bluuebunny/crossref_metadata_2025 huggingface dataset:
P278 Pan-enteric capsule to assess treatment effects of vedolizumab in IBD patients: A 1 year proof of concept study
Authors: Thakor A , Johnson M , Wye J
Published: January 2022

Background

Pan-enteric capsule (PEC) endoscopy may be an acceptable alternative to more invasive endoscopy in the assessment of patients with IBD. These patients require endoscopic assessment of disease extent and severity to guide both initiation and continuation of biological therapy. There are many potential benefits including: increased patient comfort, lower complication risk, no sedation related risks and greater convenience for the patient.

Vedolizumab is an effective biological agent for both UC and Crohn’s disease. Previous studies largely concentrated their endoscopic analysis on improvements seen within the colonic mucosa. However, less is known about the effects of Vedolizumab on the small bowel Crohn’s disease.

Using a pan-enteric capsule (PillCam Crohn’s Capsule, Medtronic, USA), we evaluated the symptomatic, clinical and endoscopic improvements seen in a group of IBD patients over a 1 year treatment course of Vedolizumab. We also assessed any patient preference for PEC as opposed to colonoscopy.

Methods

A group of 10 patients starting Vedolizumab were evaluated at 0, 6 and 12 months via PEC, rather than colonoscopy +/- small bowel capsule/MRI. Biochemical and clinical evaluation used ESR, Calprotectin and symptomatic scores (HBI or mUCDAI). The extent and severity of the underlying Crohn’s disease was assessed using the Eliakim score, which has shown strong inter-reader reliability and moderate-to-strong correlation with the Lewis score. Questionnaires were completed post procedure to determine patient acceptability.

Results

We found the average ESR reduced from 30 (range 7–81) to 12.1 (2–31) after 1 year of Vedolizumab. Likewise, the average faecal calprotectin dropped from 1263.6 (189->1800) to 440.1 (30–1460). The modified UCDI score and modified HBI reduced from 5 to 0, and 7.5 to 3.5, respectively. The average small bowel PillCam Crohn’s Capsule Score reduced from 5 to 2.8, whilst the Eliakim Score dropped from 13.6 (6–30) to 5.2 (0–22).

The comfort score for PEC was on average 9.5/10, with all 10 patients reporting a preference to continue with PEC evaluation in the future.

Conclusion

PEC provides an excellent evaluation of the pan-intestinal extent and severity of IBD, and the effects of a treatment regime. We feel PEC should be considered as a 1st line assessment tool when evaluating the effectiveness of biological therapy in IBD patients, especially those with small bowel Crohn’s disease. Whilst Vedolizumab has already been shown to be beneficial in the treatment of colonic inflammation, this proof of concept study also demonstrated its beneficial effect in reducing inflammation across all 3 segments of the small bowel in those with Crohn’s disease.
P295 Proctitis during Crohn’s disease, would it be a factor in the sustainability of anoperineal fistulas?
Authors: Mtir M , Hassine H , Kahlaoui F , Cherif D , Tlili R , Kchir H , Maamouri N
Published: January 2022

Background

Rectal involvement during Crohn’s disease (CD) was identified as a risk factor associated with poor therapeutic response of anoperineal fistulas (APF).

The aim of our study was to evaluate the impact of rectal mucosal healing on the healing of APF during CD treated with anti-Tumour Necrosis Factor Alpha (anti-TNFα).

Methods

We conducted a monocentric retrospective study, including records of all patients followed for CD with APF treated with anti-TNFα over a 10-year period [2010 - 2020]. We collected clinical, biological, endoscopic and radiological data as well as the evolution of the patients on anti-TNFα. The therapeutic response was assessed clinically and radiologically by perineal MRI. Healing of the rectal mucosa was investigated by endoscopy with biopsies, and compared with that of the APF.

Results

A total of 38 patients were included, with a mean age equal to 42 years [26 - 73] and a M/F sex ratio equal to 0,4. Two patients (5,2%) had exclusively perineal involvement. APF was associated with luminal involvement in 94,7% of cases. Twenty-three patients (60,5%) had associated proctitis. APF were complex in 92,1% of cases, associated with a perineal abscess in 44,7% of cases and anorectal stricture in 7,9% of cases. All patients had received anti-TNFα after disappearance of perineal collections if initially present (Infliximab (92,1%), Adalimumab (7,9%)) combined with thiopurines in 97,4% of cases. After a mean follow-up of 40 months, the response of the APF to treatment was associated with healing of the rectal mucosa in 10 patients (43,5%), healing of the APF alone with persistence of proctitis was observed in 6 patients (26,1%), healing of the rectum with persistence of APF was described in only one patient (4,3%). The absence of rectal and anoperineal healing together was observed in 6 patients (26,1%).

In a univariate study and using the chi-square test, there was no statistically significant relationship between rectal mucosal healing and APF healing after treatment with biotherapy with p = 0,069 [95% confidence interval].

Conclusion

Our results suggest that healing of the rectal mucosa does not influence the natural history of anoperineal fistulas in Crohn’s disease. Larger scale studies are needed to confirm these results.
P301 Relapse rates after withdrawal of thiopurines in patients with Inflammatory Bowel Disease
Authors: Ranjan M K , Vuyyuru S K , Kante B , Kumar P , Mundhra S K , Golla R , Sharma R , Sahni P , Das P , Makharia G , Kedia S , Ahuja V
Published: January 2022

Background

Withdrawal of thiopurines after remission has been shown to be associated with an increased risk of relapse in patients with inflammatory bowel disease. However, long-term data on thiopurine withdrawal is limited especially from developing countries.

Methods

We retrospectively analyzed data of patients with IBD on thiopurine monotherapy who had stopped and were not on any other immunomodulator or biologics at the time of stopping thiopurines. All these were in clinical remission at the time of withdrawal.

