bluuebunny/crossref_metadata_2025_split huggingface dataset:
P230 Development of a Japanese version of the IBD Self-Efficacy Scale and evaluation of its current status in Japan
Authors: Tanaka M , Kawakami A , Sakagami K , Terai T , Ito H 
Published: May 2021

Abstract

Background
In chronic diseases like inflammatory bowel disease (IBD), self-efficacy is one of important health outcomes. The IBD-Self-Efficacy Scale (IBD-SES) is an outcome measure used in research settings. In this study, we aimed to develop a Japanese version of IBD-SES and investigate the self-efficacy of IBD patients in Japan.

Methods
We conducted a questionnaire survey with IBD patients from two different sources: outpatients of a specialized IBD clinic and respondents recruited online. The original 29-item IBD-SES, with scores from 1 (not at all) to 10 (totally) in each item, and higher scores indicating greater self-management efficacy, was translated into Japanese with permission of the original author and was used for the surveys after confirming its linguistic equivalence with the original version. The reliability of the scale was assessed by calculating the Cronbach’s alpha coefficient for internal consistency, and the validity was assessed by disease activity (remission vs. active period) for known-group validity. Items of IBD-SES score comparison between the outpatient clinic group and online group were performed by t-test.

Results
A total of 919 valid responses were obtained, 482 patients (ulcerative colitis (UC): 184, Crohn’s disease (CD): 298) from the specialized IBD clinic and 437 (UC: 255, CD: 182) online. The mean score per item for each subscale [Stress & Emotion Management], [Outpatient care & medication management], [Symptom & disease management] and [Maintenance of remission] was 4.7, 7.3, 4.9, and 4.9, respectively. Internal consistency was confirmed on each subscale (Cronbach’s α: 0.85–0.94). Comparing remission and active periods, significant differences were observed in three subscales: [Stress & Emotion Management (p &lt; 0.001)], [Symptom & disease management (p &lt; 0.001)] and [Maintenance of remission (p &lt; 0.001)], and the known group validity was mostly confirmed.

Conclusion
This study demonstrates the reliability and validity of the Japanese version of the IBD-SES and reveals the current status of self-efficacy of the self-management of IBD patients in Japan. Compared to previous studies using IBD-SES in the USA or Canada, scores observed with Japanese IBD patients are lower. It might reflect a cultural difference.
P254 Factors that may predict the need for infliximab optimization in Crohn’s disease
Authors: Flores C , Petry R , Bortolin Fonseca C , Dos Santos Harlacher L 
Published: May 2021

Abstract

Background
Biological therapy has revolutionized treatment of Crohn’s Disease (CD), increasing the rate of disease remission. Despite this, a significant percentage of patients present partial response or loss of response over time. These patients need optimization of therapy, whether by increasing the dosage or reducing the interval between infusions. The main objective of this study was to identify possible factors related to the need to optimize the dose of infliximab (IFX) in patients with CD. This finding can facilitate the early identification of the need for therapeutic optimization, reducing the risks of unfavorable evolution and decreasing costs related to the disease.

Methods
Retrospective and prospective maintained database of CD patients under IFX treatment being followed up in the Infusion Center at the Day Hospital of the Hospital de Clínicas de Porto Alegre, Brazil, from 2009 to 2018. Epidemiological, clinical, laboratory and endoscopic characteristics that correlate with worse prognosis of CD were evaluated. The main goal of the study was to identify possible factors related to the need for (IFX) optimization.

Results
121 patients were evaluated. Of these, 58 (47,93%) needed the optimization of the IFX dosage. The only variables that had significant statistical difference between the groups with or without need for optimization were anemia (p=0.019) and C reactive protein (CRP) which were persistently elevated in week 14 (p=0.039). After the adjustment with the multivariate model, only the elevated CRP during week 14 was still statistically significant, with a 119% greater risk of optimizing treatment when compared to those of normal CRP.

Conclusion
Among the factors studied, only the maintenance of higher CRP during week 14 was associated to the need for optimization of the IFX dose. This finding agrees with the literature that describes week 14 as an ideal moment for evaluating the serum levels of immunobiologics as a predictor of sustained response. Thus, in the absence of therapeutic drug monitoring, we could look at persistently high CRP as a marker of the need for therapeutic optimization. This finding needs to be confirmed in prospective studies.
P256 High disease burden of CROHN’S DISEASE (CD) in a Latin American IBD reference center
Authors: Sambuelli A , Gil A , Negreira S , Tirado P , Huernos S , Goncalves S , Lakatos P 
Published: May 2021

Abstract

Background
CD is a multifactorial, heterogeneous, disabling condition, with high surgical rates and complications. Best knowledge of regional clinical features may favor awareness, evolution and healthcare resources. AIM: to describe by means a retrospective study in a Latin American IBD reference center, clinical characteristics of our CD casuistic, and the risk for surgery.

