bluuebunny/crossref_metadata_2025_split huggingface dataset:
P677 Combination of vedolizumab and exclusive enteral nutrition in patients with moderate to severe Crohn’s Disease
Authors: Kang J , Wang J , Lu Y , Li J , Su J , Ying A , Ren H , Zhou Q , Wang Y , Ding Y , An P 
Published: January 2023

Abstract

Background
Crohn’s disease (CD) is an incurable chronic inflammatory condition of the gut. It causes severe gastrointestinal and extraintestinal complications and is associated with high morbidity, poor quality of life and increased health expenditure. Although increasing randomized controlled tests (RCT) studies demonstrated the premise of efficacy of biologics including vedolizumab in adult patients with active CD, there’re still 60% of patients hard to achieve clinical and endoscopic remission in real-world studies. Here, we investigated the efficacy of combination strategy of vedolizumab and exclusive enteral nutrition (EEN) in moderate to severe active CD treatment.

Methods
Twenty-eight patients with moderately to severely active CD patients treated with vedolizumab in IBD medical center of Renmin Hospital of Wuhan University in Hubei Province were retrospectively enrolled in this cohort. All patients received EEN for 16 weeks with concomitant vedolizumab standard induction. The clinical response, clinical remission, and fecal calprotectin (FC) normalization was evaluated in short- (week 16) and moderate-term (week 32 and 48). Endoscopic response and mucosal healing were assessed at week 16 and 48 (Figure 1).
Figure 1: Study design

Results
Following vedolizumab intravenous induction and 16-weeks EEN treatment, patients achieved 71.4% (20/28) of clinical remission, 73.1% (19/26) of endoscopic response and 71.4% (20/28) FC normalization at week 16. For moderate-term assessment at week 32, sustainable efficacy of current treatment induced 19/24 (79.2%) of clinical response, 15/24 (62.5%) of clinical remission and 16/24 (66.7%) of FC normalization. Clinical response (15/22, 68.2%) and mucosa healing (14/22, 63.6%) were also observed in over 60% of patients at week 48 since treatment induction (Figure 2,3).
Figure 2. Clinical and biochemical endpoints

Figure 3. Endoscopic endpoint

Conclusion
Combination of Vedolizumab and 16-weeks EEN increased clinical and endoscopic outcomes in short and moderate term for patients with moderate to severe Crohn’s Disease.
P679 Is the burden of obesity in IBD bigger than just weight?
Authors: Madigan S , Mountifield R , Barnes A ,   M
Published: January 2023

Abstract

Background
In the past IBD has been thought to cause low body weight however current estimates show that 15-40% of those with IBD are obese. Obesity is a pro-inflammatory state and has been linked to disease processes such as psoriasis and rheumatoid arthritis. There is some limited data to suggest that obesity also affects disease activity in IBD. In addition, medical therapy for IBD such as corticosteroids and TNF-alpha inhibitors are associated with weight gain. The aim was to determine the relationship between obesity and IBD disease severity. And also to determine the relationship between obesity, depression, anxiety and QoL in those with IBD.

Methods
As part of the IBD-SLEEP study a survey was emailed to patients via tertiary hospital IBD unit email lists, private gastroenterology group email lists and advertised online. IBD activity was assessed using the Harvey Bradshaw Index and the Simple Crohn’s Colitis index as appropriate. The survey included measures of clinically significant depression (PHQ9&gt;10) and anxiety (GAD7&gt;10), as well as disability (IBD-DI reduced form) and quality of life (EQ-5D-5L).

Results
They were 585 responses with mean age of 42 years (SD 13). The majority were female (80%) and had Crohn’s disease (61%). Mean weight of cohort was 79.2kg (SD 20), mean BMI was 28 (SD 7), with 61% overweight (BMI &gt; 25), and 38% obese (BMI&gt;30). People with obesity were more likely to have active disease (HBI or SCCAI &gt; 5) in those with Crohn’ disease (OR 2.39 (1.47-3.89), p&lt;0.001) but not ulcerative colitis (OR 1.26 (0.68-2.31), p=0.46). Obese patients were also found to have higher levels of disability (IBD-DI reduced form, p&lt;0.001) and lower quality of life (EQVAS, p&lt;0.001). Interestingly there was an association between obesity and depression (PHQ9&gt;10, OR 2.06 (1.42-2.99), p&lt;0.001) but not obesity and anxiety (GAD7&gt;10, OR 1.03, (0.74-1.45), p=0.16).

