bluuebunny/crossref_metadata_2025_split huggingface dataset:
P808 Use of intestinal ultrasound influences the proportion of suboptimally controlled patients: IBD Podcast Study results
Authors: Dignass A , D'Amico F , Gomollón F , Bamias G , Heatta-Speicher T , Michelena N , Leitner C , Hammer L , Magro F 
Published: January 2024

Abstract

Background
The IBD-PODCAST study estimates the proportion of patients with Crohn’s disease (CD) and ulcerative colitis (UC) with suboptimal disease control (DC) in a real-world setting. Intestinal ultrasound (IUS) is recommended in international guidelines as a non-invasive tool to assess disease activity and to guide therapeutic decisions in IBD. It is easy to use, inexpensive, can be repeatedly used without limitations and provides an opportunity for immediate patient interaction. The aim of this descriptive analysis was to assess the impact of IUS on the proportion of suboptimal DC in this cohort.

Methods
IBD PODCAST was a non-interventional, cross-sectional, multi-center study conducted across 103 sites in 10 countries. Criteria for suboptimal DC were based on STRIDE-II. Retrospective data on the frequency of imaging (i.e. endoscopies, MRI/MRE/CT and IUS) in the 12 months prior to assessment were collected. We compared clinical decision making, subjective evaluation of DC by patients and physicians and objective criteria of suboptimal DC at the time of assessment (i.e. index) in patients with (i.e. CD+IUS12, UC+IUS12) and without IUS (CD-IUS, UC-IUS) in the past 12 months.

Results
2185 patients (CD: n=1108, UC n=1077) with a mean age (SD) of 44.0 (14.8) years and mean disease duration (SD) of 12.4 (9.2) years were included (52.2% male). Imaging was performed in 43.1% (n=477) of CD and 44.6% (n=480) of UC patients within 12 months prior to index. Endoscopy accounted for 77.6% and 88.8%, MRI/MRE/CT for 21.0% and 6.7%, and IUS for 19% (n=89/477) and 16% (n=77/480) of patients with CD and UC, respectively.
The proportion of patients with signs of active inflammation at index was higher in patients where IUS was used (CD+IUS12: 34% vs CD-IUS: 9.5%; UC+IUS12: 22.6% vs UC-IUS: 15.3%; Table 1).
For UC only, numerically more patients with parameters indicating clinically active disease at index were further monitored or had their treatment adjusted, when IUS was used within the past 12 months. (UC+IUS12: 58.6% vs UC-IUS: 50.7%).
Despite the high number of patients with suboptimal DC based on objective criteria, the use of IUS minorly improved the alignment of subjective evaluation of suboptimal DC between the patient and physician, and only in UC (UC+IUS12: 37.5% vs UC-IUS: 32.7%; Fig 1).

Conclusion
Only a minority of patients underwent IUS in this cohort. Yet, this non-invasive tool may be useful if used more frequently. Consistent with others, IUS could aid in holistic disease monitoring for the detection of suboptimal treatment response, clinical decision making and the opportunity for alignment with patients on treatment targets.
P820 Targeting MM-SES-CD &lt; 22.5 for endoscopic improvement is feasible in a clinical trial of Crohn’s disease: A post-hoc analysis of SEAVUE
Authors: Narula N , Wong E C , Dulai P S , Marshall J K , Jairath V , Ungaro R C , Colombel J F , Reinisch W 
Published: January 2024

Abstract

Background
It has been demonstrated that a Modified Multiplier of the SES-CD (MM-SES-CD) &lt; 22.5 is the optimal endoscopic threshold that is associated with a low risk of disease progression using data from the CALM long-term extension study. To determine whether or not this threshold would be a pragmatic target within the setting of a clinical trial, we performed a feasibility analysis using data from the phase 3 SEAVUE clinical trial.

Methods
We considered data from 373 patients from the SEAVUE clinical trial who had available endoscopic data at baseline and were treated with ustekinumab (n=187) or adalimumab (n=186). As participants were only required to have a single ulcer at the time of enrollment in SEAVUE, we further restricted the population to those with MM-SES-CD &gt; 22.5. The primary outcome was MM-SES-CD &lt; 22.5 at week 52. Secondary outcomes were common targets for endoscopic healing in clinical trials, including SES-CD reduction of ≥ 50%, SES-CD &lt; 4, and SES-CD &lt; 3. Clinical remission, defined as CDAI &lt; 150, was also assessed at week 52. Sensitivity analyses were planned to restrict the population to those with moderate to severely active disease activity, defined as MM-SES-CD ≥ 31.