Methods
data of CD patients (pts) assisted from 1990-June 2020 (CD duration≥1 yr), registered in a database, were revised and reclassified (by Montreal) in Age at diagnosis (A)A1:≦16yrs, A2:17–40, A3:&gt;40, Behavior (B) B1, stricturing (B2), penetrating (B3), perianal modifier (p), Location (L) L1: ileal, L2: colonic, L3: ileocolonic, L4: upper GI: isolated or combined. Incidence rates of progression and surgery (major abdominal surgery and/or bowel resection) were estimated (Kaplan Meier).

Results
598 CD pts (M 313, F 285), CD median duration 13.9 yrs (IQR 7.1–21.2) were available for analysis. Montreal A1: n 93 (15.6%), A2: n 335 (56.0%), A3: n 170 (28.4%). Behavior patterns rates within 90 days from diagnosis were: B1: n 523 (87.5%), B2: n 52 (8.7%), B3: n 23 (3.8%). Location L1: n 52 (8.7%), L2: n 368 (61.5%) L3: n 176 (29.4), L4: n 2 (0.33%) and L4 combined with L1, L2, L3: n 47 (7.9%). Complicated initial behavior (or progression to complications) was observed in 252/598 (42.1%). Rates of cumulative incidence of developing either stricturing or penetrating complications at 1, 3, 5, 10 yrs were: 20.9% (95%CI 17.9–24.4), 31.4% (95%CI 27.7–35.4), 37.0% (95%CI 33.0–41.3), 48.4% (95%CI 43.5–53.4) respectively; by each complication were for B2: 15.22%, 22.9%, 27.0%, 34.1%, and B3: 6.7%, 11.1%, 14.6%, 21.9%, respectively. Both complications in same patient were present in 54 (9%) pts. B3 was more prevalent in L3 (40.8%), B2 in L1 (56.3%), (p=0.00001 for both) vs L2 (16.7%, 22.2% respectively). Perianal disease (p) was more frequent in L2 (53.2% p&lt;0.024) vs. the rest of locations (L1: 39.6%, L3: 40.8%, half of L4). CD location progression was less frequent (5%, mainly progression on small bowel). Considerable proportions of pts needed early IV steroids, immunosuppressants (58%), Biologics (at least one: 44%) and optimization. Major surgery was performed in 304/598 pts (50.8%),≥1 in 20%; 9.8% needed permanent stoma. Cumulative incidence rates of major surgery at 90 days, 1, 3, 5, 10 yrs were 5.7%, 11.7%, 23.4%, 29.1%, 42.0%. Patterns B2, B3, L1, L3, L4, A2, also (unusual) A3 were substantial contributors.

Conclusion
We found high disease burden in this Latin American referral IBD cohort with a large proportion of patients presenting/developing a complicated disease behaviour, with high need for immunosupressive/biological therapy and high rates of major surgery.
P274 Drug utilization of biologic therapy in Crohn’s disease and ulcerative colitis: A population based Danish cohort study 2015-2018
Authors: Jensen K , Jensen C B , Wennerström C , Sommer K J , Burisch J , Petersen J 
Published: May 2021

Abstract

Background
For patients with Crohn’s disease (CD) and Ulcerative Colitis (UC) that are not adequately responding to systemic immunosuppressants, or are intolerant to conventional therapies, several biologic treatments have become available. The aim of the present study was to characterize the drug utilization and switch patterns of the biologics in respect to treatment line.

Methods
Using Danish national registries, the nation-wide study included individuals diagnosed with UC or CD who were biologic-naïve when initiating treatment with Infliximab (IFX), Adalimumab (ADA), Vedolizumab (VDZ), Golimumab (GOL), or Ustekinumab (UST) during years 2015-2018. The hazard ratios (HR) of switching or discontinuing from first treatment were explored using Cox regression adjusted for health-related and socio-economic parameters at treatment initiation. A therapy switch was defined as the administration of a biologic therapy different from the current within 90 days from last biologic dispensing period.

