bluuebunny/crossref_metadata_2025_split huggingface dataset:
P756 Efficacy and safety of medical therapies for maintenance of surgically induced remission in Crohn’s disease: A systematic review and network meta-analysis
Authors: Sinopoulou V , Gordon M , Vuyyuru S , Darie A M , Limdi J , Moran G 
Published: January 2024

Abstract

Background
Approximately half of patients with Crohn’s disease (CD) undergo surgical resection in first decade after diagnosis. Majority experience disease recurrence following surgery requiring further intervention. There is limited evidence on efficacy of medical therapies in this setting. We performed a network meta-analysis to evaluate comparative efficacies of medical therapies for the prevention of clinical and endoscopic relapse after surgical resection.

Methods
We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials between inception and October 2023 for randomised controlled trials (RCTs). Outcomes assessed were clinical relapse, endoscopic relapse, and safety outcomes including adverse events (AE), withdrawal due to AE, and serious AE. We performed random-effects network meta- analysis using a frequentist approach, and estimated relative risk (RRs), 95% CI values and used GRADE to ascertain certainty of evidence.

Results
A total of 37 RCTs comprising 4411 patients were included. On network meta-analysis of clinical relapse outcome, there was moderate certainty of evidence favouring adalimumab (RR 0.14, 95% CI [0.03-0.7]) over placebo with number needed to treat (NNT) of 3. There was low certainty of evidence supporting 5-amainosalycilates (RR 0.81, 95% CI [0.71-0.92]; NNT of 13) and purine analogues (RR 0.82, 95% CI [0.72-0.93]; NNT of 14) but the effect size was trivial (Figure 1). Whereas for endoscopic relapse outcome, vedolizumab (RR 0.23, 95% CI [0.07-0.8]) and adalimumab (RR 0.32, 95% CI [0.17-0.62], low certainty) and infliximab (RR 0.63, 95% CI [0.48-0.82], low certainty) were the only agents superior to placebo but not purine analogues (RR 0.87, 95% CI [0.7-1.08], very low certainty), 5-ASA (RR 1.04, 95% CI [0.85-1.26], very low certainty), antibiotics (RR 1.13, 95% CI [0.83-1.53], very low certainty), probiotics (RR 1.15, 95% CI [0.94-1.39], very low certainty), vitamin-D (RR 0.9, 95% CI [0.62-1.31], very low certainty) and curcumin (RR 1.17, 95% CI [0.73-1.87], low certainty). On analysis of total adverse events outcomes, all therapies were safe.

Conclusion
On network meta-analysis, adalimumab had a large magnitude of effect size for preventing clinical and endoscopic relapse (low certainty), vedolizumab a large magnitude for preventing endoscopic relapse (low certainty) and 5-ASA a small magnitude result for preventing clinical relapse (low certainty). Overall certainty of evidence is very low to low suggesting need for further research in this field.
P761 Clinical efficacy and durability of subcutaneous infliximab in patients with moderate-to-severe inflammatory bowel disease : a real-world data from a Korean multicentre prospective cohort study
Authors: Kim K , Hong S N H , Kang S B K , Lee K M , Koo J S K , Jung Y , Lee B J L , Yoon H Y , Kim H W , Lim Y J , Lee H S , Lee Y J , Lee J , Lee C K , Moon J M , Shin S Y , Seo J , Choi C H 
Published: January 2024

Abstract

Background
Subcutaneous infliximab (IFX-SC) has shown comparable efficacy and safety with IV infliximab in ulcerative colitis (UC) or Crohn's disease (CD) since its launching in 2021. We aimed to investigate the one-year real-life efficacy and durability of IFX-SC in Korea.

