bluuebunny/crossref_metadata_2025_split huggingface dataset:
P735 JAK inhibitors and S1P receptor modulators for the treatment of antibiotic refractory chronic pouchitis: an ECCO CONFER Multicentre Case Series
Authors: Testa G , Ribaldone D G , Verstockt B , Molnar T , Savarino E , Schmidt C , Vieujean S , Teich N , Meianu C , Juillerat P , Grellier N , Lobaton T 
Published: January 2024

Abstract

Background
Data regarding effectiveness and safety of JAK inhibitors and S1P receptor modulators in chronic antibiotic refractory pouchitis (CARP) are lacking. This ECCO-CONFER project collected cases of CARP treated with JAK inhibitors or S1P receptor modulators.

Methods
This retrospective multicentre study collected cases across Europe through the ECCO-CONFER project, including patients with ulcerative colitis (UC) diagnosis who underwent proctocolectomy with ileal pouch anal anastomosis (IPAA), treated with JAK inhibitors or S1P receptor modulators for CARP and at least three months of follow up. Main outcomes were steroid and antibiotics-free clinical response at three months (T3) for each drug, defined as clinical part of modified Pouchitis Disease Activity Index (mPDAI) reduction by ≥1 points, steroid and antibiotics-free clinical response at 1 year (T12) assessment, defined as mPDAI reduction by ≥2 points, steroid and antibiotics-free clinical remission (mPDAI=0) at T3 and T12, endoscopic response at T12 (improvement in PDAI Endoscopic Inflammation subscore reaching &lt;3) and endoscopic remission at T12 (endoscopic PDAI ≤1). Non-response imputation was applied.

Results
Seventeen treatments with small molecules of CARP in 15 patients were collected from nine centres in seven countries. Eight patients were treated with tofacitinib; steroid and antibiotics-free clinical response at T3 was achieved in six patients (75%) and steroid and antibiotics-free clinical remission was achieved in five patients (62.5%). One patient discontinued tofacitinib for loss of response after eight months. Of the patients with at least 12 months of follow-up, steroid and antibiotics-free clinical response was achieved in 50.0% of patients, steroid and antibiotics-free clinical remission in one patient (16.7%), endoscopic response in 50.0% and endoscopic remission in 50.0%. One patient was treated with filgotinib, neither steroid and antibiotics-free clinical response nor steroid and antibiotics-free clinical remission were achieved. Six treatments with upadacitinib were collected: at T3 steroid and antibiotics-free clinical response was achieved in 33.3% and steroid and antibiotics-free clinical remission was achieved in 16.7% of cases. Two cases were treated with ozanimod. At T3 steroid and antibiotics-free clinical response was achieved in one patient (50.0%) and steroid and antibiotics-free clinical remission was not achieved. No side effects were reported. Baseline characteristics and results are summarized respectively in figure 1 and table 2.

Conclusion
In a multiple biologic-refractory population, small molecules might be a suitable treatment option for CARP. Based on current limited data, the use of JAK inhibitors should be further investigated.
P747 Assessment of a microlearning programme for patients with Inflammatory Bowel Disease (The ADEII project) on ansiety/depression status and illness perception
Authors: De Castro Parga M L , Hernández V , Sanromán L , Martínez-Cadilla J , Figueira M , Rodriguez-Prada I 
Published: January 2024

Abstract

Background
Information and communication technologies (ICTs) represent a novel approach to chronic disease management. However, their use in Inflammatory Bowel Disease (IBD) is lacking and their results as far unknown, because no specific tools are available, The prevalence of anxiety and/or depression in IBD ranges from 30-35% in clinically inactive phases. Furthermore, negative perceptions of the disease in the dimensions of consequences and emotions have been related to depression and anxiety. We aim to evaluate the outcomes of a novel microlearning programme for IBD patients in.anxiety/depression status and illness perception.

Methods
Prospective cohort study in adult patients with IBD (18 to 70 years old) who underwent a microlearning programme over a 2-month period, throught 4-minute videos organised in individualised video pathways that were sent via mobile phone using a Telegram bot. All patients received the 4-video main pack, consisting of 2 videos with information about their disease (ulcerative colitis or Crohn's disease), 1 video on adherence and another one on steroid treatment. To these were added as many videos as the number of drugs used by the patient to control IBD. Before starting the programme and at 6 months, patients completed the Hospital Anxiety and Depression Scale (HADS) and the Brief Illness Perception Questionnaire (BIPQ).

