bluuebunny/crossref_metadata_2025_split huggingface dataset:
P619 Efficacy of zinc acetate hydrate administration for zinc deficiency in patients with inflammatory bowel disease: a multi-centre retrospective study
Authors: Sakurai K , Katsurada T , Otagiri S , Yamanashi K , Nagashima K , Onishi R , Nishimura H , Ito T , Furukawa S , Maemoto A , Sakamoto N 
Published: January 2020

Abstract

Background
Zinc deficiency is common in patients with inflammatory bowel disease (IBD), and the frequency is about 42.1% in Crohn’s disease (CD) and 38.5% in ulcerative colitis (UC). Patients with IBD with serum zinc deficiency are more likely to have adverse disease-specific outcomes. However, there are few studies about the effect of administering zinc preparations in IBD patients with zinc deficiency. The purpose of this study was to investigate the efficacy of zinc acetate hydrate (Nobelzin®︎) preparation for patients with IBD with zinc deficiency.

Methods
56 IBD patients who were treated with Nobelzin®︎ for zinc deficiency from March 2017 to November 2019 were analyzed. We conducted a multicenter retrospective observational study to investigate changes in serum zinc concentration or changes in disease activity before and after administration and their contributing factors.

Results
Among 56 cases, 4 cases were excluded due to self-interruption of internal use, and 52 cases (39 cases of CD, 13 cases of UC) were included. The median observation period was 27.5 (13–47) weeks, the median serum zinc concentration before administration was 58.5 (50.8–65.3) μg/dl, and the average of starting dose of Nobelzin®︎ was 67.8±31.1 mg/day. Nobelzin®︎ administration normalised serum zinc concentration(Zn ≥80 μg/dl) in 94.2 % (49/52) of patients. The median administration period required for normalisation of serum zinc concentration was 5 (3–8) weeks. In the group of CD patients who achieved zinc normalisation, the median CDAI score significantly improved after the normalisation from 171.5 to 129.5 (p &lt; 0.001). Similarly, the partial Mayo score in the same group of UC significantly improved after the normalisation (p = 0.035). There were 77.6 % patients who did not have additional treatment without Nobelzin®︎ administration until zinc was normalised. In CD patients of this group, the median CDAI score significantly improved after the normalisation from 152 to 120 (p = 0.029). All 3 cases in which zinc normalisation was not achieved within the observation period were CD cases, and they had a history of multiple surgeries, changes in biologics, or a long medical history. In one patient, side effects of Nobelzin®︎ administration were observed and these were abdominal discomfort and nausea. During the observation period, serum copper concentration was measured in 27 patients after administration of Nobelzin®︎, and one patient presented with copper deficiency.

Conclusion
Our findings show that administration of zinc acetate hydrate preparations may be effective in improving zinc deficiency and contribute to improve disease activity in IBD patients with zinc deficiency.
P620 Maintenance of clinical remission with SB5 biosimilar after switch from adalimumab originator: Real-life experience of a tertiary referral centre
Authors: Dragoni G , Pieraccini A , Bagnoli S , Caini S , Macrì G , Rogai F , Milani S , Galli A , Milla M 
Published: January 2020

Abstract

Background
Adalimumab (ADM) biosimilars have been demonstrated as safe and effective as the ‘originator’ in trials for other autoimmune disorders, but real-life evidence in inflammatory bowel diseases (IBD) is lacking. The aim of the study was to demonstrate maintenance of clinical remission (CR) after switch from ADM ‘originator’ to biosimilar SB5.

Methods
Data were retrospectively collected from November 2018 to September 2019. All IBD patients in CR after at least 6 months of ‘originator’ and switched to SB5 were included. The primary outcomes were maintenance of CR at 6 months after switch (defined as Partial Mayo Score 0–1 for ulcerative colitis and Harvey–Bradshaw Index ≤4 for Crohn’s disease) and overall comparable safety. A historical cohort of patients treated only with the ‘originator’ was included for comparison, using a Cox regression model with a time-varying covariate.

Results
In total, 96 patients were included. Baseline characteristics of the cohort are reported in Table 1. Maintenance of CR after 6 months of switch was reported in 89/96 (92.7%) patients. Levels of C-reactive protein (CRP) significantly increased over time from baseline to 6 months (from 2.67 ± 2.61 to 4.98 ± 5.81 mg/dl, p = 0.03), but no difference between the two time points was found when considering a relevant flare only for CRP above the lab cut-off (5 mg/dl). A comparison of CR persistence over time between ‘originator’ cohort and SB5 ‘switching’ cohort did not show any statistical difference (Hazard Ratio 1.07, 95% CI 0.57 – 2.01). With regard to adverse events, SB5 showed an overall safety profile, with only 2/96 (2.1%) patients interrupting the treatment due to anti-TNF-induced psoriasis. In 42/96 (43.8%) of patients, at least one injection site reaction was reported; only in one case a re-switch to ‘originator’ was needed for local intolerance.