Methods
From September 2021 to November 2023, patients with moderate-to-severe UC or CD, who are naive to any types of biologic agents or IFX were prospectively enrolled from 41 tertiary referral centers in Korea. After IV infliximab induction from Week (W) 0 to W2, patients received IFX-SC every 2 weeks from W6. Patients who administered IFX-SC less than W14 were excluded. Clinical remission (CREM), clinical response (CRES) at W26, W50, and one-year drug survival were assessed. In patients with CD, CREM was defined as Crohn’s disease activity index (CDAI) &lt;150 points, and CRES was defined as a reduction in CDAI ≥70 points from baseline. In patients with UC, CREM was defined as partial Mayo score(pMS) of ≤1 points with no individual subscore of &gt;1 point, and CRES was defined as a reduction from baseline in pMS of ≥2 points and ≥30% along with either a reduction in rectal bleeding subscore (RBS) of ≥1 point or an absolute RBS of ≤1 point19. Drug survival was evaluated based on the time of drug persistence from W0 to the last date of IFX-SC administration among drug-off cases.

Results
A total of 192 patients (UC with 53, and CD with 139) were enrolled, consisting of about 80% of biologic naïve cohort. Enrolled patients included young adults with a male predominance (Table 1). At W26, patients with UC showed 54.5% CREM and 88.6% CRES (Figure 1A). Among patients with CD, rates of CREM and CRES were 92.1% and 97.0%, respectively. Similarly, W50 CREM and CRES were also favorable with a rate of 57.1% and 89.3% among UC patients. In addition, among CD patients, favorable outcome was more obvious, showing 84.6% and 93.8% of CREM and CRES. Meanwhile, one-year drug survival was also investigated. As shown on the Figure 1B, one-year drug survival probability seemed favorable with a survival rate over 97% in both UC and CD patients (UC; 98.1% at W26 with 95% confidence interval [CI], 0.874–0.852, 96.1% at W50, 95% CI, 0.852–0.990, and CD; 97.8% at W26 with 95% CI, 0.933–0.993, 97.8% at W50 with 95% CI, 0.933–0.993). During the study, 3.1% (six patients) of serious adverse events were reported.

Conclusion
IFX-SC seems to be efficacious therapeutic option for patients with moderate-to-severe UC or CD patients in real-world settings. With a favorable drug survival and tolerable safety profile, it may facilitate individualized treatment with a good compliance.
P773 Clinical decision support tool for vedolizumab is useful in predicting endoscopic remission in Crohn's disease – a retrospective real-life single-centre cohort study
Authors: Maček P , Molinari N , Ocepek A 
Published: January 2024

Abstract

Background
Early control of inflammation could modify the disease course and improve outcomes in patients with Crohn's disease (CD). Positioning of advanced therapies is becoming more important as treatment options expand. Dulai et al. derived and externally validated a clinical decision support tool (CDST) for predicting response to vedolizumab (VDZ). They noticed that the high probability group, according to CDST, has the highest probability of achieving clinical remission (CR), corticosteroid-free remission (CSFR) and mucosal healing. In contrast, low and intermediate-probability groups are more likely to need surgery.

Methods
We performed a retrospective single-centre cohort study based on the UR-CARE registry. Data for 57 CD patients treated with VDZ from July 2016 until April 2023 were analysed. We stratified patients according to CDST for CD into three response probability groups: group 0 with low (≤13 points), group 1 with intermediate (14-19 points) and group 2 with high (&gt;19 points) probability of response to VDZ. CDST was calculated using five variables: no prior bowel surgery, no prior tumour necrosis factor (TNF) alpha antagonist exposure, no prior fistulising disease, baseline albumin and baseline C-reactive protein (CRP). For analysis of the association between CDST, CR (defined as PRO2 ≤1 with rectal bleeding score 0), CSFR and endoscopic activity (defined as no change in endoscopic activity, endoscopic improvement (EI), or endoscopic remission (ER)) chi2 test was used.

Results
In our cohort, 38.6% of CD patients were male, the median age was 34 years at the time of diagnosis, and the median duration of disease until VDZ treatment was 4.1 years. Fistulising disease was present in 33.3%, 24.6% had upper gastrointestinal involvement, 56.1% had prior surgery, and 57.9% had prior anti-TNF exposure. The average follow-up duration was 27.0 (standard deviation = 19.2 months). We found a significant association between the CDST group and endoscopic activity at follow-up endoscopy but no statistically significant association between the CDST group and CR nor CSFR at weeks 14 and 52. The majority (69.2%) of patients stratified into CDST group 0 had endoscopically active disease, while in contrast, 68.8% of patients in CDST group 2 achieved ER. In group 1, EI was found in 45.8% and ER in 41.7% of patients.