Results
Between June and October 2022, 1226 videos were sent to 200 IBD patients: 51.5% female (103), UC 52.5% (105), mean age 46.1 (13.2) years (Table 1). Median number of videos per patient was 6 (6-7). Attendance to ADEII programme ranged between 78% and 90%.The median score on the HAD anxiety subscale was 8.1 (4.3), while the median score on the HAD depression subscale was 6(4-8), Initially, anxiety was diagnosed in 60 patients (30%) and depressión in 16 (8%) as subescales scores&gt;11. We found significant differences between the pre-intervention versus post-intervention medians and IQR in anxiety score 8(5-11) vs 7(4-11) (p=0.008) but no in depression. Regarding BIPQ test post -intervention there were significant decreases in P8 negative emotions 6(3-8) vs. 5(3-7) (p=0,003) and P5 identity 6(4-8) vs 5(3-7) (p=0,003) as well as a significant increase in P7 comprehensibility of disease 7(5-9) vs. 8(7-9) (p=0,003).

Conclusion
An ICT-based educational program was widely accepted by IBD patients and showed a decrease in anxiety and negative emotions and representations, along with improvement in the understanding of disease.
P749 Comparison of bowel preparations for colonoscopy in inflammatory bowel disease- A systematic review and network meta-analysis of randomized trials
Authors: Chatterjee A , Kaur S , Jena A , Patil A , Dutta U , Sebastian S , Sharma V 
Published: January 2024

Abstract

Background
Colonoscopy is important in the management inflammatory bowel disease. Adequate bowel preparation (IBD) is a prerequisite for colonoscopy and may be difficult to achieve in setting of IBD

Methods
We performed a systematic review and network meta-analysis of randomised trials of various bowel preparations used before colonoscopy in IBD. Various electronic databases were searched to identify eligible studies. A frequentist network meta-analysis was done to compare the effectiveness of various bowel preparations. Risk of bias was assessed using Cochrane risk of bias tool 2.0. Other outcomes were assessed qualitatively.

Results
We included 7 trials including 960 patients. All bowel preparation had a similar effectiveness of bowel preparation as compared to 4 litres of polyethylene glycol (PEG) (OR when compared with PEG4L: OSS- 1.1043 95% CI 0.6553-1.8610; PEG/Ascorbate 2L- 0.9838, 0.6519-1.4848; PEG 1L -1.0011, 0.5522-1.8150; PEG2L plus bisacodyl -1.0864, 0.7130-1.6554; PEG 4L plus simethicone -1.0069, 0.6721-1.5084; PEG/SPMC 1.5L -0.9966, 0.5569-1.7835; SPMC 2L -1.0996, 0.6123-1.9745 had a similar effectiveness. Low-volume preparations had better compliance, tolerance, and acceptance, and willingness to repeat. No difference in additional outcomes like change in disease activity after colonoscopy, procedure-related outcome after colonoscopy like cecal intubation rate, and change in electrolyte levels were found.

Conclusion
Various bowel preparations had similar effectiveness in respect to colonoscopy preparation in IBD patients. Low-volume preparations have better compliance, tolerance, and acceptance. The systematic review was limited by a small number of included RCTs.
P752 Difficult-to-treat inflammatory bowel disease: effectiveness and safety of 4th and 5th lines
Authors: Caron B , Habert A , Bonsack O , Camara H , Jeanbert E , Parigi T L , Netter P , Danese S , Peyrin-Biroulet L 
Published: January 2024

Abstract

Background
Many patients with inflammatory bowel disease (IBD) have signs or symptoms of active disease despite multiple treatment attempts. This emerging concept is defined difficult-to-treat IBD. The objective of this study was to investigate for the first time treatment persistence, efficacy and safety of biologics or small molecules used in 4th or 5th line therapy.

Methods
We reviewed all consecutive patients with IBD treated at Nancy University Hospital between July 2022 and April 2023 with the 4th or 5th line treatment for at least three months. The primary outcome was to assess the persistence rate of 4th and 5th line therapy.

Results
We enrolled 82 patients with IBD (4th line: 44; 5th line: 38). On Kaplan-Meier analysis the duration of risankizumab, ustekinumab or vedolizumab therapy did not differ significantly (p&gt;0.05) as 4th and 5th line treatment. The restricted mean survival time analysis showed that persistence rate of risankizumab was the highest as 4th line therapy (risankizumab vs. vedolizumab: 36.0 and 29.4 weeks respectively, p=0.008; risankizumab vs. ustekinumab: 36.0 and 32.8 weeks respectively, p=0.035). In multivariate regression, Crohn’s disease diagnosis (Odd ratio 4.6; 95% confidence interval 1.7-12.4) was significantly associated with treatment persistence.

