bluuebunny/crossref_metadata_2025 huggingface dataset:
DOP81 Quality improvement by semi-automated benchmarking of a core outcome quality indicator set in Inflammatory Bowel Disease: A multicentric feasibility study
Authors: Bossuyt P , Baert D , Baert F , Hoefkens E , Huys I , Lembrechts N , De Jonckere E , Dewint P , Pouillon L
Published: May 2021

Background

Quality of care in inflammatory bowel disease (IBD) depends on multiple factors and is assessed through structure, process and outcome indicators. Structure and process indicators are more static and can easily be measured by an audit. Patient-oriented outcome indicators that impact on the quality of life are more difficult to assess.

The aim of the project was to build a platform that automatically captures key outcome quality indicators and provide benchmarking output to improve quality of care in IBD centres.

Methods

Literature was reviewed for relevant quality indicators in IBD. After two non-anonymized Delphi like review and consensus meetings, twelve quality indicators were selected for implementation. The definitions of the outcomes were aligned in consensus with the available International Consortium for Health Outcomes Measurement (ICHOM). A web-based interface was built in three large volume IBD centres in Belgium to collect data on multiple ways: (i) Patients complete patient-reported outcome questionnaires and disease specific questions when attending the outpatient clinic and/or day clinic; (ii) The software automatically extracts data from the electronic medical files including biochemical and endoscopic reports; (iii) The medical baseline characteristics and outcome indicators for each patient are completed by the healthcare professional at inclusion and after this on a yearly basis.

Results

In total 265 patients were included in the participating IBD centres. Three indicators could be directly extracted from the patient-reported outcome questionnaires (clinical remission, fatigue, work productivity). Two items could be retrieved by use of the bot that automatically extracts biochemical and endoscopic reports from the medical files (anaemia, deep remission). The other items were collected throughout yearly confirmation by a health care professional (colorectal cancer, steroid use [systemic/topical], severe infections, hospital admission, IBD surgery [perianal/abdominal]). All items are benchmarked in an anonymous way on a benchmarking dashboard. Each centre can only see his own position in the benchmarking diagram. Additionally, the case mix per centre (type IBD, severity, demographic data) was added to the benchmarking output to provide a balanced evaluation of the outcome indicators.

Conclusion

This is the first partially automated benchmarking initiative for quality of care in IBD. The data collection is feasible and provides an objective assessment and comparison of the IBD related quality of care in different centres. Further prospective evaluation needs to confirm that implementation of benchmarking improves the performance and quality of IBD management.
P187 Change in Urgency Status Among Ulcerative Colitis Patients: Understanding the Impact of Treatment Changes from the Corrona Inflammatory Bowel Disease Registry
Authors: Wolf D C , Naegeli A N , Moore P C , Janak J C , Crabtree M M , Shan M , Hunter T M , Sontag A , Cross R K
Published: May 2021

Background

Stooling urgency (also known as urgency to defecate) is one of the most common symptoms among Ulcerative Colitis (UC) patients (pts). Understanding factors associated with changes in urgency status, such as the association between timing of treatment changes and subsequent onset or resolution of urgency symptoms, are essential in addressing unmet pts needs. Our aim was to explore treatment frequency and persistence among UC pts stratified by a change in urgency status from enrollment to the 6-month follow-up (6M) visit.

Methods

Participants included UC pts in the Corrona Inflammatory Bowel Disease Registry between 5/3/17–9/1/20. Stooling urgency was defined as no urgency or urgency using the categories, none and hurry/immediate, from the Simple Clinical Colitis Activity Index (SCCAI). Urgency status groups were formed by urgency at enrollment and the 6M visit: no persistent urgency (NPU), i.e., no urgency at both visits; change from urgency to no urgency (UN); change from no urgency to urgency (NU); and persistent urgency at both visits (PU). Chi-square tests were conducted to compare treatment use and change between urgency status groups (NPU=reference group). Kaplan Meier curves and log-rank tests were used to assess time to first treatment change between urgency status groups.

Results

The urgency status groups (n=400) included: 44% NPU (n=175), 21% UN (n=86), 14% NU (n=56), and 21% PU (n=83). A higher proportion of UN (47%, p=0.03) and PU (51%, p=0.01) pts received two or more treatments compared to NPU (33%) pts. Compared to NPU pts, pts in all three groups, UN (52% vs. 27%, p< 0.001), NU (45% vs. 27%, p=0.02), and PU (53% vs. 27%, p< 0.001) were more likely to change treatment between enrollment and the 6M visit. Similarly, a higher proportion of pts on a biologic at enrollment, UN (24% vs. 11%, p=0.01), NU (23% vs. 11%, p=0.03), and PU (35% vs 11%, p< 0.001), changed treatment between enrollment and the 6M visit vs. NPU pts. The time to first treatment change was shorter for all other urgency status groups when compared to NPU pts (log-rank tests, all p<0.02) (Figure 1). Among pts without urgency at enrollment, the time to first treatment change was shorter for NU vs. NPU pts (p=0.01) whereas it was similar for pts with urgency at enrollment, UN vs. PU pts (p=0.93) (Figure 1).

Conclusion

Among UC pts in a real-world setting, there were significant differences in change of treatment and time to treatment change between pts who experienced urgency either at their enrollment visit, 6M, or both, compared to those without urgency. Urgency at any time point is a symptom of great concern to UC pts and is a sign of inadequate therapy, and often is an indication to switch treatment therapy.
P252 Medication adherence in inflammatory bowel diseases in the era of biotherapies
Authors: Hassine A , Hammami A , Ben Ameur W , Dahmani W , Elleuch N , Ben Slama A , Braham A , Ksiaa M , Bannour R , Jaziri H , Jmaa A
Published: May 2021

Background

Failure or poor adherence to therapy is a general problem ofpublic health, particularly common in chronic inflammatory bowel disease (IBD). In these pathologies, good compliance is, however, one of the keys to obtaining remission and in preventing relapses and complications. The objective of this study was to assess treatment compliance in our patients followed for IBD.

