bluuebunny/crossref_metadata_2025_split huggingface dataset:
P979 Diet, disease activity and extraintestinal symptoms in IBD outpatients
Authors: Wilke E L , Knoedler L L , Atanasova K , Ebert M P , Reindl W , Thomann A K 
Published: January 2024

Abstract

Background
Patients with inflammatory bowel disease (IBD) show higher rates of fatigue and symptoms of depression and anxiety. Growing evidence reports a beneficial influence of plant- based diets on IBD as well as psychological disorders. The Mediterranean diet shows favorable characteristics in this regard and is simple to implement. We aimed to examine adherence to a Mediterranean diet as well as its associations with disease activity, quality of life and fatigue or affective symptoms in outpatients with IBD.

Methods
We delivered questionnaires to IBD outpatients, assessing adherence to the Mediterranean diet (MEDAS), symptoms of depression and anxiety (HADS), as well as fatigue (FACIT-F) and quality of life (SHS). Disease activity was measured with HBI or pMS, respectively. Associations between the parameters were determined using spearman correlation.

Results
We collected data of n=281 patients. Adherence to the Mediterranean diet was generally low in our sample with a median MEDAS score of 6 (0-13). The greatest deficit was observed in the regular consumption of fish (10 %) and fruit (16.6 %). However, we found a very high adherence for olive oil as the main source of fat (81.9 %), as well as a preference for white meat over red meat and processed meats (63.7 %). The prevalence of depressive symptoms (HADS-D ≥ 8) was 22.4 %, while symptoms of anxiety (HADS-A ≥ 8) were found in 35.9 % of the participants. Severe fatigue (FACIT &lt; 30) was present in 33.8 % of the patients. Patients with clinically active disease were more likely to experience fatigue (ρ=-.231, p=&lt;.001), symptoms of anxiety (ρ=.132, p=.010), depressive symptoms (ρ=.216 p=&lt;.001), and reduced quality of life (ρ=.359, p&lt;.001), all Figure 1a. There were no significant associations between the MEDAS score and disease activity (ρ=.033, p=.522), fatigue (ρ=-.009, p=.831), anxiety symptoms (ρ=.049, p=.294), or depressive symptoms (ρ=-.035, p=.461). Women showed significantly higher adherence to Mediterranean diet (mean MEDAS score 5.2 vs. 6, p=.003). We found a negative correlation between adherence to Mediterranean diet and level of calprotectin (ρ=-.146, p=.023, Figure 1b).

Conclusion
The preliminary analysis of our sample suggests low levels of adherence to the Mediterranean diet in our patient population. Contrary to our expectation, there were no statistically significant associations between diet and disease activity, quality of life, or psychological complaints. However, the inverse correlation between adherence to Mediterranean diet and level of calprotectin can support the anti-inflammatory characteristics this diet. It remains unclear, to which intent an anti-inflammatory diet can impact the course of disease and clinical symptoms in patients with IBD.
P984 VEST: The UK vedolizumab real life experience study in Inflammatory Bowel Disease
Authors: Bodger K , Booker C , Kok K , Lobo A , Ahmad T , Bloom S , Butterworth J , Irving P , Cummings F 
Published: January 2024

Abstract

Background
The characteristics and outcomes of patients treated with vedolizumab in routine healthcare settings have not been widely evaluated in the UK.

Methods
Prospective, multicentre observational study of 364 patients started on vedolizumab in UK practice from January 2017 until February 2019 using the UK IBD Registry clinical web-based tool. For the present analysis, the primary outcome was drug survival (persistence) at 1-year, defined as attendance for infusion ≥48 weeks after the first dose. Secondary outcomes were: Clinical remission (CR, based on partial Mayo score [≤1] or Harvey Bradshaw index [≤4]), physician global assessment (PGA), IBD-Control Questionnaire (IBD-Control-8, IBD-Control-VAS and individual item scores), laboratory parameters and adverse events.

Results
Age (mean): 44 yrs; Males: 48%; IBD duration (mean): 6 yrs; Prev. resection: 18%; Steroids at baseline: 39%; Outcomes are summarized in Table 1. 37% of CD patients were assessed as being in clinical remission at baseline. Overall, 210 (58%) continued treatment beyond 48 weeks. At 1 year, 67.1% and 52.3% of CD and UC patients were in clinical remission with a clear improvement in QoL as assessed by IBD-Control -8. There were significant improvements across each IBD-Control-8 domain, including fatigue, with few patients considering switching treatment at that point (Figure 1).