Conclusion
In our retrospective study, CDST for VDZ predicted ER and EI in our cohort of patients with CD. We could not confirm the association between CDST and CR or CSFR, probably due to the definition used in a retrospective design, namely PRO2, which does not correlate well with endoscopic activity in CD.
P777 Is the long-term Budesonide use have any influence on Bone Mineral Density in Inflammatory Bowel Diseases?
Authors: Eskazan T , Durcan E , Bakkaloglu O K , Kurt E A , Onal U , Hatemi İ , Erzin Y Z , Celik A F 
Published: January 2024

Abstract

Background
Systemic steroid use, and IBD itself, both have negative effect on bone mineral density. Budesonide is a synthetic steroid with high topical glucocorticoid activity and low systemic bioavailability. When compared to systemic steroids, the frequency of side effects of budesonide appears to be quite low, however, there is no documented report about the long term budesonide use on BMD in IBD patients. We also do not know other potential side effects of long term budesonide use. In this study, we aimed to evaluate the long term budesonide use on BMD and its’ other potential side effects, in IBD patients.

Methods
We retrospectively reviewed the files of the patients who had been using budesonide for ≥24 months and had DEXA measurements during the follow-up period (Budesonide group). Patients in the budesonide group were matched 1:1 with patients without a history of budesonide use, in relation to pre or post registry number of each index case under budesonide. Matching between groups has been done, in terms of gender, age, type of IBD, history of resection, concomitant medications, and comorbidities. For the exact matching, move on for the next or further next available patient, pre or post of each index case, was taken as a choice. (Control group). At the initiation and completion of budesonide treatment, DEXA scans were taken, and biochemical parameters and bone fractures were recorded. We also recorded other causes of secondary osteoporosis in patients (such as comorbidities, medications, alcohol, and cigarette use), as well as cumulative steroid doses and durations in those using conventional corticosteroids.

Results
A total of 104 patients were included in the study, with 52 in the budesonide group and 52 in the control group. The mean duration of budesonide use was 46.13 ± 15.4 months (range: 25-94 months), and the mean cumulative budesonide usage dose was found to be 34.9 ± 11.8 g (range: 14-64.8 g) in the budesonide group. Table 1a presents the comparison of the two groups. None of the patients in the budesonide group showed deterioration in BMD during the follow-up (Table 1b and 1c). No other prominent long term side effects, valued for the file recording, was found.

Conclusion
Budesonide treatment seems to be safe in consideration for maintaining long term remission in IBD. Relatively low number of patients, not considering the first two year’s follow up and dropping of the cases with earlier side effects, missed for the long-term judgement under budesonide, may explain the lacking of the other potential side effects (indicated in the literature).
P784 Efficacy of ustekinumab in biologically naïve patients with Inflammatory Bowel Disease
Authors: Šubic Ž , Novak G 
Published: January 2024

Abstract

Background
In recent years, there are several new treatment options for inflammatory bowel disease (IBD). Tumour necrosis factor α inhibitors have been joined by novel advanced therapies (vedolizumab, ustekinumab (UST) and Janus kinase inhibitors). These drugs are mostly used as second-line treatments after tumor necrosis factor α inhibitors, with subsequent poorer efficacy. There are few data available on the efficacy of first-line treatment with UST. The aim of our study was to assess efficacy of UST in biologically naïve patients with IBD.

Methods
All patients older than 18 years who had a confirmed diagnosis of IBD, treated in a tertiary IBD centre (University Medical Centre Ljubljana, Slovenia), who started first-line treatment with UST, were included in this retrospective cross-sectional cohort study. Demographics, clinical characteristics of patients, treatment persistence of UST, clinical disease activity scores, C-reactive protein (CRP), faecal calprotectin (FC), UST concentrations, and endoscopic scores were collected retrospectively in medical files. We determined a Kaplan-Meier curve of treatment persistence.

