bluuebunny/crossref_metadata_2025 huggingface dataset:
P506 Prevalance of the osteoporosis/osteopenia and related factors in patients with inflammatory bowel disease : An observational single-center study
Authors: Celebi G , Ekici R , Buyukturan G , Gul Aydın E , Uygun A
Published: January 2024

Background

Inflammatory bowel disease is characterized by chronic progressive inflammation of the gastrointestinal tract which is mainly includes Crohn’s disease and ulcerative colitis. Patients with inflammatory bowel disease are at risk for osteopenia and osteoporosis. However,this topic is not well investigated and results of the studies are contradictory. The objective of this study was to investigate of the osteopenia/osteoporosis prevalance and related risk factors in patients with inflammatory bowel disease.

Methods

Patients with inflammatory bowel disease were consecutively recruited between September 2022 to September 2023 in our single-center, cross-sectional observational study. Bone mineral density was measured by dual energy X-ray absorption scans at the femur total, femur neck, femur ward’s and spine total. Relevant patients’ and disease-spesific parameters such as clinical (MAYO score or Harwey-Bradshaw index), biochemical, endoscopic and treatment history were recorded.

Results

A total of 177 inflammatory bowel disease patients, encompassing 60 with Crohn’s disease (33.9 %) and 117 (66.1%) ulcerative colitis, were enrolled. The median age was 42.3 years (range,18-75), the mean body mass index (BMI) was 23.87 kg/m2 (range,12.4 - 42.24) and the mean disease duration was 6.9 years (range,1.8 - 32.4). Prevalance of the femoral osteoporosis and osteopenia were 7.9% (n=14) and 16.4 % (n=29) in our study population respectively. Lumbar osteoporosis and osteopenia were more prevalent in our study cohort, 16.9% and 28.2% respectively. According to our study results,female patients were significantly more effected from osteoporosis than male patients and BMI was negatively correlated with femoral osteoporosis in inflammatory bowel disease (p=0.019 and r= -0.210, respectively). The disease activity (total MAYO score) was significantly associated with femur total T score in patients with ulcerative colitis (p=0.007). Similar association was documented with high sensitivity C-reactive protein (hsCRP) and femur total T score, spine total T score (P=0.014 and p= 0.027, respectivey).

Conclusion

Based on our study results, inflammation is the most important risk factor for osteoporosis in patients with inflammatory bowel disease. Effective anti-inflammatory treatments may reduce prevalance of the osteoporosis in patients with inflammatory bowel disease.
P535 Effectiveness of upadacitinib in patients with Ulcerative Colitis: a real-life, multicenter, Italian report
Authors: Teani I , Bevilacqua N , Gabbiadini R , Bezzio C , Ferronato A , Saibeni S , Armuzzi A , Comberlato M , Desideri F
Published: January 2024

Background

Upadacitinib (UPA) is an oral, selective JAK inhibitor, that has recently received approval in Italy for the treatment of Ulcerative colitis (UC). To our knowledge, only few data of real-life studies are available. The aim of our observational data collection is to report the first real-life experiences with UPA in UC in terms of effectiveness and safety.

Methods

These data come from four Italian IBD centers. Adult patients with a diagnosis of UC, who have been prescribed UPA for active disease, after failure of at least one anti-TNF therapy, were enrolled. After an induction period of 8 weeks with a 45 mg daily dosage, treatment efficacy were assessed using the partial Mayo score (pMS) and the fecal calprotectin levels (CP). Treatment-related adverse events were also recorded.