Results

Among, 1264 patients of IBD who were treated with thiopurines, a total of, 461 patients had to stop thiopurine because of various reasons. Among these, 218 (UC=179; CD=39) patients were eligible for further study (Table-1). Overall, 36.7% (n=80) had relapsed after a median duration of months of, 20 months (IQR:, 9–49). There was no difference in relapse rate between UC and CD (39.6% vs, 23%; P:, 0.055). The overall cumulative probabilities of relapse were, 17%, 34%, and, 44% at the end of, 1, 3, and, 5 years respectively (Figure-1). The cumulative probabilities of relapse at, 1, 3, and, 5 years after thiopurine withdrawal were significantly lower in patients who had received azathioprine for at least, 48 months (14%, 20%, and, 31%) in comparison to those who had received for less than, 48 months (28%, 45%, and, 54%) respectively (P=0.007) (Figure-2). On multivariate Cox regression analysis, male sex [(HR:, 1.7 (1.1–2.7), P=0.014] and short duration of therapy with thiopurines [HR:, 0.98 (0.98–0.99), P=0.003] before withdrawal were associated with increased risk of relapse (Table-2).

Conclusion

Approximately, 50% of patients with IBD will relapse within, 5 years of thiopurine withdrawal. Male sex and shorter treatment duration (<, 4 years) predict relapse after thiopurine withdrawal. Treatment should be continued even beyond, 4 years in patients who tolerate and maintain remission on thiopurines.
P312 Combination corticosteroids with, 5-aminosalicylic acid versus corticosteroids alone in the treatment of hospitalized patients with acute severe ulcerative colitis: A multi-center randomized controlled trial
Authors: Ben-Horin S , Har-Noy O , Katsanos K H , Xavier R , Chen M H , Gao X , Schwartz D , Cheon J H , Cesarini M , Bojic D , Protic M , Theodoropoulou A , Abu-Kaf H , Engel T , Tang J , Veyrard P , Lin X , Mao R , Christodoulou D , Karmiris K , Knezevic-Ivanovski T
Published: January 2022

Background

Corticosteroids are the mainstay of treatment for hospitalized patients with acute severe ulcerative colitis (ASUC). However, whether the addition/continuation of, 5-aminosalicylates (5ASA) with corticosteroids during hospitalization is superior to corticosteroids alone is unknown

Methods

This was a randomized controlled investigator-blinded clinical trial conducted in ten centers in six countries. Patients hospitalized with ASUC (Lichtiger score ≥10) were eligible. Patients received corticosteroids alone or corticosteroid+5ASA (4gr/day mesalamine) by a stratified randomization according to, 5ASA use prior to admission. The primary outcome was the percentage of patients who responded to treatment by day, 7, defined by a drop>3 points in the Lichtiger score and an absolute score<10 without the need for rescue medications or colectomy.

Results

346 patients were screened and, 149 were included (70/149 females, median age, 41). Of these, 73 received corticosteriods+5ASA and, 76 corticosteroids alone. For the primary outcome, 53/73 (72.6%) of patients receiving corticosteroids with, 5ASA responded versus, 58/76 (76.3%) of patients on corticosteroids alone (OR, 0.82, 95%CI, 0.39–1.72, p=0.60). There was no difference between groups in duration of hospitalization or CRP normalization rate. Colectomy rate up to day, 90 was similar, but in an exploratory analysis the need for biologics among patients receiving combination corticosteroids with, 5ASA was numerically lower by day, 30 (p=0.11) and day, 90 (p=0.07).

Conclusion

In this prospective randomized controlled trial, combination, 5ASA with corticosteroids during hospitalization did not benefit patients admitted with ASUC more than corticosteroids alone. An exploratory finding of a reduced need for biologics at, 90 days in the combination group merits further evaluation.

ClinicalTrials.gov ID: NCT01941589
P330 Immunity in patients with inflammatory bowel disease on biologic therapy after COVID, 19 vaccination
Authors: Knezevic T , Cujic D , Odanovic O , Kralj D , Gnjatovic M , Kalaba A , Vrinic Kalem D , Svorcan P , Markovic S
Published: January 2022

Background

IBD patients, especially on immunosuppressive therapy, are in high-risk of developing infections, the outbreak of the SARS-CoV-2 pandemic, made us approach to the whole situation with special caution. At beginning, we wondered if these patients were at increased risk of developing severe COVID19 infection. Knowledge and experience, in this area have progressed, however, with the beginning of vaccination a new question has arisen about what the humoral response to the vaccine would be in these patients.

In Serbia, 3 different types of vaccines from, 4 manufacturer (Pfizer-BioNTech, AstraZeneca/ ChAdOxl nCoV-l9 COVISHIELD, SARS-CoV-2 Vero Cell, SPUTNIK V Gam-COVID-Vac) were available and the aim was to evaluate presence of neutralization antibodies after immunization against SARS-CoV-2.

Methods

328 patients with IBD, from a single tertiary IBD center, were asked about immunization against SARS-CoV-2 during treatment with biologic therapy (anti-TNF, anti-integrin- Vedolizumab) with two doses of available vaccines. Patients who were immunized were selected and analyzed on SARS-Cov-2 IgG response which was measured using ELISA anti-spike protein-based serology (INEP, Belgrade, Serbia) with cut off level of, 15 as negative, 15–20 intermediate, and >, 20 as positive.

