bluuebunny/crossref_metadata_2025 huggingface dataset:
P195 Predictors of colectomy in patients with acute severe ulcerative colitis: single-center retrospective analysis
Authors: Mingazov A , Achkasov S , Vardanyan A , Baranova T
Published: May 2021

Background

Acute severe ulcerative colitis is observed in 25% of patients1. Near 40% of this severe patients might undergo surgery2 and the mortality rate in this group of patients reaches 6.3%3. Untimely surgery leads to severe metabolic disorders, infectious postoperative complications, and increases the risk of death4,5. Eventually, the purpose of this study is identify predictors of colectomy in patients with acute severe ulcerative colitis.

Methods

A retrospective study included 74 patients with acute severe ulcerative colitis, who were treated at the clinic in 2017(Fig. 1). The patients were divided into the groups: group of colectomy - 54/74 (73%) and group of conservative treatment 20/74 (27%) (Fig 1). The predictors, like serum albumin, C-reactive protein, hemoglobin, endoscopic picture of «extensive ulcers», and clinical data were analyzed. The statistical analysis was performed using the software«Statistica 13.3» and «RStatistica».

Results

There were no difference by gender, age and duration of the disease in the groups. Mean of albumin and hemoglobin levels were significantly lower in the colectomy group. The endoscopy «extensive ulcers» was significantly more common in the operated patients (Tab 1). Also univariate, multivariate and ROC analyses were performed (Tab 2), (Fig 2).

The risk of colectomy when endoscopy «extensive ulcers» combined with an albumin level<31 g/l and hemoglobin<107 g/l, was 100%. A nomogram for predicting the probability of colectomy was constructed (Fig 3). This logistic model has a statistically significantly high predictive value (AUC=0.93, p=0.006).

Conclusion

The endoscopic picture of «extensive ulcers» in combination with an albumin level of less than 31 g/l and hemoglobin less than 107 g/l are predictors of colectomy with high predictive value.
P213 Having Inflammatory Bowel Disease Negatively Impacts Household and Family Life
Authors: Paulides E , Cornelissen D , van der Woude C J
Published: May 2021

Background

Inflammatory bowel disease (IBD) can have a major impact on different aspects of life. This study aimed to provide insight into the impact of IBD on household and/or family life, and to determine whether this differed between sex.

Methods

Between September and December 2020, adult IBD patients from the outpatient clinic of the Erasmus Medical Center (Rotterdam, the Netherlands) were invited to fill out a survey. A questionnaire was developed to measure the impact of IBD on functioning in the household and on family planning. Generic disability and work disability were measured with the IBD Disability Index (IBD-DI) and the Work Productivity and Activity Impairment Questionnaire (WPAI-IBD). Data were analysed using descriptive statistics and tests for independent groups.

Results

Of the 229 patients who participated (response rate 74%), 68% had Crohn’s disease, 69% was female and the median age was 38.0 years. Many patients experienced difficulties with domestic activities (55.0%), leisure (53.9%), parenting (50.6%), sexual activities (48.4%) and interpersonal relationships (39.1%) because of IBD in the past week. Furthermore, 32.7% of patients felt that IBD interfered with their desire to have children. Female sex was associated with more severe limitations in various aspects of household life, more interference in family planning and higher generic disability scores.

Conclusion

IBD had a markedly negative impact on household and/or family life in many patients. In order to optimize patient care, physicians need to be aware of household and family related difficulties and strive for a holistic treatment approach.
P227 Timing of acute severe colitis in the course of an inflammatory bowel disease: is it a prognostic factor?
Authors: Sahar N , Dahmani W , Nour E , Aya H , Wafa B A , Aida B S , Ahlem B , Mehdi K , Hanene J , Ali J
Published: May 2021

Background

In this study, we aimed to compare outcomes of patients with a severe acute colitis (SAC) inaugurating their inflammatory bowel disease (IBD) with SAC occurring in those with Known diagnosis of IBD.

