bluuebunny/crossref_metadata_2025 huggingface dataset:
P831 Acute infusion reactions due to different biologic agents in a large cohort of patients with Inflammatory Bowel Disease
Authors: Colantuono S , Caruso C , Rumi G , Capobianco I , Blasi V , Termite F , Coppola G , Laterza L , Lopetuso L R , Mignini I , Napolitano D , Parisio L , Pugliese D , Scaldaferri F , Gasbarrini A , Papa A
Published: January 2024

Background

The therapeutic armamentarium for inflammatory bowel disease (IBD) includes several biological agents: infliximab (IFX), adalimumab (ADA), vedolizumab (VED) and ustekinumab (UST). Persistence in therapy with these drugs is not satisfactory, not only due to the loss of clinical response over time but also due to adverse events. Acute infusion reactions (AIRs) occur during or within 24 hours of the infusion. The intensity of AIRs ranges from mild (flushing, dizziness, headache, itching, rash) to severe (anaphylactic). The primary aim of this study was to compare the prevalence rates of AIRs due to the different biological agents in a large cohort of patients with IBD and to assess risk factors for AIRs.

Methods

All reports of AIRs occurring from January 2021 to October 2023 in IBD patients treated with different biological agents (IFX, ADA, VED and UST) in a tertiary IBD center were retrospectively reviewed. The electronic records of the identified patients were checked for the type of IBD, whether Crohn's disease (CD) or ulcerative colitis (UC), type of biological agent, route of administration (intravenous or subcutaneous), concomitant immunosuppressive therapies, atopic status. Furthermore, the type of treatment for the AIRs and the subsequent therapy undertaken for IBD were also recorded.

Results

22 AIRs were recorded out of 1911 patients (1.1%). Of these, 16/550 in patients on IFX biosimilars (2.9 %), 4/590 (0.7%) in patients on ADA biosimilars, 2/318 (0.6%) in patients on VED and 0/453 (0%) in patients on UST (Table 1). The difference in the prevalence of AIR rates observed with the different biological agents was statistically significant (p<0.01). 7 of 16 post-IFX AIRs were moderate-severe, with two episodes of anaphylaxis occurring in patients with CD. The two patients treated with VED experienced only mild symptoms, and no anti-reactive treatment has been used; two mild and two moderate AIRs, respectively, have been reported among patients on ADA. 12 of 22 AIRs occurred during the induction period (from the first to the third administration). 7 of 22 patients had previous allergic reactions.

Conclusion

Our real-world data on a large population of IBD patients treated with biologic agents confirm that AIRs are rare and occur mainly in patients treated with IFX biosimilars. Most patients who experienced AIRs were atopic. Almost all patients after AIRs changed biological agents within or out of the same biological class. Further studies are necessary to confirm our results and better characterise the profile of patients at greater risk of AIRs.
P835 Acceptability, feasibility, and adherence of an emulsifier-free diet in healthy volunteers
Authors: Wellens J , Luppens M , Hoekx S , Vanderstappen J , Van Elst L , Vissers E , Ferrante M , Verstockt B , Verbeke K , Matthys C , Vermeire S , Sabino J
Published: January 2024

Background

Emulsifiers are associated with intestinal inflammation and therefore excluded in new dietary strategies in inflammatory bowel diseases (IBD). We aimed to investigate the feasibility, acceptability, and adherence of an emulsifier-free diet (EFD) in healthy volunteers as part of the FOod Additives on the Mucosal barrier (FOAM) study.

Methods

We recruited 60 healthy volunteers to a 7-week interventional trial. After 1 baseline week of their habitual diet, participants followed an EFD for 6 weeks. Participants were instructed on how to follow an EFD yet were not advised on ultra-processed food (UPF) reduction. Every 2 weeks after starting the EFD (week 2, 4, and 6), subjects were asked about their experience on a 12-item questionnaire, including 5-point Likert scales, open-ended and multiple answer-type questions. Food logs were kept in the smartphone application 'Fatsecret', including photographs to capture brand names. Manual calculation of all days with plausible energy intakes (800-4200 kcals per day for men and 600-3500 kcals for women) for at least 79.5% of the time was performed to exclude incomplete reporting. Emulsifier intake was measured as number of servings of emulsifier-containing foods. Adherence rate was calculated as a percentage of mistake-free days.

Results

Of the 60 healthy volunteers, 2 were excluded due to NSAID use. Median (IQR) age was 25.5 years (23.0-33.0), median BMI was 22.7 kg/m2 (21.2-25.6) and 19.0% were male. Median percentage of plausible food logs was 100% (98.0-100%), and 1 subject was excluded due to inadequate dietary reporting.

During the EFD, emulsifier intake significantly decreased (baseline vs week 1; p=2.3x10-9, vs week 6; p=5.3x10-9, Figure 1A), as well as UPF consumption according to the NOVA classification (baseline vs week 1; p=5.6x10-7, vs week 6; p=1.6x10-7, Friedman test with post-hoc paired Wilcoxon, Figure 1B). The adherence rate to the EFD was very high (median 88.1%, IQR 76.2-95.2%). Median number of mistakes during the EFD was 6 (2-14), for a median number of 3 selected food items (1-5). Most mistakes were made in the categories of dairy-like products, meat products, and bakery goods. The top 3 reported challenges included restricted food choices, checking food labels, and longer shopping times (Table 1). At week 6, For 70.7% the EFD was tasty to very tasty and for 72.4% it was acceptable to very acceptable. Hot meals and snacks were the most challenging meal types.