Results

From, 328 patients, 61.5% (202/328) patients had CD, and, 38.1% (125/328) had UC. Gender distribution was relatively equal, 53.6% men (176/328), with an average age of, 55.7 (SD ±15.1) years. From those patients, 25 were excluded because biologic therapy was stopped. On ADA were, 105 patients, IFX were, 91, VDZ, 106. From, 303 patients, 58.08% (176/303) were vaccinated (with Pfizer-BioNTech COVID-19, 59 patients, AstraZeneca/ChAdOxl nCoV-l9 COVISHIELD, 9 patients, SARS-CoV-2 Vero Cell, 97 patients and SPUTNIK V Gam-COVID-Vac, 11 patients). In, 16 patients IgG antibodies weren’t measured because they were vaccinated after IgG were measured. From, 160 patents, 31.2 % (50/160) didn’t have detectable IgG antibodies and that is in, 5 patients vaccinated with Pfizer-BioNTech COVID-19, 43 patients with SARS-CoV-2 (Vero Cell) and in, 2 patients with SPUTNIK V Gam-COVID-Vac. When we look in contest of therapy. IgG antibodies were detectable in, 53.9% (34/63) from, 63 vaccinated patients on VDZ and in, 53.06% (52/98) from, 98 vaccinated patients on anti TNF.

Conclusion

In patients with inflammatory bowel disease on biologic therapy from February to September, 2021 rate of immunization were satisfying with more than, 50% vaccinated patients with detectable IgG antibodies in, 68.6% of patients with highest neuralization IgG antibodies present after immunization with Pfizer-BioNTech COVID-19 vaccine, however further studies are needed to determine efficacy of each vaccine.
P339 Effect of antinuclear antibodies on pharmacokinetics of anti-TNF therapy in patients with Inflammatory Bowel Disease
Authors: Theodoraki MD- MA- PhD c E , Orfanoudaki E , Foteinogiannopoulou K , Andreou N P , Gazouli M , Koutroubakis I
Published: January 2022

Background

The detection of antinuclear antibodies (ANA) in serum of patients with inflammatory bowel disease (IBD) has been associated with a worse response to anti-TNF therapy and the development of cutaneous or arthritic manifestations. The aim of this study was to investigate a possible association of serum ANA with infliximab (IFX) and adalimumab (ADA) trough levels (TLs) and anti-drug antibodies in IBD patients treated with IFX or ADA.

Methods

Consecutive IBD patients under maintenance therapy with IFX or ADA in whom there was at least one available measurement of anti-TNF TLs, antibodies to IFX or ADA, and ANA in serum were included. The cut off of therapeutic TLs for both IFX and ADAs was, 5μg/ml. For anti-drug antibodies the cut off of, 10 AU/ml for IFX and, 3 AU/ml for ADA (as positivity of anti-drug antibodies was defined) was applied. The correlation of ANA positivity with demographics, clinical characteristics, treatment, TLs and anti-drug antibodies, of all patients was analyzed.

Results

A total of, 102 IBD patients [mean age (SD), 43.4 (13.8) years, females, 40 (39%), Crohn’s Disease, 85 (84%), under IFX, 50 (49%), under combination therapy with immunomodulator, 36 (35%), median duration of treatment (IQR), 33 (21–81.8) months] were included. Among them, 53 (52%) were ANA positive with, 28 (27.5%) positive also to anti-ds-DNA in serum. In the univariate analysis ANA positivity (ANA greater than, 1:80) was found to be correlated with age (P=0.008), female gender (P=0.03), duration of treatment (P=0.06), arthralgias (P=0.04) and TLs (P=0.007). In multivariate logistic regression analysis only age and TLs remained significantly associated with the presence of ANA positivity (P=0.04 and P=0.003 respectively). Studying separately IFX and ADA treated patients, the median IFX TLs of ANA(+) group (N=28) was, 3.51 (1.2–7.12) μg/ml significantly lower than the median IFX TLs of ANA(-) group [7.38 (4.83–10.3) μg/ml, N=22], P=0.017. The median antibodies to IFX of ANA(+) group was, 2.65 (2.4–3.24) AU/ml, significantly higher than the median antibodies to IFX of ANA(-) group [2.53 (2.11–2.83) AU/ml, P=0.03]. Regarding ADA treated patients, the median TLs of ANA(+) and ANA(-) group was, 7.33 (2.03–9.85) VS, 9.32 (6.17–10.05) μg/m (P=0.14), while antibodies to ADA in ANA(+) and ANA(-) group was, 1.42 (1.40–1.43) VS, 1.41 (1.40–1.43) AU/ml (P=0.52). No significant association of ANA positivity with the development of cutaneous or rheumatological manifestations was found.

Conclusion

In IBD patients under maintenance therapy with anti-TNF ANA positivity is associated with lower TLs, more remarkably with IFX TLs. The clinical significance of this finding remains to be defined in future larger prospective studies.
P372 Accelerated dosing schedule with ustekinumab in anti-TNF refractory Crohn`s disease
Authors: Aleman Gonzalez H , Stamp K , Whitehead E , Pattinson A , Turnbull J , Myers S , Talbot A , Sebastian S
Published: January 2022

Background

The efficacy of ustekinumab in prior biologic exposed refractory patients with inflammatory bowel disease is significantly inferior to those who are bio naïve. The optimal therapeutic level and hence the optimal dosing strategy in this setting is uncertain. Whether early dose optimisation is beneficial in this group of patients has not been evaluated. We aimed to compare the effectiveness and safety of early dose optimisation for maintenance compared to conventional maintenance regime in a retrospective cohort of refractory IBD patients

Methods

All patients initiated on ustekinumab following failure of one or more anti-TNF agents were included. Patients who received conventional maintenance regime (Q8W) was compared to those who received accelerated maintenance regime (Q4H). The primary end point was steroid free remission at, 12 months or at last follow up. The secondary end points were ustekinumab persistence at, 6 months and, 12 months, need for surgery and drug related infectious or non-infectious complications

