bluuebunny/crossref_metadata_2025_split huggingface dataset:
P950 Advancing Precision Nutritional Assessment in Inflammatory Bowel Disease (IBD): Adding Fecal Calprotectin in the Malnutrition Inflammation Risk Tool (MIRT) score
Authors: Dhoble P , Desai D , Abraham P , Gupta T , Dharap V , Kutar M 
Published: January 2024

Abstract

Background
Most of the nutritional assessment tools assess only nutrition. The Malnutrition Inflammation Risk Tool (MIRT) incorporates both malnutrition and inflammation (CRP).1 However, CRP is a less sensitive biomarker than fecal calprotectin for the assessment of inflammation. Adding fecal calprotectin (FC) in the MIRT score may improve the assessment of malnutrition risk. FC level cutoff of &lt; 250 mg/kg in adults correlate with endoscopic remission with good sensitivity and specificity.2 Fecal calprotectin level greater than 800 µg/g is predictive of a need for rescue therapy.3

Aim
To study if adding fecal calprotectin to CRP by improves the yield of MIRT score

Methods
This is a single center, prospective, cohort study including consecutive patients with IBD (Ulcerative colitis {UC} and Crohn’s disease {CD}). Malnutrition was defined as per European society for clinical nutrition and metabolism (ESPEN guidelines): BMI &lt;18.5 kg/m2 or unintentional weight loss &gt;10% (indefinite time). MIRT score was calculated with BMI, weight loss and CRP and MIRT-FC by adding FC to CRP with as shown in the table below:

Results
During 2019 to 2021, 200 patients included, median age 39 years (IQR 28-53) (105 UC, 93 CD and 2 IBD-U), 60 (30%) patients had malnutrition (32 UC, 26 CD and 2 IBD-U and 27 (45%) malnourished IBD patients had MIRT score &gt; 3. CRP values were normal in 30 (50%). Adding fecal calprotectin to MIRT score malnourished IBD patients, 46 (76%) malnourished IBD patients had MIRT score &gt; 3 (P=0.005). This modification (MIRT FC) increased the yield of existing MIRT score by 31%.

Conclusion
MIRT-FC score improved the yield of MIRT score. Prospective studies are required to validate this further.
References:
1. Jansen I, Prager M, Valentini L, Büning C. Inflammation-driven malnutrition: a new screening tool predicts outcome in Crohn’s disease. British Journal of Nutrition. Cambridge University Press; 2016;116(6):1061–7.
2. D'Haens G, Ferrante M, Vermeire S, et al. Fecal calprotectin is a surrogate marker for endoscopic lesions in inflammatory bowel disease. Inflamm Bowel Dis 2012; 18:2218-2224.
3. Sasidharan S, Sasson AN, Shannon KM, Ananthakrishnan AN. Fecal Calprotectin Is a Predictor of Need for Rescue Therapy in Hospitalized Severe Colitis. Inflamm Bowel Dis. 2022;28(12):1833-1837.
P964 Vedolizumab trough concentrations during subcutaneous treatment in patients with inflammatory bowel diseases
Authors: Heijnen M , Straatmijer T , Maljaars J , van Schaik F , Visschedijk M , Tack G , Jansen J , Löwenberg M , van der Meulen A , Šebek L , Vasbinder E , Duijvestein M 
Published: January 2024

Abstract

Background
An exposure-response relationship has been described for intravenous (IV) vedolizumab (VDZ), but little is known about through levels and real life outcomes of subcutaneous (SC) VDZ treatment. We aimed to study the effect of SC VDZ in a prospective real life cohort and assessed what clinical variables are associated with vedolizumab trough concentrations.

Methods
IBD patients initiating VDZ SC treatment were included in our nationwide, prospective Initiative on Crohn and Colitis (ICC) registry. Adult IBD patients were included if a known trough level during IV and SC therapy was available. Two different assays were used for trough levels measurements : i.e. an enzyme linked immunosorbent assay (ELISA) and liquid chromatography-tandem mass spectrometry (LC-MS/MS). The primary outcome measure was the mean VDZ trough concentration during maintenance treatment (after at least four SC injections). In addition, associations between VDZ serum trough concentrations and corticosteroid-free clinical remission were assessed. A Receiver Operating Characteristic (ROC) analysis was performed to determine the concentration threshold that was associated with corticosteroid free clinical remission after 4 SC VDZ injections (i.e. defined as a Harvey Bradshaw Index (HBI) score ≤ 4 for CD and a Short Clinical Colitis Activity Index (SCCAI) score ≤ 2 for UC).

