bluuebunny/crossref_metadata_2025_split huggingface dataset:
P413 Antibody response to the COVID-19 ChAdOx1nCov-19 and BNT162b2 vaccines in the immunosuppressed (RESCUE)
Authors: Tran A P , Tassone D , Nossent J C , Ding N S 
Published: January 2022

Abstract

Background
Immunocompromised patients are inherently vulnerable to severe outcomes to vaccine preventable infections compared to the general population. This study aims to investigate the impact of immunosuppression on response to the ChAdOx1nCov-19 and BNT162b2 vaccines to better inform vaccination efforts in this cohort.

Methods
A three-armed randomised controlled trial was performed. Patients with autoimmune disorders on immunosuppressive therapies and healthy controls were recruited from two sites. Participants receiving immunosuppression were randomly assigned to either withhold or continue treatment contemporaneous to vaccine administration. Serum SARS-Cov2 immunoglobulin assays were performed at baseline and, 4-weeks following first and second vaccine doses. Between group comparisons were performed to examine differences in vaccine seroconversion and immunogenicity.

Results
A total of, 253 participants of median age, 55 years (IQR:, 45.5–64) including, 193 patients receiving immunosuppression and, 60 healthy controls were studied. Immunosuppressed patients were randomly allocated to continue (n=105) or withhold (n=88) treatment. Of those receiving immunosuppression, 27.08%, 40.63% and, 32.29% of patients were exposed to cDMARDs, bDMARDs and tsDMARDs respectively while rates of BNT162b (Pfizer) vaccination were, 52.33%, 60.67% and, 48.33% among the continue, withhold, and control groups respectively. Post-first dose vaccination seroconversion rates were highest among healthy controls (90%) and patients who temporarily withheld immunosuppressants (76.32%) compared to patients continuing treatment (48.24%) p=0.000. Post-second dose vaccination seroconversion rates were, 100% in both the control and withhold groups and, 86.75% in the continuation (p=0.001). Mean quantitative serum SARS-CoV-2 IgG titres were, 8.58 U/ml, 5.11 U/ml and, 3.29 U/ml (p=0.0001) between the controls, withhold and continue groups respectively following first vaccination. While post-second vaccination mean serum IgG titres were, 96.31 U/ml, 91.86 U/ml, and, 49.73 U/ml (p=0.0066) between these groups.

Conclusion
COVID-19 vaccine response in terms of seroconversion and the level of antibody production was highest among healthy controls compared with patients with autoimmune diseases receiving immunosuppression. Temporary cessation of immunosuppressant therapy, contemporaneous to COVID19 vaccination appears to improve vaccine response in this cohort.
P418 Development and validation of a digital health platform (IBD NutriCare) for telenutrition in patients with Inflammatory bowel disease
Authors: Gupta A , Singh N , Madan D , Farooqui M , Singh N , Singh M , Virmani S , Verma M , Bajaj A , Markandey M , Kante B , Vuyyuru S K , Kumar P , Sahu P , Makharia G , Kedia S , Ahuja V 
Published: January 2022

Abstract

Background
Introduction-Telenutrition with digital health platforms is the future step towards improving patient care in patients with inflammatory bowel disease(IBD). Additionally, it offers an advantage of conducting multicenter longitudinal dietary intervention studies. Aim-To develop and validate a digital health platform for patients with IBD to provide nutrition care and record longitudinal diet data on a large-scale basis.

Methods
Methods-The development of the digital health platform was done from October, 2019 -June, 2021 by gastroenterologists and dieticians. For validation, patients with IBD at All India Institute of Medical Sciences, New Delhi recorded, 7 days diet in the App. 24-hours diet recall for, 3 days at random during the same week was also done. Energy, protein, carbohydrate, fat, fiber, cereals, fruits, vegetables, grain, legumes, milk products were compared between two methods.

Results
Results-An Android and iOS-based digital health platform, ‘IBDNutriCare’ was developed in English and, 7 Indian languages. This user-friendly interface can be downloaded by the patients free of cost from Google store and App store. This platform provides a recording of diet variables based on, 600 Indian food recipes, patient parameters like subjective global assessment, medications, and clinical activity scores. It also provides a graphical representation of nutrient analysis, with web applications generating comprehensive reports to enable large-scale data analysis. Forty-nine patients with IBD were enrolled in a validation study comparing ‘IBDNutricare’ based analysis with dietary recall method. The mean intake of all food groups and macronutrients was comparable between the two methods. There was a significant interclass correlation [excellent for macronutrients and all food groups except vegetables (moderate, 0.79] and Bland-Altman plot analysis showed good agreement between the two methods.