Results
Of the 373 participants, 55.2% (206/373) participants achieved a MM-SES-CD &lt; 22.5. A total of 206 participants had a MM-SES-CD &gt; 22.5 at baseline, of which 91 (44.2%) attained a MM-SES-CD &lt; 22.5 at week 52. A greater proportion of participants achieved this outcome compared to SES-CD reduction of ≥ 50% (85/206, 41.3%), SES-CD &lt; 4 (52/206, 25.2%), and SES-CD &lt; 3 (36/206, 17.5%) at week 52 (Table 1). A total of 144 participants had moderate to severely active endoscopic disease at baseline (MM-SES-CD ≥ 31), of which 55 (38.2%) achieved a MM-SES-CD &lt; 22.5 at week 52. This was similar to the number of patients who achieved SES-CD reduction of ≥ 50% (61/144, 42.4%), and greater than the number of patients who achieved SES-CD &lt; 4 (34/144, 23.6%) or SES-CD &lt; 3 (21/144, 14.6%) at week 52. Of the 144 participants with a MM-SES-CD ≥ 31 at baseline, a total of 71 received adalimumab and 73 received ustekinumab. Compared to adalimumab, a numerically greater proportion of those treated with ustekinumab achieved MM-SES-CD &lt; 22.5 [33/71 (45.2%) vs. 22/71 (31%), p=0.079] and clinical remission [48/73 (65.8%) vs. 36/71 (50.7%), p=0.067] at week 52.

Conclusion
Based on this feasibility analysis, a MM-SES-CD &lt; 22.5 is a feasible target to attain in clinical trials of Crohn’s disease. Further, use of the MM-SES-CD for measurement of endoscopic burden could lead to different conclusions being obtained from clinical trials of CD that are clinically and prognostically more relevant.
P855 Have biological agents changed the need for abdominal surgery in inflammatory bowel disease over time?
Authors: Suria C , Bosca-Watts M M , García-Trueba A , Tosca J , Antón C , Sanahuja A , Merino V , Abril C , Ballester M P , Romero E , Marti D , Galvez C , Ponce M , Pascual I ,   IBD Unit
Published: January 2024

Abstract

Background
Inflammatory bowel disease (IBD) is a chronic relapsing-remitting inflammatory intestinal disorder with two main categories: Crohn’s disease (CD) and ulcerative colitis (UC). CD patients can develop strictures and penetrating complications over time, that can lead to an increased number of bowel resections which, if extensive, can end up as short bowel syndromes. Aggresive UC is related to an increased colectomy rate. Controlling flares in CD and achieving mucosal healing in UC may decrease the need for abdominal surgery. Irruption of biological agents at the begining of the twenty-first century could be related to the fulfillment of both objectives decreasing number of surgeries. Our aim was to analyze the impact of biological treatment in abdominal surgery among patients with CD and UC.

Methods
We conducted a retrospective two cohort study of patients with IBD and abdominal surgery, using our prospectively collected ENEIDA data base. Patients were included in two periods of time, before and after biological irruption. The first cohort included all the patients operated between 1993 and 1998 (before biologics) and the second one between 2013 and 2018. We analyzed differences in the number of surgeries per patient and time between IBD diagnosis and first surgery, among other variables.

Results
We included 55 patients (89.1% CD and 10.9% UC) in the first cohort and 69 patients (82.6% CD and 17.4% UC) in the second one. 44 patients in the second cohort (63.8%) received biological agents before first surgery. There were no significant differences in the number of surgeries (two or more) per patient in both periods of time (10.9% vs 7.3%, p 0.69). The main indication of surgery was strictures (44.6% vs 46.6%) followed by penetrating complications (25.0% vs 30.1%) and medical refractoriness (21.4% vs 15.1%). No differences were observed in the reason to indicate surgery (p 0.78). The main surgical procedure was ileocecal resection (60.0% vs 54.1%), followed by small bowel resection (11.7% vs 17.6%) and proctocolectomy (10.0% vs 5.4%), without significant differences over time (p 0.67). There were 7 immediate post-surgical complications in both cohorts (11.3% vs 9.5%) without significant differences between them (p 0.94). The median time between IBD diagnosis and first surgery was greater among patients in the second cohort who had received any biological agent (19.0 vs 71.2 months, p&lt;0.05), [image 1].

