bluuebunny/crossref_metadata_2025 huggingface dataset:
P398 Disease clearance: a potential target for management of patients with Ulcerative Colitis
Authors: Andronic A M , Toader E
Published: January 2023

Background

Disease clearance defined by the absence of symptoms and intestinal inflammation at endoscopic and histological examination, is proposed as a target in the evaluation of the ulcerative colitis (UC) course. The purpose of this study was to evaluate disease remission on the UC evolution according to disease clearance concept.

Methods

Between January 2020 - March 2022, 79 patients with UC were evaluated clinically, laboratory testing, endoscopically and histologically. Patients positive for COVID and CDI were not included in the study. Disease remission, in accordance with the concept of disease clearance it is defined as clinical (partial Mayo score ≤2), endoscopic (endoscopic Mayo score ≤1) and histological (Nancy Index) remission. Disease clearance was measured at inclusion in the study and during follow-up after 12 months. Results were compared in patients who did or did not achieve disease clearance.

Results

The patients were divided into 2 groups according to disease clearence: group 1: 35 out of 79 patients with UC evaluated, were considered with disease clearance at the initial moment of the evaluation. Group 1 did not present complications and did not require surgical interventions during the follow-up period, compared to group 2: non-disease clearence patients, 44 out of 79 patients (0.0% vs. 31.8%, p=0.03, OR=23.1). During follow-up, 38.6% patients (N=17 pts, Incidence Rate=0.3864) from group 2 obtained clinical remission, of which 15.9% patients obtained endoscopic remission, 6.81% patients obtained histological remission (p=0.025) and 27.2% patients were under biological therapy. A total of 27 patients from both groups required hospitalization, significantly shorter for patients with initial values ​​of fecal calprotectin below 200 μg/mg, and without endoscopic and/or histological activity (8.57% vs. 54.54%, p=0.002, OR=0.57, RR=0.224). 51.8% patients presented severe forms of disease with surgical and non-surgical complications (35.7% vs. 64.2%, p=0.91, OR=1.07). Surgical complications include toxic megacolon (N=2 pts, 14.2%), colonic perforation (N=1 pts, 7.1%), gastrointestinal hemorrhage (N=1 pts, 7.1%) and stricture with bowel obstruction (N=1 pts, 7.1%). Non-surgical complications include gastrointestinal hemorrhage (N=6 pts, 42.8%), venous thrombosis (N=1 pts, 7.1%) and colorectal cancer (N=2 pts, 14.2%). No deaths were reported.

Conclusion

According to the concept of disease clearance, our data indicate that UC patients in clinical, endoscopic and histological remission present a significantly lower risk of hospitalization, complications and surgical intervention.
P409 Using antidepressants for refractory symptoms of Inflammatory Bowel Disease: a prospective service evaluation
Authors: Moulton C , Avery P , Hart A
Published: January 2023

Background

One third of patents with inflammatory bowel disease (IBD) have refractory gastrointestinal symptoms, such as pain and diarrhoea, even after exhaustion of medical therapies. A further 40% have persistent fatigue. Although antidepressants can improve such symptoms, their role in treatment-refractory IBD has not been studied.

Methods

We evaluated a Consultant Psychiatrist clinic for patients with refractory IBD symptoms. Patients were reviewed remotely over 3-6-month follow-up. For pain, we used duloxetine or venlafaxine first-line. For nausea and insomnia-driven fatigue, we used mirtazapine first-line. For refractory fatigue or diarrhoea, we used bupropion, reboxetine or vortioxetine. Ineffective medications were changed after 6-8 weeks. Antidepressants were combined and augmented with antipsychotic if required. The primary outcome was change in the self-report IBD Control Questionnaire, scored from 0 (poor) to 16 (good). Secondary outcomes were changes in depression (PHQ-9), anxiety (GAD-7), IBD Fatigue Scale and average daily bowel frequency. Data were presented as mean (SD) if parametric and median [interquartile range] if skewed. Changes over time were measured using 2-tailed paired t-tests (parametric) or Wilcoxon signed rank tests (skewed data).

Results

Of 62 patients with IBD offered antidepressants, 80.1% started treatment. Mean age was 41.8 years and mean IBD duration 16.6 years. Of these, 88% had Crohn’s disease, 70% were refractory to multiple biologics, 62% had previous bowel resection and 14% had intestinal failure. At baseline, 92% had severe fatigue (IBD-Fatigue >10), 52% had diarrhoea/high stoma output, 50% had pain and 18% nausea/vomiting. At baseline, 86% met ICD-10 criteria for moderate/severe depression and/or generalised anxiety disorder, and 26% had existing treatment-resistant depression.

At follow-up, IBD Control score improved from 1.5 [0-4] to 5 [1.5-8] (p<0.001), as did depression (mean 24% reduction, p<0.001), anxiety (mean 28% reduction, p<0.001) and fatigue (mean 18% reduction, p=0.01). Although 27% of patients responded to first-line antidepressants, the rest required changes in treatment, combination therapy or augmentation. Ultimately, 51.5% were prescribed bupropion, reboxetine or vortioxetine, collectively in whom median bowel frequency fell from 6/day to 4/day (p<0.001). Only 8% could not tolerate antidepressants.