Conclusion
Conclusion- This study developed and validated a digital health platform for telenutrition in patients with IBD. This app helps in real-time tracking of dietary details and recording the data on a large scale.
P420 Long term efficacy of ustekinumab in Crohn’s disease patients after vedolizumab failure
Authors: Melotti L , Dussias N K , Belluzzi A , Salice M , Calabrese C , Rizzello F , Gionchetti P 
Published: January 2022

Abstract

Background
Ustekinumab (UST) and vedolizumab (VDZ) are approved biologic therapies for moderate-to-severe Crohn’s disease (CD). Data regarding their comparative efficacy in patients previously treated with anti-TNF agents are available. However, data is lacking regarding their long-term effectiveness after failure of a second or third-line biologic treatment. Our aim is to evaluate ustekinumab efficacy after swapping from vedolizumab therapy for primary or secondary failure.

Methods
We conducted a single-centre, retrospective study in CD patients treated with UST as third line biologic therapy who swapped from VDZ therapy upon failure between January, 2019 and October, 2021. We assessed clinical (HBI), laboratoristic (CRP), endoscopic (SES-CD) activity and use of steroids at the beginning of ustekinumab therapy and after, 12 months of treatment. We also collected data regarding previous biologic treatments. Clinical remission was defined as HBI &lt;, 5, while clinical response was defined as a reduction of at least three points of HBI from baseline and/or the suspension of steroids.

Results
Of, 43 patients treated with UST after VDZ failure, 26 had a minimum follow up of, 12 months and were included in the study. All patients had previously been treated with antiTNF agents. After, 12 months, 4 patients have suspended treatment for failure; among patients still on treatment, clinical remission was evident in, 63% (n = 14) of cases, 13 of them were also in laboratoristic remission. Endoscopy at, 12 months was available in, 11/14 patients in clinical remission; of these, 6 (55%) were in endoscopic remission. In patients who did not achieve clinical remission, 18% (n = 4) obtained clinical response. The last, 18% (n = 4) of patients persisted on therapy.

Conclusion
Ustekinumab seems to be a viable and effective therapeutic option in patients with failure to multiple prior biologic therapies, obtaining deep remission after, 12 months of treatment in a large proportion of patients.
P425 Rates of tuberculosis infection in Crohn’s Disease patients before and during anti-tumor necrosis factor therapy
Authors: Georgieva PhD A C , Atanassova A , Mirchev M 
Published: January 2022

Abstract

Background
In the last, 20 years, IBD treatment has made great progress with the implementation of biological drugs. Although the use of anti-tumor necrosis factor-alpha (anti-TNF-α) agents is highly effective in achieving and maintaining remission, 1, anti-TNF-α agents are associated with a, 5-fold increased risk of reactivation of various opportunistic infections, including TBI, 2,3.
Our study aims to determine the incidence of TBI (active tuberculosis (ATBI) and latent tuberculosis (LTBI)) among patients with Crohn’s disease (CD) receiving anti-TNF-α therapy.

Methods
For the period between June, 2010 to December, 2019, we performed a retrospective analysis of a total of, 109 CD patients, screened before the start of biological treatment. Anti-TNF-α therapy was initiated by, 97 patients, 74 of whom were retested for TBI during follow-up. All patients were BCG vaccinated.

Results
Before starting biological treatment, we etablished LTBI in, 11/109 (10.1%):, 8/11 (72.7%) patients were TST (+) alone, 2/11 (18.2%) were IGRA (+) and TST (-), 1/11 (9.1%) were both IGRA and TST (+). Chest x-ray abnormalities were not detected in all, 11 patients.
After prophylaxis with isoniazid (INH), 300 mg / daily for, 9 months, 9/11 (83.3%) patients with LTBI reached treatment with an anti-TNF α agent. Of this group, 7/9 (77.8%) patients were retested for TBI:, 6/7 (85,7%) were TST and IGRA were (-), and one (14,3%) developed active pulmonary tuberculosis. Two patients were lost to follow up.
In the follow-up of patients under anti-TNF-α therapy, 74/97 (76.3%) patients were retested for TBI, with median duration of anti-TNF-a therapy was, 24 (IQR, 6–90) months.
A total of, 16/74 (21.6%) patients were newly diagnosed with LTBI:, 5/16 (31.3%) had TST conversion alone, 8/16 (50.0%) were TST(+) and IGRA (-), 1/16, 6.3%) were both TST and IGRA (+), 1/16 (6.3%) had IGRA conversion alone, 1/16 (6.3%) were TST (-) and IGRA (+).
ATBI developed in, 3/74 (4.1%) patients, one of them on the background of chemoprophylaxis with INH for LTBI. Median duration after the first dose of biologic therapy to detection of TBI was, 12 (IQR, 6–60) months.