Conclusion

In this 7-week interventional trial in 60 healthy volunteers, adhering to an EFD was feasible and acceptable. While following the EFD, an inadvertent and stable decrease in UPF intake was noted. These finding represent important considerations when designing future dietary trials in IBD.
P836 Prospective evaluation of the switch from adalimumab originator to different biosimilars in IBD patients : acceptability and persistance at 1 year
Authors: D’Abbundo G , Nachury M , Hambli S , Desreumaux P , Gerard R , Pahul M , Blondeaux A , Duveau N , Wils P
Published: January 2024

Background

The use of biological therapies represents a major source of direct healthcare costs for inflammatory bowel disease (IBD) in industrialised countries. Several adalimumab (ADA) biosimilars are available for Crohn's disease (CD) and ulcerative colitis (UC) patients. The aims of our study were to assess the acceptance of switching from Humira® to different ADA biosimilars in IBD patients, the biosimilar persistence at 1 year, and the acceptability of the switch.

Methods

From July 2020 to September 2021, we proposed for consecutive and ambulatory IBD patients on maintenance Humira® to switch to one of the five ADA biosimilars available at the time of the study (Amgevita®, Idacio®, Imraldi®, Hulio®, Hyrimoz®) at Lille University Hospital (France). Patients accepting the switch chose a ADA biosimilar with an IBD nurse and were followed prospectively for 1 year. Biosimilar persistence was assessed at 6 and 12 months using the Kaplan-Meier method. Factors associated with switch acceptance and biosimilar persistence were identified by logistic regression tests (Chi-2). Data on efficacy, safety and rate of return to ADA originator were assessed at 6 and 12 months. At 12 months, acceptability of the switch was assessed by a questionnaire.

Results

97 patients (84 CD patients; 13 UC patients) were included in the study. 89/97 patients (91.8%, including 76 CD patients) accepted the switch from ADA originator to a biosimilar. Poor opinion of generic drugs was the only factor associated with refusal to switch. At 12 months, 61 patients (71%) were still on ADA biosimilar and 54 patients (60%) were still treated with the biosimilar initially introduced. During the follow-up, the proportion of patients treated with Hulio® remained stable (around 30%), while the proportion of patients treated with Amgevita®, Idacio®, Imraldi® and Hyrimoz® decreased (from 33.7% to 22.5%, from 20.2% to 5.6%, from 8% to 4.5% and from 10.1% to 5.6%, respectively) (Figure 1). One quarter of patients switched back to ADA originator at 12 months. Thirty-seven patients discontinued the treatment. Among them, 22 patients (59.5%) discontinued due to injection site reactions. Clinical remission rates were stable between the baseline and the 6 and 12 months evaluation (94.4%, 88.8% and 89.2% respectively). The switch from ADA originator to a biosimilar was considered acceptable for 31/38 patients (81.6%) evaluated at 12 months.

Conclusion

A large proportion of IBD patients (91.8%) accepted the switch from ADA originator to a biosimilar and 60% continued ADA biosimilar at 1 year. The high acceptability of the switch encourages the use of ADA biosimilars in clinical practice.
P841 Exploring Factors Influencing Rutgeerts Score Changes After Ileocecal Resection in Crohn's Disease Patients
Authors: Siham B , Amri F , koulali H , zazour A , Ismaili Z , kharrasse G
Published: January 2024

Background

Ileocecal resection (ICR) is the most common surgery in Crohn's disease patients with a high risk of postoperative endoscopic and clinical recurrence. The Rutgeerts score is an endoscopic tool used to predict postoperative clinical recurrence and guide therapeutic management. The aim of this study is to identify factors influencing the evolution of this score.

Methods

We included all Crohn's disease patients undergoing ICR and who had undergone at least two postoperative colonoscopies during the period [2019-2023]. at the Hepato-Gastroenterology Department of MOHAMMED VI university hospital of Oujda,Morocco.

Results

Forty-six Crohn's disease patients underwent ICR, including 19 females and 27males (sex ratio M/F: 1.4). The mean age of patients was 36 years [26-73], with an average duration of 4 years between diagnosis and ICR. The mean time between surgery and the first follow-up colonoscopy was 10 months, with an average of 18 months between two follow-up colonoscopies. Endoscopic results revealed stability in the Rutgeerts score for 22 patients without the appearance of clinical recurrence signs. Among these patients, 40% were on immunosuppressants (methotrexate n=5, thiopurines n=4), and 60% were on combination therapy. Worsening of the Rutgeerts score was noted in 13 patients, including 30% with perianal manifestations (PAM), 23% with stomas or those who underwent a second surgical intervention during the interval between two colonoscopies, 37% with therapeutic non-adherence, and 10% who stopped treatment. Improvement in the Rutgeerts score was observed in 11 patients, half of whom underwent therapeutic switching or optimization.Identified factors included the use of immunosuppressants or combination therapy, PAM, therapeutic non-adherence, the occurrence of surgery, stomas, therapeutic switching, or optimization.

Conclusion

In conclusion, our study highlights the complexities in post-ileocecal resection management for Crohn's disease. While stability in Rutgeerts scores was observed in some patients, factors such as perianal manifestations, stomas, and therapeutic non-adherence were associated with score worsening. These findings underscore the need for personalized approaches to optimize postoperative care and inform therapeutic decisions in Crohn's disease patients undergoing ileocecal resection.
P863 Prospective outcome following ustekinumab treatment in a real-world cohort of inflammatory bowel disease patients
Authors: Ramos Lopez L , Ramos-Díaz R , Benítez-Zafra F , Morant-Domínguez A , Vera-Santana B , Mourani-Padrón I , Alonso-Abreu I , Carrillo-Palau M , Reygosa C , Medina-Chico J S , Gutierrez-Nicolás F , Nazco-Casariego J , Hernández-Guerra M
Published: January 2024

Background

Therapeutic drug monitoring (TDM) serves as a valuable tool for improving efficacy and reducing rates of drug toxicity .However, the utility of TDM with non-anti-TNF agents (such as Ustekinumab-UST) is less well defined, although it may be useful in optimizing UST posology and improving efficacy. In this study, we aimed to evaluate clinical outcomes and UST plasmatic concentration in real-world IBD patients.