Conclusion

Even in very difficult-to-treat IBD, antidepressants can improve IBD control, depression, anxiety and fatigue. However, specialist- or combination antidepressants are often required in this specific group. Clinical services should consider expansion of psychiatry provision to improve IBD outcomes. Trials of antidepressants for patients with refractory IBD symptoms are needed.
P411 Early ultrasound assessment predicts therapy response: an easy tool for clinical decision making
Authors: Calabrese PhD E , Castiglione F , De Cristofaro E , Rispo A , Capacchione C , Testa A , Guarino A D , Caiazzo A , Monteleone G , Zorzi F
Published: January 2023

Background

Intestinal ultrasound (IUS) is an effective and easy-to-use tool in monitoring Crohn’s disease (CD) lesions during different biological therapies. Aim of our study was to evaluate whether lesion improvement during biological therapy could predict transmural healing.

Methods

We performed a prospective study enrolling CD patients (pts) with indication to biological therapies. IUS and doppler US parameters at baseline, at 3 and 12 months were: bowel wall thickening (BWT), lesion length, echopattern, complications, blood flow according to Limberg’ score. Transmural healing (TH) was defined as normalization of all parameters; IUS responders were defined as pts with improvement of BWT associated with decreased lesion length, Limberg’ score improvement, and no worsening of the other parameters. Delta (Δ) signified the difference between IUS parameters at baseline and at 3 months. Changes in parameters and in Δ values at baseline and after 3 months were analyzed using Mann Whitney test; the area under (a ROC) curve was calculated. Differences between combination of parameters were tested by Chi-square test.

Results

One hundred and fifteen CD pts were enrolled (63.5% males; median age 37 years; median disease duration 96 months). Forty-nine per cent of pts had L1, 9% had L2, 42% had L3 according to the Montreal criteria. TH rate at 12 months was 20% and IUS responder rate was 43%. At baseline, no statistical differences in terms of BWT were observed between pts achieving TH vs no TH. Similarly, no differences were observed in pts defined as IUS responders vs non responders. Patients achieving TH at 12 months had a higher ΔBWT than patient without TH (p=0.0004). On ROC curve, ΔBWT improvement of 1.25 mm showed sensitivity and specificity of 73% and 61%, respectively, in predicting pts who achieved TH. Similarly, IUS responder group at 12 months had a higher ΔBWT than patients IUS non-responder group (p<0.0001). On ROC curve, ΔBWT improvement of 1.25 mm showed sensitivity and specificity of 83% and 57%, respectively, in predicting IUS responders. A combination of a ΔBWT (≥1 mm) and Limberg’ score improvement (1 point) was associated with a higher risk of TH at 12 months (p=0.0007; OR 5.1; 95% CI, 1.8-12.8). A combination of a ΔBWT (≥1 mm) and Limberg’ score improvement (1 point) was associated with a higher risk of IUS responders at 12 months (p<0.0001; OR 15.7; 95% CI, 4.5-52).

Conclusion

An early ΔBWT, and a combination of a ΔBWT and Limberg’ score improvement showed high diagnostic accuracy in predicting pts who achieved TH and IUS responder at 12 months. This information may help clinical decision making in terms of prompt optimization or switching/swapping therapies in CD.
P414 Comparative real-world effectiveness and persistence of vedolizumab versus anti-TNF therapy in biologic-naïve patients with Crohn′s disease with propensity score adjustment: two-year maintenance phase results from the prospective VEDO-IBD study
Authors: Bokemeyer B , Plachta-Danielzik S , Efken P , Mohl W , Hoffstadt M , Krause T , Schweitzer A , Schnoy E , Atreya R , Teich N , Trentmann L , Ehehalt R , Franzenburg S , Hartmann P , di Giuseppe R , Schreiber S
Published: January 2023

Background

To gain insight into vedolizumab (VEDO) use as a first-line biologic in Crohn′s disease (CD), this comparative, two-arm prospective real-world-evidence (RWE) study with propensity score (PS) adjustment aimed to assess, within the maintenance phase, the 2-year comparative effectiveness and persistence of VEDO vs anti-TNF therapy in biologic-naïve CD patients.

Methods

Between 2017-2020, 1200 consecutively enrolled biologic-naïve and biologic-experienced patients with ulcerative colitis (UC) and CD were prospectively included in the VEDOIBD study from 45 IBD-experienced centres across Germany. 260 biologic-naïve CD patients starting a new therapy with VEDO or anti-TNF were included in this RWE comparison of VEDO vs anti-TNF. The Kaplan-Meier curve was used to summarize the treatment persistence from the start of therapy through week-104. The primary outcome was two-year clinical remission (HBI ≤ 4). Patients were analysed on a modified intent-to-treat basis (mITT; switchers considered as outcome failure). To reduce the effect of confounders, PS adjustment with inverse probability of treatment weighting (IPTW) was implemented. A weighted logistic regression was used to evaluate the effectiveness. The results were reported as odds ratio (OR) and 95% confidence interval (CI).

Results

63 VEDO and 197 anti-TNF (ADA: 58.4%, IFX: 41.6%) biologic-naïve CD-patients were evaluated. Two years after treatment initiation approximately 83% of VEDO patients were still in continuous treatment vs only 56% of anti-TNF patients (Fig. 1). In the mITT analysis (Fig. 2), there was a significantly higher clinical remission rate with VEDO when compared to anti-TNF after two years (VEDO: 64.2% vs anti-TNF: 44.7%), and a higher steroid-free remission (VEDO: 62.5% vs anti-TNF: 41.6%). Both differences were statistically significant (p<0.05). Additionally (Fig. 3), using IPTW to examine the two-year maintenance effectiveness in week-14 induction phase responders, there was a significantly better response in terms of clinical remission for VEDO (88.6%) compared to anti-TNF (45.8%) (p=0.0001) and in steroid-free remission of 86.8% for VEDO compared to 44.1% for anti-TNF (p<0.001).