Results
We included 71 patients, 11 of which had ulcerative colitis and 60 had Crohn’s disease. Persistence of treatment with UST in biologically naïve patients is 88% at one year (Figure 1). Clinical remission was achieved in 57.7% of patients. Biochemical remission was achieved in 77.6% (CRP&lt;5mg/ml) and 71.1% (FC&lt;100mg/kg) of patients. Endoscopic remission (Mayo endoscopic score &lt;2 in ulcerative colitis or absence of ulcers in Crohn’s disease) was achieved in 50.0% of patients. There was no significant difference (P&gt;0.05) between the median serum concentrations of UST in the group of patients who achieved remission (clinical (5.86μg/ml), biochemical (5.93μg/ml based on CRP, 5.63μg/ml based on FC) and endoscopic (7.14μg/ml)) and who did not achieve remission (5.31μg/ml, 3.25μg/ml, 4.47μg/ml and 4.64μg/ml, respectively).

Conclusion
Treatment of UST in biologically naïve IBD patients shows high treatment persistence with high biochemical and endoscopic remission rates. It appears that UST is more efficacious if used as first-line therapy compared to the use after other advanced therapies. Further prospective data are needed to confirm our findings.
P791 Trends in gender representation in inflammatory bowel disease randomized trials from 1955-2023
Authors: Gros B , Bassi M , Sleiman J , Charabaty A 
Published: January 2024

Abstract

Background
Historically women have been underrepresented in the field of gastroenterology and continue to be under-represented in academic scholarship and leadership despite the rising number of female medical graduates in recent years.This study aims to characterize the representation of women in authorship of published clinical trials in inflammatory bowel diseases (IBD) and the trend in gender representation since 1955.

Methods
IBD randomized trials published between 1955 to 2023 were included. Author gender, trial specifics (phase, intervention, population) source of funding were examined.

Results
We included 241 trials with a total of 3,264 authors: 2,418 were men (74.1%), 834 women (25.6%) and 12 (0.4%) had unknown gender. Women authorship representation increased from 0% in 1971 up to 30% in 2023 (0.41% annual increase) Figure 1A. Women were first, second, corresponding and last authors in 36/241 (14.2%), 41/241 (15.3%), 27/241 (10.5%) and 30/241 (11.7%) of published trials, respectively, Figure 1. Statistical differences in authorship by gender were found in all study categories, with women being less represented than men in unicenter vs multicenter trials, adult vs pediatric population trials, different trial phases, type of intervention [standard, advance or other] and source of funding (p&lt;0.0001 for all comparisons) Table 1.
From 2000 to 2023, industry-sponsored studies (n=119) included 1,680 authors, with 1,295 (77.1%) men and 379 (22.9%) women. Among these authors, 576 had industry affiliation, and 318 (55.2%) were men and 258 (44.8%) women. Women were first, second, corresponding and last authors in 15/119 (12.6%), 12/119 (10.1%), 11/119 (11.2), 10/119 (8.4%) of these studies.
Linear regression analysis revealed an upward trend since 1995 in the total number of authors listed per published trial, but with men consistently outnumbering women authors, the ratio of women to men authors per publication remains low over the years (p&lt;0.0001) Figure 1B.

Conclusion
Our findings underscore persistent gender disparities in published IBD trials authorship. Despite an increase in representation over time, women still make up less than 35% of authors and less than 15% of lead authors with little if any improvement over recent years (Figure 1C, 1D). Recognizing that lead authorship in trials has an impact on research funding and academic promotion, this gender disparity in authorship contributes to the many barriers women face in advancing their career in the field of IBD.
P795 Efficacy and safety of etrasimod as a first-line advanced treatment following 5-aminosalicylic acid and/or thiopurines: Data from the ELEVATE UC 52 and ELEVATE UC 12 phase 3 clinical trials
Authors: Sonnenberg E , Lees C W , Baert F , Piperni C , Wu J , Bhattacharjee A , Wosik K , Marshall J K 
Published: January 2024

Abstract

Background
Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). We present data from the ELEVATE UC 52 and ELEVATE UC 12 phase 3 clinical trials1 assessing etrasimod efficacy and safety in patients (pts) who were biologic/Janus kinase inhibitor (JAKi)-naïve and previously took 5-aminosalicylic acid (5-ASA) and/or thiopurines.