Methods

We conducted a retrospective chart review of patients who were admitted to our unit for severe acute colitis over 7 years. Demographics, characteristics of the disease, clinical presentation, laboratory, morphologic investigations, treatments and outcomes were reviewed from medical records. Patients were divided in two groups: SAC inaugurating IBD (A) and SAC occurring during the course of Known IBD (B) and compared in terms of clinical presentation, response to medical treatment and colectomy rate. Statistical analysis was performed with SPSS software version 19.

Results

A total of 62 patients were colliged (23 males and 39 females). Mean age at the onset of SAC was 36 years (14–78 years). There were 34 patients of group (A) and 28 patients of group (B). Overall, there were 28 patients with Crohn’s disease, 31 patients with UC and 3 others with indetermined colitis. There were no differences between both of the groups with regard to sex, age at the onset of SAC, smoking status, family history of IBD, body mass index and laboratory findings including full blood count and C reactive protein. Mean Truelove–Witts score was higher in group A vs group B (4 Vs 3, p<0.0001). Erythrocyte sedimentation rate was slightly higher in group A than group B (68 Vs 53, p=0.07). Overall, endoscopic signs of severity were significantly more common in patients from group A vs group B: deep colonic ulcerations (p=0.05) and diffuse mucosal abrasions (p=0.04). Patients from group B seem to respond better to steroid therapy than patients from group A (68% Vs 58%, p=0.5). There was no difference between both of the groups with regard to use of cyclosporine, colectomy, and recurrence of SAC.

Conclusion

Patients with severe acute colitis inaugurating their IBD seemed to have more severe clinical presentation than in those followed for IBD and complicated by SAC. However, response to therapy and need for colectomy are similar in both groups.
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

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 < 0.001)], [Symptom & disease management (p < 0.001)] and [Maintenance of remission (p < 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

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

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:>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<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

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

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 <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<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

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

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

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.
P310 Is ileoanal pouch excision a destination therapy for Inflammatory Bowel Disease? Data from a quaternary pouch referral center
Authors: Choi S , Lightner A , Lipman J , Hull T , Steele S , Holubar S , Rieder F
Published: May 2021

Background

Although ileal pouch-anal anastomosis (IPAA) is the surgical procedure of choice of many patients with ulcerative colitis and other conditions, some patients may require pouch excision (PEx). We aimed to describe our experience with pouch excisions and associated outcomes with an emphasis on late medical, endoscopic, and surgical interventions for inflammatory bowel disease (IBD).

Methods

We performed a retrospective review of a prospective colorectal surgery database. All pouch excisions performed at our quaternary pouch center from 2006 – 2019 were included; pelvic exenteration, PEx with neo-IPAA or Kock-pouch were excluded. Early complications occurred <30 days, late complications >30 days. Medications taken prior to PEx were included if taken within 12 weeks of pouch excision. Data are reported in frequency (proportion) or median (interquartile range).

Results

A total of 197 cases met inclusion criteria, and were performed by 23 surgeons, median 6 excision (IQR 2 - 14) cases over a 14-year period: of these, 105 had their index pouch created at our quaternary pouch referral center (overall PE rate 2.7%). Indications for PEx are shown in Table 1. Median time to PEx was 7 years and 94 (48%) patients had re-diversion prior to PEx. Medications prior to PEx: 34 (17%) steroids, 27 (14%) biologics, and 22 (11%) immune-modulators. The median duration of surgery was 4 hours (3.2-5). The median estimated blood loss was 263 ml (150-500) with 24 patients (12%) requiring at least one unit of packed red blood cells intra-operatively. Most pouch excisions were done through laparotomy; 2 cases (1%) were started robotically and 11 cases (10%) laparoscopically with a 26% conversion rate. Intersphincteric dissection was used in 172 cases (87%) while 26 cases (13%) required abdomino-perineal resection, of which 58% had a neoplastic indication. Intra-operative, early and late complications are shown in Table 2; 40 patients (20%) had perineal wound complications in less than 30 days, while 26 patients (13%) had long-term perineal wound complications, of which 15 patients required return to the operating room. After PEx, 23 patients out of 167 patients (14%) required continuation of IBD medications, 6 patients (3.6%) required surgery, and 4 patients (2.4%) required endoscopic intervention for their IBD.