Methods

A prospective study was conducted including IBD patients who initiated UST therapy between August 2020 and June 2023. Clinical outcomes were prospectively collected (clinical remission as Harvey-Bradshaw Index (HBI) <4 or partial Mayo score (pMS)≤1; biochemical remission as fecal calprotectin (FC)<150 g/kg); physician global assessment (PGA) (active/ not active) and patient-reported outcome (IBDQ-9)) and UST plasmatic concentration was assessed by ELISA every 8 weeks for 12 months. The need for drug escalation, surgery, hospitalization, or discontinuation of treatment at the end of the follow-up (September 2023) was recorded.

Results

A total of 91 patients were included (population described in Table 1). After a median follow-up of 12 (9.6-10.7) months, clinical remission was observed in 90.4% of CD and 66.6 % of UC patients, 52.7% presented biochemical remission and 61.5% of IBD patients were inactive by PGA. 81% of patients showed a good quality of life as measured by IBDQ-9 >60 points. 9.9% needed IBD hospitalization and only 1 (1.09%) patient required IBD surgery. UST-dose escalation was indicated for 33% of patients, mainly in UC patients (UC 46.1% vs CD 28.1%; p=0.42). Treatment discontinuation was required in 13.2% (12/91) of patients after a median follow-up of 15 (14.8-19) months, due to loss of response in 66.6% of these patients (Figure 1A).

The mean UST concentration at induction (8 weeks) was significantly higher than at maintenance (16 weeks) (9.2 (7.7-10.7) µg/ml vs 4.8 (3.9-5.7); p>0.0001); no differences in UST concentration were found during the maintenance treatment (Figure 1B). UST concentration was not related to age, sex, body mass index, type of IBD, or previous exposure to biological agents. In multivariate analysis, UST concentration >7 µg/ml in maintenance (16 weeks) showed an independent predictive value for IBD hospitalization (OR 7.6, 95% CI 2.5-23.1) and UST-dose escalation (OR 4.1, 95% CI 1.4-11.9) in the next 12 months.

Conclusion

Ustekinumab (UST) is an effective treatment, bringing about clinical remission and an enhanced quality of life for individuals with inflammatory bowel disease (IBD). In our prospective cohort, UST concentration at maintenance serves as a predictive indicator of IBD outcome.
P865 Screening for low-processed breads - compositional analysis of food additives used in commercially available breads
Authors: Shakhman S , Pfeffer-Gik T , Elial-Fatal S , Broitman Y , Yanai H , Gophna U , Dotan I , Godny L
Published: January 2024

Background

Ultra-processed food (UPF) intake has been associated with the development of inflammatory bowel diseases (IBD), particularly Crohn’s disease (CD). Of UPF subgroups, commercially available breads showed greater risk, possibly due to the increasing presence of food additives (FA) like emulsifiers. As bread is a staple food worldwide, often consumed daily, we aimed to screen the ingredients and FA used in bread industry and to assess the availability of low processed breads.

Methods

We consecutively screened breads available at supermarket and health food store chains popular and widely distributed in Israel. Breads, pita breads and buns (excluding products without food labels), were analyzed by dietitians and categorized into one of three categories according to their processing level and FA types. Low processed category included ingredients used in traditional, home-made breads; medium processed category included FA like malt and added fibers; high processed category included FA like emulsifiers and preservatives, previously associated with impact on microbiota composition or implications on IBD.

Results

A total of 233 breads were screened, 160 are available at the supermarket, 56 at the health food store, and 17 in both. We categorized 195 (84%) as highly processed, 9 (4%) as medium processed and 29 (12%) as low processed. We identified 36 different types of FA and ingredients used. Most breads contained emulsifiers- 178 (76%) and –preservatives-189 (81%). The most used emulsifier was sodium stearoyl-2-lactylate (SSL, E-481), present in 86 breads (37%), followed by mono- and diglycerides of fatty acids (E-471), DATEM (E-472e) and carboxymethyl cellulose (CMC, E-466), found in 22%, 16% and 2% of breads, respectively. Interestingly, the emulsifier E-481, previously shown to induce microbial alterations, was found in 86 breads (52%) sold in the supermarket compared to none of the breads available in the health food store. Out of the 5 common preservatives, most of the breads contained calcium propionate (E-282) found in 112 (48%) and potassium sorbate (E-202) found in 42 (18%). Additives like enzymes were present in 159 (68%), gluten was added to 148 (64%) and 88 (38%) breads had added fibers. A greater portion of the breads contained yeast (85%) compared to sourdough (47%), with 30 (13%) containing only sourdough.

Conclusion

Most of the commercially available breads in Israel are highly processed. The use of emulsifiers, preservatives, added gluten and fibers is very common, yet low processed breads are available. These may be more recommended to patients with IBD. Further understanding of the role of FA in IBD etiology may potentially guide dietary recommendations for specific food choices.
P866 Management of fistulizing Crohn's Disease in a moroccan population: about 125 cases
Authors: Aouroud H , Aouroud M , Lairani F E , Nacir O , Ait errami A , Oubaha S , Samlani Z , Krati K
Published: January 2024

Background

Crohn's disease is an inflammatory enterocolitis, which may be complicated by enteroenteric, enterovesical, rectovaginal, enterocutaneous and anoperineal fistulas. This is a retrospective study of fistulizing Crohn's disease cases followed in our gastroenterology department.

