bluuebunny/crossref_metadata_2025_split huggingface dataset:
P748 Place of thiopurine monotherapy in the treatment of Crohn's Disease in the era of biologic therapies: results of a long-term tertiary single-center experience
Authors: Aouroud H , Aouroud M , Lairani F E , Nacir O , Ait errami A , Oubaha S , Samlani Z , Krati K 
Published: January 2024

Abstract

Background
Crohn's disease (CD) is a chronic and disabling immune-mediated disease of the digestive tract, and immunosuppressive drugs are a cornerstone in the therapeutic approach, particularly purine analogues which are widely used in the treatment of CD as an agent to maintain remission. Despite their widespread use, adverse effects are frequent and lead to discontinuation of treatment in a significant proportion of patients so the increasing use of anti-TNFα biologics may have had an impact on the use of thiopurines. We present a long-term retrospective experience from a tertiary hospital center aimed at studying the evolution of thiopurine monotherapy use in the era of biologics, based on current therapeutic goals and safety standards.

Methods
We performed a retrospective analysis of all Crohn's disease patients followed up in our hepato-gastroenterology department who received AZA monotherapy at the standard dose (2-2.5 mg/kg/d) or 6-MP (1-1.5 mg/kg/d) at any time during their follow-up between January 2016 and June 2023 and who were still being followed up at that time. Patients who had received prior or concomitant biological treatment were excluded from the analysis. Various socio-demographic and phenotypic data were collected. Failure was defined as discontinuation of treatment due to lack of efficacy or AE. Statistical analysis was performed using SPSS2.0 software. Statistical significance was set at p &lt; 0.05.

Results
A total of 383 patients were included: 46.5% were men and the mean age was 31 years (range 17-65). Median follow-up was 66 months. Indications for thiopurine monotherapy were cortico-dependence (306 patients, 80%) or prevention of postoperative recurrence (77 patients, 20%). Overall, 147 patients (38%) failed. The observational study of our patients showed that 74 patients (18.4%) discontinued AZA due to an adverse event (most of which occurred during the first month of treatment), 73 (19%) due to lack of efficacy. Among the main indications for AZA we note: prevention of postoperative recurrence, male gender gave better results than steroid dependence (p =0.001); perianal fistulization of CD and grecal localization gave worse results (p = 0.002).

Conclusion
In our experience, a significant proportion of CD patients on thiopurine monotherapy failed. Although IS monotherapy remains useful for CD in the era of biologics, current clinical practice is moving towards anti-TNFα biologics in an increasing proportion of patients.
P764 Darvastrocel in Treatment of 152 Patients with Perianal Crohn's Disease - Observational Study
Authors: Serclova Z , Tremerova A , Ryska O , Zuskova P , Lengalova M , Vlkova K 
Published: January 2024

Abstract

Background
Complex perianal fistulas significantly affect quality of life and treatment costs in patient with Crohn's disease (CD). Application of adult allogeneic expanded adipose-derived mesenchymal stem cells (Darvastrocel, Takeda Pharmaceuticals) represents novel treatment modality for this challenging condition.
The aim of this study was to examine the long-term effects of Darvastrocel (DVS) in patients with complex perianal fistula associated with Crohn’s disease.

Methods
The study was conducted at two Czech medical facilities (NH Hospital, Horovice and ISCARE, Prague). All consecutive CD patients with complex perianal fistula (up to 2 internal and 3 external openings) treated by the same team with DVS between August 2019 and July 2023 were enrolled into the study and followed prospectively. All fistulas persist despite previous biologic and surgical treatment. The technique of DVS application was based on the ADMIRE CD study protocol and was in accordance with SPC. Fistula tract was curetted, internal opening closed and leak test performed under GA. DVS was applied below the internal opening and along the fistula tract subsequently. Perianal area was then assessed at week 3, month 3 and 6 and then every year postoperatively.