Conclusion

Compared to previous RCTs, this prospective two-year RWE study comparing VEDO with anti-TNF showed that, in biologic-naïve CD patients, remission rates at two years with VEDO were remarkably higher than with anti-TNF. Given the favourable side effect profile of VEDO, these findings may aid physicians’ decision-making on the choice of VEDO as a first-line biologic for CD.
P436 Efficacy and safety of intravenous ustekinumab re-induction therapy in Crohn’s disease patients with secondary loss of response to ustekinumab maintenance therapy: Week 16 results from the POWER trial
Authors: Schreiber S W , Lee S , van der Woude C J , Marín-Jiménez I , Wolf D , Schnoy E , Salzberg B , Busse C , Nazar M , Langholff W , Borghorst S , Gasink C , Baker T , Godwin B , Feagan B ,   POWER Investigators
Published: January 2023

Background

After successful induction, a subset of patients with Crohn’s disease (CD) experience a secondary loss of response (LoR) to ustekinumab (UST) maintenance therapy. Dose intensification may assist in regaining response. The phase 3b randomised, double-blind, multicentre POWER study evaluated efficacy and safety of a single intravenous (IV) re-induction UST dose vs continued UST subcutaneous (SC) treatment in CD patients with LoR to standard UST every 8 weeks (q8w) maintenance therapy.

Methods

Adults with moderately–severely active CD who initially responded to UST IV induction therapy per label and subsequently experienced LoR were included. LoR for inclusion was defined as CDAI score of ≥220 and ≤450, in addition to elevated CRP (>3mg/L), fCal (>250mg/kg) or endoscopy performed ≤3 months before W0 with evidence of active CD (≥1 ulcerations in the ileum and/or colon). At baseline (W0), randomised patients received either ~6mg/kg IV UST/SC placebo (IV arm), or IV placebo/SC UST 90mg (SC arm), followed by SC UST 90mg dosing in both groups at W8/16. Clinical and biomarker assessments were made at W0/8/16 and optional ileocolonoscopy at W0/16. Primary endpoint: clinical response (CRes; decrease of ≥100 points from W0/CDAI <150) at W16. Additional outcome measures included clinical, biomarker, endoscopic and quality of life endpoints assessed at W8/16.

Results

The analysis set comprised 215 patients at W0 (IV, n=108; SC, n=107). At W16, 92.6% and 86.0% completed treatment from IV and SC arms, respectively. In both arms (IV, 58.3%; SC, 57.9%) most patients experienced ≥2 biologic failures before initiating UST (Table 1). At W16, 49.1% in the IV arm and 37.4% in the SC arm achieved CRes (p=0.089). Percentages of patients with normalisation of fCal, normalisation of CRP and/or fCal, endoscopic remission and improvement, and improvement in IBDQ score were greater in the IV vs SC arm (Table 2). At W16, similar proportions of patients had ≥1 adverse event (AE) (IV, 60.2%; SC, 61.7%) and serious AEs (IV, 5.6%; SC, 5.6%). The proportions of patients with infections were similar between arms (IV, 23.1%; SC, 21.5%), with only 1 serious infection in each arm.

Conclusion

POWER is the first randomised, controlled, double-blind trial to assess the efficacy and safety of UST IV re-induction in patients with LoR during UST maintenance therapy. The CDAI-based primary endpoint at W16 was not met. However, patients in this heavily pre-treated population who received IV re-induction showed clinically meaningful improvements at W16 compared with those receiving SC, particularly for objective endpoints, including inflammatory biomarkers and endoscopic outcomes.
P437 Early therapeutic drug monitoring of Adalimumab, but not HLADQ*A1 determination, predicts inflammatory bowel disease outcome
Authors: Carrillo Palau M , Alonso-Abreu I , Morant A , Vera B , Vela M , Ramos L , Franco A , Reygosa C , Barrios Y , Medina Chico J S , Globio V , Hernández-Perez A , Jiménez A , Hernández-Guerra M
Published: January 2023

Background

Anti-TNF drugs are effective treatments for the management of Inflammatory Bowel Disease (IBD), yet treatment failure is common. Monitoring drug levels and their antibodies (ATIs) can be useful to optimize the management of patients. In addition, the HLA-DQA1*05 gene has been recently related as a possible marker of immunogenicity and loss of response to anti-TNF therapy.The aim of this study was to evaluate the clinical impact of determining adalimumab (ADA) levels and anti-adalimumab ATIs in patients with IBD, and the influence of the HLA-DQA1*05 allele on the response and maintenance of adalimumab treatment in this population.