Conclusion
Biological treatment considerably increases the time between IBD diagnosis and the first surgery. Future research will allow us to determine if this is associated to less surgeries in each patient and a reduction in long-term post-surgery complications (short-bowel syndrome, abdominal adhesions, eventrations, etc).
P892 Do anti TNF alpha drugs reduce cardiovascular risk in Crohn's disease ?
Authors: Fissah M , Rechach A , Charifi M , Menzou F , Djouhri M , Taharboucht S , Karch A , Talbi L , Touati N , Chibane A 
Published: January 2024

Abstract

Background
We now know that Crohn's disease (CD) is characterised by a higher cardiovascular risk, despite the low frequency of traditional risk factors. Arterial stiffness (AS) and its relationship with chronic inflammation seem to explain this paradox. Given that inflammation plays an important role in AS, reducing it should make it possible to reduce this stiffness. This led us to evaluate the effect of anti TNF alpha on AS

Methods
This was a prospective observational study involving 118 patients with CD, 63 of whom were taking anti TNF alpha (Adalimumab, Infliximab). AS was assessed by pulse wave measurement (aPWV) using a validated Sphingmocor Syndney device at the time of recruitment and during patient follow-up. Statistical analysis was performed using SPSS statistical software and Student's t-test for paired samples.

Results
The mean age was 37 years [19-67], sex ratio = 1.5, 22.2% were active smokers, 62.9% of patients were in a flare and 43.3% had had at least two relapses in the year prior to recruitment, median duration of disease was 30 months. The mean duration of follow-up was 9 months [6-24]. The reduction in aPWV was highly significant for patients on anti-TNF alpha therapy, whether with flexible or rigid arteries: the mean aPWV was 7.67+/-1.4 vs 7.08+/-1.07 for patients on anti-TNF alpha therapy, with a p=2*10-5. The aPWV was 8.49+/-1.07 vs 7.42+/- 0.44 for patients with rigid arteries with a p= 3*10-4.

Conclusion
Treatment with Anti TNF alpha appears to slow down aPWV in Crohn's disease, and may therefore be a good way of reducing the cardiovascular risk and the risk of developing cardiovascular disease in Crohn's disease.
P895 Analysis of the efficacy of intravenous ustekinumab maintenance treatment in patients with refractory Inflammatory Bowel Disease
Authors: López-Sáez B , Brunet-Mas E , Melcarne L , Puy A , Lario S , Ramirez-Lázaro M J , Llovet L P , Garcia-Sagué B , Frisancho L E , Altadill A , Villoria A , Calvet X 
Published: January 2024

Abstract

Background
Ustekinumab (UST) is a monoclonal antibody that inhibits the p40 subunit of IL-12 and IL-23, approved for the treatment of Crohn's Disease (CD) and Ulcerative Colitis (UC). Its administration is intravenous during induction and subcutaneous during maintenance. Several studies have assessed the efficacy of reinduction and intensification of this treatment in patients with loss of response. However, there are few studies evaluating the effectiveness of intravenous UST for maintenance.
The aim of the study is to evaluate the efficacy and safety of maintenance with intravenous UST in patients with Inflammatory Bowel Disease (IBD).

Methods
Observational, retrospective, and single-center study. All patients receiving maintenance with intravenous UST until June 2023 were reviewed. Clinical response was evaluated with Harvey-Bradshow Index for CD and partial Mayo for UC. Biochemical response was evaluated with calprotectin and C-reactive protein.

Results
A total of 29 patients with IBD (24 CD and 5 UC) were included. The mean follow-up of patients was 449 days (74-948). The cohort's characteristics are summarized in Table 1.
In all cases, intravenous maintenance was performed with UST 130mg/4 weeks. In 4 cases (13.8%), maintenance was initiated directly with intravenous UST. In 9 (31%) patients due to primary failure to UST and in 16 (55.2%) patients due to secondary failure.
The clinical response to intravenous UST maintenance in patients with CD at week 8 and 16 and at one year of follow-up was 87.5% (n=21/24), 83.3% (n=20/24), 73.3% (n=11/15) respectively. For UC, the response was 60% (n=3/5) at week 8 and 16 and at one year. The drug survival was 723 days (± 74) (Figure 1). No predictive variable for treatment response was identified. Two patients (both with CD) experienced recurrent respiratory infections as an adverse effect, without the need to discontinue UST.

Conclusion
Maintenance treatment with intravenous UST can be useful and safe in patients with severe IBD and/or failure of subcutaneous UST maintenance.
P898 Hesitancy on COVID-19 Vaccination Among Patients with Inflammatory Bowel Disease in South Korea: A Multicenter Survey
Authors: Kang S B , Moon H S , Jung Y , Kim D S , Koo H S , Huh K C 
Published: January 2024

Abstract

Background
Despite many clinicians recommending COVID-19 vaccination to patients with inflammatory bowel disease (IBD) due to high susceptibility, COVID-19 vaccine hesitancy was a worldwide phenomenon. Although previous studies to identify the cause of this vaccine hesitancy are being published, few studies have been done on COVID-19 vaccine hesitancy among IBD patients in South Korea. Therefore, the aim of our study was to find out the factors that cause vaccine hesitancy in patients with IBD in South Korea.