Methods

We conducted a single-center cross-sectional study, including all patients with IBD, who presented to our consultation during the three months preceding the study. We used the Morisky questionnaire to assess treatment adherence. This was considered low if the score is less than 6, medium if the score is between 6 and 8, and good if the score is equal to 8.

Results

We collected 100 patients, average age of 42.18 ± 15.71 years and a sex ratio (M / F) = 1.5. Sixty eight patients (68%) had CD and thirty two patients (32%) had UC. The mean duration of IBD progression was 9.02 ± 6.57 years. Anoperineal lesions were present in 38.2% of cases. Fourteen patients (20.6%) followed for CD and ten patients (31.3%) with UC had severe disease activity. The history of surgical resection was noted in 18.75% of patients followed for UC and 47.05% of those followed for CD. Extensive ileal resection was noted in 6.5% of patients with CD. At the time of the study, 20% of patients were on systemic corticosteroid therapy, 22% on Azathioprine, 4% on Salazopyrine, 8% on 5-ASA and 46% on Anti-TNFα in combination therapy. The mean Morisky score was 6.78 ± 1.31. Adherence to treatment was poor in 42% of cases, average in 34% of cases, and good in 24% of cases. Good treatment adherence was observed in 34.78% of patients taking Anti-TNFα vs. 14.81% in other patients with no statistically significant difference (p = 0.077). Morisky score was correlated with age (p = 0.032, r = 0.38). In addition, no significant association was found, with the duration of evolution (p = 0.75), the existence of other chronic diseases (p = 0.3), the number of outbreaks of IBD (p = 0.52), and disease activity (p = 0.38 for CD, p = 0.22 for UC).

Conclusion

The overall rate of treatment non adherence in IBD patients was significant in our series. It concerns nearly one in two patients. Prescribing Anti-TNFα does not appear to improve compliance. The integration of therapeutic education into our therapeutic strategy should be an asset major in improving treatment adherence.
P279 Potential of managed care programmes for patients with inflammatory bowel diseases – results from a large survey study among physicians and IBD-patients in Germany, Austria and Switzerland (the EASEIBD study)
Authors: Bokemeyer B , Kaiser C , Primas C , Novacek G , Biedermann L , Seibold F , Tappe U , Bettenworth D , Graw J , Hartmann P , Plachta-Danielzik S , Schultz C
Published: May 2021

Background

IBD-care may be challenging and benefits from a multidisciplinary, cross-sectoral treatment approach and active patient involvement. However, occasionally there is a lack of patients′ empowerment and additionally, a necessity for the optimisation of physicians′ treatment is apparent. Furthermore, there is a deficiency in evidence regarding the effectiveness of structured care approaches (“managed care”) on patient-related outcomes (PROs). Therefore, our study aims to evaluate the potential of managed care programmes for IBD patients.

Methods

EASEIBD is a cross-border study conducted by IBD-DACH, an IBD working group in Germany (D), Austria (A) and Switzerland (Ch). Within the DACH-region, a cross-sectional survey of patients and physicians from IBD hospital-outpatient departments and gastroenterology practices was carried out. The questionnaire evaluated the effect of instruments and contextual factors of IBD-care with regard to quality of life (QoL). Additionally, the effects of “managed care” instruments were examined while considering centre-related structural characteristics. The analysis was performed using a multivariate multilevel regression model, controlled by various physician and patient characteristics.

Results

2536 IBD-patients from 66 centres (643 IBD-patients/quarter; 31% hospital out-patient departments) were consecutively enrolled in EASEIBD (centres/IBD-pat.: D-52/1735; A-10/647; Ch-4/154). Overall, patient satisfaction (77-84%) (Fig. 1) as well as perceived quality of care (82-87%) (Fig. 2) was high and comparable in the descriptive analysis between German, Austrian and Swiss IBD-patients. Statistically significant differences were only found in single characteristics, e.g. in quality of life (EQ5D-VAS) (p=0.004) (Fig. 3). However, these do not appear clinically relevant with regard to the absolute values. In the entire DACH-region there were detectable effects of elements representing structural quality and assessments of the centres, with regard to the perceived quality of patient care (Fig. 4), whereby, in particular, a positive influence of web-based instruments (e.g. homepage) (p=0.040) and potential use of homecare calprotectin (0.046) had the most pronounced effect. Noteworthy, in Germany, the implementation of specialised IBD nurses was associated with a beneficial impact on patients′ QoL (0.027) when compared to the cumulative results from the entire DACH region (p=0.681).

Conclusion

Our study shows that the use of elements of managed care programmes resulted in a high process quality, which is evident from the reported high patient satisfaction and quality of care by IBD-patients in the entire DACH region, and qualifies this area as a suitable common study landscape.
P332 Population pharmacokinetics of ozanimod and active metabolite CC112273 in patients with ulcerative colitis
Authors: Shen J , Tatosian D , Sid-Otmane L , Teuscher N , Chen L , Zhang P , Tirucherai G S , Chitakara D , Marta C
Published: May 2021

Background

Ozanimod is an oral small molecule sphingosine 1-phosphate receptor modulator approved for relapsing forms of multiple sclerosis (RMS) and under development for ulcerative colitis (UC) and Crohn’s disease (CD). Following multiple dosing of ozanimod in healthy subjects, ozanimod and two of the active metabolites CC112273 and CC1084037 represent approximately 6%, 73%, and 15% of circulating total active drug exposure, respectively. Two separate pharmacokinetic (PK) models were developed for the most prominent metabolite CC112273 and ozanimod. CC1084037 was not modeled due to the high correlation between CC112273 and CC1084037 plasma concentrations. Therefore, this analysis aims to characterise the PK of ozanimod and the major metabolite CC112273 in UC and RMS population.