Methods

This observational, multicentric and prospective study enrolled patients who started treatment with ADA from October 2020 to October 2022. Demographic data and IBD characteristics were recorded. Clinical Activity Index (Harvey Index and Parcial Mayo Score) and C reactive protein(CRP), faecal calprotectin (FC), endoscopy or radiological activity, Global Physician Assesment (GPA) and PRO (by IBDQ-9) were prospectively collected at baseline and at the same time that ADA levels: week 4, 10, 30 and 12 months. HLA-DQA1*05 was genotyped at baseline. Pearson coefficient was used to assess the correlation between ADA levels and activity disease at different points

Results

We included 131 (age 42±17 years, 56% female) IBD patients (78% Crohn`s Disease, 21% Ulcerative Colitis and 1% Indeterminate colitis) who started treatment with ADA (80% were naïve to anti-TNF and 57% started ADA combined with immunomodulator treatment). At baseline, 81% had an active disease (Global Physician Assesment=1), 49% had CRP >5 mg/L and 77% had FC > 150 mg/kg. PRO at baseline was 63±9.1. HLA was determined in 99 patients, of whom 42 (42%) were HLA-DQA1*05 positives. We found a positive correlation between PRO score and Hb levels and albumin, meanwhile a negative correlation with FC and CRP at week 0. No correlation with ADA levels or ATIs was established. Patients HLA-DQA1*05 positive had not more adverse reaction or ATIs during the observational period. Patients with ADA serum concentration >7µg/mL at week 4 had CRP <5mg/dL at week 4 (p=0.04) and at week 10 (p=0.01). Patients with ADA serum concentration >7µg/mL at week 10 had more stable disease (PGA =0) and CRP <5mg/L, FC <150 mg/kg at week 10 (p<0.05), CRP <5mg/L at week 30 (p<0.05) and FC <150 mg/kg at 12 months.

Conclusion

Early Drug level monitoring of Adalimumab (after induction) may improve the management of IBD patients. Our study shows that ADA levels >7 µg/mL is associated with a better clinical response in short and long-term, independent of HLADQA1*05.
P444 A systematic literature review (SLR) of real-world studies of advanced therapies in moderate-to-severe ulcerative colitis (UC): study, patient and clinical characteristics, and outcomes assessed
Authors: Irving P M , Hur P , Gautam R , Guo X , Vermeire S
Published: January 2023

Background

Variability in real-world (RW) study designs is often seen as a limitation for drawing conclusions. With more RW studies assessing effectiveness and safety of advanced therapies (ATs) in patients (pts) with moderate to severe UC, there is a need to better understand the study characteristics, clinical characteristics, treatments (Tx), and outcomes.

Methods

We conducted a SLR as per methodology described by Cochrane Collaboration and PRISMA guidelines, using Embase®, MEDLINE®, and MEDLINE®-In Process databases to find RW studies assessing biologics [bio] (adalimumab, golimumab, infliximab, vedolizumab/VEDO, and ustekinumab) or small molecules (filgotinib/FIL, ozanimod/OZA, and tofacitinib/TOFA) for adults with UC. Only products approved at the time of search were included. Studies published in English as full papers (Jan-2005–Feb-2022)or conference abstracts (Jan-2019–Feb-2022) were included. Studies with <30 pts or with only bio-naïve pts were excluded.

Results

From 3930 search results, 139 studies were included. Of these, 75% were published between 2019–2022; 64% were retrospective observational; and 53% were from 5 countries (Italy, US, Spain, UK, and Belgium). The median age of pts across studies was 26–55 years and male proportion ranged 25%–73% (Fig 1). 13% of studies had only bio-exposed pts, 63% had >50% pts bio-exposed and 28% presented sub-analysis for bio-exposed pts.

Most studies (87%) were single arm; VEDO (41%) was the most evaluated Tx, followed by TOFA (20%). No studies were found for FIL or OZA. Clinical remission (CR; 69%), clinical response (69%), and steroid-free CR (46%) were commonly reported outcomes, whereas histologic (6%) and sustained remission (4%), and patient-reported outcomes (PROs; 5%) were uncommon (Fig 2). In studies reporting CR, Partial Mayo Score (PMS) or Full Mayo Score ≤2 alone or combined with rectal bleeding and stool frequency subscore ≤1 were commonly used definitions, followed by PMS ≤1 and Simple Colitis Clinical Activity Index ≤2. Most studies assessed outcomes within 52 weeks (76%). Any adverse event (AE; 46%), colectomy (46%), withdrawal due to AE (37%), and infections (24%) were frequently reported safety events. Only up to 12% of studies reported data on MACE, malignancies and VTE.

Conclusion

More than half of RW studies in moderate to severe UC originated from five countries with VEDO and TOFA being the most frequently assessed ATs. Comparative studies were limited. Several definitions of CR were used to describe effectiveness, and few studies assessed PROs and effectiveness beyond 1 year. Inconsistent reporting of safety events was identified. Future research should consider these findings when designing a study.
P447 Early predictors of the need for surgery in patients with acute severe ulcerative colitis: results of the prospective, observational, international ESCP MASC study
Authors: Frasson M , Pinkney T , Gisbert J P , Rodriguez-Lago I , Blackwell S , Gecse K B , Buskens C J , Knowles C , Zmora O , Brookes M , Fiorino G , Nos P , Gallo G , Pata F , Verjee A , Leone S , Pellino G
Published: January 2023

Background

Acute severe ulcerative colitis (ASUC) is a potentially life-threatening condition, requiring immediate hospitalization. Delayed colectomy is associated with increased risk of post-operative complications. This study aimed to identify early predictors of failure to medical treatment and need for colectomy in patients with ASUC.

Methods

The Management of Acute Severe ulcerative Colitis (MASC) Audit was an international, prospective, observational, cohort study, in which data on consecutive patients hospitalised for ASUC at participating units over a minimum 6-month period in 2019-20 were collated. The need for surgery during the first 90 days after admission was the primary outcome of the study. Data on all consecutive patients admitted for ASUC at the participating units were prospectively entered in an online secure database. A multivariate regression logistic model was developed to identify early predictors of colectomy.

The study was developed by a multidisciplinary panel of collaborators, including gastroenterologists, surgeons, and patients, and it was discussed at the 5th IBD National Study Group of the ECCO. The study was led by the European Society of Coloproctology (https://tinyurl.com/vfwmahva).

