bluuebunny/crossref_metadata_2025 huggingface dataset:
P721 Dutch Crohn’s disease patients’ (pediatric and adult) perspectives of CDED diet and Modulife program
Authors: Wijers F , van Zundert S , Verburgt C , van der Kruk N , van Limbergen J , Wierdsma N
Published: January 2024

Background

The Crohn’s Disease Exclusion Diet (CDED) with partial enteral nutrition can induce remission in patients with mild-to-moderate Crohn’s disease. As adherence is the key of (possibly) success of a medical therapy and CDED might be a complicated diet to perform, we aimed to investigate patients’ experience with CDED and the available tools (Modulife programme) to improve patientcare.

Methods

All mild-to-moderate active Crohn’s disease (CD) (adult and pediatric) patients treated with CDED as nutritional therapy as part of their medical treatment at Amsterdam UMC between 2019-2022 were approached for this retrospective qualitative study. A structured telephone interview was conducted by a dedicated dietician/doctor with the patients and/or parent/guardian in case of children. Questions about CDED-experience and Modulife program were either measured with the NET Promotor Score (NPS -100 - +100), as yes/no answer options or with 5-point likert scales (1=strongly agree/always to 5=strongly disagree/never). Lastly, patients were asked to evaluate the effectiveness of CDED on complaints and experience on a scale from 0-10.

Results

44 patients (33 pediatric/11 adults; 26 women) participated in the interviews. The majority (61%) of the pediatric patients started CDED at diagnosis. The remaining 39% started 1-11 years (median 3[IQR 2-5]) after diagnosis at an age of 7-17 years (median 15[IQR 12-16]). 91% of the adult patients started CDED 3-37 years (median 11[IQR 4-28]) after diagnosis and only 1 immediately after diagnosis at an median age of 48 [IQR 33-60] (range: 19-69). The majority of the pediatric participants would recommend CDED to others (77%) and consider to start the diet again (55%). All of the adults would recommend CDED to others and consider to start CDED again. The NPS scores on CDED experiences are shown in figure 1. The median score for the effect of the diet on complaints was 8[IQR 5-9] (range 0-10) and 7[IQR 6-7](range 2-8.5) for experience. The majority of the patients (75%) used the Modulife program always or often during therapy and did (strongly) agree that the Modulife program was helpful. A NPS of 31 was given for recommending the app to others. The recipes-feature was the most used and most esteemed part of the app and was assessed with a good NPS of 27 for recommendation to others.

Conclusion

The majority of the pediatric and all of the adult participants would recommend CDED to others and would reconsider starting the diet again. CDED is better assessed by adults (positive NPS) then children and/or their parents (negative NPS). Most of the patients, assess the Modulife programme very positively and the majority would rate this as helpful in performing the diet.
P723 Upadacitinib in Crohn’s disease: Real world experience from an early access program in Greece
Authors: Papathanasiou E , Leonidakis G , Michalopoulos G , Manolakopoulos S , Siakavellas S , Theodoropoulou A , Tasovasili A , Giouleme O , Tzouvala M , Tsironi E , Viazis N , Michopoulos S , Zampeli E
Published: January 2024

Background

Upadacitinib is a novel selective Janus kinase 1 inhibitor, recently approved for the management of Crohn’s disease (CD) by Food and Drug Administration. In Greece, upadacitinib is available through an early access program for refractory patients who have exhausted their therapeutic options. Our goal was to describe our real practice experience.

Methods

This is a multicenter retrospective cohort study of adult patients with moderate to severe CD, who received upadacitinib. The primary endpoint was clinical response, defined by a reduction ≥3 in Harvey-Bradshaw index (HBI). Clinical remission was defined as HBI ≤4. Secondary endpoints included endoscopic and biochemical improvement based on physician’s assessment and CRP measurement, respectively. Outcomes were assessed at 12 weeks and at patient’s latest follow up. All patients received 45mg upadacitinib for 3 months and then 30mg for another 3 months, whereas the maintenance dose (30mg or 15mg) was based on the patient’s response. We also evaluated short -term safety.

Results

A total of 22 CD patients (12 female) received upadacitinib and were included in the analysis. Mean age 42.2 years (24-63). Five patients were active smokers. Mean treatment duration was 5.4 months (1-20). Two patients have not yet reached 12 weeks of treatment and were excluded from the efficacy analysis. Ten patients (45.4%) had ileocolonic Crohn’s, seven (31.8%) ileal disease and five (22.7%) Crohn’s colitis. Four patients had perianal disease and seven patients Crohn’s related surgery (5 ileocecal resection, 2 seton placement). Four patients had active extraintestinal manifestations: Three inflammatory arthritis and one atopic dermatitis. The majority of patients (15/20) had failed ≥ 3 biologics. All of them failed treatment with anti-TNF and 15 (75%) with ustekinumab. Six patients have just completed the induction period of 12 weeks, ten are on 30mg upadacitinib and four on 15mg. At 12 weeks, 18 patients achieved clinical response (90%). CRP was normal for 15/20 (75%) patients at 12 weeks. At last follow-up (mean 5.9 months, 3-20), all patients were in clinical remission. Endoscopy was available for six patients and improvement was documented for all of them. Adverse events occurred in 3 patients (15.7%): An episode of abdominal pain, a skin infection and a case of neutropenia. All adverse events resolved without discontinuing treatment.