Methods

Subjects from 11 studies (Phase 1 to Phase 3) in healthy volunteers, RMS, and UC patients were included in this population PK analysis. The analyses included a total of 18901 concentrations from 2890 subjects for CC112273 and 18834 PK concentrations from 2977 subjects for ozanimod.

A 2-compartment model was used to describe the concentration-time profiles of both ozanimod and CC112273, separately. The influence of weight, age, sex, race, disease, or smoking status and hepatic function on the PK of ozanimod and CC112273 were explored. The impact of concomitant corticosteroids on CC112273 PK were evaluated post hoc.

Results

While the overall apparent clearance of ozanimod was 7% lower in RMS patients compared to UC, similar exposures were observed in both populations. The most influential covariate on ozanimod PK was body weight, with a modest 23% increase in apparent clearance for a 102-kg subject relative to a 70-kg subject (Figure 1).

The apparent clearance of CC112273 was 16% greater in RMS patients compared to UC patients, resulting in a slightly higher exposure for UC patients. Increasing body weight had a modest reduction in clearance, while smoking had the largest influence on CC112273 PK of approximately 108% increased clearance (Figure 2). Post-hoc results showed no impact of concomitant prednisone or prednisolone on the PK of CC112273.

Other factors, including age, race, sex, or hepatic impairment did not impact the PK of ozanimod or CC112273 PK.

Conclusion

The population PK model of CC112273 indicates that covariates with the largest effect on CC112273 PK parameters were body weight and smoking status. However, no covariate impacted clearance by more than 25%. The PK of ozanimod and CC112273 were not meaningfully impacted by age including in the elderly, body weight, race, sex, hepatic function, or concomitant prednisone or prednisolone. Overall, the PK of ozanimod and CC112273 were comparable in UC and RMS patients.
P424 Treatment persistence of first-line anti-TNF therapy in patients with inflammatory bowel diseases: results from a real-world study over 20 years
Authors: Blesl A , Binder L , Högenauer C , Wenzl H , Borenich A , Pregartner G , Berghold A , Mestel S , Kump P , Baumann-Durchschein F , Petritsch W
Published: May 2021

Background

Anti-TNF therapy is still the most frequently used first-line biologic treatment in inflammatory bowel disease (IBD). This study aimed to determine length of treatment persistence and to describe reasons for discontinuation of first-line anti-TNF therapy used in the standard care of IBD patients.

Methods

A single-center, real-world, retrospective study including IBD patients (Crohn’s disease (CD), ulcerative colitis (UC), IBD unclassified (IBD-U)), who received an anti-TNF therapy in the last 20 years at the study center, was conducted. Length of first-line anti-TNF therapy, differences in treatment duration between infliximab (IFX) and adalimumab (ADA) and between CD and UC, reasons for discontinuation, side effects leading to cessation, treatment following first-line anti-TNF therapy, rates of surgery and death, and factors being associated with treatment failure were assessed.

Results

586 patients were identified as having received first-line anti-TNF therapy at the study center. 48 patients were excluded due to shortness of available data. 538 patients (CD: 367, UC: 147, IBD-U: 24) with a median follow-up of 8.1 years were included in the analysis. Median (IQR) treatment persistence was 21.0 (6.0, 57.0) months in the total cohort. Treatment withdrawal arose frequently (40%) within the first year of therapy and treatment persistence was longer in CD compared to UC (CD: 27.0 (8.0, 71.0) months, UC: 11.0 (3.0, 34) months, p<0.001). Treatment failure (51%) and side effects (24%) were the most commonly noticed reasons for withdrawal from therapy. 14% withdrew from therapy due to remission. The diagnosis of UC, female sex, the absence of prior intestinal resections, lower hemoglobin and albumin levels at anti-TNF initiation predicted treatment failure. Patients with CD continued ADA treatment longer than IFX treatment (ADA: (40.5 (14.2, 80.5) months, IFX: 18.0 (4.8, 65.0) months, p<0.001). Within the follow-up period, 17% of UC patients underwent colectomy and 34% of CD patients had at least one intestinal resection after start of first-line anti-TNF therapy. 2% of all patients died due to various reasons.

Conclusion

Treatment persistence of first-line anti-TNF therapy is limited in IBD patients due to a large proportion of treatment failures and side effects.
P508 Dose adjustment in patients with moderate to severe ulcerative colitis: results from year 3 of the UNIFI maintenance study long-term extension
Authors: Rowbotham D S , Scherl E J , Sands B E , Panaccione R , Peyrin-Biroulet L , Zhang H , Miao Y , Leong R W , Afif W , Arasaradnam R P , Danese S , Marano C
Published: May 2021

Background

The UNIFI randomized-withdrawal maintenance study and long-term extension (LTE) evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) in patients with moderately to severely active ulcerative colitis (UC) who had responded to intravenous (IV) UST during induction. We evaluated the efficacy of UST dose adjustment through Week (Wk) 152 of the long-term extension (LTE).

Methods

523 intravenous UST induction responders were randomized to SC maintenance therapy (SC placebo [PBO], n=175; UST 90mg every 12 weeks [q12w], n=172; or UST 90mg q8w, n=176). 284 UST patients who completed wk44 entered the LTE. PBO patients were discontinued after wk44 unblinding. Based on the investigator’s clinical judgement of their UC disease activity, patients in the LTE were eligible to receive dose adjustment starting at Wk 56: PBO to q8w, q12w to q8w, and q8w to q8w (sham adjustment). Patients in PBO or q8w groups were only eligible for dose adjustment or sham dose adjustment before unblinding. Patients were assessed for symptomatic remission, partial Mayo scores, and inflammatory markers ≥16 wks after dose adjustment.