Results
Among 1,836 CD patients and 1,886 UC patients, IFX was used as first line biologic treatment in 91% (1,667) of CD patients and 92% (1,740) of UC patients. This was followed by ADA with 7% (129), VDZ with 2% (35) and UST with 0.2% (5) for CD patients, and ADA with 5% (88), VDZ with 2% (34) and GOL with 1% (24) for the UC patients, (figure 1).
In total, 18% (338) of CD patients and 24% (451) of UC patients switched biologic during the study period. Among CD patients with IFX as first-line treatment, 12% (207/1667) switched to ADA, whereas 6% (96/1667) switched to VDZ. UC patients with IFX as first-line treatment, 6% (105/1740) switched to ADA, and 12% (201/1740) to VDZ. When administered ADA as first-line treatment, 11% (14/129) shifted to IFX in the CD patients, and 17% (15/88) shifted to IFX in the UC patients. Overall, 6% (111) of CD patients and 9% (163) of UC patients experienced ≥2 therapy switches during the study period.
Comparing ADA to IFX as first-line treatment, there was a higher risk of discontinuation of treatment among CD patients (HR: 2.25 (95% confidence interval: 1.71; 2.97)) and in UC patients (1.93 (1.42; 2.63)), whereas no difference in risk of switch to another biologic treatment was observed. In both CD and UC patients, analyses of VDZ, GOL, and UST as first-line were impaired due to few events.

Conclusion
More than 90% of CD and UC patients initiating biologic therapy had IFX as their first-line biologic treatment, which is recommended by the official treatment guidelines. The reason for deviation from treatment guidelines or switch in therapy should be explored in further studies as well as the higher incidence of treatment discontinuation for ADA as first-line treatment.
P296 Stopping 5-aminosalicylic acid in patients with ulcerative colitis who are in clinical remission does not increase risks of flare
Authors: Mak J W Y , Yuen N T K , Yip T C F , Lam R H M , Lam B K H , Chan F K L , Ng S C 
Published: May 2021

Abstract

Background
5-aminosalicylic acid (ASA) has been the mainstay of treatment for ulcerative colitis (UC). However, it is unclear whether the medication can be stopped in patients with stable disease. We aimed to examine whether 5-ASA can be safely withdrawn in UC patients who have been in steroid-free clinical remission for at least 1 year.

Methods
This is a retrospective cohort study using a territory-wide healthcare database in Hong Kong. Primary outcome was development of UC flare defined as a composite of new corticosteroid use, UC-related hospitalization or surgery within 5 years after stopping-5ASA. UC patients who were on oral 5-ASA ≥ 2grams daily for at least 1 year, who had C-reactive protein &lt;1mg/dL and no escalation of 5-ASA dosage, no UC-related hospitalization and no use of corticosteroid in the past 1 year were included. UC patients who were on biologics were excluded. Patients were classified as stopping 5-ASA if 5-ASA had ever been withdrawn for at least 90 days within the follow-up period. We performed multivariable Cox regression models adjusting for demographics, blood parameters and immunosuppressants used. Adjusted hazard ratio (aHR) with 95% confidence interval (CI) was reported comparing groups stopping 5-ASA and those continuing 5-ASA.

Results
A total of 1408 patients with UC were included with a median follow-up duration of 41.8 months [Interquartile range (IQR): 17.2-60 months)]. Stopping 5-ASA was not associated with an increased risk of UC flare (aHR 0.99, 95% CI 0.76-1.30, p=0.722). Higher haemoglobin level at baseline was protective against flare (aHR 0.91, 95% CI 0.85-0.97, p=0.03), while higher CRP level at baseline was associated with an increased risk of flare (aHR 1.06, 95% CI 1.03-1.09, p&lt;0.001). Results were similar in sensitivity analysis investigating stopping 5-ASA for ≥ 180 days which showed no difference in risk of flare comparing groups continuing and stopping 5-ASA (aHR 1.02, 95%CI 0.71-1.48,p=0.912). There were no differences in the risk of requiring colectomy (HR: 2.23, 95% CI 0.67-7.49, p=0.193) or development of colorectal cancer (HR: 0.76, 95% CI 0.22-2.65, p=0.671) in patients who stopped 5-ASA and those who continued 5-ASA.