Conclusion

In a small cohort of medically resistant Crohn’s patients, the short- term clinical efficacy of upadacitinib was high. No serious safety issues were recorded.
P729 Prospective observational study evaluating the effects of GLP1-RA on Inflammatory Bowel Disease (IBD) in patients with Type 2 Diabetes Mellitus (TDM2)
Authors: Piumatti A , Beccuti G , Armandi A , Bugianesi E , Broglio F , Ribaldone D G
Published: January 2024

Background

GLP-1 RA are antidiabetic drugs approved for treatment of TDM2 as second-choice therapy for long-term treatment in patients with TMD2 without previous cardiovascular events or as first-choice therapy in patients with previous cardiovascular events and without heart failure (SID/AMD guidelines).

Their beneficial effect is not only associated with glycol-metabolic control, but also with a systemic anti-inflammatory action. In view of this anti-inflammatory action, we wanted to assess whether GLP1-RA could have a possible beneficial effect on IBD in terms of laboratory and clinical parameters. Moreover, these drugs have proven to improve liver function and histology, therefore, liver wellbeing may also be included as a cross-sectional element of evaluation in the possible benefits of these therapies.

Methods

Through the evaluation of 981 medical records of IBD patients followed in the gastroenterology department of the Hospital San Giovanni Antica Sede (SGAS), 71 TDM2 patients were identified. Among these, 21 were recruited for the study. The recruited patients were scheduled for a diabetological examination: GLP-1 RA treatment could then be introduced where indicated. At a 3-month follow-up interval, both the GLP-1 RA treatment group and the subjects that did not have any changes in therapy (control group) underwent re-evaluation of the parameters of interest. All patients in the study were offered the possibility to receive a FibroScan to measure liver stiffness at the start of the study and at the 3-months follow-up.

Results

A prevalence in the IBD population of TDM2 was found to be 7.2% (vs. Piedmont population prevalence 6.2%, p = 0.31). Out of the 21 patients recruited, 6 received GLP-1 RA treatment. At 3 months, an analysis of the results through the Wilcoxon test showed that the GLP-1 RA treated patients had a reduction in faecal calprotectin levels, an improvement in disease scores, an improvement in glycemic balance and a reduction in CAP and FIB4 when compared to the control group; these results did not reach statistical significance. In contrast, the reduction in BMI reached statistical significance. A comparison of the deltas for the variables under analysis between the two groups was also carried out using the Mann-Whitney test. Concordant and positive trends were observed in the GLP-1 RA-treated group: in this case the reduction in HbA1c reached statistical significance.

Conclusion

Treatment with GLP-1 RA in patients with TDM2 and IBD appears safe and seems to show benefits from an intestinal, metabolic and hepatic viewpoint. Studies with a larger number of subjects are certainly needed to effectively confirm the benefit of GLP-1 RA in this specific category of patients.
P754 Inadequate Pregnancy Specific Knowledge among Patients with Inflammatory Bowel Disease: A Multi-Center Survey in China
Authors: Li R , Wu T , Li X , Zhou H , Shi Y , Wang F , Liang J
Published: January 2024

Background

Perceptions and attitudes of inflammatory bowel disease patients on pregnancy may influence their fertility planning and disease progression. There was data published about knowledge as well as the impact of education in relation to inflammatory bowel disease and pregnancy. However, it is unknown in China. Facing the sharp decline in birth rate, we need to understand the pregnancy-specific knowledge of Chinese gastroenterologists and patients with inflammatory bowel disease and the significance of education.

Methods

A cross-sectional questionnaire, regarding pregnancy-specific knowledge, was carried out among China's 63 inflammatory bowel disease centers. 794 questionnaires were obtained, including 185 from physicians and 609 from patients. Our center then led the educational intervention.

Results

Compared to physicians, patients' knowledge levels of fertility (39.1% vs. 70.8%, p < 0.001), imaging examinations (22.8% vs. 72.4%, p < 0.001), and endoscopy performed during pregnancy (19.9% vs. 71.4%, p < 0.001) and vaccination (16.6% vs. 46.5%, p < 0.001) were significantly lower. There was a lack of knowledge among gastroenterologists regarding the delivery mode (36.8%), medications (36.8%), and emergency surgery (26.5%) during pregnancy in patients with inflammatory bowel disease. The following six aspects were significantly improved after education, including the medication (26.7% vs. 51.7%, p=0.005), fertility (45% vs. 63.3%, p=0.044), heritability (40% vs. 58.3%, p=0.045), indications for emergency surgery (15% vs. 53.3%, p<0.001), imaging examinations during pregnancy (20% vs. 40%, p=0.017) and vaccinations (26.7% vs. 45%, p=0.036).

Conclusion

Pregnancy-specific inflammatory bowel disease knowledge was lacking among certain gastroenterologists and inflammatory bowel disease patients in China. Educational interventions can partially improve the knowledge levels of patients in this area.
P755 Long-term need for restart of biologics after withdrawal in patients with Inflammatory Bowel Disease in mucosal healing
Authors: Ruz Zafra P , Luque Carmona A M , Nuñez Ortiz A , Trigo Salado C , Leo Carnerero E
Published: January 2024

Background

In patients with inflammatory bowel disease (IBD) on biologic therapy, once remission has been achieved, withdrawal is a frequent issue in clinical practice that generates uncertainty in aspects such as the reduction of adverse effects and costs, but also the risk of recurrence of activity and the need to restart treatment. The aim of this study was to determine the rate of long-term reintroduction of biologics after withdrawal due to mucosal healing (MH) in IBD, the response to reintroduction and the associated factors.