Results

Out of 706 patients included in the database, data from 699 patients from 123 centres located in 32 different countries were included in the analysed (Figure 1).

Median age was 38 (IQR, 28-54) years; 265 (38%) patients had a previous admission for UC and 39 (6%) had undergone previous appendicectomy. At admission, 13% patients were on monotherapy with 5-ASA, 19% systemic steroids, and 19% biologic agents. Within 90 days after admission, 258 (37%) patients required surgery: 29.7% received second-line and 1.4% received third-line medical therapy. Overall mortality was 1%. Among those patients requiring surgery, postoperative morbidity was 36% (Table 1).

Being a current smoker (OR 2.6, 95%CI 1.2-6.0), previous appendicectomy (OR 6.3, 95%CI 2.1-20.0), previous admission for UC (OR 2.6, 95%CI 1.5-4.4), admission to a surgical unit (OR 9.8, 95%CI 4.3-22.5), type of pre-admission therapy and C-reactive protein levels on day 3 after admission (OR 1.01 per mg/L, 95%CI 1.00-1.01, ROC curve in Figure 2) were independent predictors of failed medical treatment.

Conclusion

Mortality for ASUC did not exceed 1% in this series. Patients who smoked or had previous appendicectomy were at increased risk of medical failure. These factors seem to challenge the current knowledge on UC course, and the findings merit further investigation. C-reactive protein on day 3 after admission was identified as a potential marker to predict the subsequent need for surgery.
P467 5-ASA is not superior to no-maintenance in patients with newly diagnosed Crohn’s disease - a nationwide cohort from the epi-IIRN
Authors: Atia O , Goren I , Sharar Fischler T , Loewenberg Weisband Y , Greenfeld S , Kariv R , Ledderman N , Matz E , Magen Rimon R , Dotan I , Turner D , Yanai H
Published: January 2023

Background

5-aminosalicylates (5-ASA) are widely used in Crohn's disease (CD) despite guidelines advising otherwise. In this nationwide study, we aimed to assess the outcomes of first-line 5-ASA-maintenance therapy (5-ASA-MT) compared with no-maintenance treatment (no-MT) in patients with newly diagnosed CD.

Methods

We utilized data from the epi-IIRN cohort, including all patients with CD diagnosed in Israel between 2005-2020. Outcomes included therapeutic failure, hospitalization, surgeries, steroid dependency, escalation to biologics, and 5-ASA-related adverse events. Propensity-score (PS) matching was utilized to compare outcomes in the 5-ASA-MT vs. no-MT groups.

Results

Of the 19,264 patients diagnosed with CD, 3,027 (16%) received first-line 5-ASA-MT and 5,583 (29%) received no-MT. Both strategies declined over the years; 5-ASA-MT from 21% in 2005 to 11% in 2019 (p<0.001) and no-MT from 36% to 23% (p<0.001). The probability of maintaining therapy at one, three, and five years from diagnosis: 5-ASA-MT- 78%, 57%, and 47%, no-MT- 76%, 49%, and 38%, respectively (both p<0.001). PS analysis successfully matched 1,993 pairs of treated and untreated patients and demonstrated comparable outcomes of time to: biologic (p=0.2), steroid-dependency (p=0.9), hospitalization (p=0.5), and CD-related surgery (p=0.1). On the other hand, rates of acute kidney injury (5.2% vs. 3.3%; p<0.001) and pancreatitis (2.4% vs. 1.8%; p=0.03) were higher in the 5-ASA-MT group.

Conclusion

First-line 5-ASA-monotherapy was not superior to no-MT but associated with a slightly higher rate of adverse events, while both strategies have declined over the years. These findings suggest that a subset of patients with mild CD may be offered a watchful waiting approach.
P484 Inflammatory Bowel Disease exercise and diet habits (IBDeat) study: chronic metabolic disease risk factors among IBD patients in New Zealand
Authors: Yap J , Wall C , Meredith-Jones K , Iosua E , Osborne H , Schultz M
Published: January 2023

Background

Recent literature shows that patients with inflammatory bowel disease (IBD) are at higher risk of developing chronic metabolic diseases which may be amenable to a healthy lifestyle. However, this may be challenging for IBD patients as disease symptoms may result in unfavourable lifestyle habits such as avoidance of healthy foods and reduced physical activity. In this study, we aim to describe the nutritional status and lifestyle habits of adults with IBD in New Zealand (NZ).

Methods

A cross-sectional nationwide study was undertaken from December 2021 to October 2022 in NZ. Participants were recruited through social media and the Dunedin public hospital patient database. An online questionnaire collected demographics, disease severity scores (harvey-bradshaw index and simple clinical colitis activity index), quality of life (QoL), physical activity, and dietary intake data. A subset of patients living in Dunedin had anthropometrics, handgrip strength, blood pressure, body composition (bioelectrical impedance), blood nutritional markers (lipid profile, iron studies, vitamin D, vitamin B12, folate) and faecal calprotectin measured. Descriptive analysis was conducted and data were compared to population reference values. The study received University of Otago, Dunedin, NZ ethical approval (reference: H21/135).