Conclusion
Obesity is not only a risk factor for metabolic disease but is also associated with active IBD in those with Crohn’s disease. Obesity was also associated with clinically significant depression, increased disability, and lower quality of life. Although causation is not established, consideration should be given to more aggressive management of obesity in an IBD outpatient setting.
P683 Risk factors for fatigue in IBD patients.
Authors: Sina M , Djegsi A , Pemaj X , Telaku* S , Babameto A , Prifti S 
Published: January 2023

Abstract

Background
Fatigue is a common symptom, in IBD patients, ranging from 40% to 86% in patients with active disease, and 20% to 48% in those in remission. The aim was to determine the degree of fatigue and to identify possible factors associated to its presence in our patients.

Methods
Consecutive patients presented at our outpatient IBD clinic from 2021 to 2022 were included. Demographic data, disease activity scores, endoscopic scores, disease duration, localization, hospitalization, laboratory data, were collected for each patient. Working status was determined on the patient’s actual ability to work. Total Mayo score (TMS) and Crohn’s disease activity index (CDAI) were used to assess disease activity in patients with ulcerative colitis (UC) and Crohn’s disease (CD) respectively. Clinical remission was defined as TMS ≤ 2 points, or CDAI &lt; 150 points. Presence of inflammation was defined C-reactive protein ≥ 5.1 mg/L. Presence of anxiety and depression was evaluated using Hospital Anxiety and Depression Scale HADS and fatigue was assessed with self-administered questionnaire IBD Fatigue Rating Scale (FRS). Based on FRS, 2 groups of patients were created: group A with slight to moderate fatigue (1-60 points) and group B patients with severe fatigue (61-120 points).

Results
A total of 48 IBD patients were included; mean age was 40.9±16.0 years, 60.4% females; 89.6% UC. Mean disease duration was 5±4.6 years. Of UC patients, 44.2% were in clinical remission, 16.3% had mild disease, 30.2% moderate disease, and 9.3% severe disease. Of CD patients, 40% were in clinical remission and 60% had active disease.
Severe fatigue was found in 8/48 (16.7%) of patients, and was significantly higher in those with active disease (p=0.039), presence of inflammation (p=0.018), and anxiety (p=0.059). Mean fatigue score was 35.4±22.4 points with no statistical difference between CD and UC (p=0.404). Higher fatigue scores were observed among patients with presence of active disease (p=0.036); among patients with higher TMS scores (p = 0.022); in patients with anxiety (p=0.01), and in patients with depression (p=0.004).
On multiple linear regression, only vitamin D levels and working status were associated with fatigue severity (p= 0.052; p= 0.049, respectively R2 =0.062).

Conclusion
Our study findings confirm that the most important factors associated with fatigue during IBD course, are disease activity, presence of inflammation, presence of anxiety and/or depression. Low vitamin D level and working status were predictive factors for fatigue severity. These results highlight the complexity and variability of fatigue in IBD patients.
P684 Extra intravenous reinduction of ustekinumab on an already shortening interval is an effective optimisation strategy for patients with refractory Crohn’s disease
Authors: Yao J , Liu T , Min Z 
Published: January 2023

Abstract

Background
Designing treatment optimisation strategy for ustekinumab (UST) is challenging. We aimed to evaluate the efficacy and safety of extra weight-based intravenous reinduction of UST on an already shortening interval in patients with refractory Crohn’s disease (CD). To the best of our knowledge, this is the first study to report optimised UST treatment in a Chinese population.

Methods
This was a single-center retrospective observational study. Dosing optimisation strategies were designed for CD patients showing partial or loss of response to standardised UST with a shortened interval of every-8-week (q8w) dosing, or an extra weight-based intravenous reinduction followed by q8w subcutaneous administration. Clinical, biochemical, and endoscopic findings and trough concentrations of UST were analyzed.