Methods

We report a retrospective and descriptive study, covering all cases of fistulizing Crohn's disease, collected in the hepato-gastroenterology department at our university hospital center during a 9-year study period, from 2015 to 2023. All patients with digestive and/or anal crohn's fistula were included. Comparison of categorical variables was performed with Fisher's exact test using SPSS 10.0 software. The significance level was p < 0.05.

Results

125 patients had a fistulizing form of Crohn's disease. The location of fistulas was represented by anoperineal fistulas (32.6%), followed by enteroenteral (22.9%) and enterocutaneous (23%) fistulas, then enterovesical (9%) and rectovaginal (3.8%) fistulas. Surgical treatment was immediately indicated in all cases of enterocutaneous and enterovesical fistulas, and 66.7% of rectovaginal fistulas. Proctological drainage was performed in 57.1% of cases of anoperineal fistulas. 33 cases of anoperineal fistulas and one case of recto-vaginal fistulas were treated with infliximab. Clinical remission was also significantly associated with medical treatment with biologics versus immunosuppressants (P=0.0018). Surgical treatment remains indicated in the majority of cases of fistulizing Crohn's disease.

Conclusion

Fistulizing Crohn's disease poses a problem for medical and surgical management. Surgical treatment remains indicated in the majority of Crohn's fistula cases. This study also showed that endoscopic recurrence and clinical remission were significantly associated with the type of postoperative medical treatment.
P867 Abdominally targeted yoga-based physical exercises as a therapeutic intervention for Inflammatory Bowel Diseases
Authors: Izhar R , Werner L , Fibelman M , Shapiro I , Siderskyi A , Ostrinski Y , Hirsch A , Ron Y , Fliss Isakov N , Maharshak N
Published: January 2024

Background

Physical activity (PA) has positive effects on general well-being and stress. The effect of abdominally targeted PA on IBD disease measures and patient’s quality of life (QoL) is currently unknown.

We aimed to examine the effect of routine, abdominally targeted, physical exercise sets, designed exclusively for IBD patients, on patients’ QoL and clinical response.

Methods

This randomized (1:1), controlled, double-blinded study assessed the effect of a set of 10-minute videos of specific abdominally targeted physical exercises inspired by Yoga, postulated to increase blood flow to the abdomen, on patients' disease activity and QoL, compared to a control general exercise videos. All patients signed an informed consent form. Patients performed either abdominally targeted (intervention) or control exercises, sequenced and performed by a trained and experienced yoga instructor, through an online application, at least 5 times/week.

Disease activity (HBI/ SCCAI), inflammatory indices (CRP, fecal calprotectin), and QoL measures (PROMIS questionnaire), were compared before and after 30-days of the intervention. For collective analysis of patients, a combined clinical score scale was used (Table 1). Change in calprotectin was calculated as the initial minus the end value.

Results

Twenty-six mild-moderate patients with IBD (age 39.3±10 years) were randomized to perform either intervention (8 CD, 7 UC), or control (7 CD, 4 UC) sets of exercise. Upon completion, most IBD patients training with either the interventional or control videos, exhibited significant improvements in their clinical scores. Among the patients in the interventional arm, the clinical score decreased from 1.1±0.4 to 0.4±0.6 (p<0.001), and in the control group from 1.4±0.5 to 0.9±0.7 (p<0.01). Interestingly, calprotectin significantly decreased only in the interventional group, in comparison to the control (Delta calprotectin: 40.8±122 vs. -431±652μg/g, respectively, p≤0.01). No improvements were observed in CRP. QoL measures improved in the intervention group in pain (13.6±14%, p<0.005), anxiety (14.3±24%, p<0.05), fatigue (18.8±19%, p<0.05) and in social activities (7.1±9%, p<0.05). In contrast, in the controls, only anxiety score improved (8.3±9%, p<0.05). No differences were observed in scores of sleep disturbances, depression, and physical function in either group.

Conclusion

Routine PA can significantly improve IBD clinical scores and symptoms. Abdominally targeted exercises are associated with an additional improvement in clinical scores, fecal calprotectin and in self-perceived level of interference in pain and routine daily functions. These results suggest a positive effect of physical exercise in IBD and prompt further study.
P869 Deep ulcers in acute Ulcerative Colitis at index endoscopy predict corticosteroid resistance
Authors: Goncalves J , Macedo Silva V , Macedo C , Arieira C , Cúrdia Gonçalves T , Dias Castro F , Magalhães J , João Moreira M , Cotter J
Published: January 2024

Background

Ulcerative Colitis (UC) is a chronic inflammatory disease affecting the colon. Its acute form can be life-threatening, necessitating hospital admission and intravenous (IV) corticosteroid treatment. This study aimed to predict IV corticosteroid response in acute UC patients based on endoscopic findings at admission.

Methods

Individuals admitted to the hospital for acute UC for intravenous corticosteroid treatment were selected. Those with gastrointestinal infections and those without endoscopy at admission were excluded.

Results

A retrospective analysis was conducted on a cohort of 62 patients, of which 25.8% did not respond to IV steroids. No significant associations were found between demographic, clinical, and laboratory parameters and corticosteroid response at admission. Rectosigmoidoscopy was performed for all patients upon hospitalization, and the Mayo Endoscopic Score (MES) and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) were obtained. The results revealed significant differences in median UCEIS scores between non-responders and responders (7, IQR 3 vs. 5, IQR 1, p=0.011). Notably, a UCEIS score of ≥5 demonstrated a sensitivity of 100% in identifying patients who did not respond to corticosteroids, although with a lower specificity of 22.7%. Furthermore, the MES exhibited a statistically significant association with treatment response (p=0.002), with a MES≤2 having a negative predictive value of 92.9% for IV steroid resistance. Importantly, the presence and type (small vs. large) of ulcers at the initial endoscopy were found to be the most effective predictive factor for corticosteroid response (AUC=0.745; 95%CI=0.594-0.896; p=0.005), as 57.1% of patients with deep ulcers were non-responders.