Results

One hundred and four patients were included (male: female, 48:56). Median follow up was, 11 months (IQR, 5–14). Fifty-six patients received accelerated dosing regimen while, 48 patients received standard dosing regime. Dose escalation was required in, 18 patients (37.5%) of standard dosing regimen while four patients (7.1%) in the accelerated dosing regimen had dose de-escalation. Higher proportion patients in the accelerated dosing regimen were in steroid free remission, 87.5% vs, 68.8% (p=0.018). Proportion of patients requiring surgery was higher in the standard dosing regimen group (22.91, 5 vs, 7.14%, p = 0.02). Ustekinumab persistence in patient started on the accelerated regime and conventional dosing regime was not significantly different at, 6 months (94.1% and, 95.3%, p=0.58) and, 12 months (84.4% and, 95.3, p=0.1). No serious drug related complications observed in either group

Conclusion

Early dose optimisation of ustekinumab improves steroid free remission rates and reduces the need for surgery in patients with anti-TNF refractory patients with IBD
P387 Rapid Implementation of an Evidence-Based, Virtual COVID-19 Vaccine Education Clinic at the Nova Scotia Collaborative Inflammatory Bowel Disease Clinic (NSCIBD) Program
Authors: Komeylian H , Stewart M , Currie B , Phalen-Kelly K , Heisler C G , Jones J
Published: January 2022

Background

The COVID-19 global pandemic has been associated with significant morbidity and mortality. Rapid adaptation of approaches to clinical management as well as policy decisions in relation to implementation of vaccination programs for persons living with IBD has been required throughout the pandemic. To meet the sudden demand of large scale public health-mandated COVID-19 vaccine education for patients living with IBD in Nova Scotia a novel, evidence-based, virtual COVID-19 vaccine educational intervention was developed, implemented, and evaluated.

Methods

This was a prospective, observational, cross sectional, implementation-effectiveness study conducted at the NSCIBD program between April-July, 2021. The educational intervention consisted of a standardized email outlining evidence relating to risks and benefits of COVID-19 vaccinations. The intervention was offered to all patients contacting the NSCIBD program with questions or concerns about the vaccine. During one-on-one virtual visits, standardized and evidence-based information was provided by a gastroenterologist or IBD nurse practitioner. Following the session, an anonymous questionnaire (NoviSurvey) evaluated key implementation metrics including satisfaction, appropriateness, usefulness, perceived impact on knowledge and vaccine hesitancy, willingness to participate in future sessions, and recommendations for improvement. Descriptive analyses were conducted, with group means expressed as proportions for categorical variables and means for numerical variables.

Results

A total of, 265 patients were invited to participate in the online survey, with a response rate of, 49% (131/265). Before the session, 48.9% (64/131) expressed COVID-19 vaccine hesitancy and, 26% (35/131) expressed concerns relating to risks versus benefits of COVID-19 vaccines. Ninety-one percent (119/131) of respondents found the education program to be helpful and, 92% (121/131) indicated there was no information perceived to be lacking from the session. Following the intervention, the proportion of those willing to get vaccinated rose from, 61% to, 86.3%. Only, 1.5% (2/131) indicated that they would likely not get vaccinated. Most participants (77%, 101/131) found the written and virtually administered educational content to be satisfactory and, 88% (115/131) were willing to participate in similar virtual education offerings in the future.

Conclusion

Implementation of an evidence-based, multidisciplinary COVID-19 vaccination education intervention delivered using a virtual platform was perceived to be feasible, acceptable, and effective by IBD patients. Further research on innovative, evidence-based, multidisciplinary educational interventions and the impact of these interventions on IBD clinical outcomes are needed.
P392 To study the prevalence of depression and anxiety in patients of Inflammatory Bowel Disease (IBD) and the efficacy of psychopharmacotherapy in these patients: A pilot study
Authors: Patel A , Joshi H , Wagh A , Bhatt C
Published: January 2022

Background

There is high prevalence of psychiatric disorders amongst IBD patients which independently affect quality of life. Studies have shown psychological stress leads to IBD flare. Non pharmacological psychotherapy has been studied in treatment of IBD, but not psychopharmacotherapy. We feel treatment for mental disorders in IBD patients may improve outcomes.

Methods

This is a prospective, observational single centre pilot study. After ethics committee approval, 200 patients were accrued between November, 2019 & June, 2021, with, 1 year follow up for patients with anxiety or depression. All patients >18 years with Ulcerative Colitis (UC)/Crohn’s disease (CD) were enrolled. We excluded patients with IBD-Unclassified, post ileostomy/colostomy, on biologicals, malignancy. For assessing disease activity in UC we used UCEIS & pMAYO scores; CDEIS & Harvey-Bradshaw scores for CD. HADS-A & HADS-D scores were used to determine anxiety and depression, respectively. Patient with HADS-A or HADS-D >, 7 were considered to have significant anxiety/depression, were given psychopharmacotherapy as per psychiatrist. All patients received IBD therapy as per standard of care. These patients were followed up at, 3, 6, 9 and, 12 months to assess the clinical parameters and HADS scores at each visit. Colonoscopy was repeated after a year to assess endoscopic activity.

Results

In our pilot study of, 200 patients CD was seen in, 84 (42.0%) & UC in, 116 (58.0%). Prevalence of Anxiety was, 15%, Depression, 7% & pooled prevalence, 22%., 86 patients (43.0%) received only IBD therapy., 66 (33.0%) received, 1 antipsychotic drug, 33 received, 2 (16.5%), 15 (7.5%) were prescribed, 3. Patients receiving psychopharmacotherapy, showed significant improvement in HADS-A or HADS-D scores at, 3, 6,9 and, 12 months. Amongst patients with UC, there was a significant improvement in UCEIS score (4.73 to, 2.36) in patients who received psychopharmacotherapy in addition to IBD standard of care after, 1 year (p<0.05). Similarly, the mean p-MAYO score dropped from, 4.91 to, 2.17 in patients receiving psychopharmacotherapy (p<0.05). The same pattern was observed in patients with Crohn’s disease receiving psychopharmacotherapy, in whom the mean CDEIS score dropped from, 5.43 to, 2.16 after, 1 year. Also, the mean Harvey-Bradshaw score dropped from, 5.57 to, 2.86. Both in UC & CD; clinical, endoscopic scores significantly improved in patients who were given psychopharmacotherapy in addition to SOC.