Results

The questionnaire was completed by 197 adults, median age 37 (IQR 25, 51) of which 72% were female and predominantly NZ European ethnicity (82.4%). In this IBD cohort, 54% had Crohn’s disease and 46% had ulcerative colitis or IBD-unspecified with quiescent-mild disease activity. Two-thirds of patients had at least one comorbidity aside from IBD and one-third of patients had impaired QoL (defined by a score <45). Most patients had nutritional risk factors including low intakes of fruits (91.3%), vegetables (94.4%), fibre (38.3%), and excessive intakes of fat (73.2%) and saturated fat (98.0%). Two-thirds of patients reported IBD-related barriers to exercise mainly due to fatigue (53.9%), abdominal pain (25.7%), bowel incontinence (23.3%), and joint pain (22.3%) in which only 59.7% met national physical activity recommendations. The Dunedin cohort (n=102) had further chronic metabolic disease risk factors such as central adiposity (63.7%), high body fat percentage (43.9%), high cholesterol/HDL ratio (29.3%), high blood pressure (26.5%), and poor handgrip strength (43.9%).

Conclusion

Findings suggest that NZ adults with IBD have multiple risk factors for chronic metabolic diseases that could be amendable to lifestyle interventions. Future studies should explore the feasibility and efficacy of nutrition and exercise lifestyle interventions to mitigate these risk factors.
P485 An Assessment Of A Guided Self-Help and Patient Initiated Review Pathway for Ulcerative Proctitis
Authors: Saunders J , Maroo S , Brownson E , Boulton Jones R
Published: January 2023

Background

The COVID-19 pandemic has placed great strain on standard outpatient services including those with IBD. There has been interest in using guided self-management and patient-initiated review to allow patients to manage their condition, while at the same time reserving outpatient capacity for those needing seen urgently. We developed a pathway for patients with stable ulcerative proctitis, which included a leaflet on symptom managment and when to contact the IBD nurses if ongoing symptoms.

Methods

Patients were identified from clinic lists cancelled during the pandemic who had a diagnosis of ulcerative proctitis. Case notes were reviewed to ensure a correct diagnosis and inclusion criteria met(stable disease,no immunosuppressant treatment). These patients were sent a Guided Self-Management leaflet in the post. A follow on questionnaire was sent 6 months after ensuring patients were happy with the information received. Non-responders were sent a second questionnaire and/or telephone call.

Results

37 Patients were identified. We received responses (via post, phone or email) from 28/37 patients (76%). 10/28 (36%) didn’t receive or do not recall receiving the leaflet. 18/28 (64%) received the leaflet. Of those who received the leaflet, 16/18 felt it was easy to understand and contained enough information to confidently manage their symptoms. 2 patients had 1 flare and 3 patients had multiple flares after receiving the leaflet. Of those with flares, 2 patients were able to self-manage their proctitis using the guided self help information. 2 patients had to contact the IBD nurses. These patients were called back within 24 hours and received useful advice. One patient had forgotten to use the leaflet. No one required rescue steroids or admission to hospital.

Overall, 17/18 (94%) felt the service was good or excellent compared to previous clinic review systems.

Conclusion

These results suggest patients are receptive to using guided self-management and patient-initiated review. Although we were not expecting to see many flares, given the low risk selected group, the results suggest patients can successfully manage flares and contact our services for support if required. It is a concern a significant proportion of patients did not recall receiving the leaflet.

Although this is a small subgroup, the results show clinic time can be saved which remains a pressurised resource as we recover from the pandemic. The principles of guided self management and patient initiated review could be applied to other patient groups(eg stable UC patients not on immunosuppressants). In future it would be important to ensure patients receive and understand the leaflet. A clinic appointment prior to discharge into such pathways should be considered.
P487 Anti TNF induced psoariasiform skin eruptions are increasing in in the biosimilar era – a descriptive study of drug induced skin manifestations and their management
Authors: Nu K P , Stamp K , Shaji S
Published: January 2023

Background

Skin disorders as extra-intestinal manifestations of inflammatory bowel disease 9IBD) are well recognized. In addition, contribution of drugs used in IBD in development of skin cancers is now fully understood. However, there are increasing reports of drug induced immune skin disorders resulting from or contributed by anti TNF agents. We aim to describe the etiology, manifestations and therapeutic approaches of anti TNF induced skin eruptions from a large tertiary center cohort.

Methods

A prospective database of IBD patients receiving biologics for IBD was interrogated for those who developed skin eruptions following initiation of anti-TNF therapy. We excluded patients who had pre-existing skin manifestations. All patients had dermatological expert review and confirmation of diagnosis as drug induced skin disorder. We collected their disease characteristics, time interval from initiation of biologics to development of skin disorder, the putative causative agent and the treatment of the skin lesions

Results

Sixty-eight patients (median age= 30 years, Female 44, male 24) among 1478 patients who received at least one dose of biologics developed a drug induced immune skin disorder. Median duration to development of skin lesions was 7.5 months. Anti TNF agents were responsible for 88.5% of the skin lesions with the commonest lesions being psoriasiform lesions in 34 (50%) patients. In our cohort, the psoriasiform lesions were more prevalent in patients who used biosimilar anti-TNF agents compared to the originator agent (31 vs 3). Forty patients required cessation of anti TNF agents because of skin eruptions. Twenty-eight of these were switched to ustekinumab with resolution of skin eruptions in 27 patients.