Conclusion
This study instruct the clinician to be specifically vigilant when initiating anti-TNF-α therapy in IBD patients, because reactivation of TBI is a life-threatening complication in immunosuppressed patients.
P436 Efficacy and safety of biosimilars of anti-TNF-a in paediatric-onset Inflammatory Bowel Disease: Data from the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)
Authors: Dipasquale V , Pellegrino S , Cucinotta U , Citrano M , Graziano F , Cappello M , Busacca A , Orlando A , Accomando S , Romano C 
Published: January 2022

Abstract

Background
Few data regarding the use of biosimilars of anti-tumour necrosis factor-a (TNF-a) in children with Inflammatory Bowel Disease (IBD) have been reported. We aimed to assess the efficacy and the safety of biosimilars of infliximab (IFX) and adalimumab (ADA) in paediatric-onset IBD.

Methods
This was a multicentre, observational, retrospective study performed among the cohort of the Sicilian Network for the Inflammatory Bowel Disease (SN-IBD) and including all patients with paediatric-onset IBD treated with the biosimilars of IFX or ADA. Demographic and clinical data were collected from medical records. PUCAI and PCDAI scores at the time of IFX start, after, 14 and, 54 weeks were recorded. The primary outcome was the rate of clinical remission at weeks, 14 and, 54. Secondary outcomes included treatment duration and incidence of adverse events.

Results
They were included, 128 patients, of whom, 87 on IFX biosimilar (group, 1) and, 41 on ADA biosimilar (group, 2) (Table 1).
Table, 1.Baseline characteristics of patients

At week, 14, UC patients on IFX biosimilar had a median PUCAI score of, 10 (IQR, 5.0–22.5), while CD patients a median PCDAI score of, 5 (IQR, 5.00–10.8). Overall, the remission rate on IFX biosimilar at week, 14 was, 61.5%, and it was significantly associated with positive family history [OR, 13.18 (2.44–245.65, p=0.015)], older age at starting biosimilar [OR, 1.19 (1.02–1.41, p=0.038)], and diagnosis of CD (in comparison to UC) [OR, 3.45 (1.35–9.23, p=0.011)]. At week, 54, both UC and CD patients on IFX biosimilar had a median clinical score of, 5. The remission rate was, 69.1%, and no significant association with any variable was found. Patients on ADA showed a remission rate of, 75% at, 14 weeks, and of, 70% at, 54 weeks, both associated with shorter disease duration [OR, 0.67 (0.45–0.93, p=0.025) and OR, 0.55 (0.28–0.86, p=0.026), respectively]. At, 54 weeks, patients on IFX showed a &gt;90% failure-free survival (Figure, 1), which was inversely associated with the presence of extraintestinal manifestations (HR, 5.12, p=0.014) and non-naive patients (HR, 3.81, p=0.025). Patients on ADA biosimilar had &gt;83% failure-free survival at, 12 months (Figure, 2), associated with shorter disease duration (HR, 1.41, p=0.043). About safety, a total of, 13 adverse events were registered, 9 in group, 1 (incidence of, 6.13/100 PY) and, 4 in group, 2 (incidence of, 12.23/100 PY). Most (n=7) were acute infusion reactions.
Figure, 1.Failure-free survival on IFX biosimilar

Figure, 2.Failure-free survival on ADA biosimilars

Conclusion
This is one of the largest cohorts of paediatric-onset IBD on biosimilars, and confirmed these drugs are effective and safe in this group of patients, with high percentage of failure-free survival at, 1 year and low incidence of mild adverse events.
P438 The Efficacy and Safety of ustekinumab Therapy in refractory Inflammatory Bowel Disease (IBD) patients with co-morbidities and old age
Authors: Davies B , Lodhia M , Abdalla B , Gupta V 
Published: January 2022

Abstract

Background
Ustekinumab is approved for treatment of active Crohn’s Disease (CD) and Ulcerative Colitis (UC) with a more favourable safety profile to anti-TNF therapy however it is still used with caution in the elderly and those with comorbidities. We present our data on safety and efficacy of Ustekinumab in our IBD population including consideration of age and existing medical conditions.

