bluuebunny/crossref_metadata_2025_split huggingface dataset:
P578 CDST (Clinical Decision Support Tool) is predictive of steroid-free clinical remission in patients with Crohn's disease treated with vedolizumab in a specific manner which is mainly driven by the serum level of albumin
Authors: Buisson A , Nancey S , Dodel M , Gay C , Coban D , Bazoge M , Pereira B , Boschetti G 
Published: January 2024

Abstract

Background
The CDST (Clinical Decision Support Tool) was developed to predict response to vedolizumab in Crohn’s disease to identify a subgroup of super responders (SR).
We aimed to 1) confirm that prediction of CDST is specific to vedolizumab versus ustekinumab, 2) to determine the weight of each item included in CDST to predict the response to vedolizumab in order to explain its specificity.

Methods
From the VENUS cohort, all patients with CD treated with ustekinumab (UST) or vedolizumab (VDZ) after exposure to at least one anti-TNF were included consecutively in two referral centers. The primary endpoint was corticosteroid-free clinical remission (CFREM) defined by a CDAI &lt; 150 at W 54. CFREM was also assessed at W 14.
All analyzes were adjusted using propensity scores based on patient and CD characteristics, concomitant treatments and disease severity.
To understand the weight of the items, CDST was calculated only with the clinical items, by adding the CRP (CDST 4 items) and full CDST (CDST 4 items + 0.4 x albuminemia). Patients were considered as super responders (SR) if 3-items CDST &gt; 3, a 4-items CDST &gt; 3 or a complete CDST &gt; 19.

Results
Overall, 312 patients (UST = 224 and VDZ = 88) were included. After adjustment, UST was more effective than VDZ in achieving CFREM at W54 (50.6% vs 40.6%, p=0.047) with no difference at W14 (56.1% vs 56.7%, p=0.99).
The 3-item CDST was not predictive of CFREM with VDZ at W14 (52% vs 56%, p = ns) or W54 (41% vs 41%, p = ns) in non-SR or SR patients, respectively, while it predicted response to UST at W54 (44% vs 60%, p &lt; 0.01).
The 4-item CDST was associated with CFREM with VDZ at W14 (46% vs 67%) and W54 (38% vs 54%) and with UST at W14 (51% vs 73%) and W54 (44% vs 70 %) (p&lt;0.05 for all comparisons). The rate of CFREM was not different between UST and VDZ in non-SR or SR (at W14 andW54).
Full CDST was predictive of CFREM at W14 in pts treated with VDZ (50% vs 71%, p&lt;0.05) but not at W54 (41% vs 50%, p = ns). CDST did not predict UST efficacy. In SR patients according to full CDST, VDZ seemed more effective to achieve CFREM at W54 than UST (50% vs 33%), contrary to non-SR (46% vs 36% in favor of UST). The same trend was observed for CFREM at W14: 66% vs 71% in SR and 55% vs 50% in non-SR with UST and VDZ, respectively.
In VDZ group, albumin level at baseline was associated with CFREM at W14 (33.7 ± 6.0 vs 39.4 ± 5.3; p = 0.033), contrary to the UST group (37.7 ± 5.5 vs 37.4 ± 9.3; p = 0.54).

Conclusion
CDST is predictive of CFREM with vedolizumab but not with ustekinumab. The specificity of CDST to vedolizumab is mainly driven by albuminemia. The impact of albumin level on vedolizumab is not fully explained by drug clearance and suggests an increased need for albumin to transport vedolizumab to its target.
P579 Dietary beliefs, barriers, and acceptability of diet in IBD patients – a multi-centre survey from the Asia-Pacific region
Authors: Tay S , Chan P W W , Wei S C , Tan M , Hilmi I N , Leong J W H , Tan Y Y , Lim C T , Ling K L , Tey T T , Tan C K , Leong R W L , Lim W C , Hartono J L , Shim H H , Ong D , Ooi C J , Salazar E 
Published: January 2024

Abstract

Background
Dietary beliefs and behaviors in IBD patients may affect both clinical outcome and psychosocial aspect of patients’ lives. New emerging studies have shown varying efficacy of different diets in inducing and maintaining remission in IBD patients. This study aims to investigate the dietary beliefs, barriers, and acceptability of diet among IBD patients in the Asia-Pacific region.