Methods
An electronic survey was conducted on IBD patients with receiving treatment at 5 hospitals in Daejeon-Chungchung province from September 2022 to January 2023. Basal characteristics, factors for vaccine hesitancy was evaluated. Survey was designed as a voluntary and anonymous manner.

Results
A total of 272 patients participated in the survey, of which 119 patients had Crohn’s disease (CD) and 153 patients had ulcerative colitis (UC). COVID-19 vaccine hesitancy tended to decrease with age (r=-0.158, p=0.011). In IBD medication, comparing patient group using 5-aminosalisylic acid and using biologics, hesitancy was higher in the biologics group (p=0.017). Hesitancy was high in patients who preferred Moderna (p=0.049). 102 patients answered that the cause of vaccine hesitancy was concern about safety of vaccines, with the largest share.

Conclusion
The study found that the main reason of hesitancy was concerns about the safety of the vaccine. Hesitancy tended to decrease with age and was higher in patients using biologics. This study may be helpful to educate patients with more specific targets to prepare for the current COVID-19 as well as other possible future pandemics.
P901 Extended induction response over time in patients with moderately-to-severely active Ulcerative Colitis treated with mirikizumab in the LUCENT-1 and -2 trials
Authors: Rubin D T , Charabaty A , Jairath V , Walter J , McGinnis K , Moses R , Maier S , Escobar R , Baygani S , Zaremba-Pechmann L , Kobayashi T 
Published: January 2024

Abstract

Background
The safety and efficacy of mirikizumab (miri), an anti-IL-23p19 antibody, for moderately-to-severely active ulcerative colitis (UC) have been shown in Phase 3 trials (LUCENT-1 and -2; NCT03518086, NCT03524092).1 Extended induction with 3 additional intravenous (IV) doses of miri induced clinical response at Week (W)24 in more than 50% of patients who did not initially achieve clinical response to induction with miri at W12.2 Among the clinical non-responders, some had achieved partial response at W12 (Table 1). We assessed response over time in clinical non-responders at the end of induction who received extended induction with miri for an additional 12W.

Methods
In LUCENT-1, patients (N=1281) were randomly assigned 3:1 to receive miri 300mg or placebo IV at W0, W4, and W8. Patients not achieving clinical response with miri 300mg IV at W12 of LUCENT-1 (n=272) received extended induction treatment with open-label miri 300mg IV at W12, W16, and W20 (LUCENT-2). Symptomatic remission, symptomatic response, bowel urgency (BU) remission, and BU change from baseline at W16 and W20 are reported (definitions in Table 1) in addition to the previously disclosed outcomes at W24. For categorical variables, number and percentage of patients who are responders/remitters were presented. For continuous variables, mean change from baseline with standard deviation (SD) was used. Missing data were imputed as non-response.

Results
Among patients who were clinical non-responders to 12W of initial induction treatment (n=272), 53 (19.5%); 73 (26.8%); 101 (37.1%) achieved symptomatic remission and 144 (52.9%); 169 (62.1%); 197 (72.4%) patients achieved symptomatic response at W16, W20, and W24, respectively. Among miri induction non-responders with Urgency Numeric Rating Scale (NRS) score ≥3 at induction baseline (n=256), 10.9% achieved BU remission at W16, 14.8% at W20, and 19.9% at W24. There was a 1.8±2.4 (mean±SD) point reduction in Urgency NRS scores at W16, 2.1±2.5 reduction at W20, and 2.5±2.7 reduction at W24 (Table 1).

Conclusion
Among patients who were clinical non-responders to induction at W12, more than 50% achieved clinical response after 3 additional induction doses with miri. A proportion of patients benefited earlier from extended induction at W16 and W20, respectively, regarding symptomatic response and remission, and BU outcomes. The results demonstrate continued symptomatic improvement and further support the potential benefit of extended induction treatment.
References:
1. D’Haens G, et al. N Engl J Med 2023;388(26):2444-2455.
2. D’Haens G, et al. J Crohns Colitis 2023;17(Supplement_1):i682-i683.
P920 Efficacy and Drug Adherence Rates of Anti TNF Drugs in patients with Crohn's Disease: A Single Tertiary IBD Center Cohort
Authors: Eroglu Z , Yilmaz V , Guvenir T , Er R E , Toruner M 
Published: January 2024

Abstract

Background
In the last 2 decades, the introduction of biological therapies has been a significant milestone in the management of inflammatory bowel diseases. Despite the recent emergence of new biological therapies and small molecules, Anti-TNF agents still play a crucial role in treatment and still being used as first line biologic treatments rather than anti-integrins and anti-cytokines in quite a number of countries.Although many studies have been conducted previously to compare the efficacy of these drugs, there is still not a clear conclusion. In this study, we aimed to compare the persistence of infliximab (IFX) to adalimumab (ADA) in the treatment of Crohn's at a tertiary IBD center.