Conclusion
In this first real-world setting, risankizumab could have longer persistence rate as 4th line treatment for IBD than other agents. Persistence of biological agents was greater in Crohn’s disease than in ulcerative colitis. More studies are needed to compare treatment efficacy in patients with difficult-to-treat IBD.
P768 Appropriateness of small molecule agents for patients with IBD of childbearing age – a RAND appropriateness panel
Authors: Selinger C P , Laube R , Fraser A , Headley K , Kent A , Kok K , Lee V , Limdi J , Ludlow H , Rees F , Sagar N , Walker E 
Published: January 2024

Abstract

Background
Many women of childbearing age with IBD require advanced therapies. While biologics are largely low risk during pregnancy, the novel small molecules Tofacitinib, Filgotinib, Upadacitinib and Ozanimod (TFUO) have shown concerning reproductive results in animal studies. Therefore, their use in women of childbearing age needs careful consideration.

Methods
We convened a RAND appropriateness panel of 6 gastroenterologists, 2 IBD nurses, 1 IBD pharmacist and 3 expert patients. Following a literature review, 13 statements were drafted and voted upon in 2 rounds.

Results
13 statements were voted on in two rounds. All statements were deemed appropriate after one round of revisions. Here we present a selection of key statements:
1. Women with IBD of childbearing age who wish to commence therapy with TFUO, need to use effective contraception. Counselling regarding the risk of TFUO in unplanned pregnancies should be provided.
2. For women using contraception while on JAK therapy, we suggest the preferred use of progesterone-only or non-hormonal long-acting contraception over combined oestrogen-progesterone formulations to reduce the risk of venous thromboembolism.
3. TFUO are contraindicated during pregnancy due to serious teratogenicity concerns.
4. Regardless of physical wash out periods, we recommend that women currently receiving TFUO cease therapy with enough time to establish clinical remission ideally for at least 3 months prior to conception. This window allows to safely establish whether the alternative (or no) therapy can maintain remission.
5. Therapies other than TFUO should be considered as first line therapy in women with IBD of childbearing age, with the exception of select individual social or medical circumstances, or women who have completed family planning and agree to use effective contraception.
6. TFUO may be appropriate choices for women of childbearing age after failure of, intolerance of or contraindications to one biological agent licensed for IBD.
7. In women who wish to have children in the future, a minimum treatment period for TFUO should be considered. Where the wish to start a family is less than 1 year in the future it is recommended to consider agents other than TFUO.
8. TFUO are contraindicated during breastfeeding.
9. If a woman conceives while taking TFUO, the medication should be ceased, she should receive counselling about potential known and unknown maternofoetal complications, and alternative IBD therapy may be commenced if required.

Conclusion
We developed 13 practice statements derived from a RAND appropriateness panel of clinicians and patients to guide decision making for women of childbearing age regarding TFUO small molecules therapies for IBD.
P770 Proactive Infliximab monitoring improves the rates of transmural remission in Crohn’s disease – a propensity score matched analysis
Authors: Fernandes S R , Tubal Bronze S M , Saraiva S , Bernardo S , Gonçalves A , Moura Santos P , Valente A , Correia L , Cortez-Pinto H , Magro F 
Published: January 2024

Abstract

Background
Few patients can reach transmural remission in Crohn’s disease (CD) with currently available therapies. Proactive optimization of Infliximab (IFX) based on trough levels may potentially improve these results.

Methods
Retrospective cohort study including consecutive CD patients starting treatment with IFX. Rates of transmural remission were compared between patients with and without therapeutic drug monitoring (target level: 5-7 µg/mL). A propensity score matched analysis was performed to adjust for potential confounders (figure).

Results
195 CD patients were included, 57.9% receiving proactive therapeutic drug monitoring. The rates of transmural remission were higher in patients under proactive therapeutic drug monitoring (37.2% vs 18.3%, P=0.004) with similar results in the propensity score matched analysis (34.2% vs 17.1%, P=0.025). In multivariate analysis, proactive therapeutic drug monitoring was independently associated with transmural remission: OR 2.95 95%CI(1.44-6.06), P=0.003.