Conclusion

Anti TNF induced psoariasiform skin lesions appear to be more prevalent in the biosimilar era. Half of these patients will need treatment switch; ustekinumab appears to be an effective option in these patients
P495 Vedolizumab trough concentrations and histological remission in Ulcerative Colitis: Results from the LOVE-UC study
Authors: Hanzel J , Baert F , Löwenberg M , Ferrante M , Bossuyt P , Hoentjen F , Franchimont D , Palatka K , Peeters H , Mookhoek A , de Hertogh G , Clasquin E , Vermeire S , D'Haens G
Published: January 2023

Background

To date, the association between vedolizumab (VDZ) serum concentrations and histological remission in ulcerative colitis (UC) has not been studied prospectively. VDZ serum concentrations could potentially offer additional guidance for predicting histological remission. We studied the relationship between VDZ serum concentrations and histological remission in a prospective study.

Methods

LOVE-UC was a multicentre international (Belgium, the Netherlands, and Hungary) open label prospective study in patients with moderately to severely active UC treated with VDZ. VDZ serum concentrations were measured at trough prior to every infusion. Endoscopy was performed at baseline, week 26 and 52. Biopsies from the most severely affected area and endoscopy videos were scored by blinded central readers. Histological remission was defined as a Robarts Histopathology Index <3 without neutrophils. Patients who did not undergo histological assessment were regarded as not having reached histological remission. Endoscopic remission was defined as a Mayo endoscopic sub-score 0.

Results

A total of 121 patients (61 male, 62 with prior exposure to tumour necrosis factor antagonists, mean total Mayo score at baseline of 9) received at least one infusion of VDZ. At week 26, 37.2% (45/121) patients were in histological remission, 38.8% (47/121) were in histological remission at week 52. The corresponding rates of combined histological and endoscopic remission were 19.8% (24/121) and 20.7% (25/121), respectively. Median VDZ serum concentrations were numerically higher at all time points in patients who achieved histological remission at week 26 than in those who did not (Table 1). Concentration thresholds (sensitivity, specificity, positive predictive value, negative predictive value, area under the receiver operating characteristic curve) of 32.5 mg/L (66%, 68%, 54%, 74%, 0.681) at week 6 and 12.5 mg/L (76%, 60%, 61%, 70%, 0.724) at week 22 were associated with histological remission at week 26. Higher proportions of patients achieved histological remission at week 26 in higher VDZ serum concentration quartiles (Figure 1).

Conclusion

VDZ serum concentrations were positively associated with histological remission in UC, although the predictive value of serum concentrations for subsequent histological remission was modest.
P503 The risk of mild, moderate and severe infections in IBD patients: results from a prospective, multicentre, observational cohort study – PRIQ
Authors: Rezazadeh Ardabili A , van Esser D , Wintjens D , Cilissen M , Deben D , Mujagic Z , Russ F , Stassen L , van Bodegraven A , Wong D , Winkens B , Jonkers D , Romberg-Camps M , Pierik M
Published: January 2023

Background

Immunomodulators and biologicals are essential in current IBD management, but are associated with increased risk of infections. Considering the growing number of treatment options, the benefit-risk balance of drugs is becoming increasingly important in clinical decision making. To date, post-marketing surveillance studies mainly focus on severe infections. As a result, data on mild and moderate infections are scarce. These infections take longer to clear in immunosuppressed patients and can substantially impact quality of life. We aimed to assess the incidence of all infections and identify risk factors for the development of infections in IBD patients.

Methods

We previously developed and validated a Patient-Reported Infections Questionnaire (PRIQ), with excellent diagnostic accuracy, covering 15 infection categories with a 3-month recall period. The current prospective, multicentre, observational cohort study was performed between Jun, 1 2020 and Jul, 1 2021, enrolling consecutive IBD patients using the PRIQ implemented in myIBDcoach, an established telemedicine platform. Infection severity was defined as mild (self-limiting or topical treatment), moderate (oral antibiotics, antivirals or antifungals) or severe (hospitalization or IV treatment). Incidence rates (IR) were calculated for all infections, stratified for severity and subtype. Risk factors for infections were identified using multivariable logistic regression.

Results

In total, 629 IBD patients were included which completed 2391 PRIQs during 572 person-years (PY) of follow-up, resulting in 990 reported infections, corresponding to IRs of 17.3, 11.8, 5.1, and 0.4 per 10PY for all, mild, moderate, and severe infections, respectively (Tables 1-2). Upper respiratory tract (IR 26.9/100PY) and urinary tract infections (IR 14.8/100PY) were the most commonly reported mild and moderate infections (Table 3). Compared to patients without treatment, patients on immunosuppressives more frequently experienced infections of any severity (mild: IR ratio (IRR) 1.57 [95%CI 1.21-2.06] p<0.001, moderate: IRR 1.42 [95%CI 1.20-1.69] p<0.001). On multivariable logistic regression, female sex (mild aOR 1.96; moderate aOR 1.71), smoking status (mild aOR 1.66; moderate aOR 1.86), higher BMI (moderate aOR 1.05), and more comorbidities (mild aOR 2.41; moderate aOR 1.82) were all significantly associated with the development of mild and moderate infections (Table 4).