Conclusion

In this large series of ileoanal pouch excisions, we found that perineal wound complications are common, but infrequently require operative intervention. For most IBD patients in this series, pouch excision did appear to be a destination therapy for IBD with a small minority requiring ongoing medical therapy for IBD.
P352 A propensity score-matched, real-world comparison of ustekinumab vs vedolizumab as a second-line treatment for Crohn’s disease. The Cross Pennine study II
Authors: Lenti M V , Dolby V , Clark T , Hall V , Tattersall S , Fairhurst F , Kenneth C , Walker R , Kemp K , Borg-Bartolo S , Limdi J , Taylor J , Townsend T , Subramanian S , Storey D , Assadsangabi A , Stansfield C , Smith P , Byrne D , De Silvestri A , Selinger C
Published: May 2021

Background

The best choice of biological agents after failure to an anti-tumour necrosis factor (TNF)α agent in patients with Crohn’s disease (CD) is yet to be defined. Real-world data dealing with this issue are still emerging.

Methods

This is a multicentre retrospective study including eight UK hospitals (August 2014-April 2020). We retrospectively collected data of patients treated with ustekinumab. Clinical response and remission at 14 and 52 weeks evaluated through Physician Global Assessment (PGA) and adverse events were recorded. Predictors of clinical response were examined, and a propensity score-matched analysis with a cohort of patients treated with vedolizumab was performed.

Results

Overall, 282 patients (mean age 40±15, F:M ratio 1.7:1) treated with ustekinumab were included. Clinical response or remission was reached by 200/282 patients (70.9%) at 14 weeks, and by 162/259 patients (62.5%) at 52 weeks. The most common reason for discontinuation was either primary failure or loss of response, followed by the occurrence of adverse events and by the need for surgery. The rate of non-adherence was rather low (1.4%). Current smoking (OR 2.48, 95% CI 1.13-5.44; p=0.02), baseline PGA (OR 2.4, 95% CI 1.55-3.69, p<0.001), and use of steroids (OR 2.42, 95% CI 1.26-4.65, p=0.008) were associated with 52-week treatment failure. Overall, 74 adverse events occurred, of which 26 were labelled as serious (8.3 per 100 person-year). After exclusion of patients without anti-TNFα exposure prior to starting ustekinumab or vedolizumab and exclusion of patients previously exposed to vedolizumab or ustekinumab, we analysed 275/282 patients (97.5%) from the ustekinumab cohort and 118/135 patients (87.4%) from the vedolizumab cohort. Propensity score analysis revealed that at 14 weeks, patients treated with ustekinumab were 38% (95% CI 25-50%; p<0.001) more likely to achieve a clinical remission, while at 52 weeks, the difference of 9% (95% CI -15-33%; p=0.462) was not significant.

Conclusion

Ustekinumab was effective and well tolerated in this real-world cohort. While ustekinumab proved more effective at 14-week follow-up, we found no statistically significant differences in outcomes at 52 weeks.
P388 Agreement between locally and centrally reviewed Mayo endoscopic subscores in the UNIFI study of ustekinumab in patients with Ulcerative Colitis
Authors: Mishkin D , Marano C , Simi A , Lynch J , Noonan L , Zhang H , Sands B E , Reinisch W
Published: May 2021

Background

In the UNIFI clinical study of ustekinumab (UST) in ulcerative colitis (UC), an endoscopic subscore (ES) was assigned by a local endoscopist, and the video was reviewed by central readers who provided an independent ES. Here, we determined ES agreement between local and central readers.

Methods

UNIFI (NCT02407236) was a placebo-controlled double-blind trial consisting of randomized induction and maintenance studies.1

Endoscopies were performed at screening (I-0), induction Wk 8 (I-8), and maintenance Wk 44 (M-44). Mayo ESs (range 0-3) were assigned by local endoscopists and a central reader reviewing the endoscopy video. The local reader was blinded to treatment, and the central reader was blinded to local ESs, treatment, and visit. If local and central readers assigned the same ES, that was the final ES (FES). If local and central reader ESs did not agree, videos were reviewed by an adjudicator who was blinded to the two previous ESs. If the adjudicator assigned the same ES as the local or central reader, that was the FES. If not, the FES was the median of the 3 ESs.