Conclusion

The importance of evaluating ulcer severity during endoscopic assessment in patients with acute ulcerative colitis is underscored by our findings. Notably, the presence of deep mucosal ulcerations should prompt consideration for intensifying therapy.
P873 Ustekinumab Real World Evidence Study (UndieS): Assessing the suitability of patients treated in routine clinical care for participation in the pivotal phase 3 clinical trial
Authors: Young D , Booker C , Batchelor J , Bodger K , Cummings F
Published: January 2024

Background

Phase 3 randomised controlled trials (RCTs) are recognised as the gold standard for measuring the efficacy of new medicines and are essential for licensing new products. To maximise internal validity, RCTs recruit a highly selected, carefully defined group of participants, whereas patients treated in routine practice are much more heterogeneous. We set out to describe the real-world use of ustekinumab and assess the proportion of treated patients who would have been eligible for the relevant registration studies.

Methods

UndieS is a UK-based, multicentre, prospective, observational study investigating the effectiveness of ustekinumab in 593 Crohn’s disease patients. Objective evidence of active Crohn’s disease (biochemical or endoscopic) and/or failure or intolerance to another therapy were the only entry criteria. Within the limits of the study, we compared participants’ characteristics with the eligibility requirements of the UNITI clinical trial programme. The pragmatic modified Harvey-Bradshaw Index (mHBI), shown to correlate to CDAI score, was used in UndieS. No endoscopic follow up information was collected.

Results

82% of patients treated in this real-world study would not have been eligible for participation in the UNITI programme. Eight RCT eligibility criteria would each be expected to exclude at least 10% of the real-world patient population (figure 1). A low disease activity score was the eligibility criterion most frequently expected to render UndieS participants ineligible for the UNITI programme with 61% of predicted CDAI scores (i.e. estimated from mHBI) falling below the threshold for RCT eligibility, despite 80% of those treated having objective evidence of inflammation and 55% failed/ were intolerant to an alternative therapy. Only 13% of participants were using corticosteroids at baseline. 59% of UndieS participants had previously failed or been intolerant to at least one anti-TNFα medication. For those who would have been ineligible for the RCT based on laboratory tests, an elevated ALT was the commonest abnormality among UndieS participants. The requirements for multiple venepunctures and pregnancy avoidance were the most relevant impediments for UndieS patients, with 28% of females of childbearing potential not willing to agree to the specified conditions.

Conclusion

Within the limitations of this study, we have demonstrated a significant disparity between participants in phase 3 RCTs and patients treated in routine clinical care. This questions the applicability of efficacy studies to real world clinical practice. Data from high quality, observational studies should complement findings from RCTs to support decision makers. Future work will investigate whether outcomes differ according to RCT eligibility.
P877 A comparison of vedolizumab and ustekinumab treatment in patients with Ulcerative Colitis after failure of treatment with tumor necrosis factor inhibitor
Authors: Helm Wiken T E , Høivik M L , Buer L , Warren D J , Bolstad N , Anisdahl K , Lundekvam J , Hagen M , Medhus A W
Published: January 2024

Background

Data comparing vedolizumab (VDZ) and ustekinumab (UST) in patients with ulcerative colitis (UC) previously treated with tumor necrosis factor inhibitor (TNFi) and followed with regular serum-drug measurements are scarce. In the national pharmaceutical tender system of Norway, VDZ was listed as the first drug of choice after failed TNFi treatment from 2016 to 2019 and UST from 2020 to 2022. We aimed to compare drug persistence, effectiveness, drug dosing and disease activity in patients treated with VDZ or UST after failed TNFi therapy.

Methods

We included patients who had failed at least one TNFi and started either VDZ treatment (years 2016-2019) or UST (years 2020-2022). Patients were followed for one year after initiating the treatment or until discontinuation. Prospectively recorded data were obtained from the electronic patient journal (EPJ) and the local IBD-registry. Clinical remission was defined as 6-point Mayo Score ≤1, and biochemical remission was defined as CRP<5 mg/L and FC<250 µg/g. Patients were followed with regular serum-drug measurements and dose adjustments were made at the discretion of the treating physician based on serum-drug measurements and clinical activity at follow-up visits. Wilcoxon signed rank and Mann Whitney U test were used to assess differences in paired and unpaired data, respectively.

Results

A total of 116 patients were included, 59 treated with VDZ and 57 with UST. At 52 weeks, there was no difference in estimated drug persistence with 85% [73-92] for VDZ and 92% [80-96] for UST. Clinical remission increased significantly in both groups (Table 1), and no difference was found between UST and VDZ for clinical remission at week 0 and 52 (OR=2.1 [0.9-4.5] and OR=0.9 [0.3-2.3]). Contrary to the VDZ group, there was a significant decrease in CRP from week 0 to 52 in the UST group, while FC decreased significantly in both groups (Table 1). The proportion of patients in biochemical remission increased in the UST group while there was no significant change in the VDZ group. Significantly more patients treated with UST received an intensified treatment regime at 52 weeks (interval less than eight weeks) compared to VDZ treated patients (87% (95% CI [74-94]) vs 59% (95% CI [45-72])).