Methods

Observational, descriptive, single-centre, retrospective, descriptive study of 178 cases in 164 patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who were withdrawn from anti-tumor necrosis factor (anti- TNF) therapy once MH had been demonstrated, between July 2009 and February 2022. Demographic and phenotypic characteristics of IBD, characteristics of biologic and immunosuppressive therapy, analytical and endoscopic/histological variables at the time of withdrawal were collected. We analysed the risk of restarting biologics due to clinical relapse and response to reintroduction of treatment. We evaluated possible factors related to the risk of restarting treatment and response to treatment.

Results

We included 178 cases. 123 CD and 55 UC. Most had received infliximab (62.9%) and the main indication was corticodependence (68%). Median follow-up was 78 months (IQR 59-95). Clinical relapse occurred in 69% of cases and 61.2% required reintroduction of biologics, with the probability of retreatment at 1, 3, 5 and 7 years being 19.4%, 50%, 60% and 63.4%, respectively (Figure 1). The response to reintroduction was 86.2%. Only 1.68% required surgery during follow-up. Univariate analysis showed higher risk of re-introduction at younger age at diagnosis (23 vs 30 vs 30, p 0.022) and at withdrawal (32 vs 40, p 0.019) and longer follow-up time after withdrawal (82 vs 71, p 0.026). Multivariate analysis also identified the indication for corticodependence (p 0.046).

Conclusion

The risk of relapse and re-starting treatment is high in the long term after withdrawal of biologic therapy for MH in IBD. Younger age at diagnosis and withdrawal, indication for corticodependence and long-term follow-up are risk factors for poor outcome. Reintroduction of treatment is very effective with low complication rates.
P757 Patient attitudes, perceptions, and beliefs on the role of diet and nutrition in inflammatory bowel diseases. A scoping review
Authors: Magkiosi A , Strongylou D E , Gkikas K , Gerasimidis K , Androutsos O , Svolos V
Published: January 2024

Background

Despite substantial evidence implicating diet in the development and management of inflammatory bowel disease (IBD), we still lack widely agreeable recommendations for dietary therapy. As a result, patients often self-manage their disease symptoms following a range of dietary regimes, including elimination diets and specific nutrient supplementation. The aim of this in-depth scoping review is to characterise the perception of patients in the role of diet in IBD.

Methods

An extensive literature search was undertaken on PubMed (inception to August ‘23), including MeSH terms ("Inflammatory Bowel Disease" OR IBD OR Crohn's OR Colitis) AND (belief OR perception OR opinion OR views OR attitude) AND (diet OR food OR nutrition). Eligible studies included primary research exploring attitudes, perceptions, or beliefs of adults and children with IBD and/or their carers towards the role of diet in IBD onset, progression or management. We excluded animal, in vitro and non-English articles (Table 1).

Results

1,649 records were identified. After full-text review of 162, 42 papers fulfilled eligibility criteria. Another 6 papers were identified after cross-checking reference lists from included papers, resulting in final inclusion of 48 articles. All articles described that diet perceptions relate with behaviour. In 17 studies a significant percentage of participants considered diet an initiating factor for their IBD diagnosis (Median,IQR: 32%,28%-45%). In 39 studies, patients listed foods they perceived to trigger or benefit their symptoms or inflammation. Most of these studies listed foods affecting the disease for IBD in general (n=29), while fewer studies described trigger and beneficial foods for Crohn’s disease (n=13) and ulcerative colitis (n=16), separately. Spicy food, dairy, alcohol, and coffee were the most perceived as disease-trigger foods, whereas rice, chicken, gluten free products and fish were perceived as beneficial (Fig 1A). Interestingly, 23 studies described patients’ most frequent sources of diet and nutrition information for IBD management (Fig 1B). The top-ranked being patient’s own experience with diet(82%), gastroenterologists(40%), other physicians(35%) and internet(35%). Only 25% of participants reported dietitians as their source of information.

Conclusion

There is a strong belief among patients with IBD that diet is important in disease development and management. It is possible that such beliefs translate to disease management practices, hence increasing restrictive eating, diminish quality or life, including food related quality of life. Until further evidence is produced to pinpoint the exact role of diet in IBD management, it is imperative that HCPs initiate such discussions and advise their patients accordingly.
P759 Understanding how patients with moderate-to-severe Crohn’s disease describe the spectrum of bowel urgency definitions: Results from qualitative research
Authors: Dubinsky M C , Hunter Gibble T , Stassek L , Harding G , Stefan M , Fikre T , Potts Bleakman A , Moses R
Published: January 2024

Background

The objective of this study was to understand how adult patients with moderately-to-severely active Crohn’s disease (CD) describe bowel urgency (BU) remission and “no or minimal” BU.

Methods

Qualitative phone interviews were conducted with adults with HCP-confirmed moderately-to-severely active CD. The interview included open-ended questions that elicited participant (pt) perceptions of BU remission, “no or minimal” and “normal” BU. Pts indicated which score on the 11-point Urgency Numeric Rating Scale (Urgency NRS; 0 [no urgency] to 10 [worst possible urgency] (24hour recall period)) they would use to describe “no or minimal” and “normal” BU. Pts were recruited from 6 clinical sites based in the US. ATLAS.ti was used to organize the data. Descriptive statistics were used for sociodemographic and clinical characteristics.