Results
Dose optimisation strategies were developed for 27 out of 64 patients; 13 patients required a shortened q8w interval and 14 patients required intravenous reinduction. Crohn’s disease activity index [96.5 (39.8,156.3) vs. 158.0 (101.5,175.3), P=0.009] and C-reactive protein [3.3 (1.1,7.0) vs. 4.8 (0.5,15.1), P=0.023] levels decreased significantly after intravenous reinduction, while the trough concentration of UST increased [1.8 (1.2,8.6) vs. 1.1 (0.2, 6.4), P=0.009]. Clinical and endoscopic remission was achieved in 57.1% (8/14) and 33.3% (2/3) of patients, respectively, while 53.8% (7/13) and 25.0% (2/8) of patients achieved clinical and endoscopic remission at around week 8 in the q8w cohort, respectively. The incidence of patient-reported adverse effects was 3.7%. (Figure 1)

Conclusion
Intravenous reinduction improved clinical and endoscopic remission safely and effectively in patients showing poor response to standardised UST treatment, which should be an optimal rescue optimisation strategy before switching to biologics targeting other pathways.
P685 Early use of infliximab after seton technique for patients with Crohn’s disease who initially presented with perianal fistulas
Authors: Lim K Y , Hwang D Y , Lee J K 
Published: January 2023

Abstract

Background
Widespread early use of biologic agents cannot be recommended for all Crohn’s disease patients, but for patient subgroups with a predicted disabling course such as perianal fistulas, the early introduction of a biologic agent can be considered. The aim of this study was to assess the outcome of the early use of infliximab after seton technique for patients with Crohn’s disease who initially presented with perianal fistulas

Methods
We retrospectively reviewed charts of patients with Crohn's disease who initially presented with perianal fistulas between January 2020 and December 2021. After confirm diagnosis of CD by endoscopic examination, all patients underwent both seton procedure and infliximab therapy by single colorectal surgeon. After third injection of infliximab, we removed silastic seton at once, or, in the case of active fistula, replaced it with nylon, and then removed it when the fistula was in remission. Outcomes included clinical remission based on physical examination with radiologic examination (including sonogram and MRI) and endoscopic findings up to last follow up.

Results
Overall, 31 patients were identified, [29 males (94%), mean age at diagnosis of Crohn’s disease 21.2 (9-32) years]. Half of patients (15/31) showed moderate to severe bowel severity at pre-treatment colonoscopy. Mean number of fistulas was 1.6 (1-4). The overall number of primarily placed setons was 70, of which 33 were inserted through the primary opening and the other 37 were placed between secondary openings. The mean interval between seton insertion and introduction of infliximab was 17.2 (7-30) days. The number of patients who changed silastic seton to nylon was 11. The mean follow-up was 24 months. In 27 patients, Setons were completely removed until last follow up. Interval between seton insertion and complete removal was 7 months ranged from 3 to 24 months. In colonoscopy performed 1 year after infliximab introduction, luminal Crohn's disease of most patients was in endoscopic remission (20/31) or improved (11/31) and there were no case of exacerbation. In 3 patients, because of local sepsis or pain after seton removal, seton procedure was performed again. 30 patients were in clinical remission and had no anal discomfort.

Conclusion
Early use (within 30 days) of infliximab after seton technique was very effective for patients with Crohn’s disease who initially presented with perianal fistulas. Seton removal should be started at least after remission induction. And replacing silastic seton with nylon was a simple and effective method.
P688 Patient preferences in medication to treat Ulcerative Colitis: a discrete choice experiment
Authors: Straatmijer T , van den Akker-van Marle E , van der Horst D , Scherpenzeel M , Duijvestein M , van der Meulen A 
Published: January 2023

Abstract

Background
Since the number of treatment options for Ulcerative Colitis (UC) has expanded, patients and physicians face challenges regarding decisions about the medication options. In shared decision making, treating physicians help patients understand the trade-offs and their own preferences. We aimed to identify patients preferences about the relative risks and benefits of UC treatment options in patients with UC in the Netherlands. Furthermore, we assessed after how many failed treatment options, patients are willing to consider surgical treatment.

Methods
We conducted a web-based, discrete choice experiment (DCE) among adult UC patients. Patients were repeatedly asked to choose between two hypothetical treatment options with varying combinations of attribute levels (fig 1). Attributes were based on consecutively a literature search, patient interviews, surveys and a focus group. The six included attributes were: administration route, administration location, chance on symptom reduction (short and long term), chances on infection and on adverse events. A balanced overlap design was used. Patients were recruited via the patient association Crohn & Colitis NL and in two academic hospitals. Data were analyzed by using Hierarchical Bayes estimation.