Conclusion
SB5 is safe and effective in maintaining CR after switching from the ‘originator’. Injection site reaction is a frequent but usually manageable side effect. Larger multi-centre cohort and endoscopic assessment are needed to confirm the initial findings.
P625 Kinetics and outcomes of transmural healing in patients with Crohn’s disease treated with anti-TNF therapy
Authors: Pastaud C , Hordonneau C , Lambert C , Vignette J , Pereira B , Buisson A 
Published: January 2020

Abstract

Background
Transmural healing is a promising target in Crohns’ disease (CD) but remains poorly investigated. We aimed to evaluate the kinetics of transmural healing in CD treated with anti-TNF and to assess whether transmural healing is associated with more favourable outcomes.

Methods
It was a retrospective study from an MRI database of 449 patients performing MRI for luminal CD. Inclusion criteria were: CD patients older than 18 years-old receiving anti-TNF therapy, with an objective sign of inflammation on morphological evaluation (endoscopy or cross-sectional imaging), who underwent at least one MRI examination to assess therapeutic efficacy and follow-up longer than 6 months. Patients treated with anti-TNF agents for treat isolated perianal lesions were excluded. We used a statistical model based on imputation according to the last observation carry forward and clinical relevance. Each CD MRI lesions were then assessed every month during the first year. For segmental analysis, we used a division into six segments (jejunum, ileum, right colon, transverse colon, left/sigmoid colon and rectum). Transmural healing was defined as no MRI lesions.

Results
Overall, 148 patients were included. Among them, 81 were female (55.7%), 43 (34.4%) were current smokers and 56 (37.8%) had prior intestinal resection. The median CD duration at baseline was 7.6 years [1.4–15.2]. At baseline, 80 patients (54.4%) were anti-TNF-naïve. During the study, 69 patients (46.6%) were treated with infliximab, 77 patients (52%) received adalimumab while only 2 patients (1.4%) were treated with golimumab A combination therapy with thiopurines or methotrexate was found in 108 patients (74.0%) and 30 patients (20.3%) received concomitant steroids at the time of inclusion. Among 148 patients and 303 MRIs, 387 segments were analyzed. The rate of transmural healing was optimal between M6 and M8 and plateaued from the eighth month. The kinetics of transmural healing in CD patients treated with anti-TNF agents is presented in Figure 1.

Among the 148 patients with CD, 29 patients underwent intestinal resection (19.6%), 32 patients (21.6%) required an hospitalisation due to CD and 61 patients (41.2%) discontinued anti-TNF for therapeutic failure. In multivariable analyses, transmural healing was associated with decreased risk of surgery (HR=0.19[0.04–0.86];p = 0.03) and anti-TNF discontinuation (HR=0.42 [0.21–0.84]; p = 0.01) while we observed a trend for decrease risk of CD-related hospitalisation (HR=0.56[0.22–1.43];p = 0.23).

Conclusion
Transmural healing, which is associated with better outcomes in CD, can be achieved in more than half of patients with CD. The best time to assess transmural healing was between 6 to 8 months after starting anti-TNF therapy.
P631 Predictors of vedolizumab treatment persistence in bio-naïve ulcerative colitis patients
Authors: Ritter T E , Sarles H E , Mehta S A , Van Anglen L J 
Published: January 2020

Abstract

Background
Vedolizumab (VDZ) is increasingly being positioned as first-line biologic therapy for the treatment of inflammatory bowel disease (IBD) in adults, particularly for ulcerative colitis (UC). Identifying a certain subset of bio-naïve UC patients most likely to benefit from VDZ and remain on long-term maintenance therapy is important. The purpose of this study was to evaluate predictors of VDZ treatment persistence at 12 months in real-world clinical practice.

Methods
We performed a retrospective review of all adult (≥18 years) bio-naïve UC patients started on VDZ at US gastroenterology physician office infusion centres. Data collection included baseline demographics, VDZ therapy, concomitant oral agents, disease severity, and disease activity scores using the partial Mayo score (pMayo). Disease severity was characterised by prior IBD-related surgery and IBD-related healthcare resource utilisation within 1 year of VDZ initiation. Clinical response was assessed at baseline, 6 weeks, and 14 weeks and defined as a pMayo reduction of ≥2 points. Patients were divided into two cohorts, those persisting on VDZ at 12 months and those discontinuing VDZ prior to 12 months. Logistic regression analysis was used to determine predictors associated with persistence.