Results

21 pts with moderately-to-severely active CD participated in this study. Pts had a mean age of 45.4 years, 71% were female, 91% were white, and 48% were employed full-time. All pts had experienced BU and 86% (n=18/21) confirmed they had experienced a BU-related accident in the past. The majority of CD pts (n=18/21; 86%) defined BU remission as a state of normalcy, where there are normal or fewer bowel movements and BU is either gone or less frequent (Table 1). The impact of BU remission included the ability to partake in social/leisure activities and feeling less anxious overall.

Pts selected scores from 0 to 6 on the Urgency NRS to describe “no or minimal” level. The highest proportion of pts (n=7/21; 33%) selected “0 to 2,” with “0 to 3” (n=5/21; 24%) and “0 to 1” (n=5/21; 24%) also being commonly chosen ranges. The majority of pts (n=17/21; 81%) described “no or minimal” BU as having no impact on their life—thus allowing them to feel close to “normal,” and offering them the ability to live an improved life free of worry or panic. Pts were also asked to indicate the highest score on the Urgency NRS at which they could still consider their BU to be “normal” and 29% of pts (n=6/21) selected 4 or 3 (n=5/21; 24%) as the highest score that they would still consider as “normal.”

Conclusion

These interviews provided evidence that among pts with moderately-to-severely active CD, BU can still be considered “no or minimal”, “normal” or in “remission” even when some amount of BU is present. In general, responses of “0” to “6” on the Urgency NRS were considered to correlate to “no or minimal” or “normal” BU.
P760 Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: A final report of effectiveness and safety data
Authors: Matsuoka K , Motoya S , Yamamoto T , Matsuura M , Fujii T , Shinzaki S , Mikami Y , Arai S , Oshima J , Endo Y , Yuasa H , Hoshi M , Sato K , Hisamatsu T
Published: January 2024

Background

Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We present the final analysis of a 60-week post-marketing surveillance (PMS) study of tofacitinib in patients (pts) with UC in Japan.

Methods

A final analysis of safety and effectiveness data from a PMS study was conducted (final data as of 30 September 2022). All pts with UC in Japan receiving tofacitinib were registered. All adverse drug reactions (ADRs) during tofacitinib treatment were recorded. Data were excluded for 13 pts from 2 hospitals that did not obtain pt consent and were therefore not permitted for publication. In the risk-management plan, several ADRs were identified as clinically important events or as potential risks, for which all treatment-period data were used to calculate cumulative incidence rates (IRs; unique pts with events per 100 pt-years [PY] of exposure). Effectiveness was assessed by partial Mayo score as observed.

Results

In total, 2043 pts receiving tofacitinib were enrolled in the PMS study, of whom 1982 and 1969 were included in the final safety and effectiveness analyses, respectively. In total (safety analysis set), 60.5% of pts were male and mean age was 42.5 years, with 2706.4 PY of exposure. ADRs and serious ADRs were observed in 462 (23.3%) and 46 (2.3%) pts, respectively; one death occurred due to an intestinal abscess (not related to study drug per investigator’s assessment). Herpes zoster (HZ; non-serious/serious) was the most commonly reported infection (89 pts [4.5%]). The IRs of malignancy, cardiovascular events and venous thromboembolic events were all <0.5 per 100 PY of exposure (Table). At Week 60, 735 of 870 ongoing pts (84.5%) were in remission (Figure). Overall, 1038/1982 pts (52.4%) discontinued treatment, most commonly due to inadequate clinical response (508/1038 pts [48.9%]).

Conclusion

In this final analysis, the overall safety profile during the treatment period from PMS reports of tofacitinib in pts with UC in Japan was generally comparable with tofacitinib safety data previously reported in PMS reports from Japan and worldwide,1 and in the tofacitinib UC clinical programme.2 However, rates of HZ were higher in this final analysis than in the tofacitinib UC clinical programme.2 Tofacitinib was effective in Japanese pts with UC in a clinical practice setting. The majority of pts with evaluable partial Mayo scores achieved remission during the 60-week observation period, consistent with previously reported data from the tofacitinib UC clinical programme.2

References:

1. Rubin et al. Aliment Pharmacol Ther 2022;55:302–10

2. Sandborn et al. Aliment Pharmacol Ther 2022;55:464–78

Study sponsored by Pfizer. Medical writing support provided by C Duncan, CMC Connect; funded by Pfizer
P772 Comprehensive disease control in patients with Ulcerative Colitis: refinement of a multi-component endpoint using data from the filgotinib SELECTION trial
Authors: Schreiber S W , Feagan B G , Vermeire S , Danese S , Vyncke V , Faes M , Oortwijn A , Peyrin-Biroulet L
Published: January 2024

Background

Ulcerative colitis (UC) treatment requires a patient-centric efficacy endpoint to assess treatment benefits, enabling a shift towards a personalized approach. Comprehensive disease control (CDC) is an individual multi-component endpoint based on findings from a patient and expert Delphi consensus on remission assessment in UC. CDC was defined as IBDQ remission, partial Mayo Clinic Score (pMCS) remission, biomarker (faecal calprotectin [FCP]) remission and endoscopic improvement. We evaluated different definitions of CDC, and the contribution of different CDC components to the net treatment benefit (NTB) of filgotinib 200 mg (FIL200), an oral, once-daily, Janus kinase 1 inhibitor approved for UC treatment following the SELECTION trial (NCT02914522).