Conclusion
Vedolizumab was effective in clinical practice with 58% of patients remaining on treatment at one-year. Baseline status differed significantly from those recruited into RCTs. Patient reported outcomes demonstrated significant and meaningful improvements across physical, psychological, social and treatment domains.
P990 A Multi-center, Single-arm, Prospective, Observational, Real-world Study in China to Evaluate Effectiveness of Vedolizumab in the Treatment of Inflammatory Bowel Diseases: First Interim Analysis of Patient-reported Outcomes
Authors: Hong Y , Li L , Hong G , Chen Y , Hu Y , Xie L , Liu M , Chen M 
Published: January 2024

Abstract

Background
Crohn’s disease (CD) and ulcerative colitis (UC) are types of inflammatory bowel disease (IBD), causing abdominal pain, diarrhea, rectal bleeding and weight loss which is concerning due to increased prevalence and morbidity. As IBD affects quality of life (QoL), improving it is a major treatment goal. Current therapy in IBD includes corticosteroids, immunomodulators, biologics, small molecule drugs, etc. Vedolizumab (VDZ), a gut-specific antibody against α4β7 integrin, is approved in China in moderate to severe UC/CD treatment. This multi-center, single arm, prospective, observational, real-world study (NCT04872491) evaluated safety and effectiveness of VDZ in Chinese UC/CD patients. This first interim analysis presented changes in symptomatic relief and QoL. Safety results are shown separately.

Methods
Enrolled UC/CD patients (&gt;18 years) were treated with 300 mg VDZ by intravenous infusion at week 0, 2, 6, and every 8 weeks till 54 weeks. At data cut-off (October 21, 2022), 307 patients were assessed for symptomatic relief and QoL by patient reported outcomes (PRO) scores, partial Mayo score rectal bleeding sub-score [RBS], stool frequency sub-score [SFS]) in UC; abdominal pain sub-score [APS], loose stool frequency sub-score [LSFS]) in CD at days 3, 7 and 14 and IBD questionnaire (IBDQ), EuroQol-5-Dimension-5-Level index (EQ-5D-5L) and EQ-visual analog scale (VAS) scores in UC and CD from baseline to week 14. Descriptive statistics summarized the effectiveness.

Results
Of 265 patients (UC: 211, CD: 54) analysed for effectiveness, 62.9% were males with mean(±SD) age 43.1±15.0 years and median IBD duration of 883 days. At baseline, mean(±SD) for partial Mayo and HBI scores were 5.185±1.936 and 5.362±3.674 for UC and CD patients respectively.
Compared to baseline, UC patients showed significant difference in RBS and SFS scores from days 3 and 7 respectively reflecting rapid onset effect of VDZ (Figure 1). Patients with RBS=0 and SFS≤1 scores improved from 34.78% at baseline to 62.79% at day 14 after treatment. IBDQ, EQ-5D-5L and EQ-VAS mean±SD score changes of 38.853±39.569, 0.046±0.125 and 10.258±14.756 signified improved QoL (Table 1).
At baseline, mean±SD APS and LSFS scores in CD patients were 0.692±0.832 and 1.462±1.570 (n=39), which decreased to 0.425±0.594 and 1.325±1.207 (n=40) at day 14 with a mean change of -0.211±0.528 and -0.105±0.981 (Figure 1). VDZ effectively maintained remission in patients with APS≤1 and LSFS≤3 which increased from 35.90% at baseline to 50.00% at day 14. Improved QoL was observed with changes in IBDQ (13.194±31.592) (Table 1).

Conclusion
VDZ effectively improved and maintained symptomatic relief and QoL in Chinese UC/CD patients in real-world settings.
P1009 Efficacy and safety of 4 years of continuous ozanimod treatment: an interim analysis of the True North open-label extension study
Authors: D'Haens G , Sands B E , Ferrante M , Matsuoka K , Lindsay J O , Blumenstein I , Mehra D , Charles L , Cetin V , Petersen A , Wu H , Wang D , Jain A , Hanauer S B 
Published: January 2024

Abstract

Background
The phase 3 True North (TN) study demonstrated the efficacy and safety of ozanimod (OZA) over 52 wk in patients (pts) with moderately to severely active ulcerative colitis (UC); the ongoing TN open-label extension (OLE) is assessing long-term efficacy and safety. This interim analysis of the TN OLE assessed pts with up to ~4 y of continuous OZA treatment.