Results

Among 20 patients who started UPA, 12 have completed the induction and were therefore enrolled and evaluated before starting UPA and at the end of the 8 weeks induction period. 83% (10 patients) had previously failed two or more biological therapies, including tofacitinib (3 patients, 25%). 3 patients (25%) were tapering systemic corticosteroids and 3 patients (25%) were receiving topical steroids when they started UPA. In the pre-treatment evaluation, the mean pMs was 5,25 (SD 2,26) and the median CP was 1270 ug/g (411- 3152). At the end of induction (week 8), 10 patients (83%) achieved clinical remission and one patient showed clinical response with a decrease of 6 points of pMS. One patient underwent colectomy after 4 weeks of ineffective therapy. The mean pMS at week 8 was 0 (SD 0,92) (Fig. 1), with a median CP of 88 ug/g (5-4639). Reported adverse events, that however did not cause drug discontinuation, were one case of leukopenia and one case of acne. To the date of the last evaluation, all patients maintained the achieved results, with a mean follow-up period of 92 days. A further analysis excluding the physician global assessment from pMS has been performed, to obtain a sort of patient-reported outcome 2 (PRO-2): the results, in terms of percentage reduction of the scores, were in line with the presented data. Despite the limited number of patients who completed the induction (11), we observed statistical significance in the difference between pretreatment and post-induction values of all the measured variables (Tab. 1, Fig. 1).

Conclusion

With this first Italian report in a real-life setting, UPA showed promising effects in rapidly inducing clinical remission and in normalizing a sensitive marker of intestinal inflammation. Moreover, it seems to be well tolerated. Long-term real-life studies, including endoscopic and histologic evaluations, are needed to confirm efficacy and safety of UPA in maintaining stable remission in UC patients.
P539 Assessment of VEdolizumab aNd Ustekinumab in Elderly patients with Crohn’s disease (CD): the IG-IBD AVENUE study
Authors: Viola A , Ventimiglia M , Sparacino A , Orlando A , D'Antono E , De Vivo S , Scaldaferri F , Pugliese D , Varca S , Ribaldone D G , Armandi A , Balestrieri P , Castiglione F , Savarino E V , Cappello M , Viganò C , Mocci G , Allocca M , Principi M B , Soriano A , Onali S , Bodini G , Riguccio G , Festa S , Bertani L , Checchin D , Caprioli F A , Fries W ,   AVENUE Study Group: Michele Francesco Chiappetta Giulio Calabrese Piera Melatti Giorgia Orrù Francesca Maria Onidi Giorgia Orrù Maria Napolitano Francesca Onnis
Published: January 2024

Background

Comparative data regarding ustekinumab (UST) and vedolizumab (VDZ) effectiveness and safety in elderly inflammatory bowel disease (IBD) patients are limited. The aim of the present nationwide multicenter cohort study was to compare persistence and safety of these drugs in elderly versus non-elderly Italian IBD patients.

Methods

Data from 20 Italian centers were retrospectively collected. Based upon age and treatment, IBD patients aged ≥65 years were allocated to group 1 (G1) and group 3 (G3) (cases) if treated with UST or VDZ, respectively, and to group 2 (G2) and 4 (G4) (controls) if they were aged < 65 years and treated with UST or VDZ, respectively. The primary outcome was drug persistence at week 52. Propensity score analysis was performed for primary outcome using the inverse probability of treatment weighting method. Secondary outcomes included: steroid free remission (SFR) at week 52 and frequency of adverse events (AEs) at the end of follow-up.

Results

A total of 439 patients (176 elderly and 260 non-elderly) were included in the study. Among elderly patients, 93 and 83 were included in the group G1 and G3, respectively. Among non-elderly patients, 147 and 116 were included in the group G2 and G4, respectively. Baseline characteristics are represented in Table 1. No differences were found in terms of persistence between G1 vs G3, G1 vs G2 and G3 vs G4 (Figure 1). Higher baseline Harvey-Bradshaw Index (HBI) (OR=2.09, 1.15 – 3.78; 0.015) and baseline steroid therapy (OR=1.10, 1.04 – 1.15; p<0.001) were identified as predictors of a lower drug persistence at Cox model. Steroid free remission at week 52 was achieved by 80% and 77% of elderly patients in G1 and in G3 (p=0.63), respectively. Similarly, no differences for SFR were found between G1 and G2 (p=0.73) and between G3 and G4 (p=0.68). Incidence rate for AEs were G1 and G2 were 7.85 and 7.90 respectively; for G3 and G4 IR were 5.81 and 12.50 respectively. No differences were found in the UST groups (IRR=0.99; p=0.98) while in VDZ-treated patients, non-elderly had a higher rate of AEs (IRR=0.46; p=0.006).

