bluuebunny/crossref_metadata_2025 huggingface dataset:
P1040 Steroid use and dependency in South Indian Inflammatory Bowel Disease patients- A multi-center clinical audit
Authors: Mandapati C S P , Kuriakose Kuzhiyanjal A , Musunuri B , Desai G , Anasosalu S , Tantry B V , A k Satheesh R , Hajare S , Shetty S , Limdi J K
Published: January 2025

Background

Corticosteroids are effective induction agents for Inflammatory Bowel Disease (IBD) but are ineffective for maintenance. Their judicious use and steroid-sparing strategies are advocated by societal guidelines, but data from India are scarce.

Methods

An audit of steroid use in the last 12 months was conducted in unselected IBD outpatients from 4 large centres in South India using the steroid assessment tool (1). Cases that met the ECCO criteria for steroid dependency or excess were assessed to see whether steroid prescriptions were definitely avoidable, probably avoidable or unavoidable (2). Definitely avoidable and probably avoidable steroid uses were termed as inappropriate steroid excess. Categorical data were reported in proportions. Chi-square and Fischer test (expected count <5) was used to assess the association of factors associated with outcomes. Statistical significance was determined at 5% level of significance.

Results

Of 400 patients (61% male) enrolled in the study, 279 (70%) patients had ulcerative colitis (UC) and 121 (30%) patients had Crohn’s disease (CD). Baseline characteristics are outlined in Table 1. Among these, steroids were given to 208 (52%) IBD patients, and 127 (32%) patients were identified as having steroid excess or dependence:84 (66%) with UC and 43 (34%) with CD. CD patients with mild-inactive disease tended to have more steroid dependency (p<0.001), although rates of steroid use (P=0.123) and dependency were similar in overall CD (35.5%) and UC (30%) patients. Inappropriate “steroid excess” was noted in 48% of IBD patients (UC (52%) and CD (40%)) (p=0.226) (Fig. 1). The annual incidence of inappropriate steroid excess was 15.25 % (Percentage of inappropriate excess to the total cohort). Notably, 12.5% (n=26) patients commenced steroids without any biochemical or endoscopic evaluation and 128 (61%) patients did not receive any concomitant bone protection.

Conclusion

In this first study from India, steroid dependency or excess was observed in 32% of IBD patients with inappropriate steroid excess seen in 15.2%. Despite limitations posed by cost, access and logistical challenges, these observations are sobering and have triggered a quality improvement programme to improve quality of care for our patients.

References

1.Selinger CP, Parkes GC, Bassi A, et al. A multi-centre audit of excess steroid use in 1176 patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2017

2.Raine T, Bonovas S, Burisch J et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis. 2022
P1052 Ustekinumab for refractory intestinal Behçet’s Disease
Authors: Yang H , Li M , Huang Z , Gao X
Published: January 2025

Background

Intestinal Behçet’s disease (BD) is typically treated with a limited number of empirical medications. There is a continuing need for more effective and safer treatment options, particularly for refractory cases. This study reports the first use of ustekinumab in the treatment of refractory intestinal BD.

Methods

This was a retrospective review of medical records. The primary outcome was clinical remission at 12 weeks. Secondary outcomes included endoscopic remission (defined as the absence of ulcers) and normalization of C-reactive protein (CRP) levels.

Results

Five patients with refractory or intolerant intestinal BD, previously treated with corticosteroids and/or immunomodulators, received ustekinumab. All had previously been exposed to anti-TNFα monoclonal antibodies. The median follow-up duration after the first ustekinumab infusion was 12 months. Clinical remission rates were 80% (4/5) at 12 weeks, 75% (3/4) at 6 months, and 50% (2/4) at 12 months. CRP normalization rates were 60% (3/5) at 12 weeks, 50% (2/4) at 6 months, and 33% (1/3) at 12 months. Endoscopic remission rates were 50% (2/4) at 6 months and 50% (1/2) at 12 months. One patient required surgery due to refractory disease.

Conclusion

Ustekinumab appears to be a potentially effective treatment for refractory intestinal BD and represents a promising treatment option for refractory intestinal BD, especially in patients with limited therapeutic choices. Further studies are needed to confirm these findings and explore its broader applicability.
P1058 Trajectories of response in patients with moderately-to-severely active Crohn’s disease treated with mirikizumab based on biofailed status: Post hoc results from the VIVID-1 study
Authors: Schreiber S W , Clemow D B , Yu G , Keefer L A , Ananthakrishnan A N , D’Haens G , Deepak P , Kochhar G S , Melmed G Y , Chen Y F , Moses R E
Published: January 2025

Background

Mirikizumab, an anti-IL-23p19 antibody, demonstrated robust efficacy in improving clinical and endoscopic endpoints with an acceptable safety profile1. We explored the trajectory of response to treatment in patients with moderate-to-severely active Crohn’s disease (CD), in patients treated with mirikizumab based on biofailed status at study baseline.

Methods

Biofailed was defined as patients with demonstrated intolerance, inadequate response, or loss of response to an approved biologic therapy for CD (BF, N=275) and Not Biofailed (NBF, N=297) patients described previously1 were assessed via Growth Mixture Model to identify distinct clusters based on individual patient response trajectories. Change from baseline in Crohn’s Disease Activity Index total score was used in the Growth Mixture Model to identify trajectories. Modified baseline observation carried forward imputation used.

Results

There were four clusters identified for both the BF and NBF groups. Mirikizumab trajectory groups by baseline biofailed status: Super Responder (BF/NBF: 18.9%/17.8%), Responder (BF/NBF: 19.3%/25.3%), Delayed Responder (BF/NBF, 29.8%/29.3%), and Non/Incomplete Responder (BF/NBF, 32.0%/27.6%) (Figure 1). The overall response rate across responder groups for BF patients was 68.0% and for NBF patients was 72.4%.