Methods
This was a retrospective cohort analysis of patients with Crohn's disease either received adalimumab or infliximab as a first line biologic treatment. A total of 411 patients were included to this analysis. Demographic information such as gender, age, montreal classification, smoking and prior medications were noted from patients electronic medical records. Weighted Kaplan-Meier and Cox models were used to assess the outcomes.

Results
Out of the 411 patients included in the study, 165 had used infliximab, and 246 had used adalimumab as a first-line treatment. Age and gender of the patients in both groups did not differ from each other statistically. 87% of the patients treated with adalimumab and 84% of the patients treated with infliximab were thiopurine experienced. Montreal classification differed between two groups (in IFX group, 60% of the patients had either sticturing or penetrating behaviour where as in ADA group, only 46% of the patients had either sticturing or penetrating behaviour, p&lt;0.05). In ADA group, only 48% of the patients were receiving concomitant azathioprine treatment where as in IFX group, 60% of the patients were receiving concomitant azathioprine treatment. Primary non-response rates were not different between IFX and ADA group, 4.5% vs 4.6% respectively. In addition, clinical response rates after first year were 73.8% and 72.8% respectively. Drug persistency rates of adalimumab and infliximab in moderate to severe ulcerative colitis patients were not statistically different from each other (Figure 1).

Conclusion
In conclusion, it seems that there is no difference in drug persistence rates and in efficacy rates of the medications between infiximab and adalimumab treated moderate to severe Crohn's disease patients. Although disease character and concomitant treatment presence differ between two groups, these differences did not show any significant effect.
P922 A multicenter retrospective real-world study to determine the optimal cases of vedolizumab-treated UC patients
Authors: Kobayashi T , Hisamatsu T , Ishiguro K , Hirose L , Hibi T 
Published: January 2024

Abstract

Background
Vedolizumab (VDZ) is a gut-selective monoclonal antibody approved for ulcerative colitis (UC). This real-world study aimed to evaluate the effectiveness of VDZ in the treatment of UC, with the goal of further treatment optimization.

Methods
In this multicenter, retrospective, observational chart review, 370 patients with UC who received at least one dose of VDZ in clinical practice at 16 tertiary hospitals in Japan were enrolled. Comprehensive analyses of predictors of 2- and 54-week remission, drug persistence, and the development of loss of response were performed.

Results
Lower partial Mayo scores and lower Mayo endoscopic subscores were significantly associated with 2-week remission in the multivariate analysis. More 2-week remitters achieved clinical remission at Week 52 than non-2-week remitters. Clinical remission rates were significantly higher in biologic-naïve than in biologic-non-naïve patients across Weeks 2 to 54. Higher clinical remission rates at Week 54 were significantly associated with lower baseline disease severity and no prior anti-tumor necrosis factor alpha (anti- TNFα) treatment. Among patients with prior anti-TNFα treatment, longer duration of anti-TNFα treatment was associated with higher clinical remission rates at Week 54 (28.1%, 32.7%, and 60.0% for ≤3 months, &gt;3 to &lt;12 months, and ≥12 months, respectively, p=0.001 between groups). In addition, clinical remission rate at Week 54 was higher in patients who had loss of response to anti-TNFα treatment than in those who had primary nonresponse (54.4% vs 24.6%; p=0.001). The 54-week persistence rate was 64.5%. Concomitant use of tacrolimus (OR 2.76, 95% CI 1.00, 7.62, p=0.05) and shorter disease duration (median:7.8 years), (OR 0.33, 95% CI 0.13, 0.82 for ≥7.8 years vs &lt;7.8 years p=0.017) were associated with loss of response to VDZ in the multivariate analysis, but prior use of anti- TNFα treatment was not.

Conclusion
This retrospective study confirms favorable outcomes with VDZ in patients without prior exposure to anti-TNFα treatment. However, among patients with history of anti-TNFα- exposure, better outcomes were observed among those who experienced loss of response than those with primary nonresponse, as well as those who had a longer duration of anti-TNFα treatment.