Results

Overall, 60 patients (42.6%) in the q12w group and 40 patients (28.0%) in the q8w group underwent dose adjustment (or sham dose adjustment) prior to Wk 156 of the LTE; 51 and 39 patients in each group, respectively, had dose adjustment at Wk 136 or before, providing≥16 wks of data after dose adjustment (Table). At the first visit ≥16 weeks after dose adjustment, 70.6% of patients who adjusted from q12w to q8w and 61.5% who sham dose adjusted from q8w to q8w were in symptomatic remission. At the time of dose adjustment, 27/51 patients (52.9%) in the q12w group and 25/39 patients (64.1%) in the q8w group were in symptomatic remission. Of those who were in symptomatic remission at the time of dose adjustment, the majority (81.5% and 68.0%, respectively) were maintained in symptomatic remission at the first visit ≥16 wks after dose adjustment. Of those who were not in symptomatic remission at the time of dose adjustment, 58.3% and 50.0%, respectively, were in symptomatic remission at the first visit ≥16 wks after dose adjustment. Mean partial Mayo scores and CRP levels decreased after dose adjustment (Table).

Conclusion

Patients may benefit from UST dose adjustment to q8w.
P522 Effectiveness of tofacitinib in a real-world Israeli cohort of patients with moderate-severe ulcerative colitis
Authors: Avni Biron I , Bar-Gil Shitrit A , Koslowsky B , Kopylov U , Levartovsky A , Weisshof R , Aviv-Cohen N , Maharshak N , Hovel D , Naftali T , Goren I , Snir I , Ollech J , Banai H , Lena B , Dotan I , Yanai H
Published: May 2021

Background

We sought to define the effectiveness of tofacitinib in a real-world (RW) cohort of patients with moderate to severe ulcerative colitis (UC).

Methods

This was a multi-center retrospective observational cohort study (2017–2020). Clinical response and remission were defined as a reduction in Simple Clinical Colitis Activity Index (SCCAI) or partial Mayo score (PMS) of ≥3, and SCCAI ≤2 or a PMS ≤1, respectively.

Results

We included 73 patients (47% male; median age 26 years [IQR 19.5–39.5], disease duration 7 years [IQR 2.5–14.5], follow-up 7.1 months [IQR 3–12]), 91% biologics-experienced, and 74% ≥ 2-biologics. Half of patients used concomitant steroids. Overall, 56.1% discontinued therapy due to either lack of response and/or adverse events (AEs), median time to discontinuation - 9.7 months (IQR 3.4–16). Based on per-protocol analysis, after induction (week-8–16), 33.3% achieved response, 23.3% remission, and 19% corticosteroid free remission. At early maintenance (week 26), 50% achieved response, 26.8% remission, and 24.4% corticosteroid free remission. There were no differences between biologics-experienced and naïve patients. Seventeen patients (23.2%) had an AE: herpes zoster- 2.7%, hospitalization- 12.3%, and colectomy- 2.7%. Remitters had higher albumin level compared with non-remitters (4.2±0.35 Vs. 3.8±0.35, P=0.023, respectively).

Conclusion

In this multicenter RW cohort of highly biologics - experienced patients with UC, those who continued tofacitinib throughout induction achieved 50% response and 27% remission. Tofacitinib was well-tolerated.
P559 Efficacy of Ustekinumab in the treatment of patients with Crohn’s disease with failure to previous conventional or biologic therapy: an observational real-life study
Authors: Miranda A , Cuomo A , Camera S , Ciacci C , De Filippo F R , Gravina A G , D’Onofrio V , Melina R , Manguso F , Priadko K , Facchiano A , Bennato R , D’Onofrio R , Cuomo R , Mucherino C , Romano M
Published: May 2021

Background

Ustekinumab (UST), a human anti-IL12/23p40 monoclonal antibody, was approved by FDA and EMA for the treatment of moderate to severe Crohn’s disease (CD). Whether UST is effective in inducing deep remission, including mucosal healing and transmural healing, in patients with CD in a real life setting is not completely clear.

Methods

The study was performed on 92 subjects (47 males; 45 females; mean age: 42 (17–78) from six medical centers in Campania, Italy, with confirmed diagnosis of moderate to severe Crohn’s disease and no neoplasia. In all patients diagnosis of CD had been reached to years earlier. Before inclusion, all patients had been exposed and had failed to respond to conventional and/or at least one biological therapy.The administration of UST was as follows: IV infusion at week 0 (3 vials of 130 mg each if body weight of 55–85 kg; 2 vials of130 mg each if body weight < 55 kg) and subsequent SC injections (90 mg) q8w thereafter. At enrollment, all subjects underwent colonoscopy and were divided into groups according to endoscopic evaluation: 5 (5.4%) patients had erosions; 24 (26.1%) inflammation; 63 (68.5%) ulcers. Based on the CDAI value, 52 (56.5%) patients had a CDAI of 180–220, 35 (38%) had a CDAI of 220–450, and 5 (5.4%) had a CDAI >450.

All patients underwent endoscopic examination and bowel MRI or ultrasonography at baseline and at week 52 to evaluate mucosal and transmural healing. Clinical response was defined as a reduction of CDAI by at least 100 points; clinical remission when CDAI was lower than 150. Clinical response and remission were evaluated at baseline and on 5 different occasions throughout a 12 months follow-up. Incidence of treatment-related adverse events (TRAEs) was recorded during the study period.