Conclusion

Mirikizumab clinical response groups (Super Responder, Responder, Delayed Responder, and Non/Incomplete Responder) were similar for BF and NBF patients suggesting mirikizumab works consistently for BF and NBF patients, and prior biofailed status is not associated with the speed or magnitude of a MIRI-triggered clinical response.

References

1.M Ferrante, S Danese, M Chen, et al. OP05 Primary efficacy and safety of mirikizumab in moderate to severe Crohn’s Disease: results of the treat-through VIVID 1 study, Journal of Crohn’s and Colitis, Volume 18, Issue Supplement_1, January 2024., Pages i7–i9, https://doi.org/10.1093/ecco-jcc/jjad212.0005.
P1060 Exploring The Relationship Between Hormonal Contraceptive Use And Ulcerative Colitis Flares: A Longitudinal Analysis
Authors: Frutos C , Benítez J M , Soto P , Marín Pedrosa S , Iglesias-Flores E , Gros B
Published: January 2025

Background

Numerous studies have implicated hormonal contraceptive therapy (HCT) as a potential trigger for IBD onset. However, data regarding disease flares in hormonal contraceptive users are limited in ulcerative colitis (UC). This study aims to explore this association.

Methods

Female patients who were diagnosed with UC after 1st January 2014, and born between 1966-2008 were included. The Andersen-Gill extension of the Cox proportional hazards model was used to account for recurrent events within the same subjects. Two models were employed: M1: the first included each patient corresponding to only one cohort, while in the second M2: one those who initiated HCT after diagnosis, were included twice, one from diagnosis to HCT as non-exposed and as exposed thereafter.

Results

Among 2359 patients in our local database, 545 were women with UC, of whom 131 met the inclusion criteria for analysis. The majority had UC proctitis 57 (43.2%) with 24 (18.2%) were smokers. The median age was 32.5 (23.3-42) years. Of the cohort, 52 (39.1%) women exposed HCT, with a median exposure duration of 1.5 (0.5-5.0) years. Of these, 33 (25%) were exposed to HCT during follow-up.

Over 518 person-years of follow up, 173 flares and 196 courses of steroids were observed with 54 admissions, differences were observed among the hospitalization rates between groups Table 1. Additionally, there were 24 pregnancies documented in our cohort.

No differences in time to first flare (log-rank test p=0.83). However, the Cox proportional hazard model showed that HCT was associated with higher cumulative risk of flares in both models (M1: aHR 1.53, 95%CI 1.05-2.22, p=0.029) and (M2: aHR 1.47, 95%CI 1.019-2.11, p=0.039), Figure 1A and 1B. No adverse events associated to HCT occurred during follow-up.

Conclusion

Our study suggests that HCT is associated with an increased cumulative risk of flares and hospitalization rates in patients with UC. Furthermore, no safety signals were observed with the use of HTC in this cohort.
P1066 Effectiveness and safety of vedolizumab in real-world studies in Asian patients with inflammatory bowel disease: a systematic review and meta-analysis
Authors: Gu Y , Zhang X , Gu L , Zou D
Published: January 2025

Background

Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic gastrointestinal disorders with rising prevalence in Asia. Vedolizumab (VDZ) is a humanized monoclonal antibody targeting α4β7 integrin, selectively blocking gut lymphocyte trafficking. Despite numerous real-world studies on VDZ use in Asian patients with IBD over recent years, a comprehensive analysis summarizing its effectiveness and safety is still lacking. This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of VDZ in Asian patients with IBD.

Methods

A literature search was conducted to identify real-world studies evaluating intravenous VDZ in Asian patients with IBD from inception to 20th December 2023. Meta-analyses were performed separately for CD and UC patients to pool clinical and endoscopic remission and response rates across induction (6-14 weeks), medium term (22-30 weeks), and long term (over 48 or 52 weeks) using a random-effects model in R software. The incidence of adverse events (AE), serious AE (SAE), and serious infection were assessed for safety.

Results

Twenty-nine studies (15 CD and 25 UC) with 2,395 patients (827 CD, 1,568 UC) were analysed (Figure 1). In the induction phase, clinical response and remission were achieved in 57.48% and 61.15% of CD patients, and 64.72% and 40.07% of UC patients. In the medium term, clinical response and remission were 64.32% and 60.72% for CD, and 64.87% and 43.51% for UC. In the long term, the clinical response and clinical remission rate were 44.55% and 45.83% in CD patients, 61.35% and 56.14% in UC patients. Moreover, corticosteroid-free clinical remission was achieved by 36.58% of that in CD and 49.03% of that in UC for the long-term observation.

Endoscopic response was achieved by 41.37% of CD patients and 48.57% of UC patients during induction phase. Endoscopic remission rates for CD were 11.11%, 18.41%, and 36.42%, and for UC 43.19%, 54.27%, and 66.72% in induction, medium, and long term, respectively. The pooled complete endoscopic remission rates for UC were 27.98% (induction), 47.87% (medium term), and 50.61% (long term) (Table 1).

AEs occurred in 6.67% to 61.54% of CD patients and 29.69% to 75.38% of UC patients. SAEs and serious infection rates were 0.00% to 1.56% and 0.00% to 2.70% in UC patients, and 0.00% to 0.75% for serious infections in CD, with no SAEs reported in CD studies.

Conclusion

VDZ demonstrated effective clinical outcomes with a favourable safety profile in Asian patients with IBD.
P1069 Impact of Unmet Needs on Quality of Life in Patients with Short Bowel Syndrome in Japan
Authors: Ogino T , Watanabe K , Nakano H , Hayashi A
Published: January 2025

Background

Inflammatory bowel disease (IBD) is a major cause of short bowel syndrome (SBS). Patients with SBS face numerous challenges throughout their lives, leading to a reduced quality of life (QoL). Addressing unmet needs (UMNs) to improve QoL is critical; however, research on the UMNs of SBS patients remains limited. This study aimed to identify the UMNs of SBS patients with IBD (SBS-IBD) and without IBD (SBS-non-IBD) and clarify how these UMNs affect their QoL.