Results
A total of 172 patients participated in the DCE. Median disease duration was 8 (IQR 3-16) years. Most patients were anti-TNF experienced (52.9%). Symptom reduction after one year (relative importance (RI) 27.7 (95% CI 25.6-29.7)) was the most important when choosing between treatment options (table 1), followed by the chance of infection (22.3 (21.2 - 23.4)) and chance of symptom reduction after eight weeks (RI 19.5 (18.1 - 20.9)). The location of administration of the treatment and the chance of adverse events were the least important (8.7 (7.7 - 9.79) and 8.5 (7.9 - 9.2), respectively). Patients preferred oral administration over subcutaneous injections. Intravenous route of administration was least favorite. The differences in average utilities of patients previous treated with biologic therapy or small molecules or naïve patients are displayed in table 2. 133 patients filled in the trade off questions regarding surgery. Forty-four patients (33.1%) responded with unknown. Nineteen patients (14.3%) would not even consider surgery after failing all treatment options without any new available therapies left. Nine patients would consider surgery before trying any treatment options. Of the remaining patients, nine (6.8%) would consider surgery after failing six treatment options.

Conclusion
We found that symptom reduction after one year was the most important treatment attribute in UC patients. These outcomes can help understand the trade-offs and preferences of UC patients.
P690 Prolonged benefit of filgotinib in patients with Ulcerative Colitis in SELECTION
Authors: Laharie D , Sturm A , Kobayashi T , Matsumoto T , Oortwijn A , Jamoul C , Faes M , de Haas A , Vermeire S 
Published: January 2023

Abstract

Background
Filgotinib (FIL) is a once-daily, oral, Janus kinase 1 preferential inhibitor approved for the treatment of patients with ulcerative colitis (UC) in the UK, EU and Japan. In the phase 2b/3 SELECTION trial (NCT02914522),1 FIL 200 mg (FIL200) was well tolerated and effective in inducing and maintaining clinical remission vs placebo (PBO) in patients with UC. This post hoc analysis of SELECTION data further evaluated the prolonged benefit of FIL treatment from week 10 (W10) until W58.

Methods
In SELECTION, adults with moderately to severely active UC were randomized 2:2:1 to receive FIL200, FIL 100 mg (FIL100) or PBO once daily for 11 weeks in Induction (IND) Studies A and B (biologic-naïve and -experienced patients, respectively). Patients in clinical remission or with a Mayo Clinic Score (MCS) response at W10 (responders) were rerandomized 2:1 to continue their IND FIL dose in the 47-week Maintenance (MNT) Study. This post hoc analysis evaluated the hazard ratio (HR) for protocol-specified disease worsening (PSDW) in patients who continued FIL200 during MNT (FIL200→FIL200) vs those rerandomized from FIL200 to PBO (FIL200→PBO). The proportion of patients with a prolonged benefit at W58 was also evaluated across all FIL200 and FIL100 MNT arms. A prolonged benefit was defined as clinical remission or an MCS response at W58, among W10 responders. Among patients with prolonged benefit at W58, the proportion of those who had Inflammatory Bowel Disease Questionnaire (IBDQ)-remission at W58 was also assessed across all FIL200 and FIL100 MNT arms.

Results
Baseline characteristics were similar between MNT arms, although biologic-experienced status was more common in patients who did not have a prolonged benefit vs those who did. FIL200→FIL200 treatment (n=199) reduced the risk of PSDW by 74% vs FIL200→PBO (n=98) (HR [95% CI]: 0.26 [0.17–0.40]; p&lt;0.0001) (Figure 1). PSDW was the most common reason for discontinuation among patients without prolonged benefit, across all arms. In the FIL200→FIL200 arm, 66.8% of patients who were in clinical remission or had an MCS response at W10 had a prolonged benefit at W58 vs 32.7% in the FIL200→PBO arm. Among patients in clinical remission at W10, 79.3% in the FIL200→FIL200 arm had a prolonged benefit (62.1% clinical remission; 17.2% MCS response) vs 44.4% in the FIL200→PBO arm (30.6% clinical remission; 13.9% MCS response) (Figure 2). In the FIL200→FIL200 arm, 82.0% of patients with prolonged benefit at W58 had IBDQ remission at W58 (Figure 3).

Conclusion
After a year of FIL200 treatment, two-thirds of patients who were in clinical remission or had an MCS response at W10, and ~80% who were in clinical remission at W10, had a prolonged benefit.
1. Feagan BG et al. Lancet 2021;397:2372–84.
P699 Ustekinumab therapy after biologic failure in patients with Crohn’s Disease – A real-world single centre experience
Authors: Majumder S , Bazarova A , Lorenzo Parigi T , Love M , Davis J , Ghosh S , Iacucci M , Shivaji U N 
Published: January 2023

Abstract

Background
Patients with Crohn’s disease (CD) often require multiple biological therapies due to loss of response. Anti-TNF drugs are generally used as first-line biologics followed by a switch of class. Ustekinumab (UST), an IL-12/23p40 antagonist is used often after anti-TNF failure. The aim of the study was to report on the outcomes of UST therapy with a median follow-up period of nearly 24 months.