Methods
Clinical responders after 52 wk of continuous OZA treatment (0.92 mg/d) during TN who subsequently entered the TN OLE were included in this analysis. Data were analysed up to OLE Week (W) 142, representing up to ~4 y of continuous OZA treatment. Symptomatic response (≥1-point and ≥30% decrease from baseline [BL] in the combined 6-point rectal bleeding subscore [RBS] + stool frequency subscore [SFS] and ≥1-point decrease in RBS or absolute RBS ≤1) and symptomatic remission (RBS=0 and SFS ≤1 [and ≥1-point decrease from BL SFS]) were evaluated from OLE W5 through OLE W142. Clinical remission, clinical response, endoscopic improvement, and corticosteroid (CS)-free remission were evaluated at OLE W46, W94, and W142. Endpoints were evaluated using observed case (OC) and nonresponder imputation (NRI) analyses. Adverse events were monitored throughout TN and the OLE.

Results
In all, 131 pts entered the OLE after achieving clinical response on OZA at W52 in TN. At the data cutoff, 87.0% of pts completed OLE W46, 71.8% completed OLE W94, and 64.1% completed OLE W142. Most (67.9%) pts had left-sided UC disease, 23.7% had concomitant CS use at TN BL, and 32.1% had prior exposure to tumour necrosis factor inhibitors. Symptomatic response and symptomatic remission were observed in 100.0% and 84.4% of pts, respectively, at OLE W5 in the OC analysis (93.1% and 78.6%, respectively, in the NRI analysis). By OLE W142, symptomatic response and symptomatic remission rates were 98.7% and 88.3%, respectively, in the OC analysis and 58.0% and 51.9%, respectively, in the NRI analysis. Rates of clinical and endoscopic endpoints during the OLE are shown in Figure 1A (OC) and 1B (NRI). Of note, 65.3% of TN W52 clinical responders achieved clinical remission and CS-free remission at OLE W142 in the OC analysis (35.9% in the NRI analysis). With this additional year of follow-up in the OLE, there were no new cases of bradycardia, third-degree atrioventricular block, hypertension, herpes zoster, or macular oedema, and no clinically meaningful change in malignancy exposure-adjusted incidence rates (Table). No serious hepatic events occurred.

Conclusion
Clinical responders after 1 y on OZA sustained response for an additional 3 y and achieved clinical remission with continuous OZA exposure. OZA is a safe, tolerable, and durable therapy for pts with UC.
P1022 One-year safety and effectiveness of ustekinumab in patients with Crohn’s disease: The K-STAR study
Authors: Lee C K , Moon W , Chun J , Kim E S , Kim H W , Yoon H , Kim H S , Lee Y J , Choi C H , Jung Y , Park S C , Song G A , Lee J H , Jung E S , Kim Y , Jung S Y , Choi J M , Ye B D 
Published: January 2024

Abstract

Background
We aimed to investigate the safety and effectiveness of ustekinumab (UST) for Korean patients with Crohn’s disease (CD).

Methods
Adult patients with CD treated with UST were prospectively enrolled in the K-STAR (Post-MarKeting Surveillance for Crohn’s Disease patients treated with STelARa) study from April 2018 to April 2022. After single intravenous infusion of UST ~6 mg/kg, UST 90 mg subcutaneous injection was followed at week 8 and then maintenance treatment with subcutaneous UST 90 mg every 8 or 12 weeks were given, following up to week 52 to 66. Both adverse events and clinical effectiveness of UST therapy were analyzed (ClinicalTrials.gov Identifier: NCT03942120).

Results
Of the 464 patients enrolled from 44 medical centers across South Korea, 457 and 428 patients (Crohn’s disease activity index 150 or over) were included in the safety analysis and effectiveness analysis set, respectively (Table 1). At week 16–20 after starting UST, rates of clinical response, clinical remission and corticosteroid-free remission were 75.0% (321/428), 64.0% (274/428), and 61.9% (265/428), respectively (Figure 1A). At week 52–66, rates of clinical response, clinical remission and corticosteroid-free remission were 62.4% (267/428), 52.6% (225/428), and 50.0% (214/428), respectively (Figure 1B). Combined effectiveness (clinical response + biochemical response) was achieved in 40.0% (171/428) and 41.6% (178/428) of patients at week 16–20 and week 52–66, respectively. Bio-naïve patients exhibited significantly higher rates of combined effectiveness than bio-experienced patients (50.3% vs. 30.7% at week 16–20, p&lt;0.001; 47.7% vs. 36.0% at week 52–66, p=0.014) (Figure 1A;1B). No additional benefits were observed with the concomitant use of immunomodulators. Using a multivariable analysis using backward selection, colonic involvement (vs. ileal involvement, odds ratio [OR], 0.32; 95% confidence interval [CI], 0.12–0.89; p=0.028), ileocolonic involvement (vs. ileal involvement, OR, 0.45; 95% CI, 0.23–0.89; p=0.021), baseline C-reactive protein levels (OR, 0.90; 95% CI, 0.84–0.97; p=0.009), and the exposure to two or more biologics (vs. bio-naïve, OR, 0.38; 95% CI, 0.20–0.73; p=0.003) were inversely associated with achieving clinical remission at week 52–66. Any adverse events and serious adverse events were observed in 28.2% (129/457) and in 12.7% (58/457), respectively with no new safety signal associated with UST treatment.