Results
A total of 141 UC patients receiving VDZ as first-line biologic therapy were identified: mean age 44 ± 14.5 years, male gender 82 (58%), median disease duration 5.5 (IQR 1.6–13.3) years. VDZ treatment persistence at 12 months was observed in 102 (72%) patients (Figure 1). The remaining 39 patients discontinued VDZ within the first 12 months. Amongst those who discontinued VDZ, reasons included lack or loss of response in 35 (90%), antibodies in 3 (8%), and intolerance in 1 (3%). In the logistic regression analysis, the only factor associated with VDZ treatment persistence was clinical response at 14 weeks (OR 6.5 [95% CI 2.9–14.5]). No other variables (age, gender, smoking status, disease duration, concomitant oral agents, or severity of illness) influenced persistence at 12 months.

Conclusion
Almost three-fourths of bio-naïve UC patients treated with vedolizumab experienced treatment persistence at 12 months. Our data suggest that response to induction may be used to predict those who will remain on maintenance therapy.
P632 Vedolizumab dose escalation in patients with inflammatory bowel disease experiencing loss of response: A systematic review and meta-analysis of real-world evidence
Authors: Varghese D , Patel D , Martin S , Luo M , Ursos L , Lirio R , Wang S 
Published: January 2020

Abstract

Background
Moderately to severely active inflammatory bowel disease (IBD), featured as Crohn’s disease (CD) and ulcerative colitis (UC) collectively, is commonly treated with biologic therapies. A proportion of patients experience loss of response (LOR) over time. The approved dose of vedolizumab (VDZ), 300 mg every 8-week (Q8W), is known to be safe and effective in the treatment of UC and CD. In an open-label long-term safety study (GEMINI LTS), patients who experienced LOR during maintenance benefitted from dose escalation to an every 4-week (Q4W) regimen. Clinical response and remission were regained in 41% and 28% respectively in UC patients (N=32) and 47% and 32% respectively in CD patients (N=57) through 52 weeks of escalated dosing. The aim of this study was to conduct a meta-analysis of existing real-world evidences to evaluate the effectiveness of VDZ dose escalation to Q4W in IBD patients experiencing LOR to Q8W dosing.

Methods
A systematic literature review was performed using PubMed and Embase databases for articles and conference abstracts from January 2014 through January 2019 for real-world studies reporting clinical outcomes to VDZ dose-escalation among adult patients with UC or CD. Relevant congresses were also screened for accepted abstracts through June 2019. Summary estimates for the proportion of regained response and remission were synthesised under a random effect model (given considerable heterogeneity as measured by I2 statistic) using the DerSimonian-Laird approach.

Results
The search yielded a total of 842 citations from the databases and 12 citations from hand searching. Of these, 5 full-text articles and 1 abstract were included in the meta-analysis. The 6 study cohorts included a total of 297 patients with IBD. The random-effects pooled regained response rate from the 6 studies was 56.5% (95% confidence interval [CI], 44.9%–67.5%) within 52 weeks (figure). Subgroup analysis showed a regained response rate of 62.7% (95% CI,52.8%–71.6%) when measured within 30 weeks vs. 50.2% (95% CI, 38.3%–62.2%) when measured after 30 weeks. Of the 6 studies, 2 reported remission rates that were included in the pooled analysis among 203 patients experiencing LOR. The random-effects pooled estimate of recaptured remission was 42.4% (95% CI, 25.1%–61.8%) within 52 weeks.

Conclusion
More than half of IBD patients who experienced LOR during maintenance phase after initial response to VDZ Q8W dosing regained response on the escalated Q4W regimen within 52 weeks. These findings and the data from the open-label clinical trial support the benefits of VDZ dose escalation among patients experiencing LOR to Q8W dosing.
P636 Changes in peripheral helper T-cell was associated with sustained response to a 12-week EEN therapy in active Crohn’s disease: A pilot study
Authors: Guo K , Gong W , Zheng T , Li W , Fang M , Xie H , Wang G , Gu G 
Published: January 2020

Abstract

Background
Exclusive enteral nutrition (EEN) is an effective solution in inducing remission in patients with active Crohn’s disease (CD). However, the underlying mechanism is not completely clear. Evidence is accumulating that potential beneficial in regulating the inflammatory immune response of CD, a chronic inflammation dominated by pathogenic TH1 and TH17 cells. We investigated the relationship between changes of circulating helper T cell and clinical response in CD during treatment with EEN.