Methods

A survey on patients’ UMNs was conducted between February and May 2024 in Japan, involving adult patients with SBS, both those receiving parenteral support (PS) and those not. The survey included 54 items addressing patient concerns and consultations with healthcare professionals (HCPs). A comparison was made between adult-onset SBS-IBD and SBS-non-IBD. UMNs were defined as the discrepancy between the level of concerns and the frequency of consultations with HCPs, measured on a 7-point Likert scale. UMNs related to disease/treatment and daily life aspects were evaluated separately. QoL was assessed using the SBS-Quality of Life scale (SBS-QoL). Multiple regression analysis was performed to assess the factors influencing UMNs and their impact on QoL.

Results

Ninety-four patients had SBS-IBD, the majority of whom had Crohn’s disease, while fifty-eight had SBS-non-IBD. The mean ages were 47.4 years and 46.0 years, respectively. Among those with SBS-IBD, approximately half had a stoma, with a significantly higher proportion compared to the SBS-non-IBD group. Additionally, 68% of the SBS-IBD group received PS, compared to 52% in the SBS-non-IBD group (p=0.04), and the duration of PS dependence was longer in the SBS-IBD group (7.3 years vs 4.6 years, p=0.02). Regarding disease/treatment UMNs, the most common issue in the SBS-IBD group was depression or anxiety (33%). For daily life UMNs, concerns about the future (38%), financial situation (31%), and work/school (30%) were identified. Similar trends were observed in the SBS-non-IBD group. Multiple regression analysis showed that QoL was impacted by disease/treatment UMNs (p=0.02), daily life UMNs (p=0.01), PS volume (p=0.02), and hospitalization due to catheter-related bloodstream infection (p<0.01) in patients with SBS-IBD.

Conclusion

For both SBS-IBD and SBS-non-IBD patients, depression or anxiety had the highest discrepancy level in disease/treatment UMNs. It is essential for doctors to prioritize these UMNs by actively engaging in discussions with patients about their individual needs and treatment goals, staying informed about the latest research and emerging trends in holistic management of SBS.

Funding

This study was supported by Takeda Pharmaceutical Co., Ltd.
P1071 Trajectories of response in patients with moderately-to-severely active ulcerative colitis treated with mirikizumab: Results from the LUCENT-1 study
Authors: Schreiber S W , Clemow D B , Keohane A , Zhu B , Ritter T , Regueiro M , Hudesman D , Chen Y F , Owen C
Published: January 2025

Background

Mirikizumab, an anti-IL-23p19 antibody, demonstrated robust efficacy in improving clinical and endoscopic endpoints with an acceptable safety profile1. We explored the trajectory of response to mirikizumab treatment in patients with moderate-to-severely active ulcerative colitis.

Methods

Mirikizumab patients described previously1 were assessed via Growth Mixture Model (GMM) to identify distinct clusters based on individual patient response trajectories. The sum of stool frequency and rectal bleeding modified Mayo subscores was used in the GMM to identify trajectories. Week 12 clinical endpoints were assessed by trajectory group. Modified baseline observation carried forward imputation was used.

Results

Trajectory groups were identified as Super Responder (N=223; 25.7%), Responder (N=409; 47.1%), and Delayed or Non/Incomplete Responder (N=236; 27.2%) (Figure 1). At week 12, a different proportion of patients achieved efficacy endpoints by Super Responder, Responder, and Delayed or Non/Incomplete Responder trajectory groups, respectively: symptomatic remission: 70%/58%/0%; bowel urgency improvement: 72%/51%/22%; clinical response: 95%/75%/14%; clinical remission: 36%/32%/0% (Figure 2).

Conclusion

Three response trajectory groups were identified for mirikizumab treatment of ulcerative colitis: Super Responder, Responder, and Delayed or Non/Incomplete Responder. At week 12 of treatment, the proportion of patients achieving efficacy endpoints in general was greatest in Super Responders followed by Responders and then Delayed or Non/Incomplete Responders, with an overall response rate of 72.8%. Efficacy was similarly robust across both the Super Responder and Responder groups.

References

1.D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940. Erratum in: N Engl J Med. 2023 Aug 24;389(8):772. doi: 10.1056/NEJMx230004.
P1072 The influence of anxiety and depression and the online mindfulness interventions on the quality of life among patients with Inflammatory Bowel Disease (IBD) : Web-Based Survey Study
Authors: Hu S , Xu D , Zhu C , Wang Y , Li S , Chen Y , Chen Y , Wang C
Published: January 2025

Background

Patient diagnosed with Inflammatory Bowel Disease (IBD) experience distressing psychological symptoms and a diminished quality of life (QOL). The efficacy and feasibility of online mindfulness intervention for patients with IBD is unknown.We conducted a mobile-delivered mindfulness intervention among IBD patients to study its feasibility and efficacy in lowering their anxiety or depression level and improving their QOL.

Methods

We utilized individuals diagnosed with IBD to investigate the correlation between the severity of depression/anxiety and their QOL. The severity of anxiety and depression symptoms was evaluated using the Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9), respectively. QOL was assessed using the Short Health Scale (SHS). The relationship was analyzed through regression analysis. Additionally, a randomized parallel design was employed to conduct the Online MINdfulness-based stress reduction with Daily EXercise (MINDEX) program, and its effects on QOL and psychological symptoms were studied over a period of 2 months.