Conclusion

In this real-world prospective study, immune suppressive therapy was associated with mild and moderate infections of any kind in IBD patients. These infections particularly occur in females, smokers, patients with higher BMI and more comorbidities. This information should be considered in personalised treatment selection.
P513 Prospective study on patients’ satisfaction and impact on quality of life of corticosteroid therapy in patients with Inflammatory Bowel Disease
Authors: Navarro Llavat M , García-Bosch O , Castro-Poceiro J , Bargalló García A , Ruiz Arroyo D , Navas Bravo Y , Erice Muñoz E , Barquero Declara D , Mata Bilbao A , Martín Llahí M , Ariza Solé X , Hernández Ballesteros C , Juan Juan A , Bustamante Robles K , Berbel Comas C , Blasco Pelicano A , Albareda Riera M , Domènech Morral E
Published: January 2023

Background

Corticosteroids (Cs) remain the first-line therapy for moderate-to-severe flares in patients with inflammatory bowel disease (IBD), both Crohn’s disease (CD) and ulcerative colitis (UC). On the other hand, their use has been associated to multiple adverse events (AEs) in randomized controlled trials and registries. Nevertheless, recent studies have repeatedly observed that the use of Cs has not decreased in spite of the increasing availability of biological agents and new small molecules licensed for IBD. The impact of Cs therapy on patients’ quality of life (QoL) and the patients’ perception on Cs have not been properly assessed in IBD. The purpose of this study was to assess the impact of a standard Cs course on the patients’ QoL and their satisfaction with treatment.

Methods

A prospective, longitudinal and observational study was conducted in adult IBD. All subjects received the same standard Cs regimen: starting dose of 1mg/kg/day (maximum 60mg/day) and tapering after 14 days with 10mg per week until reach 20mg/day, thereafter reduction was 5mg per week. QoL was assessed by the IBDQ-9 questionnaire at baseline, week 4 and at the end of Cs. Treatment satisfaction was assessed by the TSQM1.4 questionnaire at week 4 and at the end of Cs.

Results

Sixty-three patients were included in the study (54% CD and 43% UC; mean age 38.5±14.9 years; 46%females). Cs therapy failed in 41% of cases (active disease upon Cs discontinuation or need for rescue therapy). AEs attributable to Cs were reported in 84.1%, the most frequent were dermatologic (acne and moon face) (60.3%), hypokalemia (44.8%) and poor quality of sleep (40%). Serious AEs were reported in 20,6%, mostly mild or moderate infections that resolved without sequelae. IBDQ-9 scores increased 12.4 and 13.5 points at 4 weeks and at the end of Cs, respectively (p<0.05). Improvement in QoL was not associated with any of the analysed factors (gender, age, type of IBD, response to treatment and AEs). The overall degree of satisfaction with Cs was 68.5 over 100 points, with the highest score related to satisfaction with adverse events (82/100). Satisfaction with treatment was only associated with the achievement of clinical remission or development of steroid dependence.

Conclusion

A standard Cs course significantly increases the QoL of patients with IBD. Furthermore, a high satisfaction with treatment was perceived by patients.
P517 Ustekinumab monitoring levels predict the need for intensification in patients with inflammatory bowel disease.
Authors: Ramos Lopez L , Ramos-Díaz R , Alonso-Abreu I , Mourani-Padron I , Carrillo-Palau M , Reygosa M C , Medina-Chico S , Gutierrez-Nicolas F , Nazco-Casariego G J , Hernandez-Guerra M
Published: January 2023

Background

Therapeutic drug monitoring (TDM) is a valuable tool to optimize anti-TNF biologics in inflammatory bowel disease (IBD). However, for the non-anti-TNF agents (such as Ustekinumab-UST- an anti-IL12/23) TDM value and evidence in real-world IBD patients is scarce although emerging data suggest that higher drug concentration (>4.5 µg/ml) of these biologics agents predicts better clinical outcomes. We evaluated associations between UST levels and clinical outcomes in real-world IBD patients.

Methods

A cross-sectional study was performed in IBD patients who received maintenance therapy (≥16 weeks) with UST and followed in our IBD unit between June 2020 and May 2021. UST trough concentration was assessed at the time of inclusion and clinical outcome were reviewed by starting UST use (PRE), at the time of blood extraction (inclusion-EXT), and after 6 months of follow-up (POST). Clinical response was determined by Harvey-Bradshaw Index (HBI) (clinical remission; HBI≤4 points or pMayo ≤2 points) and biochemical response by fecal calprotectin (FC) (biochemical response CF>50 % reduction from basal value and biochemical remission CF <150 g/kg). The need for surgery, intensification, or change of treatment at the end of the follow-up was registered.

Results

A total of 62 patients (53.2% male; mean age 46 (41-50) years; Crohn’s disease n=57/ ulcerative colitis n=3/indeterminate colitis n=2) were included. The time from diagnosis to initiation of UST treatment was 149 (122-176) months. 35.5% of patients received co-treatment with immunosuppressors and 95,6% had received previous biologic agents (15,6% more than 2 previous biologics). The mean time of UST use was 13 (10-16) months. The mean UST level was established at 7.1 µg/ml (SD 4.3) with higher levels in intensified patients (UST every 4 weeks; n=17) at the time of extraction (9.4 µg/ml (4.3) vs. 6.2 µg/ml (4.0); p= 0.03). However, no differences were found in UST levels between patients achieving clinical remission (n=52,83.9%)) compared to non-responders (7.2 µg/ml (4.4) vs. 6.7 µg/ml (4.4), respectively; p=0. 71); nor in those achieving biological remission at 6 months (n= 31, 56.4%)) compared to non-responders ((7.0 µg/ml (4) vs 6.6 µg/ml (4.5), respectively; p= 0.7). Only 2 patients discontinued UST treatment and 7 patients needed to intensify treatment every 4 weeks during follow-up. In logistic regression analysis, the UST level lower than 4.5 µg/ml showed an independent predictive value for the need for UST intensification in the subsequent 6 months (OR 5.7, 95% CI 1.01-32.9).

Conclusion

UST is an effective drug for achieving clinical and biological remission in patients with IBD. UST level (<4.5 µg/ml ) may guide the need for treatment intensification at 6 months.