Conclusion
Stopping 5-ASA in patients with UC who have been in clinical remission for over one year was not associated with increased risk of flare. These results should be validated in prospective randomized controlled trial.
P301 Ustekinumab improves health-related quality of life in patients with moderate-to-severe Crohn’s disease: results up to Week 48 of the STARDUST trial
Authors: Danese S , Vermeire S , D’Haens G , Panés J , Dignass A , Magro F , Nazar M , Le Bars M , Lahaye M , Ni L , Bravatà I , Gaya D R , Peyrin-Biroulet L 
Published: May 2021

Abstract

Background
A treat-to-target (T2T) strategy may optimize inflammatory bowel disease management. The STARDUST trial compared a T2T maintenance strategy against standard of care (SoC) in Crohn’s disease (CD) patients treated with ustekinumab (UST). The primary endpoint, safety, and efficacy data of STARDUST have been published previously.1 Here we present results for health-related quality of life (HRQoL) measures and impact of UST on work and activities at Week (W)48 of UST maintenance, comparing T2T and SoC.

Methods
Adult patients with moderate–severely active CD received iv, weight-based UST ~6 mg/kg at W0 (baseline [BL]); then SC UST 90 mg at W8. At W16, CD activity index (CDAI) 70 responders were randomized (1:1) to either T2T (maintenance dosing, q12w or q8w, assigned based on endoscopic activity and further dose escalations up to q4w if clinical and biomarker-directed targets were not met) or SoC (maintenance based on EU SmPC; q12w or q8w based on clinical judgement). In this analysis we assessed changes from BL in the following HRQoL measures at W48: Inflammatory Bowel Disease Questionnaire (IBDQ), EuroQoL 5 Dimension 5 Level (EQ-5D-5L), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) tools, and Hospital Anxiety and Depression Scale – anxiety and depression subscales (HADS-A and -D) alongside the Work Productivity and Activity Impairment (WPAI) questionnaire; time lost from work was also recorded. Percentage of patients with IBDQ response (16 point improvement from BL) and remission (IBDQ score ≥170) at W48 were also analysed.

Results
Of 500 patients enrolled, 441 were randomized to T2T (n=220) or SoC (n=221); 79.1% and 87.3%, respectively, completed W48. At W48, the percentage of patients in T2T and SoC arms with IBDQ response (58.2% and 67.0%, respectively) and remission (45.0% and 53.4%, respectively) were similar (both p=ns). Similar changes from BL at W48 in IBDQ, EQ-5D-5L (visual analogue scale and index score), FACIT-F, HADS-A and -D and WPAI were noted in both treatment arms (Table 1). WPAI 7-Point Improvement from BL per domain at W48 are presented in Table 2. During the last 4 weeks preceding the visit at W48, patients in T2T and SoC arms on average lost 1.7 and 2.2 fewer days from work due to CD, respectively, compared to BL (p=ns). At W48, 62.3% and 72.3% were in employment in T2T and SoC arms, respectively (p=ns), compared to 61.8% and 63.5%, respectively at BL.

Conclusion
UST treatment improved HRQoL and work productivity and helped decrease time lost from work in patients with moderate-to-severe CD, regardless of T2T or SoC strategy. Improvements were generally maintained up to W48.

Reference
P302 Serum IL-6 is associated with treatment refractoriness in acute severe ulcerative colitis
Authors: Li Wai Suen C , Morris R , Choy M , Nigro J , Visvanathan K , De Cruz P 
Published: May 2021

Abstract

Background
Response to therapy in acute severe ulcerative colitis (ASUC) is highly variable ranging from steroid response to salvage therapy failure and emergency colectomy. Biomarkers that accurately predict outcomes in ASUC early in the admission may help improve its management. We aimed to ascertain whether peripheral serum cytokine levels on admission correlate with refractoriness to medical therapy.

Methods
Peripheral blood was collected from 34 subjects, including 29 patients with ASUC on admission (baseline) and 5 healthy controls. All patients with ASUC received intravenous steroids, with those refractory to steroids going on to receive infliximab (IFX) salvage. Eight cytokines were measured at baseline using a multiplexed cytokine assay (Bio-Rad). Clinical response to steroids and/or to the first IFX dose was assessed and used to classify patients based on increasing order of disease refractoriness (steroid-responders, IFX-responders and IFX non-responders). These groups were then evaluated to check for correlations with baseline cytokine levels.