Conclusion

Our study confirmed the high prevalence of anxiety and depression amongst Indian IBD patients. IBD patients with significant anxiety or depression benefit from Psychopharmacotherapy in addition to standard of care treatment, showed improvement in clinical as well as endoscopic disease activity.
P414 Stoma in patiens with IBD: friend or foe? -\tEffect of stoma on course of disease, psychological well-being and working capacity
Authors: Bianchi R , Von Känel R , Roth R , Schreiner P , Rossel J B , Barry M P , Dora B , Kloth P , Juillerat P , Greuter T , Misselwitz B , Schoepfer A , Scharl M , Rogler G , Biedermann L
Published: January 2022

Background

Knowledge on the impact of stoma formation surgery on course of disease, psychological well-being, quality of life (QoL) and working capacity in patients with IBD is scarce.

Methods

To investigate this, we analysed prospectively followed-up patients from the Swiss inflammatory bowel disease cohort study (SIBDCS), comparing ulcerative colitis (UC) and Crohn’s disease (CD) with vs without stoma surgery, for both temporary and permanent stoma formation.

Results

From a total of, 3825 SIBDCS patients, 352 patients were included in our analysis -, 176 with stoma surgery (52.8% and, 47.2% with CD and UC, respectively) - amongst these, 111 with permanent and, 65 with temporary stoma - matched with, 176 patients without stoma. Mean and maximal disease activity was lower in patients with vs. without stoma overall in CD but not in UC (Fig., 1, A/B). However, in UC, disease activity was lower in permanent vs. temporary stoma patients (Fig., 1, C/D).

Figure, 1 A-D: Average disease activity with mean Crohn’s disease activity index (CDAI; A) in CD and Modified Truelove & Witts activity index (MTWAI; B) and UC for patients with vs. without stoma as well as (within the stoma group) permanents vs. closed ostomy (C,D).

Furthermore, active EIM as well as need for steroids, immuno-modulators and biologics were lower in stoma vs. control patients. Amongst stoma patients, quality of life and psychological wellbeing was similar in permanent vs. closed stoma (Inflammatory Bowel Disease Quality of Life questionnaire Total score (IBDQ); Hospital Anxiety and Depression Scale Total Score (HADS); Posttraumatic Diagnostic Scale Total Score (PDS); and effort-reward ratio – all mean values obtained during prospective SIBDCS follow-up). However, we found a significantly lower (i.e. more favourable) PDS avoidance score in permanent vs. closed ostomy (Fig., 2A). Working capacity was lower in permanent vs. closed stoma patients (Fig. 2B).

Figure, 2 A,B: IBDQ, HADS total, PDS total and Effort-Reward ratio (A), Working status, absentism from work and need for disability insurance (B) in permanent vs. closed IBD patients with stoma.

Conclusion

In CD patients with stoma surgery disease activity was significantly reduced after ostomy. Moreover, in UC we observed a benefit of patients with permanent compared to their counter-parts with temporary stoma to control disease activity. We found no differences in psychological functioning and QoL between temporary and closed stoma, with the exception of higher avoidance indicative of posttraumatic stress in the latter. In contrast, working capacity revealed to be higher closed vs. permanent ostomy.
P417 Seroconversion after COVID-19 Vaccination in Inflammatory Bowel Disease Patients
Authors: Horvath M , Csontos Á A , Sárközi M , Cseprekal O , Szijártó A , Miheller P
Published: January 2022

Background

Data about the effect of different immunosuppressive treatments of IBD patients on seroconversion and on different SARS-CoV-2 vaccinations are scarce. To avoid impaired vaccine responses and worse outcome of COVID-19, factors attenuating protective immunity shoud be shought.

Methods

Anti SARS-CoV-2S antibody levels of IBD patients in remission were measured by immunoassay (Roche) before vaccination and on the second week. Antibody responses were compared among different treatment groups (biologics, combination, azathioprin, without immunomodulation) and between mRNA and other type of vaccines. Anti TNF alpha levels were also assesed, 24 hours before vaccination considering correlation with seroconversion.

Results

Thirty-eight (31.7%) ulcerative colitis and eighty-two (68,2%) Crohn’s disease patients were included (median age, 39.1 years, 53.3% female). No serious comorbidities were present. Eighty-two patients (68.3%) were on biological therapy, fifty-two (43%) were treated with azathioprine alone or in combination. Two doses of mRNA vaccines were administered to ninty-eight patients ((81,7%) Moderna:, 20, Pfizer:, 78). The other type of vaccines were AstraZeneca (16) Sputnik V (3) and Sinopharm (3). The median anti-SARS-CoV-2S antibody level was, 2733 U/mL (IQR:, 535–7764) on the, 14th day after vaccination (IQR:, 14–17). Significant differences were revealed between the groups of patients treated with biological agents or non-biological therapy (median:, 1649 U/ml vs., 5711.5 U/ml; p=0.013) and between patients recieving mRNA and non-mRNA vaccine (median:, 3367.5 U/ml vs., 392.6 U/ml;p<0.001). Considering the varying effect of immunosupression related to combination therapy, biological drugs, azathioprin and other non-immunomodulating treatments antibody response were assesed in these groups also. The median antibody levels were, 850,5 U/ml (IQR:, 251.0–4899.5), 1837 U/ml (IQR:, 544.5–5902), 3141 U/ml (IQR:, 1066–7988), 7764 U/ml (IQR:, 5601–13808) demonstrating significant differences among them (p<0.001). No correlation between anti-TNF-alpha serum level and antibody response were found.