Methods
A multi-centre survey was conducted across 4 countries in Asia-Pacific. An anonymized online electronic survey was disseminated at 10 participating IBD centres. Patients were asked to rank acceptability of IBD-related diets on a Likert scale of 1 to 5, with 1 being strongly unacceptable and 5 being strongly acceptable. The survey is currently still ongoing and preliminary results from the initial 3 months are reported below.

Results
A total of 402 responses were recorded. Patient demographics and disease characteristics are shown in Table1.
Most patients received dietary advice from their doctor (n=279,69.4%) and social media (n=150,37.3%). 168 (41.7%) patients believe that diet plays a role in the development of IBD. Conversely, 107(26.6%) did not believe so, and 128(31.8%) were unsure. Most patients (n=336,83.6%) patients would avoid certain foods during a flare. Diet modifications were attempted by 188 (46.8%) patients and the most common dietary modifications were the low fibre diet (n=106, 56.4%), followed by the Exclusion diet (n=69, 36.7%), and gluten free diet (n=54,28.7%). 100 (24.9%) patients are currently on an IBD-related diet.
The barriers to the acceptance of IBD-related diet were identified and the two most common reasons cited were difficulty in meal preparation (n=196,48.8%) and interference of social life (n=176,43.8%). Acceptance of IBD-related diets would increase if the diet is effective in inducing remission or reducing symptoms (n=315, 78.4%) and easy to prepare (n=284,70.6%). Patients were most accepting of the low fibre diet (n=260, 64.7%) and Mediterranean diet (n=189,7.1%). Exclusive enteral nutrition (n=71,17.7%) and low FODMAP diet (n=109,27.1%) were the least acceptable.
Type of IBD, duration of disease, current use of steroids and small molecules were not associated with previous dietary modification. Use of biologics, current use of more than one medication, the belief that diet can induce remission and reduce flare were independently associated with previous attempted dietary modification (p&lt; 0.05).

Conclusion
Exclusive enteral nutrition has the lowest acceptance despite its role in inducing remission. Future IBD-related diet studies should consider the aforementioned barriers to make it more widely acceptable among IBD patients.
P601 Intestinal ultrasound correlates with clinical, biochemical, endoscopic and histologic biomarkers in patients with Ulcerative Colitis: a cross-sectional study
Authors: Bravo A , Revés J , Nascimento C , Abreu B , Bargas A , Bragança S , Rafael M A , Estevinho M , Silva J , Guedes A , Borralho P , Glória L , Roque Ramos L , Palmela C , Torres J , Frias-Gomes C 
Published: January 2024

Abstract

Background
Intestinal ultrasound (IUS) is emerging as a non-invasive monitoring tool in patients with ulcerative colitis (UC). Our goal was to correlate IUS with clinical, biochemical, endoscopic and histological activity.

Methods
Cross-sectional multicentric study of patients with left (E2) or extensive (E3) UC. Consecutive patients were included and clinical (Patient-Reported Outcome (PRO2) and Simple Clinical Colitis Activity Index (SCCAI)), biochemical (fecal calprotectin (FCal) and C-reactive protein (CRP)), endoscopic (Mayo endoscopic sub-score (sMayo)) and histological (Nancy score) activity were evaluated. IUS activity was characterized by Milan Ultrasound Criteria (MUC). Clinical, biochemical, ultrasonographic, endoscopic and histologic remission were defined as SCCAI≤2, FCal&lt;250 ug/g, MUC&lt;6.2, sMayo=0 and Nancy=0, respectively. All evaluations were performed within 1 month. Pathologist was blinded to endoscopic and IUS results. In patients in IUS remission, the sigmoid colon was considered for analysis.