Results
In total, 152 patients (53.9% male, 46.1% female) with median age of 36.6 (20-72) years were enrolled (tab. 1). Primary success rate detected within the period of 19.8 (4.2-50.2) months after application was 80.3% (122 patients). Fistula recurred in 9 patients (at the site of original fistula in 6 and in a new location in 3 cases), resulting in a sustained healing rate of 74.3% (113 patients) observed within average of 27.2 months. The Perianal Crohn's Disease Index was significantly lower 3, 6, and 12 months after application in the healed compared to failed group - 1 (0-9), 0 (0-8) and 0 (0-9) vs. 7 (1-13, 8 (0-12) and 6 (0-12), p&lt;0.005. Postoperatively, 48 patients (31.6%) were prescribed antibiotics due to inflammatory changes in perianal area. Out of 122 healed patients 31 (25.4%) received antibiotics for 17 (5-37) days, while 17 (56,6%) patients with treatment failure were treated for 16 (7-70) days.

Conclusion
This real-life study showed that Darvastrocel is highly effective in treatment of complex perianal Crohn’s disease resistant to conservative and surgical management. Moreover, for some patients (anal stricture, chronic changes in anorectum) this may be the only available therapeutic option. Intermittent antibiotic treatment did not affect long-term outcomes. We consider clinical response (crucial for the patient's quality of life) sufficient for predicting sustained long term remission.
P776 A Prospective, Multicenter, Single-arm, Observational Study to Evaluate the Safety and Effectiveness of Vedolizumab in Real-world Clinical Practice in China: Interim Analysis of Safety results
Authors: Zheng C , Chen B , Yu J , Wang X , Li L , Hu Y , Xie L , Liu M , Chen M 
Published: January 2024

Abstract

Background
Crohn's disease (CD) and ulcerative colitis (UC) are categorized as inflammatory bowel disease [IBD] usually treated by corticosteroids, immunomodulators and biologics, etc. Vedolizumab, a gut-selective α4β7 integrin antibody, has been approved in China for IBD patients who are intolerant /lost response to conventional therapies or TNF-α inhibitors. Of late, there is a paucity of data on the safety and effectiveness of vedolizumab in real-world clinical practice in China. This study evaluates the safety and effectiveness of vedolizumab in adult patients with UC or CD Here, we present the first interim analysis.

Methods
In this multicenter, single arm, prospective, observational, real-world study (NCT04872491), adults (aged &gt;18 years) with UC or CD were administered intravenous vedolizumab 300 mg at week 0, 2, 6, and thereafter every 8 weeks. Incidence of adverse events (AEs), serious AEs (SAEs), Treatment-related AEs (TRAEs) and AEs of special interest (AESIs) were the primary endpoints Patients with administration of at least 1 dose of VDZ were included and observed 18 weeks after completion of the study or early termination, up to maximum of 72 weeks. AESIs included infections, malignancies, infusion-related reactions, and hypersensitivity. The secondary endpoints included the effectiveness of vedolizumab in terms of clinical response, clinical remission and endoscopic remission assessed at week 14 and week 54 after vedolizumab initiation.

Results
A total of 307 patients (UC, n=245; CD, n=62) with a median age of 41 years (range: 18-86) were included in the interim analysis. Median duration was 883 days (UC: 1035 days; CD: 731 days) and 105 days (UC: 107 days; CD: 99 days) for IBD and vedolizumab exposure, respectively. A total of 105 (34.20%) patients (UC: 35.92%; CD: 27.42%) developed 225 AEs and the most frequent AEs were infections and infestations (16.61%) followed by gastrointestinal disorders (GID) (14.66%) and general disorders (GD) (4.56%). Colitis and pyeria were the most common GID and GD, respectively occurred in 7(2.28%) patients each (Table 1).
Forty-one TRAEs were observed and ten AEs lead to study discontinuation. Total 13 AESIs and 34 SAEs were reported and at least one AESI was reported in 10 patients. No deaths were reported during the study (Table 2).
A total of 79.19% (118/149) and 34.48% (10/29) patients with UC and CD respectively, achieved clinical response at week 14 (±4 weeks). Clinical remission and endoscopic remission was achieved by 2/2 and 1/1 patients with UC, respectively at week 54 (±4 weeks).