Results

Seventeen patients interrupted therapy while 75 patients continued follow-up until the fifth visit. Clinical response at week 52 was achieved in 38 (50,5%) patients and clinical remission in 29 (39%). Twenty-six (34%) patients showed mucosal healing, 34 (45%) showed partial endoscopic response. Fifteen patients (20%) did not show any change during endoscopic evaluation at follow-up. All patients showing mucosal healing also showed transmural healing, as assessed by ultrasonography or MRI. No major TRAEs were observed during treatment.

Conclusion

In this multi-center, real life study, we show that UST was well tolerated and effective in inducing clinical response and clinical remission in patients with moderate to severe CD who had previously failed to respond to conventional or biologic therapy. UST showed limited efficacy in inducing deep remission (i.e. mucosal+transmural healing).
P560 Clinical outcomes of vedolizumab maintenance treatment for Korean patients with inflammatory bowel disease who failed anti-TNF therapy: A KASID prospective multicenter cohort study
Authors: Oh K , Kim J , Kim N , Yoon H , Lee K M , Park D I , Choi C H , Lee C K , Eun C S , Kang S B , Kim E S , Kim Y S , Jung S A , Jung Y , Kim T O , Park S J , Im J P , Seo G S , Ye B D
Published: May 2021

Background

We investigated the real-life effectiveness and safety of vedolizumab maintenance treatment among Korean patients with Crohn’s disease (CD) or ulcerative colitis (UC) who previously failed anti-tumour necrosis factor (anti-TNF) therapy.

Methods

Adult patients with CD or UC who have previously failed anti-TNF therapy and received vedolizumab were prospectively enrolled from 16 hospitals in Korea. The primary outcome was clinical remission at week 54. Clinical remission was defined as a Crohn’s disease activity index (CDAI) <150 and a partial Mayo score ≤2 with a combined rectal bleeding and stool frequency subscore ≤1. We also analyzed factors associated with clinical remission at week 54.

Results

Between August 2017 to July 2020, a total of 165 patients (81 with CD and 84 with UC) received vedolizumab therapy, of whom 154 patients (93.3%) (75 with CD and 79 with UC) received vedolizumab maintenance therapy (Table 1). Clinical remission and response rates at week 54 were 22.2% and 24.1% among patients with CD and 41.4% and 45.7% among patients with UC, respectively (Figure 1A and 1B). Among 70 patients with UC with baseline Mayo endoscopic subscore ≥2, endoscopic remission (Mayo endoscopic subscore ≤1) at week 54 was observed in 19 patients (27.1%). Out of 50 patients with CD with ulcers in baseline endoscopy, 2 patients (4%) showed a disappearance of ulcers at week 54 (Figure 1C). In the multivariable analysis, age at baseline (adjusted odds ration [aOR] 1.065, 95% confidence interval [CI] 1.003–1.131, P=0.041) and Mayo endoscopic subscore at baseline (aOR 0.141, 95% CI 0.026–0.746, P=0.021) were significantly associated with clinical remission at week 54 among patients with UC (Table 2). No factors were found to be associated with clinical remission at week 54 among patients with CD. Among patients who experienced one or more adverse events (n=134, 81.2%), serious adverse events occurred in 82 patients (49.7%) (Table 3). Disease exacerbation was the most common adverse events (n=89, 53.9%).

Conclusion

The real-life effectiveness of vedolizumab maintenance treatment for Korean patients with UC who failed anti-TNF therapy was generally similar with the outcomes reported from the previous Western studies. A substantial proportion of patients with CD experienced a loss of response during the first year of treatment. Less severe disease at baseline was associated with clinical remission at 1 year of vedolizumab therapy among patients with UC.
P611 Incidence, clinical presentation, and severity of SARS-CoV-2 infection in IBD patients in the second and the third wave of infection
Authors: Algaba Garcia A , Guerra I , Castro S , Jiménez L , Garza D , Aller M D M , Granja A , Guardiola A , Bellart M , Pizarro N , Bermejo F
Published: May 2021

Background

Data about the SARS-CoV-2 infection in inflammatory bowel disease patients (IBD) are scarce. Our aim was to analyse the incidence, clinical presentation, and severity of SARS-CoV-2 infection in IBD patients in the second and the third wave of infection.

Methods

Cross-sectional, observational study in IBD patients with confirmed SARS-CoV-2 infection by RCP and/or antigen tests from 01 July 2020 to 01 March 2021. All data were collected by telephone interview and reviewing the electronical medical records.

Results

Fifty-one of 805 IBD patients followed in our Unit were diagnosed of SARS-CoV-2 infection in this period (6.3%; 95% CI 4.6–8.0). Mean age: 45±13 years old; 56.9% female, 23.5% smokers, 56.9% Crohn’s disease, 29.4% comorbidities and 17.6% asymptomatic. Digestive symptoms were reported in 22 patients (43.1%), with diarrhoea as the most common (39.2%, median duration: 4 days; IQR 1–7). The most frequent symptoms other than diarrhoea were low-grade fever/fever in 43.1% (median duration: 3 days; IQR 1–6.5) and dysosmia/dysgeusia in 39.2% (median duration: 15 days; IQR 7–30). Only one patient (2%) was diagnosed with IBD flare-up during infection. Six patients (11.8%) temporarily withdrew their IBD treatment because of COVID-19. Most of the patients had a mild disease (88.2%), no patient had to be admitted in the intensive care unit. Only one patient died (2%) due to SARS-CoV-2 infection and multiple previous comorbidities, 52 years old male with ulcerative colitis in treatment with Mesalazine and dendritic cell sarcoma, common variable inmunodefiency, and primary sclerosing cholangitis progressing to cirrhosis. In the multivariate analysis, the presence of dyspnoea was associated with more severe infection (p=0.007; OR:25.7; 95% CI 2.4–277.8). Patients on immunomodulators and/or biological therapy did not have more severe disease compared to non-immunosuppressed patients (p>0.05).

