPV 26.3%] and 97.1 % (33/34) patients with a CRP on day R+3 &lt; 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 &lt; 6 [Sensitivity 26.9%, Specificity 66.7%, PPV 92.6%, NPV 5.6%] and 100% (72/72) patients with CRP on day R+3 &lt; 22mg/L responded to MRT [Sensitivity 85.7%, Specificity 100%, PPV 100%, NPV 33.3%]. In patients with both UCEIS &lt;6 and CRP on day R+3 &lt; 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 &lt;6, 19 (95%) patients and 28/34 (82.4%) patients with CRP on day R+3 &lt; 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 &lt; 6, 24/27 (88.9%) and 66/72 (91.7%) patients with CRP on day R+3 &lt; 22mg/L had avoided a colectomy at 12 months. In patients with both UCEIS &lt;6 and CRP on day R+3 &lt; 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 &lt; 6 at admission and CRP on day R+3 &lt; 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

Abstract

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

Abstract

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

Abstract

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

Abstract

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.
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

Abstract

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 &lt;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&lt;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&lt;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&lt;0.05) in EOs, while the use of budesonide was higher (p&lt;0.0001) [Table 1].
During follow-up, more malignancies and deaths were recorded in EOs (p&lt;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.