Results
In total, 24 with Crohn’s disease (CD) and 32 with ulcerative colitis (UC) patients were included. Twelve patients started SC VDZ after a maximum of three VDZ infusions and 44 patients switched to VDZ SC after at least four VDZ infusions. The mean VDZ trough concentration was 34.4 µg/mL (SD 12.9) after 13 (IQR 11-20) weeks of SC treatment. The mean VDZ trough concentration increased from 20.5 µg/mL to 35.2 µg/mL (P &lt; 0.001) in patients who switched from IV to SC VDZ. Biochemical remission (defined as a C-reactive protein (CRP) ≤ 5 µg/mL with a faecal calprotectin (FC) ≤ 250 µg/g) prior to the switch, VDZ measurements using LC-MS/MS and higher VDZ levels during IV therapy were associated with higher VDZ serum levels during SC therapy. Active smoking and prior use of &gt;1 biologic and/or tofacitinib were associated with lower VDZ levels during SC therapy (table 1). A VDZ trough concentration of ≥ 34.5 µg/mL during SC maintenance therapy predicted corticosteroid free clinical remission with a sensitivity, specificity, positive predictive value and negative predictive value of 60%, 75%, 86% and 43%, respectively.

Conclusion
VDZ serum concentrations were significantly higher during SC therapy versus IV treatment. A VDZ trough concentrations ≥ 34.5 µg/mL was associated with corticosteroid free remission.
P971 The relapse rates and dynamics of disease severity of inflammatory bowel disease after forced biologic treatment discontinuation: Taiwanese multicentre retrospective study
Authors: Le P H , Chang C H , Chou J W , Hsu H , Chen C M , Tu C H 
Published: January 2024

Abstract

Background
The reimbursement regulations in 2011 for inflammatory bowel disease (IBD) in Taiwan require patients (pts) to discontinue biologic treatment after using the medication for one year and pts can be retreated after ≥ 6 months of forced discontinue. This study aimed to evaluate relapse rates, predictors of relapse and dynamics of disease severity under Taiwan reimbursement policy.

Methods
This was a multicentre retrospective study using electronic medical record (EMR) database to identify the association between clinical variables and relapse after forced discontinuation in the real-world setting. Pts aged ≥ 20 years old with at least 6 months of biologic treatment were further analyzed to identify the disease severity prior to biologic treatment (closest endpoint before receiving 1st biologic), 1st forced discontinuation, 2nd biologic and 2nd forced discontinuation. EU PAS register number: EUPAS48289.

Results
We identified 455 newly diagnosed IBD pts from February 2008 to March 2020 in Taiwan. The percentage of relapse after biologic discontinuation was 47.0% (N=353), 41.4% (N=87), and 40.0%(N=15) for 1st, 2nd and 3rd biologic treatment cycle (TxC), respectively.
Among pts in the 1st biologic ST, 353 pts were identified who received at least 6 months of biological treatment. Only 87 (24.6%) pts were able to be re-treated for the 2nd biologic TxC under reimbursement criteria after forced biologic discontinuation.
Prior to biologic treatment, the use of anti-diarrheal symptom control treatment (HR: 1.452, p = 0.0186) and IBD-related surgery (HR: 1.434, p = 0.0216) were factors associated with an increased risk of relapse on 1st biological TxC. Pts who received the 1st biologic TxC and 2nd biologic TxC with a long biologic treatment duration at the end of treatment (HR: 0.998, p &lt;0.0001); (HR: 0.998, p =0.0003) were less likely to experience relapse. Consistent results were found in the 3rd biologic TxC (HR: 0.963; p =0.0292) long biologic treatment duration was a protective factor against relapse.
The percentage of severe pts prior to biologic treatment was 43.7% and dropped to 11.4% after receiving the 1st biologic treatment. However, the percentage of severe pts increased to 32.0% at 1st forced discontinuation and further rose to 35.7% at 2nd forced discontinuation.

Conclusion
The predictors of relapse could assist physicians in clinical decision-making especially when pts faced with discontinuation. Proportion of moderate to severe disease severity decreased after receiving each TxC and due to forced discontinuation, half of the pts exhibited moderate to severe disease severity after forced discontinuation, suggesting that one year of treatment time was insufficient to reach the desired therapeutic goals.
P980 Dietary perceptions and practices in patients with Inflammatory Bowel Disease
Authors: Khemiri W , Ayari M , Ghannouchi A , Mtir M , Abdelaali Z E I , Douggui M H , Taieb J 
Published: January 2024

Abstract

Background
Patients with Inflammatory bowel disease (IBD) have a strong interest in the role that diet can play in the disease.However, studies evaluating the perception of diet in Tunisian patients are lacking.The aim of this study was to investigate the dietary beliefs and behaviours of adult patients with IBD.