Conclusion
UST was well-tolerated, effective, and safe as induction and maintenance therapy for patients with CD in Korea. The results from this study enhance our understanding of the role of UST in managing CD patients with diverse characteristics and may help inform clinical decisions.
P1040 Comparative effectiveness of upadacitinib versus ustekinumab in patients with moderately to severely active Crohn’s disease: a matching-adjusted indirect comparison
Authors: Ma C , Dubinsky M C , Axelrad J , Anyanwu S , Tran J , Lacerda A , Joshi N , Griffith J 
Published: January 2024

Abstract

Background
Upadacitinib (UPA), an oral Janus kinase inhibitor, and ustekinumab (UST), a parenteral IL 12/23 antagonist, are effective treatments for moderately to severely active Crohn’s Disease (CD). In the absence of head-to-head data, a placebo (PBO)-anchored matching-adjusted indirect comparison (MAIC) was conducted to indirectly compare efficacy of UPA vs UST.

Methods
Individual patient (pt)-level data from phase 3 UPA trials and published data from phase 3 UST trials were used. For induction, pts received UPA 45mg daily or PBO for 12 weeks or UST ~6mg/kg IV or PBO IV at week 0 with 8-week follow-up. For maintenance, UPA clinical responders were re-randomized to UPA 15mg, 30mg, or PBO daily for 52 weeks. UST clinical responders were re-randomized to 90mg SC (every 8 or 12 weeks) or PBO SC for 44 weeks. UPA pts had baseline (BL) CD Activity Index (CDAI) 220-450; those with prior UST or vedolizumab exposure were excluded. Treatment effect modifiers, including BL mean CDAI, Simple Endoscopic Score for CD (SES-CD), median C-reactive protein, prior biologic(s) failure, and disease location, from UPA data were weighted to match the UST population. Outcomes assessed were CDAI response (≥100-point decrease or CDAI &lt;150), CDAI remission (CDAI &lt;150), endoscopic response (SES-CD ≥50% decrease), and SES-CD ≤2. Separate MAICs were conducted for induction and maintenance; data reported for induction clinical outcomes are stratified by prior inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Results
A greater proportion of UPA- vs UST-treated pts achieved endoscopic response (difference 26.3%, P&lt;0.001) and SES-CD ≤2 (difference 9.9%, P&lt;0.05) at the end of induction. In TNF-IR patients, a greater proportion of UPA- vs UST-treated pts achieved CDAI response at the end of induction (difference 18.2%, P&lt;0.05) and at the end of Week 8 (difference 26.0%, P&lt;0.001). CDAI remission rates were also higher at end of Week 8 for UPA- vs UST-treated pts (difference 13.3%, P&lt;0.05). Rates of achieving CDAI response and remission were similar between UPA- and UST-treated pts at the end of induction and Week 8 among bio-naïve pts. Following maintenance treatment, similar rates of SES-CD ≤2, endoscopic response, and CDAI remission were obtained in the total population of UPA and UST-treated pts.

Conclusion
Pts with moderately to severely active CD treated with UPA achieved higher rates of endoscopic (total population) and clinical (TNFi-IR population) outcomes during induction compared to UST-treated pts. Outcomes at the end of maintenance were similar for UPA and UST, however, results should be interpreted with caution due to low sample size.
P1075 Outcomes in patients stopping biologic during the first trimester of pregnancy : a retrospective monocentric study
Authors: Monin L , Reenaers C , Grandfils S , Latour P , Van Kemseke C , Kropp S , Louis E , Vieujean S 
Published: January 2024

Abstract

Background
Both the American Gastroenterological Association (AGA) and the European Crohn's and Colitis Organisation (ECCO) recommend to continue biologic during the whole pregnancy and until the third trimester, respectively. However, these positions are associated with a baby's exposure to the drug and from our clinical practice are not necessarily in line with patients' wishes and fears. In patients in full clinical and biologic remission, stopping biologic before it is actively transported through the placenta (around the week 20) would be a possible approach to get around these drawbacks. We aimed to assess the outcome of disease activity and pregnancies in patients stopping biologic before the week 20.