Conclusion

Altough all vaccines cause seroconversion in IBD patients who are in remission, the rate of seroconversion is lower in patients treated with immunosupressant, biological agent or combo therapy or recieving non-mRNA vaccines. As the level of anti-TNF-alpha agents do not affect the rate of seroconversion there is probably no need for matching the time of vaccination and anti-TNF therapy.
P421 Correlation of bowel activity parameters in intestinal ultrasound to drug retention and trough drug levels in Crohn’s disease
Authors: Albshesh A , Ungar B , Kopylov U , Ben-Horin S , Carter D
Published: January 2022

Background

Introduction: Intestinal ultrasound can be used to assess transmural healing and response in Inflammatory bowel disease (IBD). Bowel wall thickness (BWT) appears to be the most applicable parameter for defining inflammation. Other parameters include amplified color Doppler signal, disappearance of the normal bowel wall layers and proliferation of mesenteric fat. The implication of incorporating these parameters in defining transmural healing and response is not clear. Our aim was to examine the significance of combining these parameters with BWT for defining transmural healing and response.

Methods: Methods

A post-hoc analysis of data from, 2 trials was used to examine the correlation of the different IUS parameters on drug retention and trough drug levels.

Results: Results

The study cohort included, 94 patients (median age, 24.5) with Crohn’s disease., 44 patients were treated with adalimumab (ADA) and, 50 with infliximab (IFX). There was a significant correlation of failure of drug retention and terminal ileum (TI) BWT >, 3 mm (P=0.07), amplified doppler sign (p<0.001), abnormal bowel wall stratification (p=0.005) and fat hypertrophy (p=0.001). This correlation remained significant when adding any other single abnormal parameter to the BWT (p<0.001), 2 abnormal parameters (p<0.001) or, 3 abnormal parameters (p=0.003). There was also a significant correlation between sufficient trough drug levels (ADA>7.1, IFX>5) and terminal ileum BWT <, 3 mm (P<0.001). However, there was no significant correlation between sufficient trough drug levels and the other ultrasonographic parameters and no significant correlation when combining any other ultrasonographic variables with the BWT.

Conclusion

Conclusions: Increased BWT was correlated with failure of drug retention. The addition of other ultrasonographic activity parameters did not significantly improve the predictive model. Therefore, TI-BWT should be used as the main target in the definition of transmural healing and response.
P423 Azathioprine still remains the first step-up therapy in patients with Inflammatory Bowel Disease in low-middle income countries
Authors: Ranjan M K , Kumar P , Vuyyuru S K , Kante B , Sahu P , Mundhra S , Golla R , Singh M , Virmani S , Sharma R , Panwar R , Das P , Makharia G , Kedia S , Ahuja V
Published: January 2022

Background

Inflammatory bowel disease (IBD) including Ulcerative Colitis (UC) and Crohn’s Disease (CD) is characterized by remitting/relapsing course. A proportion of patients with UC, and almost all patients with CD require long-term immunosuppression to maintain endoscopic and clinical remission and prevent disease progression. The present study aimed to evaluate the long-term efficacy of thiopurines, their predictors, and the effect of the early use of thiopurines on disease outcomes in patients with IBD.

Methods

A retrospective cohort analysis of patients with IBD following up in IBD clinic at AIIMS, New Delhi, India from, 2004–2020. Efficacy was defined as a state of not requiring hospitalization, anti-TNF agents, surgery, and only minimum (≤, 1 steroid course in, 2 years) steroid requirement during follow-up. Early and late thiopurine initiation was defined as commencement of thiopurines ≤2 and >2 years of disease onset, respectively.

Results

Of, 1264 consecutive patients on thiopurines (both, 6-MP and azathioprine), 988 (UC:720, CD:268) were considered for efficacy analysis (males-60.8%, mean age at disease onset-31.69±12.34 years and thiopurine initiation-35±13.14 years). Time to event analysis showed a median efficacy rate of, 79%, 72% and, 68%, 61% at, 5 and, 10 years in UC and CD patients respectively after thiopurine initiation. On multivariate analysis, only the male sex was found to be a significant predictor of relapse (HR:, 1.49, 95% CI:, 1.021–2.194; P=0.039) in UC and Ileal involvement (HR:, 0.391, 95% CI:, 0.176–0.86; P=, 0.021) and steroid-dependent disease (HR:, 0.429, 95% CI:, 0.186–0.965; P=, 0.041) were associated with decreased risk of relapse and presence of any adverse event was associated with increased risk of relapse (HR:, 2.37, 95%CI:, 1.39–4.05; P=0.008). Kaplan Meier survival analysis showed no difference between the efficacy of early and late thiopurine groups, both in UC (Log-rank test P = 0.72) and CD (Log-rank test P = 0.76).

Figure, 1: Kaplan Meier curve showing relapse-free survival on thiopurine in ulcerative colitis and Crohn’s disease.

Figure, 2: Kaplan Meier survival analysis comparing relapse-free survival in early vs late thiopurine initiation group in UC (Log-rank test P = 0.72).

Figure, 3: Kaplan Meier survival analysis comparing relapse-free survival in early vs late thiopurine initiation group in CD (Log-rank test P-value:, 0.764).

Conclusion

Thiopurines still remains a viable long-term option for maintenance of remission in patients with IBD, especially in resource-limited countries. Their use can be further enhanced by optimizing their therapy and regular monitoring for adverse events.
P426 Association Between vedolizumab therapy outcome and Pre-treatment DUBLIN Score & CRP-Albumin Ratio in Ulcerative Colitis
Authors: McCormick E , Singh P , Kevans D
Published: January 2022

Background

The DUBLIN score is a measure of ulcerative colitis (UC) inflammatory burden and is associated with clinical outcomes. A high CRP/albumin ratio (CAR) is associated with disease severity in IBD. The aim of our study was to evaluate if there was an association between vedolizumab therapy outcome and pre-treatment DUBLIN score and CAR in UC.