Methods
We conducted a longitudinal study using a self-administered questionnaire distributed online to the «Association Tunisienne des Maladies de Crohn et de RCH» group. Through 17 items, we collected data assessing the dietary behaviours and beliefs of patients with Crohn's disease (CD) or ulcerative colitis (UC).

Results
A total of 121 patients (CD: 59%,UC 41%)were enrolled, with a mean age of 38.1±11.4 years and a sex ratio of M/F= 0.73.Twenty-three patients were active smokers. At the time of the enrollment, 26.4% of patients had an active disease. Eighty-three patients believed that diet was a trigger for the disease, with a male predominance(80% versus 60.8%, p=0.02) but no difference between the UC and CD groups was found(p=0.61). Fourty-one patients felt that diet was more important than medical treatment for disease control, with equal importance for 47 patients and no impact for 6 patients. Ninety-two patients thought that diet could induce a relapse of the disease, with 86.8% resorting to an exclusion diet, and 76% thought that a change in diet could induce remission of the disease. The most frequently avoided were spices(33.1%),and gluten(17.4%). Spicy foods were considered to be the main responsible for IBD flares by 90.1% of patients,followed by fast foods(75.9%), citrus fruits(70.4%) and legumes(64.7%). Respectively 57% and 34.7% of the patients believed that milk and dairy products could induce or worsen disease symptoms. Around half of our patients thought that pasta had no impact on the disease course, while rice was considered to be the major aliment able to prevent relapse and improve symptoms by 47.7% of patients. On the other hand, 52.2% of patients considered high fiber vegetables to be potentially responsible for relapses. Fourty-two percent of the patients believed that fruits could have a negative impact on IBD while 20.4% thought they have a positive effect. Around half the patients thought that red meats and coffee had no impact on the course of the underlying disease. Fifty-five percent of the patients believed that fasting could prevent relapses, while 53 patients felt that it had no significant effect. Half of our patients had at least once consumed nutritional supplements, with a medical prescription noted in 65.6%.

Conclusion
Our study underlines the importance of a holistic approach to the treatment of IBD, taking into account both traditional medical treatments and appropriate dietary education.
P992 Nutraceutical treatment based on a multi-compound formulation composed of Hericium erinaceus, berberine, quercetin, niacin, and biotin could improve the oral 5-ASA effectiveness in mild-to-moderate ulcerative colitis: Results from a two-arm multicentric retrospective observational study
Authors: Gravina A G , Tursi A , Pellegrino R , Brandimarte G , D'Avino A 
Published: January 2024

Abstract

Background
The use of nutraceuticals as adjunctive therapy for ulcerative colitis (UC) is increasingly emerging. HBQ-Complex® (a compound consisting of Hericium erinaceus, berberine, and quercetin), when added to biotin and niacin (a compound called Enteroflegin®), has already shown promising results in ex vivo models of UC as well as in other gastrointestinal disorders such as symptomatic uncomplicated diverticular disease. This multicentric observational retrospective study aimed to weigh the effectiveness and safety of Enteroflegin® in mild-to-moderate UC as adjunctive therapy to oral 5-aminosalicylic acid (5-ASA).

Methods
Mild-to-moderate UC patients [i.e., with a partial Mayo score (PMS) between 2 and 7] on exclusive therapy with oral 5-ASA (i.e., without taking steroids, biologics, small molecules or other prebiotics/symbiotics/antibiotics) were divided into two groups and evaluated at baseline (T0), after three months (T1) and after six months (T2). One group of patients (G1) took 5-ASA plus two Enteroflegin® tablets for six months, while the other control group underwent only 5-ASA treatment (G2). PMS, faecal calprotectin and 5-ASA dose were collected at each time. Clinical response at T1 and T2 (i.e., reduction in PMS ≥ 2 from baseline) and clinical remission at T1 and T2 (i.e., PMS &lt; 2) were the main outcomes of the study, including compound safety.