Results

Agreement between individual local and central reader ESs was fair (κ=0.25-0.33, Figure 1) and was less than the agreement between central reader and adjudicator (κ=0.55–0.56) at all timepoints. However, at I-0, when determining study entry eligibility (ES≥2), local and central reader agreed more than 85% of the time.

At I-0, 98.2% of 1051 endoscopies with FES 2/3 were also scored 2/3 by local ES, while for the 104 with FES 0/1, 49% had a local ES 2/3. At I-8 and M-44 (primary endpoint timepoints), the local ES and FES agreed 87% (785/899) and 80% (497/625), respectively. The proportions of subjects with clinical remission and endoscopic improvement were slightly higher when using the local ES compared to the FES (Figure 2), whereas clinical response rates when using the local ES were similar to FES. Despite these findings, treatment differences between UST and placebo were generally similar when local ES and FES were used to calculate clinical remission at I-8 and M-88.

Approximately 90% of endoscopies had an image quality considered “optimal” or “readable with certainty but with minor technical difficulties” by central readers. Overall, image adequacy did not impact agreement between readers.

Conclusion

Even though agreement between local and central readers was fair and less than that between the central reader and adjudicator, the overall impact on primary and secondary study endpoints was minimal. Overall, the use of both local and central ES to determine the FES yielded a robust and reliable measure for study endpoint determination, however, efforts facilitating reproducible endoscopic assessments in UC are warranted.
P389 Efficacy and safety of ustekinumab in patients with Crohn’s disease refractory to anti-tumour necrosis factor: real clinical practice
Authors: Saiz Chumillas R M , Alba Hernández L , Chivato Martín-Falquina I , Badia Aranda E , Arias García M L , Sicilia Aladrén B
Published: May 2021

Background

The efficacy of ustekinumab in patients with Crohn’s disease (CD) refractory to anti-TNF is worse than in anti-TNF naïve patients.

Methods

Retrospective study of patients with CD refractory or intolerant to TNF initiating ustekinumab between January 2013 and March 2020, with a minimum follow-up of 12 months, and without corticosteroid treatment. Our aim was evaluated clinical response (reduction of CDAI >100), clinical remission (CDAI <150) and biochemical remission (CDAI <100 and CRP <1 mg/L and faecal calprotectin <100 µg/g) in short and long term.

Results

A total of 49 patients with a medium follow-up of 28 months (IQR:13-37) were included. Patients baseline characteristics are reflected in Table 1. In 20% patients the induction was made subcutaneous (90 mg/week for 4 weeks). At week 52, clinical response, clinical remission and biochemical remission was 93%, 82% and 54% respectively (Figure 1). In the long term (3 years), 62% had clinical response, 52% remained in clinical remission, and 48% showed biochemical remission. 1/3 of patients needed intensification every year. Ustekinumab treatment discontinuation was observed in 13 patients (27%) mainly due to lack of response (6[12%]: primary, 7[14%]: secondary). No serious adverse effects have been reported.

Conclusion

About 50% of the patients are in clinical and biochemical remission at week 152 in a real-life cohort of anti-TNF-exposed CD patients. With a harder remission definition including biochemical parameters, our results in real life are similar to pivotal studies at week 152. Nevertheless, at week 52 our remission rates were higher.
P403 Adherence to vaccination recommendations in patients with Inflammatory Bowel Disease: a long way for improving
Authors: Ferreiro Iglesias R , Hernández Camba A , Saldaña R , Rodríguez-Lago I , Zabana Y , Barreiro-de Acosta M
Published: May 2021

Background

Despite the existence of specific recommendations, patients with inflammatory bowel disease (IBD) have shown low immunization rates. The aim of this study was to evaluate the adherence to vaccination recommendations by physicians to their IBD patients.

Methods

An online anonymous survey was sent to 8000 patients from a national patient association (ACCU-Spain). Three invitations were sent between October-December 2020. Questions were jointly designed by ACCU and GETECCU. Potential reasons for vaccination compliance were evaluated and analysed for different vaccines: age, gender, type of IBD, type of healthcare and treatments. Descriptive analyses and logistic regression were performed to identify factors associated with adherence to vaccination recommendations.