Conclusion

SARS-CoV-2 infection was relatively frequent is our series. Dyspnoea was associated with a more severe infection. Severity of SARS-CoV-2 infection was not related to immunosuppression or development of IBD flare-ups and only a small percentage of patients needed to modify IBD medication during infection
P644 Hospitalization and abdominal surgery rates in CD according to drug-dispensing: a temporal trend analysis from the Brazilian public healthcare national system
Authors: Magro D O , Kotze P G , Quaresma A B , Damiao A O M C , Valverde D A , Panaccione R , Coward S , Ng S C , Kaplan G G , Coy C S R
Published: May 2021

Background

The impact of current medical options in Crohn’s disease (CD) on hospitalization and surgical rates may be conflicting, and there is lack of data in newly industrialized countries. This study aims to describe temporal trends of proportional hospitalization and CD-related abdominal surgery rates according to drug-dispensing in Brazil, using public healthcare datasets.

Methods

All CD patients from the unique public healthcare national system (DATASUS) were included from January 2012 to December 2020 and identified according to ICD codes, medication or CD-related procedures. Data extraction was performed with the platform “TT Disease Explorer” (Techtrials Healthcare Data Science), which collects publicly available data via electronic algorithms with automatic updates. Annual rates of all-cause hospitalization and CD-related abdominal surgical procedures were captured and stratified by type of drug dispended. Average Annual Percent Change (AAPC) and 95% confidence intervals (CI) were calculated using poisson (or negative binomial) regression.

Results

The absolute number of registries of overall drug-dispensing for CD was 178,209, being 32.03% for Azathioprine (AZA), 10.91% for infliximab (IFX) and 10.52% for Adalimumab (ADA). AZA dispensing increased from 28.60% to 30.83% (AAPC 1.15; CI 0.23–2.09; p=0.015), ADA increased from 5.98% to 12.03% (AAPC 8.79; CI 6.33–11.30; p<0.001) and IFX increased from 7.09% to 12.03% (AAPC 7.52; CI 6.94–8.10; p<0.001) (figure 1). A total of 39,161 hospitalizations (all-cause) were captured in the same period. Hospitalization rates with AZA varied from 37.09% to 36.35% (AAPC -0.42, CI -1.08-0.24; p=0.209); for ADA remained stable (13.16% to 13.12%, AAPC -0.03; CI -1.10-1.05; p=0.962) and for IFX increased from 17.93% to 22.49% (AAPC 3.21; CI 1.66–4.79, p<0.001) (figure 2). Regarding CD-related abdominal surgical procedures (n=1181), rates were stable for AZA (AAPC 1.34; CI -8.41–12.12; p=0.797). Considering the use of anti-TNF agents, rates were stable with ADA, varying from 26,7% to 20,0% (AAPC -1.64; CI -13.84-12.29; p=0.807) and decreased from 33,3% to 4,5% for IFX (AAPC -17.05; CI -28.19- -4.17; p=0.011) (figure 3).

Conclusion

In this large national study, there was an increase in the number of dispensings of AZA, IFX and ADA for CD from 2012–2020 in the public healthcare system in Brazil, due in part to the increasing prevalence of CD. All-cause hospitalization rates remained stable for AZA and ADA, and increased in IFX patients. A reduction in CD-related abdominal surgical procedures was observed in patients who used IFX and were stable with AZA and ADA. These data can be used for future strategic planning in the national public healthcare system (SUS) in CD management in Brazil.
P645 Mental health, work presenteeism and exercise in IBD patients
Authors: Sciberras M , Nascimento C , Tabone T , Karmiris K , Nikolaou P , Theodoropoulou A , Mula A , Goren I , Yanai H , Amir H , Mantzaris G , Georgiadi T , Foteinogiannopoulou K , Koutroubakis I , Allocca M , Fiorino G , Furfaro F , Katsanos K H , Fousekis F , Michalopoulos G , Torres J , Ellul P
Published: May 2021

Background

IBD has been shown to increase the rates of anxiety and depression amongst diagnosed individuals, with a prevalence rate of approximately 15- 20%. Chronic diseases such as IBD can have a significant impact on productivity at work (presenteeism). This can lead to emotional distress, poor quality of life and cost effects on employers. The primary aim of the study was to assess the prevalence of psychological problems, exercise levels and presenteeism at work among IBD patients.

Methods

This was a multicentre international study whereby IBD patients (>18 years) in clinical remission over the last year, were asked to answer an anonymous questionnaire. Demographic data, type of IBD, current and previous medication, admissions to hospital, history of psychiatric referrals, Stanford Presenteeism Scale (SPS-6), Godin Score (exercise related score) were collected.

Exclusion criteria included patients with IBD flares requiring corticosteroids in the previous 12 months.

Results

573 patients (CD: n=318) from 8 European Centres and Israel participated in the study. The mean patient age was 39.9 years (SD+/- 13.0). 21.6% were smokers and 48.5% were non-smokers. The rest were ex-smokers.

10.9% of patients had a diagnosis of depression/anxiety prior to the diagnosis of IBD, whereas this increased to 20.6% post-IBD diagnosis, this being significantly commoner in the CD cohort (23.0%, p<0.05) and in females (55.8%, p<0.05). 37.7% of patients had been to a psychiatrist or a psychologist (41% of CD, p<0.05) with 11.7% of patients being on psychiatric medication (14.5% of CD, p<0.05).

Low presenteeism at work was evident in 34.7%, with no statistically significant difference between UC and CD patients (p=0.5). 39.9% had a Godin Exercise Score being in the active range, 38.8% had a sedentary/insufficient exercise score. The rest were moderately active. Patients diagnosed with depression/anxiety had a more sedentary lifestyle.