Conclusion
Vedolizumab demonstrated favorable safety profile and treatment effectiveness among Chinese adult patients with UC or CD in real-world clinical practice.
P778 The association of drugs and clinical relapse in patients with microscopic colitis. A retrospective observational study
Authors: Karling P , Bjurström O 
Published: January 2024

Abstract

Background
Smoking, the use of non-steroidal anti-inflammatory drugs (NSAID) acetylsalicylic acid (ASA), proton pump inhibitors, serotonin reuptake inhibitors (SSRI) and statins has been associated with microscopic colitis (MC). We aimed to study if these factors were associated with a higher risk of clinical relapse in patients diagnosed with MC.

Methods
All patients with a histological verified diagnosis of MC at our clinic between the years 2006-2022 were identified. Baseline factors and drugs prescribed before and after diagnosis were registered. Risk factors influence on the odds of having a prescription of oral budesonide and the odds of having a second course of budesonide (clinical relapse) were studied retrospectively.

Results
Patients with MC (n=183) with a mean age of 62.3 years (SD 13.3 years) were followed for median 5 years (25th-75th percentile 4-10 years) after diagnosis. One-hundred and thirty-eight patients (75%) had at least one prescription of budesonide after diagnosis and 90 patients (49%) had at least one clinical relapse treated with budesonide. The time to clinical relpase in patients with at least one course of budesonide are shown in Figure below. Patients who had been prescribed NSAIDs within one year before clinical relapse had higher odds for clinical relapse (OR 2.88, 95% CI 1.11-7.43) but there was no increased risk for clinical relapse for the use of ASA (OR 0.99, 95% CI 0.43-2.33), PPIs (OR 1.06, 95% CI 0.53-2.14), SSRI (OR 1.29, 0.59-2.80) or statins (OR 0.93, 95% CI 0.46-1.89). No association was seen for being a smoker and/or being prescribed NSAID, ASA, PPI, SSRI and statins at baseline and the odds of having a prescription of oral budesonide within one year after diagnosis.

Conclusion
The risk of a clinical relapse are associated with the use of NSAIDs but not with the use of ASA, PPIs, SSRIs and statins. We suggest that patients with MC use NSAID with caution.
P780 Persistence of Health-related Quality of life decline in IBD patients after the COVID-19 outbreak
Authors: Herrera De Guise C M , Mayorga Ayala L F , Serra Ruiz X , Robles Alonso V , Céspedes Martínez E , Casellas F , Pérez Martínez Z , Oller Jimenez E , Borruel Sainz N 
Published: January 2024

Abstract

Background
Inflammatory bowel disease (IBD) affects many aspects of a patient’s life and impairs their health-related quality of life (HRQoL). We previously showed that there was a negative impact of the COVID-19 outbreak on the HRQoL of IBD patients in remission. This study aimed to assess if IBD patients in stable, clinical remission could recover their pre-outbreak HRQoL once the global emergency for COVID-19 ended. We also compared their self-perceived stress scores during and after the outbreak.

Methods
We carried out a prospective, observational study on IBD patients with biological treatment and stable clinical remission who had participated in the previous study. Patients filled in the IBDQ9 and the Perceived Stress Scale (PSS) electronically. The results of the IBDQ9 pre-, during, and post-COVID-19 outbreak were compared to determine any changes. PSS scores during and after the outbreak were also compared.

Results
Ninety-three patients in clinical remission were included, with a median age of 43 years; 40% were female, and 78% had Crohn’s disease. Median pre-COVID-19 IBDQ9 was 54 (50-59) and decreased to 50 (46-58) during the outbreak, and post-outbreak was 49 (44-56) (p&lt;0.01). PSS score improved after the outbreak, with a median value of 10 (8-18) during the outbreak and a score of 14 (9-19) after the pandemic. There was a significant negative correlation between the PSS (during the outbreak) and post-outbreak IBDQ9 (r=-0.76, p&lt;0.001). Regression analysis showed that the PSS score during the outbreak was independently associated with a lower post-outbreak IBDQ-9 (p&lt;0.05).