Results
58 patients with UC were included (55% men, with a mean-age of 38 (+/-17) years, 65% with E2 UC). Clinical, biochemical, ultrasonographic, endoscopic and histologic remission occurred in 53%, 53%, 53%, 31% and 12% of the patients, respectively. The most affected segment by both IUS and endoscopy was the sigmoid colon (34.5% and 41.4%, respectively). In our cohort, IUS activity had a strong correlation with PRO2 (r=0.778, p&lt;0.001), SCCAI (r=0.810, p&lt;0.001) and endoscopic activity (r=0.758, p&lt;0.001), and a moderate correlation with FCal (r=0.517, p&lt;0.001), CRP (r=0.402, p&lt;0.001) and histological activity (r=0.475, p&lt;0.001). We observed a consistent increase in the bowel wall thickness (BWT) and MUC score as the sMayo raised. Accordingly, patients with endoscopic activity presented higher BWT and MUC score, when compared to patients in endoscopic remission (Table 1). On the other hand, patients in IUS remission showed higher rates of clinical (90% vs 10%, p&lt;0.001) biochemical (74% vs 26%, p&lt;0.001) and endoscopic remission (94% vs 6%, p&lt;0.001), with a trend towards higher rates of histologic remission (86% vs 14%, p=0.054).

Conclusion
In our cohort, IUS activity had a moderate to strong correlation with clinical, biochemical, endoscopic and even histologic activity. Additionally, patients with endoscopic activity presented worse IUS activity, suggesting this method as a reliable non-invasive monitoring tool in UC patients.
P708 Multiple Biosimilar Infliximab Switching is Not Associated with Adverse Outcomes in Inflammatory Bowel Disease: A Real-World Effectiveness Analysis in a National U.S. Cohort
Authors: Hou J K , Pham C , Xu A , Sansgiry S , Modi V , Waljee A 
Published: January 2024

Abstract

Background
Infliximab (IFX) biosimilars are available for inflammatory bowel disease (IBD). Many options of IFX biosimilars exist, however there is a paucity of data on the safety and efficacy of switching between multiple IFX biosimilars. The goal of this study is to evaluate the safety and outcomes in patients who received multiple IFX biosimilars in a National U.S. Cohort of patients with IBD.

Methods
We conducted a retrospective cohort study of IBD patients on maintenance IFX originator from 2017- 2019 in the national Veterans Affairs (VA) healthcare system. Crohn’s disease (CD) and ulcerative colitis (UC) patients were identified using a previously validated algorithm. Cases, exposures and outcomes were confirmed by chart review. Patents on IFX originator were identified by dispensed medication from the VA Corporate Data Warehouse. Patients were classified as no-switch (NS)- receiving originator but no biosimilar during study period, Single Switch (SS)- switch from originator to one biosimilar, or Double Switch (DS)-switch from IFX originator to two different biosimilars. Primary outcome was IBD flare, defined as escalation of steroid, IBD-related Emergency department visit or hospitalization within 12 months. Secondary outcomes were immunogenicity, serious infection, and infusion reaction. Event rates of the DS group were compared to NS and SS groups using univariate and multivariate (MV) logistic regression models adjusting for patient and non-patient factors.

Results
789 patients (487 CD, 298 UC) on maintenance IFX originator were identified. Of these, 410 patients were categorized as NS, 249 as SS, and 130 as DS. Overall, the rate of flare within 12 months was 19.9% (22.2% NS, 15.3% SS, 21.5% DS, p= 0.08), rate of infection was 11.2% (11.5% NS, 8% SS, 16.2% DS, p= 0.056). No statistically significant differences in rates of immunogenicity or infusion reaction were identified between the DS and NS or SS groups. In MV logistic regression including age, race, gender, medication, comorbidity and VA priority status, no significant differences in flares at 12 months was observed between DS (ref) and NS (aOR 1.12, 95% CI 0.68-1.84), or SS groups (aOR 0.64, 95% CI 0.36-1.12). In MV analyses, SS was associated with lower rate of infection compared to DS (aOR 0.41, 95% CI 0.21-0.82).