Results

1302 patients with IBD responded to the survey (mean age 43 years [SD 12], 72% women). Forty percent of patients had ulcerative colitis, 58% Crohn’s disease and 2% indeterminate colitis. 91% of patients were treated in public facilities, 5% in a private setting and 4% in both. 41% of patients were treated with 5ASA, 35% with azathioprine/methotrexate, 50% with biologics and 8% with corticosteroids. Although [IRL1] [YZ2] physicians recommended vaccination, 45% were not adherent to papilloma virus vaccine, 18% to pneumococcus, 18% to hepatitis B vaccine, 16% to influenza and 12% to tetanus. The main reason for non-compliance to physician recommendation was considering that is not necessary (Table 1). Some factors associated to vaccine compliance are shown in Table 2.

Conclusion

Non-adherence to vaccination recommendations in IBD patients is frequent. Patients with immunosuppressive therapy show less compliance to the vaccination recommendations. The importance and benefits of vaccination needs to be explained to improve the adherence in IBD patients.
P417 Long-term deep remission after adalimumab discontinuation in Crohn’s disease patients
Authors: Melotti L , Rizzello F , Calabrese C , Dussias N , Gionchetti P
Published: May 2021

Background

Adalimumab is a safe and effective drug in treatment of Crohn’s Disease (CD). Current literature is not definitive regarding an exact timing for treatment withdrawal and disease relapses after drug discontinuation.

Methods

We conducted a single-centre, retrospective, observational cohort study involving patients affected by Crohn’s Disease (CD) treated with adalimumab. Of 575 patients treated with adalimumab for CD, 149 patients suspended treatment for stable deep remission (clinical steroid-free, biochemical, endoscopic remission defined as mucosal healing). Of these, 126 have a minimum follow up of 4 years, the other 23 where lost or finished the follow-up. Patients were assessed clinically, laboratoristically and endoscopically for 4 years. Relapse was defined as clinical (HBI > 4) and biochemical (PCR > 0.5 mg/dL).

Results

Of the 126 patients with 4 years follow-up, 64 (51%) maintained deep remission during the 4 year follow-up period. Of these, 38 (59%) were on exit-therapy with thiopurines. Twenty-seven patients (18%) had relapsed by year 1, 24 (18%) by year 2, 8 (6%) by year 3, and 1 (0.8%) by year 4. Relapses needed surgical therapy in 9 (15%) cases, whereas 36 (60%) were retreated with adalimumab and 4 (7%) with another biologic agent. The remaining 11 patients (18%) were treated only with a course of steroids.

Conclusion

Patients who suspend treatment with adalimumab for stable deep remission maintain remission in the long term in approximately half of cases. The majority of relapses occur in the first 24 months after discontinuation.
P420 Comparative efficacy and safety of oral ferric maltol in Inflammatory Bowel Disease patients with mild-to-moderate vs. more severe iron deficiency anaemia
Authors: Akriche F , Jacob I , Schmidt C , Howaldt S
Published: May 2021

Background

The efficacy and safety of ferric maltol (FM) has been demonstrated in inflammatory bowel disease (IBD) patients with mild-to-moderate iron deficiency anaemia (IDA; haemoglobin [Hb] ≥ 9.5 g/dL). New data are available from a recent open-label, Phase 3b non-inferiority study comparing the efficacy and safety of FM to ferric carboxymaltose for IBD patients with more severe IDA (Hb at screening: 8.0 - 11.0/12.0 g/dL [women/men]) (NCT02680756). Though the primary endpoint was not met, this post hoc analysis aimed to utilise patient-level data to confirm the efficacy and safety of FM in patients with baseline Hb < 9.5 g/dL.

Methods

Patients assigned to FM (N=125) were grouped based on baseline Hb: <9.5 g/dL (n=38) and ≥9.5 g/dL (n=87). Univariate and multivariate analyses were performed for primary (Week 12 change from baseline [CFB] Hb) and key secondary endpoints (Week 12 responder rate [≥2 g/dL Hb increase or Hb normalisation] and long-term efficacy). Safety analysis was performed.