Methods

CDC was assessed at week 58 (W58) of SELECTION in adult patients with active UC treated with FIL200 or placebo (PBO). The CDC definitions evaluated were: 4-component CDC (CDC4) with FCP <150 µg/g, CDC4-150; CDC4 with FCP <250 µg/g, CDC4-250; 5-component CDC (with histological remission [CDC5]) with FCP <150 µg/g, CDC5-150; and CDC5 with FCP<250 µg/g, CDC5-250. The proportion of patients achieving each combination of components was visualized in UpSet plots. NTB of FIL200 was assessed for each endpoint using generalized pairwise comparisons and is reported here for CDC4-150 (and excluding different components).

Results

At W58, 21.6%, 26.6%, 19.1% and 22.6% of FIL200-treated patients achieved CDC4-150, CDC4-250, CDC5-150 and CDC5-250, respectively. Among patients who did not achieve CDC4-150, 0.5% of patients did not achieve pMCS remission compared with 5.0%, 10.1% and 6.0% who did not achieve IBDQ remission, biomarker remission and endoscopic improvement, respectively (Figure). Positive overall NTB of FIL200 versus PBO was demonstrated with all CDC definitions, including those with histological remission (CDC5). For CDC4-150 at W58, excluding pMCS remission did not substantially change the NTB (Δ −0.33; Table) versus excluding IBDQ or biomarker remission, or endoscopic improvement (Δ 3.87, 6.93 and 3.20, respectively). Similar NTB results were seen for all CDC definitions.

Conclusion

CDC is a stringent, patient-level, multi-component endpoint achieved by ~1/5 of FIL200-treated patients at W58. While CDC4-150 could be the optimal operational definition, the addition of histological remission resulted in similar stringency, potentially allowing for the use of different CDC definitions based on context or resources. Additional NTB of FIL200 was identified in patients when IBDQ or biomarker remission or endoscopic improvement were excluded. Overall, CDC appears to be a suitable endpoint to assess individual comprehensive benefit in patients with UC. Prospective validation is needed.
P779 Long term efficacy of azathioprine monotherapy in patients with Inflammatory Bowel Disease
Authors: Theodoraki E , Papatzelou I , Koutroubakis I
Published: January 2024

Background

ECCO guidelines recommend monotherapy with azathioprine (AZA) as maintenance therapy of patients with inflammatory bowel disease (IBD) mainly in steroid-dependent disease. However, in the era of the new advanced treatments AZA is not considered as a preferable option, mainly because of the referred side effects and its use is limited in combination with biologic agents.

Methods

This is a retrospective observational study using data from the longitudinal, prospective IBD registry of University Hospital of Heraklion, Greece.

Our aim was to study IBD patients who started on monotherapy with AZA, the profile of adverse effects they developed, the treatment persistence in monotherapy, as well as the possible related factors of treatment success [including age, gender, smoking status, body mass index, disease type, disease phenotype for Crohn’s disease (CD), history of IBD related surgery and the presence of extraintestinal manifestations].

Results

Of 168 IBD patients treated with AZA, 89 (53%) were under AZA monotherapy [38 (43%) female, 67 (74%) CD, median age (IQR) 47 (32-56) years, mean (±SD) disease duration 17 (±8.4) years, median (IQR) time receiving AZA 72 (7-120) months]. Thirty (34%) patients continue their treatment till now (23 CD, 7 ulcerative colitis-UC), with a median time (IQR) of 108 (81-132) months. Of these, 18 (60%) (15 with CD and 3 with UC) present endoscopic remission and 11 (36%) (8 with CD, 3 with UC) mild endoscopic activity (based on SES-CD Score for CD and Mayo endoscopic score for UC). Of the 59 who discontinued, 33 (37%) experienced adverse events, 5 (5.5%) developed malignancy, 5 (5.5%) did not respond at baseline, 6 (6.5%) had loss of response (at a median of 91 months), 3 (3%) discontinued due to advanced age, 3 (3%) discontinued their medication on their own and 2 because of treatment de-escalation due to deep remission. Using logistic regression analysis, patients who responded to AZA monotherapy were patients without a history of IBD surgery or any extraintestinal manifestation, P=0.001 and 0.004, respectively. In the multivariate analysis, these associations remained statistically significant (P=0.01 and 0.006 respectively).

Conclusion

About one third of patients with IBD under AZA monotherapy experience long term response and about two thirds of them prolonged disease remission. Patients without either a history of IBD surgery or extraintestinal manifestations seem to respond better to AZA monotherapy.
P781 Mirikizumab administration experience from Ulcerative Colitis patients and healthcare providers: Survey data from the LUCENT clinical program
Authors: Clemow D , Radawski C , Milata J , Alaka K , Hunter Gibble T , Schaum A , Ezennia O , Martinez N , Szaloki T , Ito Y , Rodriguez D , Kirk K
Published: January 2024

Background

Mirikizumab (MIRI) is an anti-IL-p19 antibody approved for moderately-to-severely active ulcerative colitis (UC). The recommended dose regimen has 2 parts: MIRI administration begins with intravenous (IV) infusion every 4 weeks (Q4W; 3 total) followed by subcutaneous (SC) injections (2 injections per dose) Q4W (Figure 1). Self-injection of SC MIRI is allowed after patient training. This study explored differences between healthcare provider (HCP) perspectives of UC patients’ experiences and patients’ actual experiences regarding MIRI administration during the LUCENT program. It also assessed HCPs’ own experiences with MIRI administration.