Results

A total of 521 participants initiated the survey and 484 completed and submitted the survey. More than 80% of the patients experienced severe symptoms of anxiety or depression, as indicated by GAD-7 scores ≥ 10 or PHQ-9 scores ≥ 10. The study found that increases in GAD-7 total scores were significantly associated with increases in SHS total scores, with an R2 value of 0.43 and coefficient of 12.6 (95% CI 9.4-15.7) for UC (Ulcerative Colitis) and R2 value of 0.27 and a coefficient of 10.4 (95% CI 8.8-12.1) for CD (Crohn’s Disease). Similarly, increases in PHQ-9 scores also showed significant correlations with increases in SHS total scores, with an R2 value of 0.37 and a coefficient of 9.2 (95% CI 6.5-11.8) for UC and R2 value of 0.22 and a coefficient of 7.2 (95% CI 5.9-8.6) for CD. However, when depression severity was considered, the significant differences between SHS and PHQ-9 scores disappeared in both UC and CD. Yet, the positive correlation between GAD-7 and SHS scores remained significant in UC. Regarding the MINDEX program, the study included 30 MINDEX patients and 22 control patients who completed the program. After 2 months, the scores of GAD-7, PHQ-9, SHS between MINDEX patients and 22 control patients were not statistically significant (.052 < P < .908).

Conclusion

IBD significantly influenced patients’ anxiety, depression, QOL, and sleep quality. Online mindfulness interventions did not show a significant reduction in anxiety or depression. When formulating personalized treatment plans, it is crucial to take into account the patient’s overall condition to optimize treatment outcomes and enhance the patient’s QOL.
P1075 Evaluation of characteristics of faecal urgency in patients with ulcerative colitis
Authors: Ivány E , Bacsur P , Horvát B , Farkas B , Bálint A , Rutka M , Fábián A , Bősze Z , Farkas K , Szepes Z , Molnár T
Published: January 2025

Background

Bowel urgency is one of the most bothersome symptoms of ulcerative colitis (UC). The Urgency Numerical Rating Scale (U-NRS) measures the degree of faecal urgency experienced over the past 24 hours by patients with UC on a scale of 0-10. We assumed that the scale has a large variance, as patients evaluate their own symptoms differently. The urge may be different quality for two patients with the same score. The score on the U-NRS may be influenced by the individual’s specific perception of symptoms (degree of pain, speed of urge). The objective of our study was to investigate the possible components of urgency using the U-NRS.

Methods

Patients with UC older than 18 years treated at our departments for at least 3 months and having complaints were enrolled in our study. The patients filled out our non-validated questionnaire with questions about fecal urgency (U-NRS), pain level, speed of urge, incontinence and lifestyle characteristics associated with incontinence. Statistical analysis was performed using SPSS program.

Results

205 patients were enrolled, median age was 40 years, the mean of disease duration was 11.8±9.4 years. The mean U-NRS score was 3.2±3.2, 64 patients (31%) had 0 score and 8 (4%) had 10 score. 12% of the patients (n=24) felt most difficult to hold mucus, 38% (n=77) stool and 31% (n=63) other secretions. 9% (n=19) had urge with every stool in the last 24 hours, 35% (n=71) had less than half of defecations. Patient reported outcome (PRO2) had a significant but weak correlation with U-NRS (ͳb=0.348 p=0.000)(Figure 1). The speed of urge defined more the level of urgency than the pain level (R2=0.798, F(1, 203)=803.86 p<0.001, β=0.894 vs R2=0.805, F(2, 202)=417.98, p<0.001, β=0.117). The duration of faeces holding in the last 7 days had significant connection to U-NRS (R2=0.211, F(1, 203)=54.432, p<0.001, β=-0.46). Patients using public restroom at least once during the last week had significantly higher score on U-NRS than other patients (4.6±3.1 vs 2.4±3 p<0.0001). The usage of diapers was also significantly more often in patients with higher U-RNS score (5.2±3.2 vs 2.9±3.1,p<0.0001). Faecal leakage both during the day and night was significiantly higher with higher U-NRS score (p<0.0001 for both)

Conclusion

Urgency is more defined by the speed of urge than the pain. Using public restroom, usage of diapers and faecal leakage are associated with higher U-NRS. Bowel urgency greatly affects the daily life of UC patients, therefore, it has to be taken into count in therapy managing.

Figure 1
P1078 Weight-loss medications and bariatric surgery are infrequently used in obese patients with inflammatory bowel disease in North and East Devon in the United Kingdom (UK)
Authors: Hodges P , Roberts C , Badrulhsisham F , Pamment D , Smith R , Cairnes V , Bewshea C , Kennedy N , Goodhand J , Ahmad T
Published: January 2025

Background

Obesity is increasingly prevalent in patients with IBD and has been linked to non-response to medical therapies and disease progression. In the last decade the management of obesity in the general population has undergone a paradigm shift following the widespread use of medical therapies and bariatric surgery. Few studies have assessed weight loss strategies used by obese patients with IBD.

Methods

We designed a Patient and Public Involvement and Engagement survey to assess past use and future interest in interventions for obesity. We also sought interest in a trial of a licensed weight loss medication as an adjunct to conventional IBD therapy. We used the MyChart application in our electronic patient record (EPIC) to distribute our questionnaire between 6th and 18th November 2024. The response rate was 31% (828/2700): 40.0% [322/828], 52.9% [426/828], 7.1% [57/828] patients were diagnosed with Crohn’s disease, UC and IBDU, respectively. Body mass indices were available in 97% (807/828) patients.