Methods
Sixty-eight adults with active CD treated successfully with EEN were prospectively study. Peripheral helper T cell (Th1, Th2, Th17 and Treg) were evaluated using flow cytometry from baseline to Weeks 4 and 12. We also determine the prognostic value of the ratio of delta Th cell at Weeks 4 to baseline (△Th w4-w0) in patients receiving EEN. Mucosal healing was assessed with endoscopy at baseline and Week 12.

Results
Treatment with EEN significantly improved disease activity scores and laboratory biochemical markers measured at Weeks 4 and 12 compared with baseline (p &lt; 0.05 and p &lt; 0.001). After the initiate of EEN, we observe early modulating effects of EEN on helper T-cell percentages, especially in Treg cell. Furthermore, we found a long-term increase in Treg cell percentages in patients who sustained response to EEN during follow-up. Mean increases of Treg cell from baseline in patients sustained response were significantly larger in a patient who loss of response (p &lt; 0.01). Receiver operating characteristic (ROC) analysis to predict sustained response at 12 weeks showed area under the curve (95% confidence interval) of Treg cell at 4 weeks (Treg w4) and change in Treg cell from baseline to 4 weeks (△Treg w4-w0) to be 0.75 (0.56–0.87) and 0.84 (0.63–0.92), respectively. Logistic regression analysis confirmed that △Treg w4-w0 (31.8%) after the EEN was significant independent predictive factors for sustained response. Mucosal healing at Week 12 was achieved by 97.1% of patients who long-term increase of Treg cell compared with 51.5% of those temporary raise (p &lt; 0.001).

Conclusion
EEN resulted in rapid improvements in laboratory markers and early increase in Th subsets percentages. Early increase of Treg cell predicts a sustained response to EEN and mucosal healing. Monitoring of Treg cell may help predicts the sustained clinical response and course.
P638 Stenotic Crohn’s disease
Authors: El Ouardi W , Nawal L , Imane B , Camelia B , Mohamed B , Fatima Zahra A 
Published: January 2020

Abstract

Background
The treatment of Crohn’s stenosis appears to be codified and complex, it depends on the inflammatory or fibrous type of stenosis. The purpose of our study was to describe the clinical, epidemiological and therapeutic characteristics of Crohn’s disease in its stenotic form and to determine the failure factors for the treatment of stenotic CD.

Methods
This is a descriptive and analytical monocentric retrospective study, involving 900 Crohn’s patients, 189 of whom had stenotic CD. The statistical analysis is performed using the SPSS 22.0 software.

Results
The average age was 32± 11 years. Followed for an average of 48 months[12–96].Sex ratio=1.14F/1H. 44(23.3%) were smokers and 29(15.3%) had a previous of appendectomy.Symptomatology was Koenig syndrome in 107 cases(56.6%), occlusive syndrome in 40 cases(21.2%), constipation in 31 cases(16.4%), vomiting in 7 cases(3.7%) and 4 cases(2.2%) asymptomatic.The localisation of stenosis was ileocaecal in 118 patients(62.4%), hail in 32 patients(16.9%), colic in 17 cases(9%), anal in 15 cases(7.9%) and high in 7 cases(3.7%).Stenosis was unique in 160 cases(84.7%) and multiple in 29 cases(15.3%). 117 patients (62%) had a short stenosis &lt;5 cm and 72 patients (38%) had a stenosis &gt;5 cm. The fibrous nature of stenosis was in 86 patients (45.5%) and inflammatory in 103 (54.5%). 40 patients (21.2%) had an associated fistulizing behaviour. Anoperineal manifestations (MAP) in 58 cases (30.7%). Therapeutically speaking:80 patients (42.3%) were treated with corticosteroids, 10 patients (5.3%) with anti-TNFa, 3 patients (1.6%) with immunosuppressants (IS), 12 cases (6.3%) with endoscopic dilation and 84 cases (44.4%) were operated. The course was marked by a good response in 53 cases (28%), the appearance of fistula± abscess in 25 cases (13.2%), intestinal obstruction in 13 cases (6.9%) and recurrence of stenotic disease in 98 cases (51.9%).There is a difference in management between fibrous and inflammatory stenosis:corticosteroids(1.2%vs98.8%),anti-TNF(10%vs90%), dilation(100%vs0%), surgery(84.5%vs15.5%), this difference is statistically significant(p &lt; 0.001). In multivariate analysis and by adjusting for confounding parameters, it appears that only MAP, ileocaecal location and fistulizing behavior are associated with treatment failure with [OR = 3.2; IC = 1.4–7.7; p = 0.005], [OR = 0.17; IC = 0.3–0.9; p = 0.037], [OR = 2.6; IC = 1.02–6.6; p = 0.04].