Conclusion
During the COVID-19 pandemic, there was a negative impact on the HRQoL of IBD patients in remission that persists after the outbreak, with higher self-perceived stress scores during the pandemic associated with a lower post-outbreak QoL. The results of this study underscore the long-term impact that unexpected situations can have on IBD patient's HRQoL. Unforeseen circumstances are mostly non-predictable, as the COVID-19 outbreak has shown, and measures to provide high-quality health care, including access to mental care, will hopefully be implemented for IBD patient care.
P782 Comparison of accelerated and standard infliximab induction regimens in Acute Severe Ulcerative Colitis using propensity score: A retrospective multicenter study in a Chinese cohort
Authors: Liu X , Li H , Tian F , Xie Y , Zhang X , Zhi M , Zhang M , Song X , Guo H , Li X , Liang J , Shen J , Li Y 
Published: January 2024

Abstract

Background
The optimal regimen of infliximab salvage in acute severe ulcerative colitis (ASUC) patients remains controversial. This retrospective multicenter study aimed to compare accelerated and standard infliximab induction in a Chinese cohort of ASUC patients, and to explore risk factors associated with poor prognosis.

Methods
Data were collected retrospectively from steroid-refractory ASUC patients who received infliximab induction as rescue therapy at seven tertiary centers across China. Accelerated infliximab induction was defined as receiving two doses of infliximab on or before day 13 and/or receiving intensified doses of ≥ 7.5 mg/kg. Outcomes including colectomy and clinical remission (Mayo score ≤ 2 and every subscore ≤ 1 at day 14) rates were compared using propensity score adjustment for potential confounders. The variables in propensity score model was determined by logistic regression analysis for accelerated induction.

Results
A total of 76 patients were included: 29 received standard induction and 47 received accelerated induction. The overall disease severity was significantly higher in patients of accelerated group (Table). The 30-day colectomy rates did not differ between two groups (4.3% vs. 0%, P=0.522). However, the accelerated group had a higher 90-day colectomy rate (17.8% vs. 0%, P=0.019) and lower clinical remission rate (27.7% vs. 65.5%, P=0.001). (Figure. A) After adjusting with propensity score and institution, there was no significant difference in colectomy (P=0.20) or no clinical remission (P=0.48) hazards. Dose-effect curves plotted by restricted cubic splines (adjusted for propensity score and institution) showed decreased colectomy hazard with higher cumulative infliximab dosage within 5 days, while no improvement was observed for increasing cumulative infliximab dosage within 28 days. (Figure. B) Multivariate logistic regression analyses revealed female gender (OR=7.69, 95%CI: 1.96-33.33) and C-reactive protein (CRP) &gt;10 mg/L at infliximab initiation (OR=5.00, 95%CI: 1.27-24.34) as independent risk factors for no clinical remission. (Figure. C)

Conclusion
After adjusting for confounders, there were no significant differences in colectomy or clinical remission rates between accelerated and standard infliximab induction among steroid-refractory ASUC patients. Elevated CRP at infliximab initiation indicated more intensive treatment or earlier surgery to be considered. And it would be better to give early intensified dosage within 5 days if needed.
P785 Obesity in the response to biological treatments in Inflammatory Bowel Disease patients
Authors: Cabrerizo Mengotti M , Agudo Fernández S , Castaño Milla C 
Published: January 2024

Abstract

Background
Obesity rates in patients with IBD reach up to 40%. Several authors suggest that obese patients have worse response rates to treatments. The aim of the study is to determine whether body mass index (BMI) influences the response to biological therapies in IBD. Secondly, other risk factors will be analyzed, and response rates to different biological treatments will be compared.

Methods
A retrospective cohort study of patients with IBD on biologic drugs under treatment between February 2013 and September 2022 is presented. Patients were recruited from IBD consultation of a tertiary center (Hospital Rey Juan Carlos, Madrid). Inclusion criteria included being under biologic treatment due to IBD and being näive to these therapies. The follow-up of these patients were carried out from February 2013 to September 2022.
The main objective of the study is to determine if BMI influences the response to biological treatment in patients with IBD. As secondary objectives we will try to find the existence of other risk factors for loss of response and between different treatments.
Treatment failure was defined as: need of dose increase, switch or swap to another biological treatment, clinical deterioration (measured by clinical indexes), use of systemic corticosteroid therapy, hospitalization, endoscopic inflammatory activity or surgical complications.
The percentage loss of response was estimated using Kaplan-Meier curves, and factors influencing long-term response were studied using Cox regression.