Results

Overall, demographic characteristics were broadly comparable with a greater, but not significant, proportion of females (63.2% vs. 50.6%), women of childbearing age (75.0% vs. 63.6%) and active Crohn’s disease (37.5% vs. 32.7%) in patients with baseline Hb < 9.5 g/dL vs. ≥ 9.5 g/dL, respectively. Mean baseline Hb was 8.6 g/dL in patients with baseline Hb < 9.5 g/dL and 10.6 g/dL in patients with baseline Hb ≥ 9.5 g/dL. There was no significant difference in mean CFB Hb at Week 12 (2.92 g/dL vs. 2.35 g/dL, p=0.960) and Week 12 responder rates (70.0% vs. 67.1%, p=0.523) in patients with baseline Hb < 9.5 g/dL and ≥ 9.5 g/dL, respectively. Mean CFB Hb was numerically but not significantly higher in patients with baseline Hb < 9.5 g/dL at every visit up to Week 52 (Table 1). Drug-related treatment emergent adverse events were similar between < 9.5 g/dL and ≥ 9.5 g/dL Hb groups (15.8% vs. 21.3%, respectively); all non-serious.

Conclusion

FM achieved consistent and clinically meaningful increases in Hb in patients with baseline Hb < 9.5 g/dL that were comparable to patients with Hb ≥ 9.5 g/dL. No safety differences were identified between both groups. These data suggest that FM is effective and well tolerated in IBD patients with IDA regardless of baseline Hb.
P443 Haemorrhoidal Artery Ligation – Recto-Anal Repair (HAL-RAR) with mucopexy for grade III hemorrhoids in IBD patients
Authors: Laureti S , Cardelli S , Gionchetti P , Rizzello F , Calabrese C , Poggioli G
Published: May 2021

Background

Symptomatic hemorrhoids represent an important and sometimes underestimate chapter of perianal Inflammatory Bowel Diseases (IBD), with an incidence reported up to 20.7%. At present, there is still no consensus in the scientific community on the exact indications of surgery in IBD patients presenting with symptomatic haemorrhoids, due to the reported high risk of postoperative complications. We describe our experience with Haemorrhoidal Artery Ligation – Recto-Anal Repair (HAL-RAR) hemorrhoidopexy in highly selected patients with IBD.

Methods

This was a single-center longitudinal study of a cohort of patients with both Ulcerative Colitis (UC) and Crohn’s Disease (CD) who underwent HAL-RAR using a dedicated doppler-guided probe (Trilogy™) for symptomatic grade III hemorrhoids not responding to medical therapy. Short and long-term postoperative morbidity were recorded. Severity of hemorrhoid symptoms, specifically bleeding, prolapse, manual reduction, discomfort or pain and impact on quality of life (Giordano score) and fecal continence status (Vaizey score) were evaluated before surgery and at minimum of 6 months after surgery.

Results

Sixteen patients with symptomatic grade III haemorrhoids underwent HAL-RAR (12 female). The mean age was 49 yrs old (37–66). Twelve had CD and 4 UC; none presented with anorectal or perianal involvement. All patients were taking optimal medical treatment for IBD. Only the patients with CDAI<150 and Full Mayo score of 1 (with endoscopic sub-score of 0) were included. Mean follow-up was 27.8 months (9–76). The mean operating time was 46 minutes. Short-term complications included one patient requiring prolonged analgesia with NSAIDs for two weeks, one patients needing hospitalization for bleeding after 10 days, treated conservatively and one patient with acute urinary retention, resolved after catheterization. The was no abscess or fistula formation. During the follow-up period, no patients suffered from recurrent haemorrhoidal bleeding and none had recurrent prolapse. A 66 yrs old female reported at 6 months post-operatively the worsening of Vaizey score from 4 to 6 due to the need of taking costipating medicines. All patients report significant amelioration of quality of life.

Conclusion

Our results show that HAL-RAR Hemorrhoidopexy is a safe and effective technique for treating grade III symptomatic hemorrhoids in highly selected IBD patients without anorectal involvement. These results need to be validated in large and multicenter trials.