Results

The median [IQR] age was 54.0 (41.0 - 65.0) years, 58.5% (484/828) were female and 92.8% [768/828] were of white European ancestry. Overall, 29.0% (234/807) were overweight and 25.0% (202/807) were obese. 30.7% (254/828) were eligible for a medication for weight management, by having a BMI ≥30 kg/m2 or a BMI ≥27 kg/m2 in addition to one or more weight-related comorbidity. Amongst these patients prior experience with weight loss strategies included: 51.6% (131/254) self-directed dieting; 33.9% (86/254) calorie counting using a smartphone app; 38.2% (97/254) had attended a weight-loss group; 16.1% (41/254) had had advice from a dietician; 2.8% (7/254) had taken part in a formal exercise program; 5.9% (15/254) had used weight loss medications [6 orlistat, 14 GLP-1 agonist] and 1.6% (4/254) had had bariatric surgery. Of 14 patients treated with a GLP-1 agonist, 5 and 9 were prescribed by public and private healthcare professionals respectively.

Amongst patients eligible for pharmacological treatment: 11.4% (29/254) expressed interest in future group-based support; 30.8% (78/254) in a formal exercise program; 37.4% (95/254) advice from a dietitian; 43.3% (110/254) drug treatment and 11.4% (29/254) endoscopic or surgical weight loss procedures. 72.8% (185/254) of patients expressed interest in participating in a trial of a licensed weight loss medication as an adjunct to conventional IBD treatment.

Conclusion

Obese patients living with IBD want access to weight loss interventions. However, previous use of weight loss medications was uncommon and usually accessed through private healthcare. Three quarters of obese patients expressed an interest in a trial of a licensed weight loss medication as an adjunct to conventional IBD therapy.
P1080 Early Biologic Therapy for Inflammatory Bowel Disease in Taiwan: A Single- Center Retrospective Cohort Study
Authors: Wong T C , Liao C Y , Lee C Y , Lin W C , Chang C W , Chen M J , Chang C W
Published: January 2025

Background

As the "top-down" strategy gains increasing importance in the management of IBD, early biological intervention is increasingly recognized as a significant focus in clinical practice. However, compared to Western countries, limited database availability has left this issue unexplored in Taiwan. To this end, we analyzed a 10-year database from a single medical center, focusing on clinical outcomes and colectomy-free survival in patients treated with biologics.

Methods

In this retrospective study, we included IBD patients who had received biologic therapy for more than 6 months between February 2012 and October 2023. Early biologic therapy was defined as initiation within two years of diagnosis. The crude risk of clinical outcomes, such as colectomy, IBD-related emergency room visits, and IBD-related hospitalizations, were analyzed using Kaplan-Meier curves, log-rank test.

Results

A total of 115 consecutive IBD patients who received biologic therapy were enrolled, including 61 patients with UC and 54 with CD. The study was divided into two groups: the early biologic therapy group (n = 43) and the late biologic therapy group (n = 72). 64.3 % of patients were male and the mean diagnostic age was 40.5 ± 16.1 years. The mean duration of the first biologic agent use was longer in patients receiving early biologic intervention. Table 1 presents the other baseline characteristics of both cohorts. During a median follow-up of 8.8 (± 6.1 years), 29.6 % of patients visited the ER after their first biologic treatment, while 26.1 % were hospitalized due to IBD flare-ups. Additionally, eight patients required a colectomy. The analysis revealed a statistically significant difference in the cumulative survival rate for hospitalization (p = 0.048). However, no significant differences were observed in the cumulative survival rates for colectomy (p = 0.166) or emergency room visits (p = 0.048).

Conclusion

Early biologic therapy significantly reduces hospitalization risk in Taiwanese IBD patients. However, it shows no significant link to emergency room visits, possibly due to higher emergency care use in Taiwan. Thus, larger studies are needed to confirm its effectiveness.
P1088 Positive effects of a mindfulness-based intervention on depression, stress and perceived control, but not on disability in patients with Crohn’s disease: results from a randomized controlled trial
Authors: Keersmaekers B , Beeckmans D , Brams S , Vanderbist K , Van den Bosch M , Vermeire S , Verstockt B , Sabino J , Van Diest I , Ferrante M
Published: January 2025

Background

Crohn’s disease (CD) often leads to significant disability and psychological distress, significantly reducing patients’ quality of life. We evaluated the impact of a mindfulness-based intervention on disease-related disability in patients with CD on stable maintenance therapy. Additionally, we wanted to assess the impact of mindfulness on anxiety, depression, stress, disease acceptance, perceived control, and disease activity.

Methods

We conducted a monocentric randomized controlled trial (RCT), where participants were randomly assigned to an immediate intervention group or a waitlist control group that received the same intervention after six months. The IBD Disability Index at baseline (IBD-Disk ≥40 or <40) was used as a stratification factor. Disease activity was assessed through patient-reported outcomes (PRO-2) and biomarkers (faecal calprotectin and C-reactive protein), measured at baseline, at 1.5 and at 3 months follow-up. Psychological factors including anxiety, depression, and stress were assessed with the DASS21 scale. Disease acceptance and perceived control were measured using the SHE model, and mindfulness levels were assessed with the FFMQ-SF. The intervention consisted of a total of four mindfulness group sessions of three hours each over six weeks. The primary outcome was the mean change in the total IBD-Disk score at three months and was analysed using a constrained longitudinal data analysis (cLDA). Based on power calculation (α=0.05, power=0.80), 54 patients had to be randomized.

Results

As shown in Table 1, 56 patients (38% male, median age 49.5 years) were randomized into the immediate intervention group (n=28) or the six-month waitlist control group (n=28). Two patients dropped out in each group before reaching the primary endpoint. Compared to the waitlist, participants in the intervention group showed significant improvements in depression, stress, perceived control, and mindfulness after three months (see Table 2). Although improvements in disease-related disability, anxiety, and disease acceptance showed positive trends, these items did not reach statistical significance. No changes were observed in clinical and biochemical markers of disease activity.