Conclusion

This study demonstrates that one-year drug persistence and clinical remission were high and comparable in both UST and VDZ treated UC patients with previous TNFi failure. Treatment with UST, but not VDZ, was associated with a significant increase in the proportion of patients in biochemical remission from induction to 52 weeks. However, a significantly larger proportion of patients treated with UST received intensified dosing at 52 weeks compared with VDZ treated patients.
P878 Assessment of Ulcerative Colitis Relapse Risk Using RDI (Red Dichromatic Imaging)
Authors: Hashimoto Y , Itoi Y , Tomaru S , Sato K , Tanaka H , Shiko K , Yoji T , Uraoka T
Published: January 2024

Background

In the management of patients with UC, mucosal healing has been proven to be a therapeutic goal and a factor influencing prognosis. It has been reported that MES 1 has a higher rate of recurrence than MES 0. However, it has been reported that MES 0 also has a relapse rate of approximately 10%. Red dichromatic imaging (RDI) is a new imaging technology that has been closely correlated with the activity index of UC. (Naganuma et al. Endosc Int Open 2017). It also correlates with histological findings and holds promise as a modality that could further stratify MES 0 (Hashimoto et al. Surgical Endosc 2023). However, it is unclear whether RDI findings is associated with UC relapse. The aim of this study was to investigate the predictive ability of RDI for UC relapse.

Methods

This was a single-center retrospective study. A total of 93 clinically remitted UC patients who underwent colonoscopy at our department from May 2019 to October 2021 were enrolled, and at least one RDI and WLI image was taken at each of six sites from the cecum to the rectum. Patient information and still images of RDI and WLI were blinded, and two physicians independently evaluated both images taken using the RDI score of Naganuma et al. Clinical remission was defined as partial Mayo Score (pMayo) 0-1, and relapse was defined as pMayo ≥ 2 and additional treatment.

Results

The median after observation was 1022 days (5-1427 days), and the overall cumulative relapse rate was 24 % (21 patients), The mean of RDI score was 2.02, with 37 patients in RDI score 1, 28 patients in RDI score 2, 17 patients in RDI score 3, and 11 patients in RDI score 4. The relapse rate for RDI score 1 was 0%, 18% (5 patients) for RDI score 2, 47% (8 patients) for RDI score 3, and 73% (8 patients) for RDI score 4.73 % (8 patients).None of the patients with RDI score 1 had a relapse, In contrast, 11% (6 of 54) of MES 0 patients relapsed, and 33% (8 of 24) of MES 1 patients relapsed. 31 patients had RDI score 1 and 17 patients had score 2 in MES 0, which could be stratified within MES 0 by using the RDI.

Conclusion

This study suggested that the RDI score can further stratify MES 0, which is defined as mucosal healing, and may be a more accurate predictor of relapse.
P887 Comparative efficacy of JAK inhibitors versus vedolizumab in patients with hypoalbumineamia and Ulcerative colitis
Authors: Pearman K , Saini V , Vincent S , Rhodes S , Harvey P
Published: January 2024

Background

The IBD community are seeking ways to personalize medication choices for individual patients. Hypoalbumineamia is a poor prognostic marker in ulcerative colitis (UC) as a surrogate marker of disease activity. Biologic molecules are intermittently dosed using albumin binding to maintain plasma concentration, therefore in low albumin states drug clearance is accelerated. This effect is potentially less significant in regularly dosed, JAK inhibitors (JAKi).

Methods

All patients at our unit taking a JAKi were included. Patients using vedolizumab were selected for inclusion based on the nearest neighbour with respect to medication start date. Vedolizumab was chosen as a second line advanced therapy used regularly in UC. Demographic and disease characteristics were collected. Blood tests immediately prior to starting medication were collected. Outcome measure was response to treatment based based on drug continuation and clinician documentation of treatment success at 6 months.

Results

56 patients were included; 28 receiving a JAKi, 28 patients using vedolizumab. The JAKi group consisted of 8 patients receiving Filgotinib, 12 Tofacitinib and 8 Upadacitinib. Patients receiving JAKi were younger (mean age 44 years, SD 14) compared to vedolizumab (56 years, SD 20). Both were predominantly white (JAKi n=16, Vedolizumab n=22). Chronic liver disease was uncommon in both groups; JAKi n=2 (7.1%) and vedolizumab n=3 (10.7%), none of whom had cirrhosis. More hospital admissions were observed in the year prior to starting treatment in patients who received JAKi (n=16, 57.1%) compared to vedolizumab (n=9, 32%). Hypoalbuminaemia (defined as ≤30g/L) was seen in 5 patients in each group. In patients receiving JAKi 16/23 (69.7%) patients without hypoalbuminaemia responded to treatment at 6 months, compared to 3/5 (60%) with low albumin. (p=0.999). In patients receiving Vedolizumab 18/23 (78.3%) patients responded to treatment at 6 months, compared to 1/5 (20%), (p=0.026).

Conclusion

In patients with hypoalbumineamia, vedolizumab was less effective compared to normal albumin states. A similar effect was not observed in patients receiving JAKi. Numerically the efficacy of both vedolizumab and JAKi was worse in patients with hypoalbuminaemia, as would be expected given the likely reflection of increased disease severity. This data suggests that those patients requiring advanced therapy with hypalbuminaemia might respond better to a JAKi. Further research is needed to investigate this finding.
P897 The association of HLA-DQA1*05 carriage with immunogenicity to anti-tumour necrosis factor therapy and drug persistence in Asian patients with inflammatory bowel disease
Authors: Liang R , Lin H , Goh L L , Lim W C
Published: January 2024

Background

HLA-DQA1*05 carriage increases anti-tumour necrosis factor (TNF) immunogenicity and lowers drug persistence in European inflammatory bowel disease (IBD) patients. There is a paucity of data for Asian patients. We hypothesize that the HLA-DQA1*05 allele is present in our local IBD population and may be associated with similar clinical and pharmacokinetic outcomes as European cohorts.