Results
A total of 135 patients were included in the study, (mean age of 46.3 years), 59.3% male, 25.9% smokers, with a mean BMI of 26.1 kg/m2 (18.5% with BMI&gt;30 kg/m2). In the study, 60% received infliximab and 45.9% received combined immunosuppressive therapy. Treatment failure was 59.1% in the non-obese and 80% in the obese (p=0.051). There were no differences in long-term response rates according to biologic treatments or disease subtypes. The only predictor factor for long-term response was combined treatment with immunosuppressants (p=0.037).

Conclusion
Obesity is not associated with a higher treatment failure rate in patients with IBD undergoing biological therapy. Combined treatment with immunosuppressants acts as a long-term response factor.
P796 Comparative Effectiveness of First-Line Infliximab and Vedolizumab in Patients with Early Ulcerative Colitis
Authors: Rozenfeld Hemed A , Cohen N A , Green O , Hirsch A , Thurm T , Ron Y , Fishman S , Leibovitzh H , Maharshak N 
Published: January 2024

Abstract

Background
Despite the increasing armamentarium of advanced therapies for the treatment of ulcerative colitis (UC), data comparing the effectiveness of biologics in early disease are scarce. We aimed to categorize selection of patients and assess the effectiveness, therapeutic persistence and safety of biologics used to treat early UC in a bio-naïve patient cohort.

Methods
This single-center, retrospective study included all bio-naïve UC patients who commenced advanced therapy within two years of diagnosis between 2012-2023. We collected demographic, clinical, and laboratory data. Clinical disease activity was assessed using the Simple Clinical Colitis Activity Index; clinical response was defined as a decrease of ≥ 3 points from baseline and clinical remission defined as an SCCAI of ≤2

Results
Out of the 1117 patients with UC who were treated at our center during the study period, 46 bio-naïve patients (mean age 36.7 years (±17)) were treated with either infliximab (IFX) or vedolizumab (VDZ), within 2 years from diagnosis. IFX was the first biologic in 19 (41%) patients and VDZ in 27 (58%) patients. At therapy initiation, 38 (82%) patients were receiving corticosteroids and 7 (15%) concomitant immunomodulators (Table 1). Patients treated with IFX had significantly lower hemoglobin (10.4 (IQR 8.5-11.3) vs 12.1 (IQR 10.8-13.9) g/dL, p=0.007) and albumin (3 (IQR 2.8-3.8) vs. 3.8 (IQR 3.4-4.2) g/dL, p=0.01) and significantly higher C-reactive protein (CRP) (48.5 (IQR 9-119) vs. 2.5 (IQR 2-3) mg/L, p&lt;0.001) compared with patients starting VDZ.
Following induction (week 14) clinical response and remission rates were similar in both treatment groups (IFX: 73% and 63%; VDZ: 74% and 67%, respectively; p=0.75). At week 52, clinical response and remission rates were similar in both treatment groups (IFX: 50% for both; VDZ: 50% for both, p=n/s). Corticosteroid (CS)-free remission rates amongst patients receiving CS at baseline (17 patients IFX and 21 patient VDZ) at week 52 were similar in both groups (IFX: 58% vs VDZ 57%, p=n/s). Treatment persistence over 2 years of follow-up was similar between IFX and VDZ (Figure 1). Safety profiles were similar in both treatment groups with no new signals noted.

Conclusion
In these real-world data in patients with early and bio-naïve UC, first line IFX was used in more severe baseline disease as highlighted by lower albumin and hemoglobin levels and higher CRP at baseline. Despite this, IFX showed equal effectiveness in induction and long-term maintenance and showed similar treatment persistence compared with VDZ.