Methods
We performed a retrospective monocentric study. All patients who gave birth between 2010 and 2023 were included. The following parameters were collected: clinical and demographic characteristics, biomarkers (CRP and faecal calprotectin before pregnancy and during the 3 trimesters), IBD treatment at time of pregnancy, whether it was stopped during pregnancy, when and in what circumstance (patient versus medical agreement). We also looked at the disease course, whether a relapse occurred (defined as the need to take corticosteroids, a biologic, or surgical resection), and the pregnancy outcome.

Results
A total of 185 pregnancies were reported in 143 patients (73.4% Crohn disease and 26.6% ulcerative colitis). Patient's characteristics are shown in Table 1. Among these women, 106 (74.1%), 32 (22.4%) and 5 (3.5%) reported one, two or 3 or more pregnancies, respectively. Figure 1 summarises the treatments during these reported pregnancies, disease activity outcomes and pregnancy outcomes. The biologic was stopped before conception for 9 pregnancies and 90 pregnancies started under biologics (anti-TNF, vedolizumab or ustekinumab). Of these, biologic was continued until delivery in 10 (11.1%) patients, whereas it was stopped before the week 20 for the others (88.9%). Among patients who stopped biologics before conception, before the week 20, and those who continued biologics through delivery: 3/9 (33.3%), 13/80 (16.3%; including 10/66 or 15.2% among those stopping on medical agreement) and 4/10 (40%) relapsed, respectively. Among the 10 relapses in patients who stopped in first trimester on medical agreement, 6 had normal biomarkers before cessation (unknown for the others).

Conclusion
Biologic discontinuation before week 20 on medical agreement was associated with relapse in 15.2% of cases. Fate of disease activity and pregnancies in patients stopping biologic before week 20 should be studied prospectively in a dedicated study.
P1109 Differences of Clinical Phenotype Between Familial and Sporadic Crohn's Disease in East China
Authors: Dong S , Xiang X , Zhang Y , Liu R , Ye L , Cao Q 
Published: January 2024

Abstract

Background
Family history is one of the strongest risk factors for Crohn's disease (CD) while few studies have focused on whether family history influences the clinical features, disease course, and severity of CD. There is still controversy about the difference between sporadic and familial CD. This study aimed to compare the phenotypic features of familial CD with sporadic CD in Chinese populations.

Methods
We included 2,043 patients diagnosed with CD. Familial CD was defined as CD patients having one or more first-, second-, third-, fourth-degree or above relatives with CD. Sporadic CD patients hospitalized during the same period were matched 1:3 by age and gender. Differences in clinical characteristics, phenotype distributions, extra-intestinal manifestations, and complications at diagnosis, as well as treatment regimens and surgeries, were compared between familial and sporadic CD.

Results
A total of 55 familial CD and 165 sporadic CD were identified. The familial CD was associated with a higher rate of past appendectomy history (20.00% vs 6.67%, P=0.009), more intestinal perforation at onset (12.73% vs 3.03%, P=0.012), more anal lesion (85.45% vs 68.48%, P=0.023) and gastrointestinal perforation (14.55% vs 5.45%, P=0.040) at diagnosis, higher rate of past intestinal surgery history (50.91% vs 29.70%, P=0.007), more number of intestinal surgeries (1.50[IQR 1.00-2.00] vs 1.00[IQR 1.00-1.00], P=0.037), longer duration of follow-up (54.00 months[IQR 21.50-125.00] vs 41.00 months[IQR 14.00-79.00], P=0.017), lower rate of taking biologicals for current maintenance (61.82% vs 76.97%, P=0.043), lower tendency to upgrade to biologicals during follow-up (69.09% vs 85.37%, P=0.013), higher possibility to experience gastrointestinal obstruction (23.64% vs 11.52%, P=0.047) and abdominal abscess during follow-up (9.09% vs 2.42%, P=0.045).

Conclusion
Familial CD is associated with a more aggressive clinical phenotype compared with sporadic CD.