Conclusion

These data confirm that ustekinumab and vedolizumab are highly effective drugs in patients with IBD, associated with a good safety profile in both elderly and in non-elderly IBD patients.
P544 Ustekinumab safety and effectiveness in ulcerative colitis patients: results from a large real-life study
Authors: Mocci G , Scaldaferri F , Pugliese D , Savarino E , Bodini G , Cuomo A , Donnarumma L , Maconi G , Cataletti G , Rodino S , Sebkova L , Ferronato A , Gaiani F , Marzo M , Luppino I , Paese P , Elisei W , Monterubbianesi R , Faggiani R , Napolitano D , Grossi L , Serio M , Scarcelli A , Lorenzetti R , Allegretta L , Rocco G , Zampaletta C , Bolognini L , Meucci C , Colucci R , Tonti P , Della Valle N , Piga R , Forti G , Onidi F M , Usai Satta P , Picchio M , Papa A , Tursi A
Published: January 2024

Background

Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC), but with limited real-world data. We assessed therefore the effectiveness and safety of UST in UC patients in a real-world setting

Methods

This is a multicentre, retrospective, observational cohort study. The primary endpoint was the clinical remission rate (partial Mayo score, PMS, ≤1). Other endpoints were corticosteroid-free remission (CSFR) rate, clinical response rate (PMS reduction of at least 2 points), and faecal calprotectin (FC) reduction at week 24.

Results

We included 256 consecutive UC patients (M/F 139/117, median age 52). The clinical remission and clinical response rates at 8 weeks were 18.7% (44/235) and 53.2% (125/235), respectively, and 27.6% (42/152) and 61.8% (94/152) at 24 weeks, respectively. At 24 weeks, CSFR was 20.3% (31/152), and FC significantly dropped at week 12 (p=0.0004) and 24 (p=0.038). At 8 weeks, patients naïve or with one previous biologic treatment, showed higher remission (p=0.002) and clinical response rates (p=0.018) than patients previously treated with ≥2 biologics (finding not confirmed at week 24). Adverse events occurred in six patients (2.3%), whereas four patients (1.6%) underwent colectomy.

Conclusion

This large real-world study shows that UST effectively and safely treats UC patients.
P546 Endoscopic findings related to the long-term response to anti-TNF-α antibody treatment in patients with Crohn's disease
Authors: Toyokawa T , Horii J , Fujita I
Published: January 2024

Background

Anti-TNF-α antibody treatment in Crohn's disease patients has been established, but loss of treatment response has become a problem in recent years. No studies have investigated the endoscopic findings related to loss of response particularly in the long-term treatment. In this study, we investigated the endoscopic findings associated with diminished efficacy of anti-TNF-α antibodies in Crohn's disease patients treated over a long period of time.

Methods

A total of 79 patients with Crohn's disease who were observed for at least 1 year after the anti-TNF-α antibody treatment was initiated at our hospital were included in this study. These patients were stratified into cases with and without loss of response to the anti-TNF-α antibody treatment, and the endoscopic findings were compared between the two groups. A case with loss of response was defined as one in which the dose was increased or the duration of treatment was shortened during the anti-TNF-α antibody treatment or the anti-TNF-α antibody preparation was changed to another due to lack of response to the initial preparation. The findings examined were aphtha, erosion, cobblestone-like mucosa, fistula, multiple ulcer, longitudinal ulcer, and anal lesion. Mann-Whitney's U test, χ2 test, and logistic regression analysis were used for statistical analysis, and differences with p < 0.05 were considered significant.

