bluuebunny/crossref_metadata_2025_split 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

Abstract

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-&gt;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

Abstract

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

Abstract

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 (&lt;, 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

Abstract

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&gt;3 points in the Lichtiger score and an absolute score&lt;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

Abstract

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 &gt;, 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

Abstract

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

Abstract

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

Abstract

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.