Conclusion
In a national U.S. cohort of patients with IBD, multiple IFX biosimilar switching was not associated with flare at 12 months compared to patients continued on IFX originator or with a single IFX biosimilar switch. However, DS was associated with increased odds of infection compared to single switch. These findings provide reassurance that multiple IFX biosimilar switching for IBD is effective but further study on infection risks may be warranted.
P725 Predictive factors for biologic therapy initiation after ileal pouch-anal anastomosis
Authors: Fischman M , Godny L , Friedeberg A , Barkan R , White I , Wasserberg N , Dotan I , Ollech J E 
Published: January 2024

Abstract

Background
Patients with ulcerative colitis (UC) undergoing proctocolectomy and Ileal Pouch-Anal Anastomosis (IPAA) frequently develop long-term complications, such as chronic pouchitis and Crohn’s-like disease of the pouch. These may eventually require biologic therapy. We aimed to identify peri-operative predictors for biologic therapy after IPAA.

Methods
All patients after IPAA followed at Rabin Medical Center pouch clinic and consenting to prospective observational follow up were included. Patients undergoing IPAA due to familial adenomatous polyposis (FAP) and those with ileostomy were excluded. Primary outcome was the initiation of biologic therapy after IPAA. We used Cox proportional hazard models to evaluate the following potential predictors: gender, race, smoking status, BMI category, UC duration until surgery, surgery indication, immediate post-operative complications (bowel obstruction, infection and leakage), and pre-operative treatment with 5-ASA, steroids, immunomodulators, and biologic therapy.

Results
Out of 174 patients in our cohort, 18 were excluded due to FAP and 8 due to ileostomy, leaving 148 for analysis. Prior to IPAA, 52 patients (35%) were treated with biologic therapy. Median follow-up from ileostomy closure to last documented visit was 15.14 years. During this period, 32 patients (21.6%) initiated biologic therapy, including 18 with adalimumab (12.2%), 10 with infliximab (6.7%), 2 with ustekinumab (1.3%), 1 with golimumab (0.6%), and 1 with vedolizumab (0.6%). Median time-to biologic therapy initiation was 10.1 years (IQR 10.0).
Significant hazard ratios (HR) for biologic therapy initiation were pre-operative treatment with biologic therapy (HR 4.8, 95% CI; 2.3-10, p&lt;0.001); Arab descent (HR 4.7, 95% CI; 1.6-14, p=0.005); pre-operative treatment with immunomodulators (HR 3.0, 95% CI; 1.3-7, p=0.011); UC duration of less than 10 years before ileostomy closure (HR 2.7, 95% CI; 1.2-6.3, p=0.02); past smoking status (HR 2.6, 95% CI; 1.22-5.7, p=0.013); and immediate post-operative complications (HR 2.0, 95% CI; 1.0-4.1, p=0.05). None of the patients undergoing IPAA due to dysplasia (n=27), required biologic therapy.

Conclusion
Pre-operative treatment with either biologic therapy or immunomodulators, Arab descent, short disease duration prior to IPAA, past smoking status, and post-operative complications were significant predictors of biologic therapy initiation post-IPAA. Patients with these risk factors may benefit from closer post-operative follow-up and earlier initiation of biologic therapy.
P727 Clinical efficacy of apheresis in Ulcerative Colitis. The experience of four tertiary centers
Authors: Papathanasiou E , Markopoulos P , Tzouvala M , Ioannou A , Tsironi E , Zacharopoulou E , Tzakri M , Pantelakis E , Leonidakis G , Bamias G , Michopoulos S , Zampeli E 
Published: January 2024

Abstract

Background
Selective depletion of myeloid lineage leucocytes by adsorptive granulocyte and monocyte apheresis (GMA) with Adacolumn ® was introduced as a nonpharmacologic treatment for ulcerative colitis (UC) in 2000. It has been reported that GMA may be effective in combination with immunosuppressive treatment in a subset of patients.
Τhe purpose of our study is the evaluation of the effectiveness and safety of GMA as a complementary treatment in patients with refractory ulcerative colitis.