Conclusion

A 6-weeks mindfulness-based intervention can significantly improve depression, stress, perceived control, and mindfulness in patients with CD, with effects sustained 3 months post-intervention. Although numerically better, no significant effects were found on disease-related disability. Further research is warranted to explore the long-term benefits and underlying mechanisms of mindfulness in CD management.
P1090 Increased advanced therapy prescribing correlates with decreased colectomy rates in ulcerative colitis: a twenty-year population-based cohort study in Lothian, Scotland
Authors: Elford A , Constantine-Cooke N , Jenkinson P , Gros B , Plevris N , Lyons M , Ong S , Greenlees N , O’Hare C , Din S , Noble C , Jones G , Arnott I , Lees C
Published: January 2025

Background

The evidence for the impact of increased advanced therapy prescribing on colectomy rates in ulcerative colitis (UC) are conflicting. Our aim was to describe prescribing trends of advanced therapies (biologics and small molecules) for patients with UC in Lothian, UK and colectomy rates (elective and emergency) between January 1st, 2004, to December 31st, 2023.

Methods

Incidence and prevalence data were obtained from the validated Lothian IBD Registry. We identified patients who commenced an advanced therapy using multiple administrative databases, and identified patients who underwent colectomy using the NHS Lothian pathology database, TrakCare theatre lists, NHS Lothian multidisciplinary meetings database, and an inpatient coding database. We collected data by manual review of the electronic health records using the TrakCare (InterSystems Corporation, Cambridge, Massachusetts, USA) system. We used SPSS Version 25 [IBM Inc., Chicago, IL, USA], Prism Version 10.0 [Graphpad Software, San Diego, CA, USA], and R 4.4.0 [R Core Team, Vienna, Austria] for statistical analyses and generation of graphs. We report advanced therapy prescription and colectomy data as both raw numbers and annual incidence rates.

Results

The prevalence of UC increased from 216 to 441 patients per 100 000 population in the twenty years from 2004, culminating in a total of 4115 patients with UC in 2023 (total Lothian population 1 million). We identified 617 patients who had received an advanced therapy (Table 1). Rates of first line advanced therapy increased from 0 per 100 UC patients in 2004 to 5.15 in 2023 (Figure 1). At the conclusion of 2023, 43%, 20%, 9%, and 3% of the advanced therapy exposed patients had received second, third, fourth, and fifth-line advanced therapy, respectively.

We identified 559 patients of the prevalent UC population who had a colectomy, of which 68% were emergency colectomies. Absolute colectomy numbers decreased from 42 in 2004 to 7 in 2023, equating to 2.48 and 0.22 per 100 UC patients. We observed that 66% (339/559) of colectomies occurred in patients with extensive disease (E3), with 68% (355/523) performed for acute severe UC, of which 32% (114/355) occurred within 90 days of diagnosis. A total of 4% (22/559) of colectomies were for cancer (n=14) or dysplasia/suspected cancer (n=8). Colectomies for "chronic active UC refractory to medical treatment" have almost completely disappeared with only 5 colectomies performed for this indication in the last 2 years of follow-up.

Conclusion

We found the incidence of colectomy in the UC population progressively decreased over time, and correlated with an increased use, and number, of available advanced therapies.
P1091 Trends in length of stay and steroid use in patients admitted with Acute Severe Ulcerative Colitis: Impact of intensified or accelerated infliximab dosing
Authors: Bartlett R , Mohamedrashed M , Yogakanthi S , Chew M , Nedumannil L , Pearce R , Lucas S , Chauhan A , Lewis D , Kashkooli S , Garg M
Published: January 2025

Background

The role of intensified (>5mg/kg), accelerated (>1 dose within first 14 days) infliximab (IFX) as rescue therapy in patients with acute severe ulcerative colitis (ASUC) remains controversial. This project evaluated the association between evolving strategies with length of stay, 12-month cumulative steroid burden, colectomy and readmission rates.

Methods

Patients admitted with ASUC between January 2016 and October 2024 to a single tertiary IBD centre were identified and reviewed. IFX rescue therapy was defined as standard dose if up to 5mg/kg or intensified/accelerated if ≥10mg/kg (further categorised as 10mg/kg or ≥20mg/kg) was administered within 14 days of admission. Outcomes assessed included length of stay, 12-month cumulative steroid exposure (in prednisolone mg equivalent), 12-month readmission and colectomy rates.

Results

147 patients (61 [41.5%] female, median age 33 [range 16-87] years) met Truelove and Witts criteria for ASUC. 83 (56.5%) patients required IFX therapy, of whom 29 (34.9%) patients received 5mg/kg IFX dose, 35 (30.1%) patients received 10mg/kg and 19 (22.9%) patients ≥20mg/kg. Disease severity as defined by CRP:albumin ratio was similar between patients receiving 5mg/kg vs 10mg/kg (p=0.880), but higher in those receiving 20mg/kg vs 5mg/kg (p=0.012); vs 10mg/kg (p=0.008). There was an increasing trend in the proportion of patients receiving intensified/accelerated IFX (≥10mg/kg) from 2016-2019 (26.3%) to 2020-2024 (76.5%) (p<0.001). Length of stay was less in patients who received 5mg/kg and 10mg/kg compared to ≥20mg/kg (median 6 vs 6 vs 11 days p=0.001). 12-month cumulative steroid usage was similar in 5mg/kg (median 1850 mg), 10mg/kg (1642.5 [1297.5-1935]mg) and ≥20mg/kg (1600 [1452.5-1715]mg), p=0.135. Readmission (19.2% (5mg/kg), 28.6% (10 mg/kg) and 11.1% (≥20mg/kg), p=0.527) and colectomy (8.7% (5mg/kg), 10.5% (10 mg/kg), 12.5% ≥20mg/kg, p = 0.958) rates were similar across IFX groups. Median length of stay was similar (p=0.193) between 2016-2019 (6 days) and 2020-2024 (6 days). 12-month cumulative steroid exposure (median 1705mg vs 1617.5mg, p=0.282) and readmission rates (15.8% vs 21.2%, p=0.488) remained stable when comparing 2016-2019 and 2020-2024. 12-month colectomy rates[MG1] declined across all ASUC patients (15.8% in 2016-2019 to 1.5% in 2020-2024, p = 0.004), and ASUC patients receiving IFX (21.1% 2016-2019 to 2.8% in 2020-2024, p = 0.025).