Methods

A single-centre retrospective study of consecutive IBD patients on Infliximab (IFX) or Adalimumab (ADM) was performed.

HLA-DQA1*05 carriage was tested with Sanger sequencing. Serum anti-drug antibody (ADA) levels were analysed at each IFX infusion and per physician discretion for ADM. Concomitant immunomodulator (IM) therapy with Azathioprine or Methotrexate was recorded.

Primary outcome was immunogenicity to IFX or ADM, defined as ADA concentration ≥10 AU/ml at any time point. Secondary outcomes were loss of response (LOR), defined as IBD symptom-related treatment intensification, and persistence, defined as anti-TNF continuation at end of follow-up. The effects of HLA-DQA1*05 carriage on outcomes and predictors of persistence were analysed.

Results 39 patients (28 Crohn’s disease, 11 ulcerative colitis) were included (mean age 39 years, median disease duration 10 years). 24 patients had IFX as first anti-TNF agent (21 with IM, 3 as monotherapy), 7 of whom had second-line ADM with IM. 15 patients had ADM as first anti-TNF agent (13 with IM, 2 as monotherapy), 2 of whom had second-line IFX (1 with IM). 15/39 (38.5%) patients were positive for HLA-DQA1*05. 42/48 (87.5%) of anti-TNF exposures were on IM.

In HLA-DQA1*05 carriers compared to non-carriers, development of ADA (61.1% vs 47.8%, p=0.397) and LOR (42.1% vs 31.0%, p=0.433) was numerically higher but not statistically different. Persistence of first anti-TNF agent was similar between carriers and non-carriers at the end of follow-up (median 28.0 months vs 21.5 months, p=0.364) (Figure 1). ADA development was not associated with LOR (p=0.07) or persistence (p=0.29).

19/48 (39.6%) of anti-TNF exposures discontinued treatment at the end of follow-up, 13 of whom experienced LOR. 10/13 (76.9%) of patients with LOR were female. Female sex was significantly associated with anti-TNF non-persistence on univariable (OR 4.82, 95% CI 1.38-16.75, p=0.01) and multivariable logistic regression (OR 7.24, 95% CI 1.35-38.90, p=0.02), after adjusting for HLADQA1*05 carriage, presence of ADA and anti-TNF order (first versus second-line) (Table 1).

Conclusion

In Asian IBD patients, HLA-DQA1*05 carriage may not affect immunogenicity nor treatment persistence, especially with proactive therapeutic drug monitoring and concurrent IM. Female sex negatively affects persistence. Larger prospective studies are needed.
P917 Ustekinumab and immunomodulatory combination therapy is more effective than Ustekinumab monotherapy to prevent relapse in Crohn’s patients classified as low to intermediate-probability responders by UST-CDST
Authors: Song J H , Shin J , Seong G , Kong S M , Cha B , Hong J T , Kwon K S
Published: January 2024

Background

Ustekinumab (UST) is a monoclonal antibody that has therapeutic effects on Crohn’s disease (CD) by blocking interleukin 12 and 23. Controversy remains about the effectiveness of the combination of UST and azathioprine(AZA) and the criteria for patients who may benefit from the combination therapy. The aim of this study was to evaluate the effect of combination therapy on relapse in patients with CD and the feasibility of UST - Clinical Decision Support Tool (CDST) as a patient selection tool for combination therapy.

Methods

Patients with moderate to severe CD showed a clinical response after UST induction therapy and observed until the relapse. Kaplan-Meier analysis was performed to evaluate the efficacy of UST with AZA and to investigate the screening ability of UST-CDST for combination therapy selection.

Results

Among 35 patients, 8 (22.9%) experienced a clinical relapse during the median follow-up period of 17.0 months of UST treatment. There was no statistically significant difference in the cumulative relapse rate according to combination therapy in all enrolled patients. (6.7% vs 35%, p=0.063) The cumulative relapse rates were 8.3% in a combination therapy group, and 43.7% in UST monotherapy group among low to intermediate-probability responders according to UST-CDST, showing a statistically significant difference. (p=0.032)

Conclusion

Combination therapy with UST and AZA seems to be helpful prevent relapse, and UST-CDST may be helpful in patient selection who effective with combination therapy.
P921 Maintenance of clinical, biochemical and transmural remission in inflammatory bowel disease patients switching from intravenous to subcutaneous infliximab
Authors: Piazza O Sed N , Maregatti M C , Pessarelli T , Viganò C , Conforti F , Noviello D , Bezzio C , Amoroso C , Molteni C , Anolli M P , Pirola L , Saibeni S , Fraquelli M , Vecchi M , Caprioli F
Published: January 2024

Background

Subcutaneous (SC) infliximab (IFX) effectively maintains biochemical, clinical and endoscopic remission in inflammatory bowel disease (IBD) with a comparable safety profile to intravenous (IV) formulation. Transmural healing is considered a desirable long-term treatment endpoint in IBD, especially in Crohn’s disease (CD). Whether switching from intravenous to SC-IFX effectively maintains transmural remission in IBD is still unknown.

Methods

This is a preliminary report from a prospective multicentre cohort study on IBD patients in clinical and endoscopic remission on IV-IFX treatment switched to SC-IFX. Enrolled patients were followed-up for 12 months, with fecal calprotectin (FC), C-reactive protein (CRP), infliximab trough levels and anti-drug antibodies (ADAs) measured at baseline, at 3, 6 and 12 months. Intestinal ultrasound (IUS) was performed at baseline and every six months. At month 12 a full colonoscopy was performed for mucosal healing assessment. Remission rates and safety profile were subsequently recorded. T-Test and ANOVA for mean comparisons and Kaplan-Meier estimates were used for survival curves.