Results

The mean observation period for all patients was 85.5 months, and the longest period was 188 months. Of the 79 patients included, 29 met the criteria with loss of response, and 50 did not (loss of response rate 37%). Comparisons between the loss of response group and the no loss of response group by univariate analysis showed that anal lesions (66% vs 42%, p = 0.028), stenosis (75% vs 48%, p = 0.021), and multiple ulcers (82% vs 53%, p = 0.011) were significantly more frequent in the loss of response group. The multivariate analysis on these items identified anal lesions (OR: 3.06, 95% CI 1.04-9.04, p = 0.042) and multiple ulcers (OR: 5.33, 95% CI 1.59-17.9, p = 0.0068) as independent risk factors for loss of response.

Conclusion

In this study, Crohn's disease patients with endoscopic findings of anal lesions and multiple ulcers were prone to loss of response to the anti-TNF-alpha antibody treatment after long-term administration. This result is considered to be very useful for developing a treatment strategy for patients requiring long-term anti-TNF-α antibody treatment.
P574 Clinical outcomes in extending of injection period of ustekinumab from every 8 to 12 weeks in patients with Crohn’s disease (CD-EXTEND Study)
Authors: Kato S , Tagawa K , Yamaga N , Yakabi K , Nagoshi S
Published: January 2024

Background

De-escalation was a useful strategy for improving patient’s QOL and reduction of medical expenses. However, de-escalation of ustekinumab (UST) for the patients with Crohn’s disease (CD) has not been reported. The aim of this study was to elucidate clinical outcomes of de-escalation of UST.

Methods

This was a single-centre prospective observational study approved by the institutional review board of our hospital. CD patients who selected de-escalate UST treatment after administration of intravenous UST 6 mg/kg and subcutaneous UST 90mg every 8 weeks until 54 weeks were enrolled in this cohort. Primary endpoint was clinical remission rate at one year, including patients treated with re-escalation. Secondary endpoints were persistency of de-escalation of every 12 weeks and re-escalation effects of every 8 weeks. We also compared backgrounds and biomarkers including CRP, fecal calprotectin (FC) for persistent and non-persistent groups. Cut-off values of prediction for non-persistent was calculated by receiver operating characteristic (ROC) curve. Definition of clinical remission was CDAI<150 for CD.

Results

In total, 30 participants were included in the final analysis. Clinical remission rate at one year was 96.7% (29/30). Persistency of de-escalation at one year was 76.7% (23/30). Persistency after re-escalation was 85.7% (6/7). There was no difference between the backgrounds of persistent (n=23) and non-persistent groups (n=7). CRP titer at week 12 was significantly higher in non-persistent group than persistent group (Median 0.59 vs 0.17 mg/dL, p=0.021). FC titer at week 0, 12 and amount of change at week 24 was significantly higher in non-persistent group than persistent group (Median 660 vs 120 μg/g, p=0.021;1341 vs 61 μg/g, p=0.001; 528 vs 4 μg/g, p=0.04). Cut-off values of prediction for non-persistent from CRP at week 12, FC at week 0, 12 were 0.33 mg/dL, 314 μg/g, 581.5 μg/g, respectively.

Conclusion

De-escalation was feasible strategy for CD patients treated with UST. CRP and FC were good prediction biomarker for non-persistence
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

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 < 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 > 3, a 4-items CDST > 3 or a complete CDST > 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 < 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<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<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

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< 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

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<250 ug/g, MUC<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<0.001), SCCAI (r=0.810, p<0.001) and endoscopic activity (r=0.758, p<0.001), and a moderate correlation with FCal (r=0.517, p<0.001), CRP (r=0.402, p<0.001) and histological activity (r=0.475, p<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<0.001) biochemical (74% vs 26%, p<0.001) and endoscopic remission (94% vs 6%, p<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

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

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<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