Conclusion

In our study 37.7% of patients were referred for psychological help. This can have several effects including poor presenteeism at work (34.7%) and reduced efficiency. These issues are commoner in patients with CD than in UC. Active involvement of a psychologist/ psychiatrist as part of the IBD team should be routine as to improve the patient’s quality of life.
P648 Physical and mental health during COVID-19 quarantine in adolescents with chronic immunocompromised conditions and inflammatory bowel disease
Authors: Lindoso L , Oba J , Miranda L C A , Deboni M , Jiro Ozaki M , Lima D C C , Queiroz L B , Astley C , Gualano B , Polanczyk G V , Toma R K , da Silva C A A
Published: May 2021

Background

Social connection is a fundamental part of the psychosocial development in adolescence; therefore quarantine has a potentially negative impact in the physical and mental health.

Therefore, the objective of this study was to evaluate physical and mental health indicators in adolescents with preexisting chronic immunocompromised conditions, including inflammatory bowel disease(IBD) compare to healthy adolescents during COVID-19 quarantine.

Methods

A cross-sectional study included 355 adolescents with chronic conditions(IBD, n=44) and 111 healthy adolescents. An online self-rated survey was used to investigate socio-demographic features, healthcare routine and the quarantine impact on physical and mental health. Validated self-reported version of Strengths and Difficulties Questionnaire(SDQ) evaluated psychosocial functioning.

Results

No differences were observed between adolescents with preexisting chronic immunocompromised conditions versus healthy adolescents during quarantine of COVID-19 pandemic for age, sex and ethnicity, as well as for household conditions and schooling(p>0.05). The frequencies of psychosocial functioning abnormalities according to total difficulties SDQ score were high and similar in patients and controls(30% vs. 31%, p=0.775). Logistic regression analysis showed that being female(OR=1.965, 95%CI=1.091–3.541,p=0.024), fear of underlying disease activity/complication(OR=1.009, 95%CI=1.001–1.018, p=0.030) were associated with severe psychosocial dysfunction in adolescents with chronic conditions, whereas school homework(OR=0.449, 95%CI=0.206–0.981,p=0.045), physical activity (OR=0.990, 95%CI=0.981–0.999,p=0.030) and sleep quality(OR=0.986, 95%CI=0.975–0.998,p=0.017) were protective factors. Further analysis showed similar median age, fear (disease activity/complication, immunosuppressive use, and COVID-19), physical activity, sleep difficulties, and total difficulties SDQ score in IBD adolescents versus with chronic conditions (p>0.05). The frequencies of psychosocial functioning abnormalities according to total difficulties score of SDQ were high and similar in IBD adolescents vs. chronic condition(37% vs. 29%, p=0.329), as well sleep difficulties(34% vs. 32%, p=0.797).

Conclusion

Being female, fear of underlying disease activity/complication and household members working outside of home were relevant issues for adolescents with preexisting chronic conditions. We also demonstrated that adolescents with IBD during COVID-19 quarantine had high risk of adverse health indicators, particularly psychosocial functioning and sleep difficulties. This study reinforces the need to establish mental health strategies for teens with chronic conditions, particularly during pandemic periods.
P654 Prevalence of Inflammatory Bowel Disease in young Greek Army male recruits from 2006 to 2018: a thirteen-year retrospective study from a tertiary center
Authors: Kyriakos N , Papaefthymiou A , Giakoumis M , Galanopoulos M , Galanis P , Mylonas I , Karatzas P , Mantzaris G , Liatsos C
Published: May 2021

Background

Prevalence and incidence of Inflammatory Bowel Diseases (IBD), vary among different countries. Data regarding prevalence of IBD in Greece are limited or outdated.

Methods

We studied retrospectively, using the official Hospital electronic-form database, medical records of IBD patients from a population of 551,808 Greek Army candidates for recruitment in a thirteen-year period from 2006 to 2018. Study population consisted of males aged 18 to 37 from Northwest, Central Greece (including Athens) and South Aegean Islands. Age, disease distribution, surgery and pharmaceutical treatment at the time of patients’ admission were recorded.

Results

Prevalence of IBD among male recruits during the studied period was 0.15% (n=839 patients), (95% confidence interval = 0.14% to 0.16%). Out of them, 448 (53.4%) had Crohn’s Disease (CD) and 391 (46.6%) Ulcerative Colitis (UC). Figures 1 & 2 illustrate the percentages of pharmaceutical treatment for CD and UC respectively, while figures 3 & 4 their distribution and fluctuation during the studied period for CD and UC respectively . Concerning CD cases, monotherapy with biologics was the most commonly used pharmaceutical choice (32.1%) with Infliximab being the predominant one (60% of them), though azathioprine had been used more often than any other isolated drug agent (27%). Interestingly, 21% of CD patients received 5-ASA as monotherapy, mainly in cases of mild CD colitis or terminal ileitis. Among UC patients, mesalamine was the most often prescribed treatment (64.2%), while biological drugs and combination therapy were not so widely administered as in CD (ratio 1:2). During the recorded period for CD patients we noticed that: i) there was a reducing trend in azathioprine prescription, ii) adalimumab presented to be an increasing predilection iii) infliximab’s use was maintained at the same level all these years. Among UC cases, mesalamine was constantly the first choice, while adalimumab was not so widely administered as in CD. A distinct reduction in steroid use was noted from 2006 to 2018, coming alongside with biologics establishment. Additionally, 8% of CD and 2.8% of UC patients had undergone a surgery due to disease complications. This low proportion could be explained by the relatively young age of the study population.