Methods
In ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 (NCT03996369), eligible pts were randomised 2:1 to etrasimod 2 mg once daily or placebo (PBO). Pts in this post hoc analysis were naïve to prior biologic and/or JAKi treatments, and included regardless of prior/concomitant corticosteroids (CS). Pts in Cohort A were previously exposed to or currently taking 5-ASA, but naïve to prior thiopurines; pts in Cohort B were previously exposed to a thiopurine with/without prior/concomitant 5-ASA. Efficacy endpoints included clinical remission and endoscopic improvement (Weeks [Wks] 12 and 52), CS-free remission and sustained clinical remission (Wk 52) and symptomatic response (Wks 2, 4, 8 and 12). Data up to Wk 12 were pooled from both trials; Wk 52 data were from ELEVATE UC 52. Safety was assessed up to 52 wks.

Results
In Cohort A, 135 and 62 pts were randomised to etrasimod and PBO, respectively; more pts in the etrasimod vs PBO arm achieved clinical remission (Wks 12 and 52), endoscopic improvement (Wks 12 and 52), CS-free remission (Wk 52) and sustained clinical remission (Wk 52; all p&lt;0.05; Figure 1A). In Cohort B, 69 and 35 pts were randomised to etrasimod and PBO, respectively; significantly more pts in the etrasimod vs PBO arm achieved clinical remission and endoscopic improvement (Wk 12) and sustained remission (Wk 52; all p&lt;0.05; Figure 1B). In both cohorts, numerical differences in the etrasimod vs PBO arm in pts achieving symptomatic response were seen starting at Week 2. In both cohorts, safety findings were consistent with the overall population, with no increases in incidence rates of serious AEs or serious infections in the etrasimod vs PBO arm.

Conclusion
This post hoc analysis further characterises the efficacy and safety of etrasimod as a first-line advanced treatment after conventional 5-ASA and/or thiopurine therapy, and is consistent with previous results in the cohort of pts naïve to biologic/JAKi which showed greater treatment effects than in pts experienced with advanced treatments.2 Limitations included post hoc analysis and small cohort sample sizes.
References
1. Sandborn WJ et al. Lancet 2023; 401: 1159–1171.
2. Feagan B et al. United European Gastroenterol J 2022; 10: 388–389.
P802 Impact of early use of immunomodulator on the outcomes of Crohn's disease: A Systematic Review and Meta-Analysis
Authors: Yoo J H , Yoon J , Jun Y K , Lee H S , Park J J 
Published: January 2024

Abstract

Background
Although immunomodulators play a crucial role in the treatment of Crohn's disease, robust evidence regarding the impact of early use of immunomodulators on its outcomes is still limited.

Methods
We searched MEDLINE, EMBASE, and the COCHRANE library to identify articles analyzing clinical outcomes according to the timing of immunomodulator administration in Crohn's disease. A meta-analysis was performed using a random-effects model to pool estimates and report hazard ratios [HRs]. Types of immunomodulators include thiopurines or methotrexate.

Results
A total of 7 studies were identified as eligible for the meta-analysis. Early immunomodulator administration within 1 to 3 years after diagnosis was associated with a lower risk of bowel resection surgery (HRs 0.57, 95% confidence interval [CI] 0.45-0.71), but it was not associated with a lower risk of perianal surgery (HRs 0.62, 95% CI 0.27 - 1.39). In subgroup analyses, early immunomodulators were effective in lowering the risk of intestinal resection in both adults and the young population.

Conclusion
Early administration of immunomodulators in Crohn's patients is associated with a lower risk of bowel resection surgery. This finding suggests that when immunomodulators are administered within an optimal therapeutic window, they possess the potential to alter the disease course in Crohn's patients.