Methods
Prospective data collection of a patient cohort with refractory UC receiving Adacolumn ® as an adjunct to their medical treatment. The therapeutic protocol has 2 phases: The induction phase entails two sessions per week for at least 3 weeks. The maintenance includes one weekly session for one month, one session every 15 days for one the next month, and monthly sessions thereafter. The patients’ medical treatment was maintained during the sessions. As a failure to GMA was considered the need for colectomy, the switch to a different treatment and inability to discontinue steroids. Response was evaluated after completion of at least 6 sessions of GMA.

Results
Ten patients with refractory UC were offered Adacolumn® between February 2021 and September 2023. Mean age was 39.6 years (22-61years). All patients had failed at least one biologic treatment and two-thirds two biologics. Their treatment which was maintained during GMA was: tofacitinib 10mg bid for 4 patients, ustekinumab 90mg sc every 8 weeks for 3, vedolizumab 300 mg every 8 weeks for 2, and corticosteroids 16mg for one. The median duration of treatment was 5.1 months (2-13 months), while the median number of sessions was 16 (6-45). Clinical and endoscopic remission was achieved in two cases (20%), after 13 sessions for both (in brackets in the Table) whereas two patients (20%) responded clinically according to partial Mayo score. Treatment failure was documented for 6 patients (60%) after 6-45 sessions. Patient number 4 performed 45 sessions in different hospitals because he was reluctant to be operated. Three underwent colectomy and three discontinued due to non-response. No adverse effects were observed. The initial median of partial Mayo score was 6 (5-9) while at the end of the evaluation was 4.5 (0-9). Table 1 summarizes the results of our study.

Conclusion
1) GMA may be beneficial as an adjunct to biologics in refractory to medical treatment UC patients.
2) Interestingly, all patients on tofacitinib showed a favorable response after the addition of GMA.
This observation may help define a subset of UC patients who may benefit the most.
P741 Characterisation of endoscopic improvements with risankizumab treatment in patients with moderately to severely active Crohn’s disease
Authors: Reinisch W , Colombel J F , Ma C , Long M , Irving P M , O'Brien D , Kligys K , Song A , Zhang Y , D’Haens G 
Published: January 2024

Abstract

Background
Endoscopy is used to objectively evaluate disease severity in patients with Crohn’s disease (CD), and endoscopic remission is a target for disease control. Ulcer size is associated with longer-term endoscopic remission, so evaluating ulcers may inform longer-term outcomes. Risankizumab (RZB) is an interleukin 23p19 inhibitor approved for adults with moderately to severely active CD. In phase 3 trials, greater proportions of patients with CD achieved endoscopic outcomes including ulcer-free endoscopy with RZB induction and maintenance therapy vs placebo (PBO).1,2 We further investigated the effect of RZB on endoscopic outcomes by evaluating improvements in Simple Endoscopic Score for CD (SES-CD) components during these phase 3 trials.

Methods
This post hoc analysis used data from the phase 3 induction studies (ADVANCE [NCT03105128] and MOTIVATE [NCT03104413]) and phase 3 maintenance study (FORTIFY [NCT03105102]). Patients received intravenous (IV) doses of RZB (600 mg or 1200 mg) or PBO for 12 weeks, and clinical responders to IV RZB received RZB maintenance therapy (180 mg or 360 mg subcutaneously [SC]) or PBO (withdrawal) for 52 weeks. This analysis evaluated change in SES-CD subscores (size of ulcers, affected surface, and ulcerated surface) at induction week 12 and maintenance week 52 across ileocolonic segments (rectum, left colon, transverse colon, right colon, and ileum); analyses of improvement were based on a nonresponder imputation for patients with baseline subscores &gt; 0 in the specific ileocolonic segment. Data from the induction studies were pooled for analysis; results for RZB 1200 mg IV induction are not reported. Shift data were from patients with available values.