Conclusion
There was a statistically significant difference (p &lt; 0.001) in terms of response to corticosteroid and anti-TNF treatments, as well as the use of surgery and dilatation between fibrous and inflammatory stenosis. And treatment failure was related to: MAP association [OR = 3.2; IC = 1.4–7.7; p = 0.005], ileocaecal localisation of stenosis [OR = 0.17; IC=0.3–0.9; p = 0.037] and fistulizing behavior[OR = 2.6;IC = 1.02–6.6;p = 0.04]
P639 Outcomes of a clinical psychology intervention in a UK IBD service
Authors: Eldridge F , Strongili K , Parkes M , Raine T 
Published: January 2020

Abstract

Background
Patients with IBD experience significant psychological distress. A variety of interventions to ameliorate this distress have been studied. However, to date, no European study has assessed the impact on patients of a clinical psychologist embedded within the IBD team. Clinical psychology is uniquely characterised by its use of a patient/therapist collaborative formulation to guide and select from a variety of evidenced-based psychological therapeutic treatment options. Such an approach is likely to be particularly beneficial for patients with IBD who may present with a wide range of needs from adjustment at diagnosis to coping with symptoms, adhering to treatment protocols and managing an on-going relationship with a medical team.

Methods
A novel clinical psychology service was established within an existing IBD service at a large UK tertiary centre. Patients were referred either by a gastroenterologist, IBD nurse, or dietician using real-world clinical selection (clinical judgement rather than screening/threshold methods). Patients could also self-refer to the service. After an assessment with the clinical psychologist, patients were assigned as either accepted for intervention, referred to other mental health services or did not require intervention. Intervention involved a range of therapeutic modalities delivered by a clinician with considerable experience of working with long-term physical health conditions.

Results
Of 42 patients referred, 25 (60%) were accepted for intervention, with completion data currently available for 21. Measures of depression, anxiety, work and social adjustment and health-related quality of life were captured for these patients pre-, during and post-intervention, as well as for 93 unselected patients with IBD attending outpatient clinics. Patients selected for intervention recorded moderate to severe scores across these domains that differed significantly from the background population. Post-intervention, patients showed highly statistically significant improvement across all domains with scores that did not differ from the background.

Conclusion
Real-world clinical selection methods appear adequate in identifying patients with greater psychological need than the baseline population. Although limited by our current small sample size, our results suggest that a clinical psychology intervention, embedded within the IBD team, can reduce patient psychological distress in IBD across a range of outcomes.
P640 Moderate to severe endoscopic inflammation is frequent after clinical remission in pediatric ulcerative colitis: A cause for disease extension and relapse?
Authors: Sarbagili Shabat C , Weiner D , Wardi J , Abramas L , Yaakov M , Levine A 
Published: January 2020

Abstract

Background
Pediatric ulcerative colitis (UC) is characterised by low sustained remission rates and frequent extension of disease even if clinical remission is obtained. Current therapy in pediatric UC is driven primarily by clinical response. Extension of disease and high relapse rates may be due to a failure to obtain mucosal healing with treatment despite clinical remission. Our aim was to evaluate this possibility by assessing endoscopic disease activity after remission was obtained.

Methods
Pediatric UC patients with clinical remission, defined as sustained PUCAI &lt; 10 three months after remission was obtained, were prospectively assessed for mucosal healing by endoscopy. Mayo score was assessed for each segment by a blinded adult gastroenterologist using central reading.

Results
41 children were enrolled after informed consent, 7 were excluded because of a PUCAI score 10–15 at the time of sigmoidoscopy. Thirty-four Sigmoidoscopies were performed 12–20 weeks after reporting clinical remission. Mucosal healing Mayo 0 was present in 15 endoscopies (44%), Mayo 1 was present in 2 endoscopies (6%) and moderate to severe endoscopic scores Mayo 2–3 was present in 17 endoscopies (50%).

Conclusion
About 50% of children assessed for mucosal healing 3–5 months after clinical remission is obtained have residual moderate to severe inflammation. Inadequate endoscopic improvement despite clinical remission may explain disease extension and the high relapse rate in children.