Results

43 IBD patients (69% males) were enrolled, 58% with CD, of whom 52% reported a history of perianal disease. Median disease duration and IFX therapy were 6 (IQR 3-12) and 5 (IQR 2-9) years, respectively. During a median follow-up of 311 (range 122-489) days, clinical remission rate was 98% (Harvey-Bradshaw Index <5 and Mayo score <2). No reactivation of perianal disease was reported. FC and CRP remained stable at each time point (p> 0.05). The median baseline infliximab level was 10.02 ( range 0.1- 41.84) ug/ml. Undetectable infliximab levels (<1 ug/ml) and positive ADAs were found in 6 and 14 patients, respectively; at 3 months, a significant increase in infliximab levels (mean increase 27.5 ng/ml; ± 12.5 SD; p< 0.001) and a progressive decrease of ADAs titer were observed, despite unchanged SC-IFX dose. At baseline, all patients had normal bowel wall thickness (i.e. ileum ≤ 3mm, colon≤4 mm) and a Limberg score ≤1at IUS; reactive lymphadenopathies were reported in 5 patients and a mild abdominal effusion in 1. No significant changes were shown during follow-up. Mild endoscopic activity was found in 2 out 30 patients who performed follow-up endoscopy. Regarding safety profile 12 mild infectious events, 2 mild cutaneous injection site reaction and 1 non-IBD related hospital admission were observed.

Conclusion

Switching from IV to SC infliximab in a selected cohort of IBD patients confirmed to be safe and effective in maintaining clinical, biochemical, and transmural remission. IUS is a useful, non-invasive and low-cost tool for periodic disease assessment in this subset of patients.
P924 Function and outcomes of ileal-pouch anal anastomosis in patients with connective tissue disorders
Authors: Schabl L , Holubar S , Erozkan K , Alipouriani A , Steele S , Spivak A
Published: January 2024

Background

Ileal-pouch anal anastomosis (IPAA) is a widely preferred surgical intervention for patients with medically refractory ulcerative colitis, familial adenomatous polyposis, and indeterminate colitis. Concerns have been raised regarding the impact of connective tissue disorders on the outcomes of IPAA due to potential alterations in collagen metabolism. To date, there is a lack of studies assessing the feasibility, long-term viability and pouch function of IPAA in patients with connective tissue disorders. We hypothesized that the presence of a connective tissue disorder might be associated with a higher rate of pouch complications and failure.

Methods

Data were collected from a prospectively maintained pouch database and chart reviews. Patients with connective tissue disorders were propensity score matched in a 1:5 ratio with control pouch patients without connective tissue disorder. A comparative analysis of demographics, long-term complications, functional outcomes, and quality of life was conducted.

Results

A total of 19 patients with connective tissue disorders were matched to 95 control pouch patients. The postoperative diagnoses were ulcerative colitis (82.5%), indeterminate colitis (7%), constipation (5.3%), Crohn's disease (4.4%), and familial adenomatous polyposis (1%) Connective tissue disorders identified, included unspecified diffuse connective tissue disorders (26.3%), Ehlers-Danlos syndromes (15.7%), Sjogren's syndromes (15.7%), and others. Patients with connective tissue disorders were more likely to experience pouchitis (79% vs. 56%, p=0.04). Differences in rates of pouch prolapses (10.5% vs. 4.2%, p=0.26) and of pouch failure (26.3% vs. 13.7%; p=0.17) were present but failed to achieve statistical significance. Functional outcomes, and quality of life were similar in both groups.

Conclusion

IPAA remains a feasible surgical option for patients with connective tissue disorders, offering comparable functional outcomes and quality of life. Physicians treating patients with these disorders should be aware of a potentially elevated risk of pouchitis, pouch prolapse and pouch failure.
P947 medical cannabis increases appetite but not body weight in patients with inflammatory bowel diseases
Authors: Fliss Isakov N , Seidenberg C , Meiri D , Yackobovitch-Gavan M , Maharshak N , Hirsch A
Published: January 2024

Background

Medical cannabis (MC) is prescribed to improve appetite and nutritional status in patients with inflammatory bowel diseases (IBD) despite no supporting evidence. We aimed to describe the effect of MC on appetite and dietary intake among patients with IBD.

Methods

An observational prospective cohort study, among patients with IBD, initiating treatment with MC for disease related symptoms, at the IBD clinic of a tertiary referral medical center. Patients' demographics, anthropometric measurements, medical history, cannabis use history, and medical treatment were documented and an appetite questionnaire (SNAQ), and food frequency questionnaire (FFQ) were filled before MC initiation and throughout 6 months of treatment.

Results

Of patients enrolled in the study (n=149, age 39.0±14.1 years, 42.3% female) and treated with MC for disease related symptoms, on top of their routine therapy regimen, while 33.6% received MC for increasing appetite and improving nutritional status. Among patients treated for raising appetite and improving nutritional status, 34.0% experienced a significant increase in appetite after 3 months. None the less, all patients experienced a modest increase in appetite (P<0.05), a trend which was more profound among patients treated with high THC/CBD ratio (SNAQ score 27.0±4.1 at 3 months vs. 25.2±3.6 at baseline, P=0.021). Nonetheless, this increase in appetite throughout the study did not result in increased energy, macronutrient intake or in BMI following MC treatment. Among patients without a significant increase in appetite by 3 months of MC therapy, a significant decrease in BMI was noticed at 6 months (24.1±3.7 at baseline vs. 23.4±3.6 at 6 months, Pv=0.010).

Conclusion

Use of MC, and specifically THC, may be a potential strategy to improve appetite among some patients with IBD. This increase in appetite was not associated with an increase in caloric intake or in BMI at follow-up.