Methods
All CD patients who commenced UST therapy were identified from EMR at a tertiary referral centre between January 2017 and December 2021. All relevant demographic and clinical data were collected. Data on clinical response (defined as a downgrade in disease activity based on clinician assessment & biochemical parameters), steroid-free duration, and long-term response to UST at 52 and 104 weeks were recorded. The response was assessed clinically and supported by biomarkers, cross-sectional imaging, colonoscopic data, and sustained maintenance of UST. The statistical analysis was carried out using the IBM® SPSS® Statistics software package Version: 28.0.0.0

Results

A total of 147 CD patients (M=65, 44%; median age 38years) were included in the analysis with a median follow-up period of 24 months (range 5-67 months). 82 (56%) patients had stricturing (B2), penetrating (B3) and perianal phenotype at baseline, and 50 (34%) had undergone the previous resection/s. 109 (75%) had documented moderate to severe disease activity and 139 (95%) patients were exposed to at least one biologic prior to treatment with UST. A total of 34 (23%) patients were on concomitant thiopurines at the start of treatment. Among 147 patients in our cohort, 143 (97%) showed clinical response to UST and remained on treatment at the end of the follow-up period. The distribution of patients as per disease activity at baseline, 52 and 104 weeks is illustrated in Figure 1. An improvement in haemoglobin levels was observed post-therapy with UST, which was statistically significant at 104 weeks (p&lt;0.001), with a corresponding significant reduction in faecal calprotectin levels (median reduction from 976 mcg/g ◊ 333 mcg at 104w; p&lt;0.001). Only 13(8.8%) patients had side effects that were directly attributed to UST therapy.

Conclusion
UST is an effective therapeutic option in patients with CD who have failed previous biologic therapy. In our cohort with a large proportion of patients with complicated and refractory disease, clinical response was observed regardless of their previous exposure status to biologics, and disease phenotype. UST appears to be well tolerated with a reasonable safety profile. The consistent response rates even after prolonged treatment periods mean that clinicians could safely continue UST for longer durations, where options are limited.
P708 Post-COVID-19 and Quality of Life in Patients with Immune Mediated Inflammatory Diseases
Authors: Schlosser T , Krasselt M , Elsing L , Hecker M , Holler B , Hoffmeister A 
Published: January 2023

Abstract

Background
Pandemic situation of the novel coronavirus disease (COVID-19) represents a challenging condition with a plethora of aspects. Symptoms of patients with immune mediated inflammatory diseases (IMID) such as inflammatory bowel disease and different rheumatic diseases are not well described. Persistent symptoms following acute COVID-19 are quite frequent.

Methods
IMID patients over the age of 18 years were prospectively asked for participation. Recruitment took place at our university outward centre between April and October 2022. Assessment was conducted as questionnaire-based study about the individual COVID-19 history since start of the pandemic in January 2020.

Results
156 patients filled in the documents. Large part of the participants had a diagnosis of inflammatory bowel disease (117 [75%] vs. 39 [25%] patients with rheumatic disease). Eightyone patients (51%) selfreported about a positive COVID-19 history. Diagnosis had usually been proven by PCR. In general, courses of infection were rather mild: Only two patients (2% of patients with reported COVID-19) were admitted to hospital due to COVID-19 with one of the two in need for intensive care. No symptoms of COVID-19 had been described by seven persons (9% of patients with reported COVID-19). Post-COVID-19 condition represents a not very well described continuum of persisting symptoms following acute course. WHO proposes a definition of at least one symptom, that persists three months from the onset of acute COVID-19. Twenty persons (25%) met this criterion; 19 patients (23%) were still suffering from post-COVID-19 at time of study participation. Quality of life (QOL) was globally assessed by a visual numeric scale (from 0 [=lowest QOL] to 100 [=highest QOL]). Mean/median of QOL reached 71.5/75 points in the cohort without post-COVID- 19 condition compared to 61.9/60 points in the post-COVID-19 cohort, respectively. One-sided t-test showed significant association of post-COVID-19 condition to lower QOL (p=.03).

Conclusion
A notable fraction of IMID patients suffered from post-COVID-19 condition. This condition had negative impact towards quality of life.