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

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 > 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 > 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

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.
P753 Early perianal abscess recurrence in patients with perianal Crohn's disease on biologic therapy predicts long-term permanent fecal diversion
Authors: Yokoo T , Yoshikawa S , Tsutomu M , Terauchi S , Uchida H , Nakao T , Yamaoka K , Inagaki M , Tani T , Okamoto K , Inatsugi N
Published: January 2024

Background

Generally, it’s difficult to estimate the efficacy of biologics (Bio) for perianal lesions of Crohn’s disease (CD) and lack of evidence. Sometimes, we experience the recurrence of perianal abscess and need to perform re-drainage even after starting 1st Bio. When the 1st bio fails, choosing an accurate 2nd Bio is difficult. The most severe result of this situation is rectal amputation. We wonder if any relationships between recurrence timing and long-term outcomes exist. We reviewed and aimed to know our institute’s perianal CD (pCD) treatment.

Methods

We retrospectively investigated patients' medical charts with pCD from 1988 to 2022 at Kenseikai Nara Coloproctology Center. We excluded the patients without using Bio or starting Bio after rectal amputation. The cases with missing values are excluded, too. We defined "early" as within two years and compared two cohorts, the early recurrence group (ER) and the no or late recurrence group (non-ER). We use the Kaplan-Meier method for calculating the time to fecal diversion.

Results

Eighty patients were recruited. The mean current age is 37.5 years old, and the onset of CD is 22.6 years old. The Perianal lesion’s onset is 24.5 years old. The male is 66, and 19 smokers are included. In this part, perianal lesion means only perianal abscess and fistula. Montreal Classification is shown in TABLE1.

The Median follow-up duration was 142.5 months. We performed perianal surveillance (PS) for these patients, including EUA, Abscess Drainage, and seton placement, 3.1 times for each person. After the surgical interventions, we treat them with four Bio. After starting Bio, we experienced 33 early recurrences. We observed eight transient stoma creations, nine rectal amputations, and one anorectal cancer. Among them, we calculate the relationships between early recurrence and rectal amputation and find that early recurrence is a risk factor for permanent fecal diversion (HR 6.84 95%CI 1.48-31.7, p=0.0047 FIGURE1).

We needed to switch the Bio for 31 patients during the observational period. To know which way of switching is effective for pCD, we calculate the relationships between the practice of switching and any treatment failure. Same class switching and changing MOA are not different for any treatment failure, which means re-abscess drainage and creation of any stoma (HR 0.40 95%CI 0.10-1.57 p=0.19).

Conclusion

Perianal abscess recurrence as we need to re-incision and drainage within two years after starting Bio treatment are related to permanent fecal diversion. We must pay attention to such kinds of patients, but the types of Bio we change didn’t affect any treatment failure. Further studies are needed in this field.
P774 Less combination therapy and more fistulotomy in perianal fistulizing Crohn’s disease in the elderly
Authors: Arjafallah Goulet O , Brochard C , Atienza P , Siproudhis L , Etienney I
Published: January 2024

Background

Prevalence of Crohn's disease (CD) is on the rise in the elderly and perianal fistulizing lesions affect nearly one in five patients over 60. Despite the specificity of luminal disease, few studies have focused on the management of perianal fistulizing CD (pfCD) in this population. This study aimed to describe pfCD in patients operated on after the age of 60 to compare findings (presentation, management, outcome) with those obtained in younger patients operated on during the same period.

Methods

Between January 2012 and December 2022, all CD patients (known or confirmed during follow-up) aged 60 years or older undergoing a first surgical intervention for anal fistula at two medical centers were included. For each older patient, two younger patients (<60 yr) operated on during the same period were matched for comparison.