Methods

35 patients with UC initiating vedolizumab with available pre-treatment DUBLIN score and CAR data were identified. Baseline characteristics, biochemistry and endoscopic findings were defined by retrospective review. A previously validated DUBLIN score threshold of ≥3 and CAR threshold >0.6 were utilised to categorise patients with high inflammatory burden. Clinical response at, 3-months and corticosteroid-free remission at, 6-months were recorded. The association between, 3-month clinical response and, 6-month remission rates & pre-treatment DUBLIN score and CAR ratio were evaluated. P values <0.05 were considered significant.

Results

Baseline characteristics of the study cohort: age [median, range], 53 [19 -87] years;, 60% male; disease duration [median, range], 11 [2–41] years. A pre-treatment DUBLIN score ≥3 and CAR >0.6 were observed in, 65% and, 51% of patients respectively., 3-month clinical response and, 6-month corticosteroid-free remission rates were observed in, 79% and, 67% of the cohort respectively. There was no significant difference between rates of, 3-month clinical response and, 6-month corticosteroid-free remission comparing high and low pretreatment DUBLIN score and CAR groups, p=0.59 and p=0.16 respectively.

Conclusion

Vedolizumab was an effective therapy in patients with a significant inflammatory burden assessed by DUBLIN score and CAR. Pre-treatment DUBLIN score and CAR were not associated with therapy outcome.
P445 Is objective disease monitoring strategy tailored to the presence of clinical symptoms, a prospective cohort study from a tertiary IBD center from Hungary
Authors: Lontai L , Gonczi L , Komlodi N , Balogh F , Barkai L , Ilias A , Lakatos PhD P L
Published: January 2022

Background

Emerging data suggest that a treat-to-target approach and early therapeutic intervention using regular objective disease assessment leads to improved outcomes. Our aim was to evaluate the value of objective disease monitoring during regular follow-up.

Methods

Patients presenting in our IBD center between January and December in, 2018 were included and followed up for, 1 year. Data from clinical visits, clinical disease activity using Crohn’s Disease Activity Index and partial Mayo Score, biomarkers (CBC, CRP, FCAL), stool culture, colonoscopy/sigmoidoscopy, CT/MRI scans, abdominal US, total number of visits, hospitalization or surgery rates, and change in medical therapy were collected. We compared monitoring strategy according to the clinical disease activity in the given quarter-year period based on the patient’s status of clinical disease activity (remission/ flare / post-flare/ continuous activity).

Results

N=161 patients were included (CD:118/UC:43; male:, 56%), with predominantly moderate-to-severe disease phenotype (70% on biological therapy). In total, n=644 quarter year periods (n=, 554 with patient visit) were evaluated (remission, 57%; continuous activity, 19%; post-flare, 11%; flare, 13%). CBC and CRP were performed in, 82.9% and, 83.9% of all patients with at least one clinical visit in a quarter-year period, regardless of clinical activity in IBD. Colonoscopy was performed in patients with flare or continuous disease activity in, 21.1% and, 18.9%, but, 10.1% of the patients in clinical remission also underwent colonoscopy in a given quarter-year period. In a sub-analysis of UC patients, 24.1% of the patients presenting with disease flare had colonoscopy in a given period. Stool culture and C.difficile stool tests were performed in, 17.2% of UC patients with flare. CT scans were performed at a low rate of, 2.4% in CD patients with disease flare, while MRI scans were similar in all subgroups of CD patients (7.7–16.7%)., 13.2% of patients with cont. activity and, 24.5% of patients with flare needed initiation or dose optimization of corticosteroids, while biological start or dose optimization was needed in, 31.1% and, 33.8% in a given quarter-year period. Mean number of follow-up visits per quarter-year period was high(1.6) even for patients in remission, and, 2.4 in flare.

Conclusion

Our study confirmed the use of regular objective biomarker monitoring, independent of clinical activity. We report high utilization of c-scope/sigmoidoscopy as well as MRI (in CD) in the objective evaluation of patients with clinical symptoms or even as part of routine monitoring. CT was reserved for emergency situations, while the use of US was relatively low. Objective monitoring resulted in frequent and early optimization of the therapeutic strategy.
P448 Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis
Authors: Kim K , Hong H S , Oh K , Lee J Y , Hong S W , Park J H , Hwang S W , Yang D H , Byeon J S , Ye B D , Myung S J , Yang S K , Park S H
Published: January 2022

Background

We aimed to investigate the efficacy of oral beclomethasone dipropionate (BDP) as an add-on therapy to concomitant drugs and to clarify the predictive factors for response to oral BDP in Korean patients with ulcerative colitis (UC).

Methods

Patients with a stable concomitant drug regimen with exposure to oral BDP (5 mg/day) within 30 days before initiation were included. The partial Mayo score (pMS) was used to evaluate response to oral BDP. Clinical remission (CREM) was defined as a posttreatment pMS ≤1 point. Clinical response (CRES) was defined as an at least 2-points decrease in the posttreatment pMS and an at least 30% decrease from the baseline pMS. Patients without CREM or CRES were considered nonresponders (NRs).

Results

Of total 100 patients, 37 showed CREM, 19 showed CRES, and 44 were NRs (Table 1). The CREM group included more patients with mild disease activity (75.7% vs. 43.2%, P=0.011) than the NR group. In contrast to NR group, responders including CREM and CRES showed significant improvement of posttreatment ESR and CRP (ESR with P=0.001, CRP with P=0.004, respectively). Moreover, initial rectal bleeding subscore (RBS) was significantly different between CREM and CRES, or NR (both with P<0.001). In multivariate logistic regression analysis, initially mild disease activity was the only predictive factor for CREM (odds ratio, 3.580; 95% confidence interval, 1.342–9.548) (Table 2).