Conclusion
Proactive optimization of IFX based on trough levels increases the rates of transmural remission in CD.
P771 Comparing obstructive symptoms and dietary restrictions with Crohn's disease stricture severity
Authors: Saunders B , Lesack K , Rosentreter R , Macci A , Novak K , Ma C , Kaplan G , Ingram R J , Seow C , Panaccione- R , Lu C 
Published: January 2024

Abstract

Background
Stricturing Crohn’s Disease (CD) is characterized by bowel narrowing often leading to obstruction. Obstructive symptoms (OS) have been evaluated in patients with CD strictures using OS scores (STRIDENT). Clinical observations suggest that OS are generally associated with end-stage strictures requiring dietary restrictions and surgery. Evaluating the prevalence of symptoms in strictures is important as regulatory agencies require symptom response to therapies in trials. Intestinal ultrasound (IUS) accurately assesses CD strictures. IUS criteria for ileal strictures includes: 1) bowel wall thickness (BWT) &gt; 3mm, 2) luminal narrowing, and 3) pre-stenotic dilation (PSD) &gt; 2.5 cm. It remains unclear whether stricture severity is correlated with OS (nausea, vomiting, bloating, abdominal pain). We aim to assess if OS and dietary restrictions occur more often in those with more severe strictures (pre-stenotic dilation size).

Methods
In this pilot study, prospective ileal CD patients with inflammatory (non-stricture) phenotype versus definitive or probable strictures were surveyed. OS for the past 2 months were queried in patients with definitive (BWT &gt;3mm, luminal narrowing &lt; 1cm, PSD ≥ 2.5cm), and probable strictures (definitive with PSD &lt; 2.5cm) as identified on IUS. OS queried included nausea, vomiting, bloating, abdominal pain, and dietary restrictions. Chi-squared tests for categorical symptoms and one-way ANOVA (Kruskal Wallis) was used to compare symptom prevalence within the non-stricture or stricture category.

Results
39 patients were recruited with a median diagnosis age of 23.5 years (range 24-69) with 12 non-stricture phenotype (30.8%), 13 definitive (33.3%), and 14 probable stricture (35.9%). Patients with definitive strictures (35.3%) have significantly more nausea than those without strictures (11.8%) (p = 0.01), and no difference with probable strictures. Nausea with probable strictures (41.2%) was not significantly different from non-stricture patients (11.7%) (p = 0.07). In those with definitive versus non strictures, bloating (53.6 % vs 61.5 %, p = 0.69), post prandial pain (57.6 % vs 25.0 %, p = 0.14), and vomiting (10.0% vs. 20.0%, p = 0.47) were not significantly different. No difference was found in obstructive pain (F=2.27, p=0.12) among all groups. Dietary restrictions occurred in 40% (5/12) without strictures, 43.8% (7/12) with probable strictures, and 69.2% (9/13) with definitive strictures.

Conclusion
Nausea was the sole indicator distinguishing definitive from probable strictures. Pain, vomiting, and bloating did not differentiate those with severe from probable strictures, possibly due to dietary restrictions. More recruitment will refine these findings and enable comparison with specific IUS parameters.
P786 Evaluation of the efficacy and safety of the use of subcutaneous infliximab in the treatment of inflammatory bowel disease in naïve patients
Authors: Escobar J , Pérez J , Plaza R , Castillo M , Sáez O , Ponferrada Á 
Published: January 2024

Abstract

Background
The use of intravenous (IV) infliximab in inflammatory bowel disease (IBD) is an established treatment with a demonstrated safety and efficacy profile. Subcutaneous (SC) infliximab is currently available, showing comparable results in disease maintenance, but lacking studies in naïve patients. This study aims to determine whether initial treatment with SC infliximab is as effective and safe in real clinical practice.

Methods
This is a single-center observational study that included patients with clinically active IBD who directly initiated SC infliximab after IV induction (IV 5 mg/kg 0-2 weeks and SC 120 mg/2 weeks at week 6). The primary objective of the study was to evaluate the response to SC treatment at 3 and 9 months in patients naïve for infliximab. Secondary objectives included the need for intensification, rescue treatments (corticosteroids, change of biologic or surgery), the occurrence of adverse effects and pharmacokinetic aspects (blood levels, development of antibodies to infliximab or ATIs). Clinical activity was assessed using the Harvey-Bradshaw Index (HBI) for Crohn's disease (CD) and Partial Mayo Score (PMS) for ulcerative colitis (UC). In addition, biochemical parameters (hemoglobin, albumin, C-reactive protein, and fecal calprotectin) were monitored.