Results
Our cohort consisted of steroid responders (n=9), IFX responders (n=12) and IFX non-responders (n=8). Median serum IL-6 level was 1.6 pg/mL (IQR:1.6-2.1) in healthy controls compared to 2.7 pg/mL (IQR:1.4-6.3) in ASUC (p=0.3). In patients with ASUC, there was a positive correlation between IL-6 and treatment refractoriness (Spearman’s correlation [rs]=0.56, p=0.002). Compared with steroid responders (1.36 pg/mL), serum IL-6 was significantly higher in both IFX responders and IFX non-responders (3.44 and 5.50 pg/mL, p=0.02 and p=0.009 respectively) (Fig 1). Patients with ASUC had higher serum IL-8 compared to healthy controls (17.8 vs 6.9 pg/mL, p=0.005). There was no correlation between IL-8 levels and ASUC treatment refractoriness (rs=0.22, p=0.3). Similarly, there was no difference in IL-8 levels in ASUC patients when classified by treatment response (Kruskal Wallis, p=0.5). Serum TNF level did not differ between healthy controls and patients with ASUC (19.5 and 22.2pg/mL, p=0.5). TNF levels did not correlate with treatment refractoriness in ASUC (rs=-0.06, p=0.75) and there were no differences between the ASUC response groups (p=0.6). Levels of GM-CSF, IFN-g, IL-2, IL-4 and IL-10 were predominantly below the detection limit of each assay.

Conclusion
In this ASUC cohort, serum IL-6 level on admission correlated with treatment refractoriness and may help identify patients at higher risk of requiring salvage therapy as well as those at higher risk of failing IFX. Further studies are needed to elucidate the function of IL-6 in ASUC and whether it may represent a potential predictor of outcomes in ASUC.
P309 Are results from VARSITY applicable to real world? Adalimumab versus vedolizumab as first line biological in moderate-to-severe IBD
Authors: Moens A , Verstockt B , Alsoud D , Sabino J , Ferrante M , Vermeire S 
Published: May 2021

Abstract

Background
Therapeutic options in IBD are rapidly growing, causing new challenges including choice of first line therapy. Both adalimumab (ADM) and vedolizumab (VDZ) are effective at inducing and maintaining endoscopic remission in moderate-to-severe IBD. The VARSITY trial (Sands et al NEJM 2019) showed superiority of VDZ over ADM in achieving clinical remission and endoscopic improvement at W52 in UC patients. Our aim was to explore if these results withstand in a real world setting of UC patients, and if they are also valid in CD.

Methods
This retrospective cohort study included adult, biological-naive IBD patients starting ADM or VDZ between 2015-2019 in our referral IBD centre. Patients had moderate-to-severe disease (endoscopic Mayo sub score ≥ 2 for UC, presence of ulcerations for CD) prior to start of therapy. For UC, we assessed endoscopic remission (endoscopic Mayo sub score 0) and improvement (endoscopic Mayo sub score ≤ 1) at W52. For CD, we assessed endoscopic remission (absence of ulcerations) and improvement (markedly better endoscopy despite still presence of ulcerations) at weeks 26-52. Missing values were imputed as nonresponses for binary outcomes, and last-observation carried-forward was used for continuous outcomes.

Results
A total of 109 UC and 86 CD patients were included (Table 1). Endoscopic remission at W52 was significantly better for VDZ than ADM in UC (35% vs 15%, p=0.03), and also endoscopic improvement was numerically, yet not significantly, better for VDZ than ADM (56% vs 37%, p=0.08). At baseline, 23 UC patients (50%) in the ADM group and 40 (63%) in the VDZ group were on steroids. By W52, 83% and 78% (p=0.75) of UC patients respectively could discontinue steroids and steroid-free endoscopic remission was not different between groups (ADM: 22% vs VDZ: 23%, p=1.00). For CD patients, similar endoscopic remission (60% vs 48%, p=0.37) and improvement (77% vs 79%, p=1.00) rates at weeks 26-52 were seen between ADM and VDZ. Twenty-five (47%) CD patients in the ADM and 16 (48%) in the VDZ group were on steroids at baseline, and 88% of them in both groups could successfully stop steroids by W52. Again, no difference in steroid-free endoscopic remission was seen between ADM (56%) and VDZ (31%) treated CD patients (p=0.20). At the end of follow-up [81 (27-157) weeks], the rates of treatment persistence were significantly different between ADM and VDZ treatment groups in UC patients, though not in CD patients (Figure 1).

Conclusion
In a real-world cohort of bio-naive UC patients, VDZ was superior to ADM in achieving endoscopic remission at W52, while in bio-naive CD patients VDZ and ADM resulted in similar endoscopic outcomes.