Methods

The study involved two cross-sectional, 30-min, web-based surveys including one for patients and one for HCPs. Patients were eligible if they were enrolled in LUCENT-3 having entered from LUCENT-1 or -2 phase 3 studies or AMAC phase 2 study. HCPs from LUCENT-3 sites were eligible if they administered or oversaw MIRI IV infusions or SC injections during LUCENT-1, -2, -3, or AMAC. Survey questions had responses based on 5-point Likert scales. Outcomes included satisfaction with and acceptability of MIRI administration (Table 1). The survey was completed during LUCENT-3; MIRI SC injection experience at the time of survey varied from >2 to ≥3 yrs.

Results

The surveys were completed by 93 patients from 11 countries and 42 HCPs (gastroenterologist/physician 31.0%, nurse 40.5%, other [coordinator] 28.6%) from 9 countries. Most patients were satisfied or very satisfied with IV infusions (82.8%) and SC injections (91.4%), which was lower than HCPs’ perspectives of patients’ experiences (IV, 92.9%; SC, 100%), but generally similar to HCPs’ own experiences (IV, 81.0%; SC, 95.2%). Consistent with patients’ actual experiences (SC Q4W, 97.8%; two injections, 96.8%), most HCPs thought that patients felt that receiving SC injections Q4W (100%) and receiving 2 SC injections for each dose (92.9%) were somewhat or completely acceptable. Patients (97.8%) were satisfied or very satisfied with MIRI administration overall and 90.3% agreed or strongly agreed that treatment benefits outweighed any administration dissatisfaction. These patient perspectives were similar to both HCP perspectives of UC patients’ experiences (95.2%; 88.1%) and HCPs’ own experiences (97.6%; 95.2%).

Conclusion

Most patients and HCPs were satisfied or very satisfied and acceptable or completely acceptable of MIRI IV and SC administration. Patients’ experiences were similar to HCPs’ perspectives of patients’ experiences as well as HCPs’ own experiences, although there was a tendency for HCPs to perceive patients’ satisfaction to be very satisfied at a higher rate than patients’ actual responses.
P793 Efficacy and safety of probiotics in inflammatory bowel disease: an umbrella review and updated meta-analysis of randomized controlled trials
Authors: Estevinho M M , Rodriguez-Lago I , Dias C C , Barreiro-de Acosta M , Magro F
Published: January 2024

Background

Probiotics hold potential in IBD, yet knowledge gaps persist. We aimed to perform an umbrella review of systematic reviews and updated metanalysis of all RCT assessing the effect of probiotics in on Crohn’s disease (CD) and ulcerative colitis (UC).

Methods

We searched MEDLINE, Web of Science, and Cochrane Central Register of Controlled Trials until September 2023 for systematic reviews and randomized controlled trials (RCT). Primary outcomes were clinical response and remission; secondary outcomes included endoscopic response, remission, and side effects. We calculated odds ratios using a random-effects model in R. Quality was assessed using the AMSTAR-2 (systematic reviews) and Jadad scale (RCTs), the Cochrane Collaboration tool was used to grade trials’ risk of bias.

Results

Out of 2613 search results, 67 studies (22 systematic reviews and 45 RCTs) met eligibility criteria. In the updated meta-analysis, the OR for clinical remission was 1.88 (95%CI 1.20-2.93, I2=60% - Figure 1). However, the positive effect was statistically significant only for UC (OR 2.00, 95% CI 1.28-3.11, I2=57%) but not for CD. Likewise, probiotics significantly decreased the odds of clinical recurrence in UC patients (OR 0.65, 95%CI 0.42-1.01, I2=52%) and in relapsing pouchitis (OR 0.03, 95%CI 0.00-0.25, I2=64%), but not in CD. The De Simone formulation consistently outperformed other probiotics in achieving remission and preventing recurrence in UC. On the other hand, the use of probiotics was not associated with better endoscopic outcomes. The occurrence of both mild and severe adverse events was comparable to control group.

Conclusion

Our results support the use of probiotics for patients with UC, both for the induction of clinical remission and for the prevention of relapse, as well for patients with previous diagnosis of pouchitis, and reinforces their good safety profile.
P794 Relationship between Ustekinumab Trough Concentrations and Clinical, Biochemical and Endoscopic Outcomes in Crohn’s Disease; A Multi-Center Nationwide Study (TARGET STUDY)
Authors: Shehab M , Alrashed F , Abdullah I , Alfadhli A
Published: January 2024

Background

Ustekinumab (UST) has been shown to be effective in inducing and maintain clinical and endoscopic remission in Crohn’s disease (CD). We aim to assess whether ustekinumab trough levels are associated with improved outcomes in CD in real life settings

Methods

We recruited patients with CD who were treated with ustekinumab for at least 6 months from January 2017 to June 2023. Patients received ustekinumab 6mg/kg intravenous induction followed by 90 mg every 4 or 8 weeks during maintenance were included. Clinical, biochemical, and endoscopic outcomes, trough concentrations of ustekinumab that was taken from week 42 to week 52 were included. Primary outcome was to assess if ustekinumab trough concentrations were associated with clinical remission, biochemical normalization, and endoscopic remission. Logistic regression was conducted to assess outcomes