Conclusion

Prevalence of IBD in Greek recruits was 0.15% with a slight CD predominance. This is the first Greek epidemiological study that recorded also the provided treatment at the time of patient’s admission giving useful information upon IBD epidemiological profile in a wide region of our country and contributing to quantification of public health burden of those diseases in Greece.
P673 Microbial diversity in newly diagnosed treatment naïve Inflammatory Bowel Disease patients
Authors: Ellul S , Rausch P , Pisani A , Bang C , Ellul P , Franke A
Published: May 2021

Background

The role of microbiome with the alteration between commensal and pathogenic bacteria, has been linked to IBD. Meanwhile Escherichia coli Nissle 1917, Lactobacillus rhamnosus GG (LGG) and faecal transplantation are used in IBD. The aim of this study was to prospectively determine faecal microbiota composition of newly diagnosed treatment naïve IBD patients.

Methods

Patients diagnosed with IBD between January 2018-September 2019 were recruited. Clinical data was collected and patients asked to submit stool samples for microbiome analysis. Stool samples from a control population were recruited and analysed via the bacterial 16s rRNA gene sequencing on illumine MiSeq.

Results

100 IBD patients (CD: n=46, UC: n=53 & IBDU: n=1) and 97 controls with specific inclusion and exclusion criteria collected.

IBD patients were noted to display reduced average species richness and community evenness compared to healthy controls (Alpha- Diversity) (Figure 1).

Beta-diversity between microbial communities of healthy individuals and IBD patients was significantly different, but no observed separation between the two types of IBD was noted (Figure 2).

11 ASVs were abundant in CD patients including: ASV-70 – Lactobacillus gasseri, Klebsiella uncl., Candidatus-saccharibacteria, ASV-157 - Acteroides clarus and ASV 249- Parasutterella uncl. In UC cohort, 10 ASVs were abundant including: ASV 6-Escherichia/Shigella uncl., ASB-41-Sutterella wadsworthensis, ASV 44- Bacteroides faecis and Actinobacteria. An association between UC and ASV 313 (Faecalibacteria) was present. In the microbiome of healthy controls, 20 ASVs were abundant, including: ASV-14 G-Alistipes uncl., ASV 20-(Akkermansia muciniphila),(bacterium belonging to the phylum Verrucomicrobia), ASV 321 (Clostridia uncl.), ASV 96 (Rumminococcaceae uncl.), Alistepes uncl. (ASV 61), Subdoligranulum uncl. (ASV 453) and the unclassifiable bacteria. A higher amount of Verrucomicrobia was present in the healthy group as opposed to the IBD.

Conclusion

ASV 249- Parasutterella unlc., was indicative of CD associated microbiome through the indicator species analysis. Typical microbiome changes in IBD patients include increased abundance of the pro-inflammatory species with a reduction in anti-inflammatory bacterial species, with a noticeable reduction in alpha and beta diversity. In the local cohort, a particular change in the local α- and β diversity was noted to be present between healthy controls and IBD cohort. This could be a potential way in which targeted therapeutic approaches using specific dosage and durations of probiotic or faecal transplant can be used to alter faecal microbiome using specific bacteria present in healthy controls and with elimination of potentially harmful bacteria in IBD patients.

Figure 1: Alpha diversity between different Groups using Chao1 species richness and Simpson 1-D

Figure 2: Beta diversity between different groups using Bray-Curtis dissimilarity, Jaccard distance.
The impact of left lower paratracheal (4L) lymph node dissection on survival in patients with surgically treated left-sided NSCLC
Authors: Gryszko Grzegorz M , Cackowski Marcin M , Zbytniewski Marcin , Woźnica Katarzyna , Orłowski Tadeusz M , Dziedzic Dariusz A ,   the Polish Lung Cancer Study Group (PLCSG), Gabryel Piotr , Rudzinski Piotr , Wlodarczyk Robert , Laudanski Wojciech , Marjanski Tomasz , Buczynski Krzysztof , Pawelczyk Konrad , Lewandowski Roman , Wawrzycki Marcin , Bala Andrzej , Brulinski Krzysztof , Gebski Arkadiusz , Talar Piotr , Lochowski Mariusz , Golota Janusz , Zel Anna , Preis Dariusz , Wojtun Kazimierz , Rybka Janusz , Lis Adam , Kobak Grzegorz , Bielewicz Michal , Pryszczek Pawel , Wilkojc Michal , Bella Mariusz , Chabowski Mariusz , Nogaj Joanna
Published: May 2021

OBJECTIVES

We aimed to investigate the clinical significance of left lower paratracheal nodes (#4L) and their impact on survival in patients with left-sided lung cancer.

METHODS

This was a retrospective analysis of prospective data. The study included 5369 patients who underwent surgery between 2005 and 2015. Six hundred fifty-nine patients underwent #4L dissection (4LND+), and 4710 did not (4LND−). Propensity score matching was used to minimize analytic error (659 vs 659).

RESULTS

The percentage of #4L metastasis increased with tumour size. Between pT2a and pT2b, it nearly doubled from 8% to 14%. The mean percentage of #4L metastasis in the pN2 group was 46, which was higher in left upper lobectomy compared to left lower lobectomy (63% vs 43%, respectively, P < 0.001). In univariable analysis, no differences in 5-year survival were observed between 4LND+ and 4LND− (48% vs 50%, respectively, P = 0.65). However, we detected a significant difference among non-metastatic 4LND+, 4LND− and metastatic 4LND+ (P < 0.0001). After propensity score matching, there were no significant differences in survival among the pN2 subgroups (pN2a1, pN2a2, pN2b1, pN2b2). Multivariable analysis after propensity score matching for each pN2 subgroup did not confirm the effect of #4L metastasis as an independent prognostic factor.

CONCLUSIONS

Despite #4L nodes not being an independent prognostic factor in lung cancer, the percentage of nodal metastases notably increases above pT2a grade and is comparable to the percentage of #5 and #7 metastasis. Therefore, lymphadenectomy in advanced stages of cancer could benefit from resections of the #4L nodes.