Results
A total of 19 patients were included, 14 with CD and 5 with UC (Table 1). Among them, 16/19 had not received previous biological treatment and 3/19 had received another anti-TNF other than infliximab. They were followed at 3 (18/19) and 9 months (18/19) (Figure 1). Significant improvement (p&lt;0.05) was observed in the parameters of clinical activity (6/18 persisting with mild-moderate activity at 9 months) and biochemical activity (fecal calprotectin). Infliximab levels were adequate at 3 (median 12; range 3.2-39) and 9 months (median 15.9; range 0.3-51). In total, 31.6% of patients (6/19) discontinued treatment: 1/19 due to mild acute urticaria at baseline, 2/19 due to the development of ATIs (one also developed lung abscesses requiring hospitalization) and 3/19 due to loss of secondary response requiring a change of biologic. Of the latter, one also needed treatment with oral corticosteroids. In none of the patients was the treatment intensified or surgery required.

Conclusion
Treatment with SC infliximab in naïve patients seems to be an effective and safe alternative with results comparable to IV infliximab in real clinical practice. In our 9-month study, clinical scores and fecal calprotectin improved significantly, with low immunogenicity rates. Only 31.6% of patients discontinued treatment due to adverse effects or loss of response.
Table 1. Baseline characteristics of patients
P797 Assessment of pharmacokinetics and clinical response in patients transitioning from intravenous to subcutaneous vedolizumab
Authors: Amor Costa C , Garcia Ramirez L , Suarez Ferrer C , Martin-Arranz E , Rueda Garcia J L , Sanchez Azofra M , Poza Cordon J , Gonzalez Diaz I , Amiama Roig C , Martin-Arranz M D 
Published: January 2024

Abstract

Background
Vedolizumab is a humanized monoclonal antibody directed against α4β7 integrin used in inflammatory bowel disease (IBS) patients1. The usual dosage of Vedolizumab is 300 mg intravenously (iv). Recently the subcutaneous (sc) formulation (108 mg every 2 weeks) has been approved, which provides more independence for the patient, avoiding visits to the hospital and possible inconveniences associated with it2.

Methods
The aim of the study is to evaluate the clinical and biochemical response of IBS patients treated with vedolizumab, 16 weeks after transitioning from iv to sc. An observational, prospective, single-center cohort study was performed. Patients with IBS and maintenance treatment with vedolizumab, stable for at least 4 months, were offered to switch to sc formulation. At the same time of treatment administration a blood test was performed, with vedolizumab levels and fecal calprotectin. Clinical index as Harvey-Bradshaw Index (HBI)/Simple Clinical Colitis Activity Index (SCCAI) and questionaries (IBDQ-9 and TSQM) were performed on each visit.

Results
43 patients were included, 12 of them (27.9%) chose to transition to sc formulation. Baseline characteristics of both groups are shown in Table 1. 34 (79.1%) patients were prescribed vedolizumab due to previous biologic failure, 7 (16.3%) in first line due to comorbidities and 2 (4.7%) because of adverse effects in prior treatment.
All included patients remained in remission during follow-up. At week 16 (w16), no significant differences were found in calprotectin levels in patients on iv treatment (mean 146.6 ± SD 45.9) vs sc (159.26 ± 53.9) (p 0.9). Vedolizumab serum levels at w16 were higher in the sc group (22364.3 ± 5141.6) vs. iv (11425.9 ± 1514.2), with statistically significant differences (p 0.009). At w16, 9 (75%) of the patients in the SC group were highly satisfied with the medication and 11 (91.7%) considered it easy to administer. 1 patient (8.3%) in the sc group returned to iv treatment. 4 patients (12.9%) in iv and 2 (16.6%) in sc treatment presented mild adverse effects. The 2 cases (100%) of the sc group the adverse event was local inflammation at the injection site.

Conclusion
In our experience, vedolizumab sc is a safe and convenient alternative to iv administration. Vedolizumab serum levels in patients who transitioned to sc were higher than iv formulation.
1. Smith, Michael A et al. "Vedolizumab: an α4β7 integrin inhibitor for inflammatory bowel diseases." The Annals of pharmacotherapy vol. 48,12 (2014): 1629-35.
2. Vermeire, Séverine et al. "Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn's Disease: Results From the VISIBLE 2 Randomised Trial." Journal of Crohn's & colitis vol. 16,1 (2022): 27-38.