Results
One hundred thirty patients [median age 39.5 (30 - 55), BMI 24.4 (22.8 - 26.4) Kg/m2, median years since UC diagnosis 10 (3.2 - 18.4)] were retrospectively included. In the sample, 51.5% were male, 47.7% had left colitis, 55.4% had proctitis, and 5.4% had pancolitis. 96.2% were on mesalazine therapy. 40.8% of patients had a PMS consistent with moderate activity. The clinical response rate at T2 (69.4% vs 47.5%, p=0.01) and clinical remission at T1 (17.9% vs 4.2%, p=0.029) and T2 (38.9% vs 19.1%, p=0.03) were higher in G1 than in G2 group (Figure A, p &lt; 0.05). The trend in calprotectin reduction was also more favourable for G1 throughout the study (Figure B, p &lt; 0.05). A dosage of 5-ASA &gt; 3.6 g (OR 4.269, 95% CI 1.322 - 13.79; p=0.015) per day, as well as the use of Enteroflegin® (OR 3.303, 95% CI 1.232 - 8.857; p=0.018), resulted as clinical remission at T2 (i.e., six months) predictors. No adverse events were reported.

Conclusion
The nutraceutical compound Enteroflegin®, when added to standard therapy with oral 5-ASA treatment in patients with mild-to-moderate UC, increased its real-life effectiveness without safety concerns.
P998 Phase 2 basket design study evaluating the efficacy and safety of an anti-TL1A antibody (TEV-48574) in moderate to severe ulcerative colitis or Crohn's Disease (RELIEVE UCCD)
Authors: Reinisch W , Stoyanov S , Raphael G , Barkay H 
Published: January 2024

Abstract

Background
TEV-48574 is a human antibody that targets tumor necrosis factor (TNF)-like ligand 1A, also known as TNF superfamily member 15 (TNFSF15). TEV-48574 is being evaluated in the first basket design trial in IBD. The basket design is uniquely suited for the efficient assessment of TEV-48574 as evidence suggests that TL1A signaling plays a key role in both ulcerative colitis (UC) and Crohn’s disease (CD). TL1A signaling is not a primary driver but an amplifier of inflammation; thus, targeting TL1A should mitigate excessive immune responses while leaving baseline immunity intact. Originating in oncology trials, the basket trial design has emerged as a new efficient approach for testing treatment efficacy in different disease indications with potentially common molecular mechanisms. The basket design approach allows the evaluation of multiple indications in a single study design that provides adequate support for initiation of confirmatory studies. Additionally, the basket design allows for shared sites and institutional review boards, data collection and analyses under consistent conditions. Herein, we describe the phase 2b basket trial evaluating TEV-48574 in UC and CD (clinicaltrials.gov NCT05499130), currently ongoing along with a long-term extension study (LTE)(NCT05668013).

Methods
In this double-blind placebo-controlled global study, TEV-48574 or placebo is administered subcutaneously to adults (n = 240) diagnosed with moderate-to-severe IBD (UC (n = 120) or CD (n = 120)). Patients who meet pre-specified inclusion/exclusion criteria are randomized to either one of two TEV-48574 dose regimens or placebo in a 1:1:1 ratio (stratified by diagnosis (UC or CD) and previous exposure to advanced IBD therapy(biologics and small molecules)) for 14 weeks. Patients who complete the 14-week induction period have the option to enter the LTE, consisting of a 44-week maintenance period for responders and a re-induction period for non-responders. Primary efficacy endpoints are induction of clinical remission (a modified Mayo Score of ≤2 points for UC), and endoscopic response (a reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 50% from baseline) for CD, at week 14. A Bayesian approach will be used to compute posterior probabilities for the response endpoints within each indication. Additional endpoints include safety assessments, measures of clinical response, biomarkers, pharmacokinetics, and immunogenicity.

Results
Conclusion
TEV-48574 is a potential novel treatment option for patients with UC and CD that may have dual antifibrotic and anti-inflammatory effects. The phase 2 basket study design offers an efficient approach to advance TEV-45874to confirmatory phase 3 studies.
P1006 Assessing sexual health care needs in patients with inflammatory bowel disease
Authors: Beattie W , Elford A , Segal J , Kaushik V , Downie A , Mitchell J , Al-Ani A , Prentice R , Christensen B 
Published: January 2024

Abstract

Background
Optimal care of inflammatory bowel disease (IBD) should encompass both physical and mental health. Sexual health is often overlooked, despite contributing significantly to patient quality of life. This study aims to further characterise the impacts of IBD on sexual health using an IBD specific scale and assess patient interest in accessing relevant expertise.