Conclusion

Despite higher disease severity, intensified and accelerated dosing for IFX at ≥20mg/kg resulted in similar length of hospital stay, 12-month steroid exposure, readmission and colectomy rates to lower doses. Intensified and accelerated IFX dosing has increased over time, associated with reduction in colectomy rate.
P1092 Real-life durability and utilization of biologics in pediatric inflammatory bowel disease: results from Italian society of pediatric gastroenterology, hepatology and nutrition (SIGENP) IBD registry
Authors: Lega S , Manuela G , D’Arcangelo G , Di Pasquale V , Scarallo L , Ancona S , Fedele F , Zuin G , Graziano F , Norsa L , Gatti S , Illiceto M T , Felici E , Corpino M , Pavanello P , Cozzali R , Alvisi P , Belluca S , Banzato C , Penagini F , Marseglia A , Faraci S , Luini C , Strisciuglio C , Moretti C , Martinelli M , Arrigo S , Lionetti P , Romano C , Aloi M , Bramuzzo M ,   SIGENP IBD Study Group
Published: January 2025

Background

Long-term data on the efficacy and safety of biologics in pediatric inflammatory bowel disease (IBD) are crucial for guiding clinicians in optimizing their use. This study aims to evaluate real-life durability, usage patterns, and factors influencing treatment discontinuation in pediatric IBD.

Methods

This registry-based study analyzed data of patients from the IBD registry of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP) who started biologic therapy between 2009 and 2022, with a minimum 1-year follow-up.

Results

1184 patients (749 Crohn’s Disease [CD], 437 Ulcerative Colitis or IBD-undetermined [UC/IBD-U]) were retrieved. The median follow-up was 43 months (IQR 28-64). Infliximab was the first biologic in 807 patients (68%) followed by adalimumab in 378 patients (31%). 393 patients (33%) received a second-line biologic, 107 (9%) a third-line and 24 (2%) a fourth-line. At last follow-up, 544 patients (47%) had discontinued the first biologic, with a median time to discontinuation of 14 months (IQR 5-27). Main reasons were loss of response (36%) followed by primary non-response (33%) and infusion reactions (13%). For first-line biologics, treatment durability was superior in patients who received adalimumab compared to infliximab (Figure 1a) and in patients managed with TDM (Figure 2b). In the multivariate analysis risk factors for first biologic discontinuation were age < 6 years (HR 1.8, 95%CI 1.3-2.4), UC/IBD-U (HR 1.4, 95%CI 1.1-1.8), moderate/severe disease activity (HR 1.3, 95%CI 1.1-1.6) and Infliximab vs adalimumab (HR 2.1; 95% CI 1.6-2.7) while the use of TDM emerged as protective, significantly lowering the risk (HR 0.50; 95% CI 0.40-0.63). Combination therapy did not influence biologic durability (HR 0.95; 95% CI 0.77-1.18).

Conclusion

strategies for optimizing treatment efficacy of biologics in pediatric IBD should be tailored considering patients age, IBD type and severity and integrating TDM in patients’ management. The contribution of concomitant immunomodulation in the pediatric setting might be negligible.
P1093 Personalized Tasty&Healthy whole-food diet for maintaining remission in children and adults with Crohn’s disease: results from the MyTasty open-label trial
Authors: Plotkin L , Aharoni Frutkoff Y , Shavit Z , Focht G , Livovsky J , Buchuk R , Lev-Zion R , Ledder O , Assa A , Sigall Boneh R , Weiss B , Slae M , Dotan I , Kierkuś J , Broide E , Griffiths A , Naftali T , Aloi M , Yerushalmy-Feler A , Schwerd T , Reifen R , Turner D ,   T&H
Published: January 2025

Background

The Tasty&Healthy™ (T&H) diet offers a flexible alternative to exclusive enteral nutrition (EEN) for inducing remission in Crohn’s disease (CD). Unlike CDED, it excludes processed foods, gluten, red meat, and most dairy but does not rely on formula or mandatory ingredients. The "MyTasty" trial aimed to assess the effectiveness and feasibility of T&H for maintaining remission in children and adults with CD, with gradual reintroduction of gluten and dairy

Methods

Patients with CD (4-37 years of age) who entered deep remission (i.e. MINI index <8 and wPCDAI<12.5/CDAI<150) with dietary treatment during one of the two induction RCTs of T&H (TASTI-MM and TASTI-E), were enrolled in this 16-week, open-label maintenance trial. Participants followed T&H with gradual reintroduction of gluten, milk, and other dairy products monthly, dictated by home-based fecal calprotectin (FC). FC increase by >30% suggested failure of the new food and thus it was excluded again.

Results

Altogether, 43 patients (mean age 16±5.8 years, 10 adults, median disease duration 1.5 months [IQR 0.49–2.95]) were enrolled, with 34 (79%) completing the 16-week dietary period. At week 16, 32/43 (75%) had FC<250, 32/43 (75%) had normal CRP, 34/43 (79%) had MINI-index<8 (implying mucosal healing), 37/43 (86%) were in clinical remission (wPCDAI <12.5/CDAI <150), and 21/43 (49%) achieved deep remission (clinical remission, normal CRP, and FC<250, figure 1).