Results
During the induction and maintenance studies, a numerically greater proportion of patients treated with RZB compared with PBO experienced improvements in any ileocolonic segment in SES-CD size of ulcers, ulcerated surface, and affected surface subscores (Figure). In general across each segment, a numerically greater proportion of patients treated with RZB induction and maintenance therapy compared with PBO experienced improvement from baseline SES-CD size of ulcer subscores of 2 or 3 (diameter 0.5–2 cm or diameter &gt; 2 cm, respectively) to subscores of 0 or 1 (none or diameter 0.1–0.5 cm, respectively) at weeks 12 and 52 (Table). Similar patterns were observed for SES-CD ulcerated surface and affected surface subscores. Safety data for the phase 3 studies have been reported previously.

Conclusion
Patients treated with RZB experienced greater improvements in SES-CD components compared with PBO during the induction and maintenance studies.
References
1. D’Haens G, et al. Lancet. 2022;399:2015–30.
2. Ferrante M, et al. Lancet. 2022;399:2031–46.
P750 Endoscopic balloon dilation associated with biological therapy in Crohn's Disease strictures: a single center experience
Authors: Lopetuso L R , Coppola G , Alfieri N , Morretta C , Di Vincenzo F , Puca P , Parisio L , Marmo C , Settanni C R , Laterza L , Pugliese D , Riccioni M E , Cammarota G , Papa A , Gasbarrini A , Scaldaferri F 
Published: January 2024

Abstract

Background
Symptomatic luminal stricture in Crohn’s Disease (CD) occurs in up to 20% of patients at the diagnosis and in more than 50% during their lifetime. A considerable percentage of patients often require further surgery for post-operative CD recurrence, with a consequent increased burden of short bowel syndrome. In this scenario, combining biological therapy with endoscopic balloon dilation (EBD) could potentially reduce this risk. Our study aimed to evaluate the efficacy of EBD combined with biologic therapy in symptomatic gastrointestinal strictures in CD patients.

Methods
We conducted a retrospective study including consecutive CD patients who underwent EBD for low gastrointestinal strictures from December 2015 until November 2022 at our tertiary IBD Center. Subsequent subocclusive/occlusive episodes, the need for steroids, and surgery due to CD stenosis were evaluated during a follow-up period of 6 and 12 months.

Results
A total of 52 patients treated with EBD with an overall number of 55 strictures were included. The mean age was 46,8 (18-77) years. The median of disease duration was 9 (0-42) years. Among the total of 55 studied strictures: 14 (25%) in patients with active smoking, 21 (38%) with increased CRP values at the time of dilation, 43 (78%) had evidence of moderate or severe endoscopic disease activity with ulcerative lesions at stricture site. Anastomotic strictures accounted for 26 (47%) of all 55 strictures. The remaining 29 (53%) were de novo stricture: 8 (15%) ileal, 11 (20%) at ileocecal valve, 4 (7%) colonic, and 6 (11%) anal . Forty-two patients (76%) were under biologic therapy at the time of EBD and 2 (4%) started after EBD. EBD technical success was reported in 60% of the procedures, and no adverse events were recorded. After 6 months from EBD, at univariate analysis, increased CRP at the time of dilation resulted in a risk factor for the need for steroids (OR 14,63, IC 2,690 to 71,50; p-value = 0,0006, Table 2). Concomitant biological therapy, active smoke, and the presence of ulcerative lesions did not show a significant correlation with considered outcomes. After 12 months from EBD, concomitant biological therapy resulted in being a protective factor for surgery (OR 0,06; IC 0,005 to 0,502; p-value=0,0047), while subocclusive and occlusive events were less frequent in anastomotic strictures than ileal stenosis (OR 0,07; IC 0,005 to 0,651; p-value=0,0152).

Conclusion
In patients with CD undergoing EBD for intestinal CD stricture, concomitant biological therapy reduces the risk of surgery for CD stenosis recurrence. Further prospective and controlled studies are underway to confirm these observations.