Methods
An electronic survey was emailed to patients with IBD at a tertiary public hospital using REDCap. Assessment of disease severity was based on clinical disease indices: Harvey Bradshaw Index (HBI) for patients with Crohn’s disease (CD); and the Simple Clinical Colitis Activity Index (SCCAI) for patients with ulcerative colitis (UC). The survey also contains de-identified demographic data, basic information about the participant’s IBD and questions derived from both the validated IBD-Specific Female Sexual Dysfunction and IBD-Male Sexual Dysfunction Scales. Comparisons of patient responses from those with clinically active versus inactive disease were made using Fisher’s exact test. Analysis was exploratory and no correction for multiple comparisons was made.

Results
A total of 101 participants took the survey, including 53 females and 48 males which comprised of 38 patients with UC, 57 with CD, three with indeterminate colitis (and three unsure of diagnosis). Age ranged from 18 to 81 years old with a median of 38; 90% of patients had a disease duration of at least 2 years. Patients with CD recorded a median HBI of five (interquartile range three to nine). Patients with UC recorded a median SCCAI of two (interquartile range one to four). Patients with clinically active CD trended toward more significant sexual dysfunction than those in remission across all domains in the sexual dysfunction scale. Patients with active CD were more likely to report that their disease had prevented engagement in sexual activity in the past year (p=0.04) and more likely to be afraid to participate in sexual activity (p=0.01) compared to those in remission. Patients with active UC were more likely to report that pelvic pain affected sexual activity (p=0.03) compared to those in remission. Regarding seeking additional support, 47% of all patients expressed interest in gaining assistance though only 20% have attempted to seek this advice. 36% of participants would wish to be contacted by their treating team if a sexual health service became available at their hospital.

Conclusion
Patients with more active IBD were more likely to report that their illness negatively impacts their sexual health. 74% of participants reported interest in accessing expert advice regarding sexual health, highlighting the need for services specifically addressing sexual health for IBD patients.
P1016 Real-world data on sequential therapy in moderate-to-severe UC: Unveiling second-line strategies after anti-TNF failure
Authors: Farkas B , Borsos M , Resál T , Bacsur P , Szepes Z , Savarino E V , Bertin L , Limdi J K , Sethi-Arora K , Miheller P , Vilmos F , Castiglione F , Bonacci L , Lukas M , Maharshak N , Berman G , Krznarić Ž , Wetwittayakhlang P , Lakatos P L , Seidelin J B , Attauabi M , Michalopoulos G , Ribaldone D G , Kagramanova A , Chashkova E , Sarlós P , Saibeni S , Shitrit A B G , Molnár T , Farkas K 
Published: January 2024

Abstract

Background
The development of anti-TNFs has brought major advances in the treatment of ulcerative colitis (UC). Yet, a significant proportion of patients do not respond favorably to first-line anti-TNF therapy, which may require the use of second-, third-, or fourth-line biologics or small molecules. Treatment selection and sequencing, however, remains a major unmet need.

Methods
We conducted a multicenter, retrospective study including patients with moderate-to-severe UC who failed first-line anti-TNFs, and received sequential therapy with biologics or small-molecules. The effectiveness of sequential therapy, more specifically second-line agents was determined and compared by treatment persistence and colectomy-free survival up to 3 years post-initiation, and assessed using Kaplan-Meier analyses. Multivariate Cox regression analysis was performed to identify the predictive value of various factors for colectomy and persistence.

Results
683 UC patients were included. The median follow-up time was 62 months (IQR: 36-98), during which 14.2% of patients required colectomy. The probability of colectomy-free survival was 97.5%, 93.9% and 92.3% at 1, 2, and 3 years. Persistence rates increased significantly with the number of therapy lines (P&lt;.0001). The presence of deep ulcers at diagnosis (HR: 0.45; P=.009), prior cyclosporine use (CYA; HR: 0.41; P=.028), and low serum albumin at first-line therapy (HR: 0.92; P=.002) appeared to be predictive for colectomy. Following anti-TNF failure, significantly higher colectomy-free survival rates were observed over 3 years with ustekinumab (UST; P=.014; Figure 1a.), than with vedolizumab or tofacitinib. Second-line UST also showed superior persistence at 3, 6, 12, and 24 months (P=.049; Figure 1b.), but not at 36 months. Neither the risk of colectomy (P=.343), nor the rate of persistence with second-line therapy (P=.19) was influenced by the reason of first-line anti-TNF discontinuation. Prior CYA use (HR: 0.42; P=.047) negatively influenced persistence with second-line therapy.

Conclusion
Despite multiple lines of sequential biological and small molecule therapy we found a low incidence of colectomy and a high rate of persistence. Following anti-TNF failure, regardless of its cause, UST might be the preferred second-line agent in moderate-to-severe UC.