Results

A total of 137 patients with CD. mean age of 34.1 years and 83 (60.6%) males. The mean serum levels of ustekinumab was 7.2 (SD 4.5). Using Spearman correlation analysis, a strong negative correlation was observed between ustekinumab drug levels and SES-CD score (r = -0.464, p < 0.001. Additionally, ustekinumab drug levels demonstrated substantial negative correlations with disease severity measured by HBI score (r = -0.582, p < 0.001), C-Reactive Protein(CRP) levels (r = -0.598, p < 0.001) and fecal calprotectin (FCAL) levels (r = -0.529, p < 0.001). A multivariate analysis adjusted for age, sex and BMI showed a significant association between ustekinumab serum drug levels and predefined outcomes. Ustekinumab serum drug level above 4.5 mcg/ml was associated with 24% increase in the likelihood of having an SES-CD score less than 3 (OR 1.24, CI 1.12-1.37, P<0.001), 44% more likely to achieve HBI score less than 5 (OR 1.44, CI 1.26-1.65, P<0.001), 52% higher likelihood of CRP less than 10 (OR 1.52, CI 1.31-1.77, p < 0.001), and 42% increased likelihood of FCAL less than 250 (OR 1.42, CI 1.24-1.62, p < 0.001).

Conclusion

Ustekinumab trough concentrations above 4.5 mcg/ml was associated with clinical, biochemical and endoscopic remission in Crohn’s disease. Prospective data is warranted to confirm these findings
P803 iGenoMed-MTT: A prospective multiomic study of response to molecularly targeted therapies in IBD
Authors: Battat R , Boucher G , Thompson Legault J , Mercier V , Bitton A , Rioux J
Published: January 2024

Background

No tools exist to individualize treatment selection in Inflammatory bowel disease (IBD) to optimize outcomes. We prospectively recruited patients prior to initiation of molecularly targeted (advanced) therapy (MTT) to identify predictive biomarkers of response and define pathways impacted by successful treatment.

Methods

Serum was collected before initiation of treatment in all patients, and at visit 1 (V1~16 wks) for a subset of patients. Serum samples were analyzed for >140 protein biomarkers (OLINK) and >1200 lipid metabolites. Whole exome sequencing and GWAS data was generated for all participants. Initial data outline proteomic data.

Results

Of the first 166 IBD patients analyzed, therapies initiated included TNF antagonists (n=85), ustekinumab (n=43), vedolizumab (n=28) and janus kinase inhibitors (n=10). Bio-naïve (n=96) and patients using baseline corticosteroids (n=77) were included. Sixty-three patients achieved remission.

In TNF-antagonist initiations, serum TNF concentrations increased between baseline and V1 (p=4E-3), while it decreased for other MTTs (p=0.07). In bio-naïve patients, serum TNF concentration had a strong correlation with CXCL10 (r=0.58, P=3E-10). From the Principal Component Analysis of analytes correlated to TNF in bio-naïve patients, we built a proxy for the level of active TNF.

At baseline, compared to TNF antagonist naïve patients, significantly higher serum TNF concentrations existed in patients with prior TNF-antagonist exposure >1-month post-cessation and a markedly high TNF concentration with cessation <1 month prior to baseline (p< 2E-16). In patients with prior TNF-antagonist exposure, serum TNF concentrations did not correlate with other cytokines (incl. CXCL10). In these patients, elevated serum TNF were found at V1, suggesting accumulation of inactive (complexed) TNF with treatment. A similar pattern was observed for IL-12 after ustekinumab treatment (elevated serum IL-12 with recent ustekinumab (p= 8E-13), large increase in IL-12 after ustekinumab (p=9E-5)). Reduced IL-12 concentrations existed in current corticosteroid users, compared to previous users and those who never used (p=4E-8). In baseline samples in bio-naive patients prior to therapy initiation, serum concentrations of six analytes provided a discriminant model of corticosteroid use, whith an area under (AUC) the receiver operation characteristic (ROC) curve showed excellent discrimination (AUC=0.91).

Conclusion

These data uniquely characterize proteomic data in patients with various advanced therapies and will enable development of predictive panels. Unique availability of multiple therapies linked to longitudinal proteomic data may allow personalized panels for treatment selection.
P804 Does Crohn's disease extent and behavior have an impact on ustekinumab effectiveness? A real-world multicenter retrospective study
Authors: Samarentsis N , Kapizioni C , Georgakopoulou N , Michalopoulos G , Striki A , Karoumpalis I , Kartsoli S , Mellos A , Vrakas S , Vougadiotis I , Neonaki A , Karatzas P , Tsiamperas N , Kourikou A , Siakavellas S , Polymeros D , Manolakopoulos S , Papatheodoridis G , Triantafyllou K
Published: January 2024

Background

Crohn's disease (CD) presents heterogeneity in clinical phenotypes. Progression of disease and response to therapy have been associated, among other factors, with the extent and behavior of the disease. Real-world data on long term effectiveness of ustekinumab (UST) in CD based on disease characteristics are limited and conflicting1,2. The aim of this study is to describe real-world UST persistence according to disease distribution and perianal involvement in patients with CD.

Methods

This was a retrospective multicenter study involving adult patients with CD who received, at least, one dose of UST until August 2023, at 5 major hospitals in Athens, Greece. UST effectiveness based on treatment persistence was evaluated using Kaplan Meier curves for survival free of treatment discontinuation among patients with different disease extent and behavior. Log-rank test was used for statistical significance.