Of the 34 completing the study, 19 (55%) successfully introduced gluten, milk, and dairy without increases in inflammation markers, and 2 introduced all three but with an FC increase at week 16. Among others, 6 tolerated milk/dairy but not gluten, 1 tolerated only milk, 3 tolerated gluten but not milk/dairy, and 2 tolerated gluten and milk but not other dairy. Only one patient tolerated no additions, staying on the unmodified T&H diet. Among 13 patients where a specific food caused >30% baseline FC increase, re-exclusion reduced FC to pre-change levels in 12 (92%).

Nutritional analysis showed T&H patients met >90% of Dietary Reference Intakes (DRI) for key macro- and micronutrients, except calcium and potassium. Additionally, 19 (55%) reported improved satisfaction with food-related life compared to the unmodified T&H diet period.

Conclusion

Overall, 49% of patients whose remission was previously induced by nutritional therapy, successfully maintained deep remission with the whole-food Tasty&HealthyTM diet over 4 months. We show the feasibility of personalized dietary treatment with home kits of FC, allowing for dietary flexibility in most patients. Oral calcium supplement may be needed with T&H.
P1094 Serum Chitinase 3-like-1 (CHI3L1) is correlated to fecal calprotectin levels in IBD patients during pregnancy
Authors: Schweistein H , Rave A , Glusman Bendersky A , Ollech J E , Ariella B G S
Published: January 2025

Background

Monitoring inflammatory bowel disease (IBD) activity during pregnancy remains a challenge due to limitations of non-invasive markers. Although fecal calprotectin is considered a reliable marker, its utility is constrained by limited patient adherence and accessibility. Blood-based markers provide a more convenient alternative, however, standard markers like CRP and ESR have reduced reliability in pregnant IBD patients. Serum chitinase-3-like-1 (CHI3L1) is a promising candidate biomarker due to its association with intestinal inflammation and its elevated levels in IBD patients.The aim of this study is to investigate whether serum CHI3L1 levels can reliably indicate disease activity in pregnant IBD patients by comparison with standard markers, including calprotectin, CRP, and ESR.

Methods

Pregnant IBD patients were recruited from our multidisciplinary IBD-MOM referral clinic for this IRB-approved, prospective observational study. Blood samples were collected for CHI3L1, CRP, and ESR levels during elective clinic visits, while stool samples were used to measure calprotectin levels. Each visit was classified as a distinct sample for analysis. Correlations between CHI3L1 and other inflammatory markers were assessed.

Results

A total of 124 samples from 80 pregnant IBD patients were collected, including 90 samples from 58 patients with Crohn’s disease (CD) and 34 samples from 22 patients with ulcerative colitis (UC). The mean participant age was 30.52±5.84 years and mean gestational age at enrollment was 21.69±9.41 weeks. Samples were distributed across pregnancy trimesters, with 33 in the first, 49 in the second, and 42 in the third trimester. Significant positive correlations were observed among several inflammatory markers. Serum CHI3L1 levels showed the strongest correlation with calprotectin (r = .366, p = .008), suggesting its potential as an alternative inflammation indicator. CHI3L1 also had a moderate correlation with ESR (r = .358, p = .001) and a strong correlation with CRP (r = .614, p < .001). CRP exhibited a moderate positive correlation with ESR (r = .478, p < .001), while no significant correlation was found between CRP and calprotectin (r = .208, p = .101).

Conclusion

The findings suggest that serum CHI3L1 is a potential biomarker for monitoring disease activity in pregnant IBD patients, particularly as it correlates with fecal calprotectin. CHI3L1 may offer a practical, non-invasive alternative to traditional markers, improving disease monitoring during pregnancy when access to reliable indicators is limited. Further research is warranted to validate CHI3L1 as a standard marker in this patient population and to explore its utility in clinical settings.
P1098 The Clinical Spectrum of Acute Severe Ulcerative Colitis in the Biologic Era
Authors: Singh D.M. A , Luthra M , Bhardwaj A , Mahajan R , Sharma R , Singh D , Jain D , Goyal O , Mehta V , Kaur K , Gupta Y , Midha V , Sood A
Published: January 2025

Background

Acute severe ulcerative colitis (ASUC) is a time critical situation requiring urgent intervention. Limited data exist on the evolving clinical spectrum of ASUC in the era of advanced therapies.

Methods

This prospective cohort study included 145 adult patients hospitalized with ASUC between January 2020 and June 2024. ASUC was defined by the modified Truelove and Witts (TW) criteria. Demographics, disease characteristics, including disease severity, probable precipitating factors, and corticosteroid failure rates were recorded.

Results

The median age of patients was 36 (26-48.5) years with 63 (43.4%) females. Most patients had left-sided colitis (53.1%). The median disease duration was 2 (IQR 1-4) years, with 91 (62.7%) patients presenting with ASUC within the first year of diagnosis of UC. One-third of the patients had previous exposures to biologics and small molecules. The most commonly reported probable precipitants of ASUC were poor compliance with treatment (n=43, 29.6%), antibiotic use (n=35, 24.1%), high perceived stress (n=32, 22.1%), and Clostridioides difficile infection (n=19, 13.1%). Forty (27.5%) patients were non-responders to intravenous corticosteroids. Twenty-nine (20%) patients received medical rescue therapy (infliximab, n=14[48.27%], cyclosporine A, n=6[20.68%], and tofacitinib, n=9 [31.03%]). Four (2.75%) patients underwent colectomy.

Conclusion

In this cohort of ASUC patients, poor treatment compliance, antibiotic use, stress, and C. difficile infection were common precipitants of flare-ups. Nearly one-third of patients required medical rescue therapy, and a small proportion underwent colectomy.