Results

Among 536 patients who underwent surgery between January 2012 and December 2022, there were 30 (6%) aged ≥ 60 yr at first surgery: 17/30 (63%) reported anal fistula and CD in the same year. Among matched younger patients, 31/60 (52%) reported anal fistula more than one year after CD diagnosis. Colonic involvement was more prevalent in the older age group (70% vs 33%); ileal forms were more common in the younger age group (23% vs 3%) and complex fistulas were predominant (93%) in both age groups. Use of biologics was similar in the two groups: anti-TNF alpha therapy in 96.7% of younger patients and in 86.7% of older patients (p=0.07); other biologics in 40% of patients in both groups. However, in patients over 60, combined therapy and anti-TNF alpha optimization were less frequent (p=0.0002 and p=0.0001), as was use of immunosuppressants (33%), with a vast majority on azathioprine. Older patients had fewer surgical interventions (3 vs 4.5, p=0.008). They also had less frequent sparing surgery (30% vs 58%, p=0.01), while fistulotomy was performed more frequently (27% vs 5%, p=0.003). The rates of anal fistula closure were comparable between the two groups (60% vs 62%).

Conclusion

Synchronous diagnosis of anal fistula and CD within the first year of care is not uncommon in patients over the age of 60, which suggests CD should not be overlooked in older individuals developing an anal fistula. Although there appeared to be age-based differences in overall medical-surgical management, and patients over 60 had more comorbidities, use of biologics was similar in the two groups, and the rates of fistula closure at the end of follow-up were comparable in the two populations.
P783 Exploring the impact of JAK Inhibitors on cholesterol levels in Patients with Inflammatory Bowel Disease: A Real-World Data Analysis
Authors: Gilroy L , Wilson A
Published: January 2024

Background

Janus Kinase (JAK) inhibitors represent a significant therapeutic advancement for individuals with inflammatory bowel disease (IBD). Previous research indicates an increase in total cholesterol (total-c) upon the initiation of JAK therapy.1The precise mechanisms remain unclear, but studies suggest that inflammation can lower lipid levels. Therefore, by addressing inflammation through JAK therapy, there may be a subsequent elevation in lipid levels. This study seeks to evaluate the impact of initiating JAK inhibitors on total cholesterol levels in patients with IBD, utilising real-world data for analysis.

Methods

A multi-site retrospective analysis was conducted on a cohort of patients with ulcerative colitis and Crohn’s disease who had been initiated on either filgotinib, tofacitinib or upadacitinib. Statistical analysis was applied to examine alterations in total cholesterol levels (total-c) before and after the initiation of JAK inhibitor therapy.

Results

A cohort of 49 patients was identified, with pre and post total-c levels available for 33 individuals included in the analysis. Utilising paired data and the Student's t-test, we examined whether initiating a JAK inhibitor led to increased total cholesterol levels. Patients commenced on tofacitinib and upadacitinib exhibited statistically significant increases in cholesterol (p=0.016, p=0.0001). Patients in the filgotinib group, although demonstrating rises in total-c in most cases, did not reach statistical significance (p=0.21). Graph 1 demonstrates the range and spread of the results. Upadacitinib increased cholesterol levels by the most on average (0.82), compared to tofacitinib (0.64) or filgotinib (0.3). Elevated cholesterol persisted beyond 12 weeks in some patients, but long-term data for all patients was not available. Notably, only one patient initiated a statin, resulting in lipid normalisation at the next assessment. No cardiac events were identified in this cohort.

Conclusion

This analysis of real-world data underscores a potential influence of JAK inhibitors on the cholesterol profiles of individuals with inflammatory bowel disease (IBD). Gaining insights into the interplay between JAK inhibitors and lipid metabolism within the realm of IBD treatment is essential for enhancing patient care and proactively addressing potential cardiovascular risks linked to these therapeutic interventions.

1.Herrera-deGuise C, Serra-Ruiz X, Lastiri E and Borruel N (2023) JAK inhibitors: A new dawn for oral therapies in inflammatory bowel diseases. Front. Med. 10:1089099. doi: 10.3389/fmed.2023.1089099