Results

A total of 147 adult CD patients who received biological treatment with UST for a median of 34 months (IQR 17-48) were included in the study. Patient baseline characteristics are shown in Table 1. UST treatment persistence rates were 93% (95% CI: 89-98) at 12 months and 87% (95% CI: 81-94) at 36 months. The persistence rate of UST differed significantly between patients with or without perianal disease (p=0.036) (Figure 1), while there was no significant difference based on disease extent (p=0.59) or behavior (p=0.31).

Conclusion

Our study showed that UST treatment persistence is similar in adult patients with CD, regardless of disease localization or behavior. Nonetheless, perianal disease involvement is associated with reduced treatment persistence.

References

1. Liefferinckx C, Verstockt B, Gils A, et al. Long-term Clinical Effectiveness of Ustekinumab in Patients with Crohn's Disease Who Failed Biologic Therapies: A National Cohort Study. J Crohns Colitis. 2019;13(11):1401-1409. doi:10.1093/ecco-jcc/jjz080

2. Iborra M, Beltrán B, Fernández-Clotet A, et al. Real-world long-term effectiveness of ustekinumab in Crohn's disease: results from the ENEIDA registry. Aliment Pharmacol Ther. 2020;52(6):1017-1030. doi:10.1111/apt.15958
P826 Exclusive Enteral Nutrition versus Crohn's Disease Exclusion Diet in pediatric patients with Crohn's Disease
Authors: Mora Massó L , Martín Adrados A , Fernández Leal A , Velasco Rodríguez-Belvís M , Palomino Pérez L M , Di Campli Zaghlul M , Martín Fernández C , Muñoz Codoceo R A
Published: January 2024

Background

Crohn's disease exclusion diet (CDED) has emerged as an alternative to exclusive enteral nutrition (EEN) to induce remission in pediatric CD patients. CDED is better accepted by the patients, thus improving adherence, and can represent a long-term strategy, as opposed to EEN. The aim is to compare the outcomes of both diets in our clinical setting.

Methods

We conducted a retrospective and observational study on CD patients who were under follow-up in a pediatric Inflammatory bowel disease (IBD) Comprehensive Care Unit from a tertiary hospital from June to October 2023. We included pediatric CD patients (under 18 years of age) who had received one of these two diets as induction treatment both as monotherapy and in combination with other drugs. Anthropometric values, inflammatory markers and clinical activity indexes were compared in both groups in three different time points: prior to induction (time 0), and three (time 1) and six months (time 2) after the induction. The study was approved by the Ethics Committee of HIUNJ. Data were analyzed with the SPSS software (v.25).

Results

A total of 53 patients were included: 24 in the CDED group and 29 in the EEN group. Up to 48 patients (90,6%) simultaneously started another drug as part of the maintenance strategy. Results are shown in table 1. The decrease of faecal calprotectin (FC) was more striking in the CDED group but kept elevated in both, whereas C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) descended to normal values after both diets (figure 1). However, there were no statistically significant differences regarding anthropometric values, inflammatory markers, or clinical activity indexes between the two groups at each time point (table 1).

Conclusion

Although the concomitant use of other drugs limits the drawing of conclusions, the therapeutic use of both the CDED and EEN diets seem to be useful to achieve clinical, analytical, and anthropometric improvement in pediatric CD patients. Conducting more studies on larger samples would help to confirm the role of CDED as an effective alternative to EEN.
P830 The potential role of artificial intelligence in selecting the modality of biological therapy in patients with inflammatory bowel disease
Authors: Mitrovic M , Milić A , Marković S , Svorcan P
Published: January 2024

Background

Selecting an appropriate treatment strategy for inflammatory bowel disease (IBD) is an important task that can significantly alter the clinical course of the disease. Advanced artificial intelligence language models, such as ChatGPT, represent a potential future option that can assist practitioners. ChatGPT can help search the internet for medical facts by summarizing information from medical sources and providing concise explanations, simplifying the process of accessing and understanding medical information.

Methods

A ChatGPT-guided analysis of 89 IBD patients treated at the Clinical Department of Gastroenterology and Hepatology at University Medical Center "Zvezdara", Belgrade was conducted, considering further treatment with some biological drugs. A treatment modality proposal was obtained through communication with the interactive software ChatGPT (OpenAI, CA USA) and providing complete clinical and laboratory data. The alignment of decisions was analyzed, along with an assessment of treatment success in the group with matching and differing choices.

Results

In 72 patients (81%), there was concordance in the choice of therapy between ChatGPT and the medical consultation, while in 17 patients, ideas about the treatment approach differed. The most common difference in the choice of therapeutic modality related to the software's selection of ustekinumab compared to our choice of vedolizumab in patients with Crohn's disease who were not biologically naive, affecting seven patients with these characteristics. In 4 patients with severe ulcerative colitis, ChatGPT recommended using cyclosporine in combination with vedolizumab, contrary to the medical consultation's decision to use Anti-TNFα therapy. The group of patients in whom the artificial intelligence advice differed from the medical consultation was in a clinically more severe stage of the disease (CRP 10.4 vs. 9.1, p=0.0293), with worse endoscopic findings (proportion of severe endoscopic disease SES CD≥33/Mayo score>2, 53% vs. 24%, p=0.019). Taking into account the baseline differences in these patient groups, multiple analyses of covariance did not reveal a significant difference in the ultimate treatment outcome - proportions of endoscopic (p=0.773) and clinical remission (p=0.296) between patient groups.

Conclusion

The integration of advanced artificial intelligence language models may represent a future tactic with the potential to assist practitioners in making decisions about the treatment modality for IBD patients, but clinical experience should be considered.