Conclusion

Oral BDP is efficacious as an add-on therapy in Korean UC patients. In case of acute aggravation, patients with mild disease activity, especially low RBS, may be good candidates for oral BDP.
P453 Underutilisation of novel and alternative oral iron preparations may incur unnecessary cost in iron deficiency anaemia treatment in inflammatory bowel disease
Authors: Sharma E , Kotecha J , Akintimehin A , Ray S , Anderson S H , Mawdsley J , Irving P M , Samaan M A
Published: January 2022

Background

Iron deficiency anaemia (IDA) is a common extraintestinal manifestation of inflammatory bowel disease (IBD). Ferric salts are the cheapest preparations at approximately £2 per treatment course compared to more costly alternative oral preparations including ferric liquid (£30) and ferric maltol (£140) which tend to be better tolerated. Intravenous (IV) treatment costs approximately £1500 including the infusion cost. The aim of this service evaluation was to review local practices related to the treatment of IDA in IBD according to a locally developed iron pathway to help guide more efficient healthcare utilisation in this regard.

Methods

We performed a retrospective review of prospectively collected clinical records of 124 patients with IBD (47 (38%) UC, 71 (57%) CD and 6 (5%) IBDU) who received IV ferric carboxymaltose (Ferinject) between April 2019 and March 2020. Demographic data, previous oral iron use, reason for referral and dose received were recorded. The history of oral iron use, haemoglobin (Hb) at time of referral and local iron treatment pathway (Figure 1) were used to determine whether patients were suitable for an alternative iron formulation.

Results

The majority (94, 76%) of the cohort (described in Table 1) were receiving advanced IBD therapies and 56 (45%) had undergone prior surgery. Reasons for referral were marked IDA (54 (44%)) unsuitability for oral iron (54 (44%)) or other / no stated reason (16 (12%)). 109 (88%) patients received the full calculated dose of whom 48 (44%) required two visits and 61 (54%) required one visit to the infusion unit in order to receive their full IV iron treatment. Hb at referral is described in Table 2; the majority of patients (78, 63%) had mild IDA (Hb 100–139 g/L). Sixty-four (52%) patients had previously tried ferric salts, 6 (5%) received ferric liquid and 13 (10%) had previously tried ferric maltol. Forty (33%) patients who received IV iron were suitable for standard oral iron and a further 68 (56%) patients were suitable for ferric maltol.

Conclusion

Our cohort was largely on advanced therapies suggesting the need for closer monitoring of IDA in this cohort. Ferric liquid and ferric maltol appear underutilised in patients who have not tolerated ferric salts and offer significant cost savings compared to IV iron preparations. Depending on its effectiveness, if ferric maltol was prescribed over IV iron in those in whom it was suitable this would correspond to a cost saving of up to £93,000. More frequent use of these oral iron preparations, according to the local pathway, would also facilitate more efficient use of IBD infusion unit capacity.
P466 Real-world effectiveness and safety of golimumab in patients with ulcerative colitis: 52-weeks of post-marketing surveillance data in Japan
Authors: Nakamura S , Asano T , Tanaka Y , Sugimoto K , Yoshigoe S , Suzuki Y
Published: January 2022

Background

Golimumab (GLM) is an anti-TNF-α drug approved for treating ulcerative colitis (UC). Although its efficacy and safety were well established in clinical trials, real-world evidence was still limited. In the present study, we evaluated 52-week effectiveness and safety of GLM treatment for UC based on post-marketing surveillance data.

Methods

The prospective, post-marketing study was conducted in 393 patients from 163 medical facilities. Patients who had been prescribed GLM were enrolled between May 2017 and September 2019 in Japan. In accordance with Japanese indication, patients received subcutaneous injections of GLM, 200 mg at week 0, 100 mg at weeks 2 and 6, followed by 100 mg every 4 weeks. Clinical remission (partial Mayo score ≤2), predictors of remission, adverse drug reactions (ADRs), and predictors of ADR development were determined at week 52.

Results

Of 393 enrolled patients, 391 and 386 were included in safety and efficacy analysis set, respectively (Table 1). Overall, clinical remission in the intention-to-treat population was 13.0%, 53.9%, 52.6%, 48.2%, and 43.3% at baseline (BL) and at week 6, 22, 36, and 52, respectively (Table 2). In biologic naïve group, clinical remission was 9.2%, 59.1%, 61.0%, 52.4%, and 47.0% at BL and week 6, 22, 36, and 52, respectively, while in biologic experienced group, it was 15.8%, 50.0%, 46.4%, 45.0%, and 40.5% at BL and week 6, 22, 36, and 52, respectively. At week 52, clinical remission rate in the patients who concomitantly used corticosteroid (CS) at BL was significantly lower than that in the patients who did not receive CS (p=0.017, 37.3% vs 49.2%) (Fig. 1). No significant difference in remission rate was observed between immunomodulator (IM) users and IM non-users at baseline. From multivariate analysis, concomitant use of CS (p=0.001, odds ratio [OR] =0.488, 95% CI [confidence interval] 0.314–0.759) and partial Mayo remission at BL (p<0.001, OR=4.329, 95% CI 2.056–9.115) were identified as independent factors associated with clinical remission. ADRs occurred in 71 patients (18.2%). The most common ADR was rash, reported in 9 patients (2.3%). Serious ADRs occurred in 40 patients (10.2%). The most frequent serious ADR was UC, reported in 8 patients (2.0%). In multivariate analysis, the presence of comorbidities was associated with ADR incidence (OR=2.000, 95% CI 1.183–3.380).

Conclusion

From the Japanese post-marketing data, the real-world effectiveness of GLM treatment was confirmed in both biologic naïve and experienced populations. Safety profile was generally consistent with previous findings, and no additional safety signals were identified. Concomitant use of CS, but not IM, may be likely to affect outcome of GLM therapy.