Methods
Clinical data on all IBD patients treated with Ustekinumab within our population between, 2016 and, 2021 were retrospectively collected from electronic records. This included baseline characteristics, diagnosis, previous medical and surgical history, comorbidities, clinical response, endoscopic response and adverse events (AEs).

Results
120 (M=57, F=63) patients were identified, 98 CD, 17 UC and, 5 IBDU with a median follow up of, 13.9 months (IQR, 3–20.5) The median age of starting Ustekinumab was, 35.5 years (16–81) with, 65% (78/120) previously treated with two or more biologics suggestive of refractory disease. Clinical response was achieved in, 18.0% (16/89) of patients at, 8 weeks, 39.3% (24/61) at, 24 weeks, 42.0% (21/50) at, 1 year and endoscopic response and/or with imaging was seen in, 9/23 (39.1%) at, 24 weeks and, 3/18 (16.7%) at, 1 year.
10% (14/120) were &gt;60 at time of starting Ustekinumab, this group had an average of, 1.4 comorbidities compared to, 0.3 in the &lt;, 60 group (p value -0.00001), 7% (8/, 120) patients had had a prior malignancy (Non-melanoma Skin Ca, 4, Solid organ, 2, melanoma, 1, haematological, 1) and, 5 of these were in the &gt;60 group with a median of, 10 years (IQR, 5–11) since being cured and no episodes of recurrence, with, 1 patient developing a malignancy post Ustekinumab.
Adverse events (AEs) were seen in, 5.8% (7/120) of patients and a serious adverse event (SAE) in, 5% (6/120), this included, 4 patients in the &lt;60 age group requiring admission for Intravenous antibiotics vs, 1 in the &gt;, 60 age group (p value, 0.57).

Conclusion
This study contributes to the real-world data being presented regarding Ustekinumab. The efficacy demonstrated in clinical response is comparable to previous studies, the majority of patients having already been treated with two or more biologics. We have demonstrated a favourable safety profile in the over, 60 age group who had a greater number of comorbidities and a higher rate of previous malignancy. With an ageing IBD population the safety and efficacy of Biologics in the older age groups need to be further examined.
P439 Stability of subcutaneous serum IFX (CTP13) levels between two injections and over two successive cycles in patients with Crohn’s disease
Authors: Roblin X , Bastide L , Veyrard P , Berger A E , Paul S 
Published: January 2022

Abstract

Background
Under IFX sc, we do not know if there is a residual level of IFX. The aim of this work was to investigate this point by analyzing the intra-individual variability of the serum level of IFX sc.

Methods
This was an observational, prospective study that included patients with CD undergoing maintenance treatment with IFX sc (120mg every, 14 days). Patients had IFX determinations (i Track, 10; Theradiag (France) at visit, 1 (day, 4 to, 6 after SC injection), visit, 2 (day, 7 to, 9 after sc injection) and visit, 3 (day, 13 to, 14 after sc injection) on two consecutive cycles. The first determinations were made only after, 8 weeks of switching from IV to SC. All patients at inclusion were in clinical remission (CDAI &lt;, 150) with calprotectin levels &lt;, 250 µg/g stool.

Results
20 patients (mean age:, 36 years, sex ratio M/F:, 1, mean duration of IFX IV:, 16 months) were included, i.e. meaning, 120 determinations., 8 patients were treated in combination with thiopurines. Mean residual levels before switch to sc were, 3.9 +/-1.2 µg/mL. Mean intraindividual levels between the two cycles were comparable (Visit, 1: cycle, 1:, 11.1 +/-, 4.4 µg/mL, cycle, 2:, 11.6 +/-, 4.6 µg/mL; p=0.65; Visit, 2: cycle, 1:, 12.0 +/-, 5.1 µg/mL, cycle, 2:, 11.3 +/-4.9 µg/mL; p=0.25; Visit, 3 cycle, 1:, 11.0 +/-4., 7 µg/mL, cycle, 2:, 10.9 +/-, 4.2 µg/mL; p=0.21. Serum IFX sc levels remained stable over the, 14 days between the two SC injections (p=0.36). Mean IFX levels at any dosing time were comparable in patients with and without thiopurines (IFX sc monotherapy: mean:, 11.5 +/-, 5.5 µg/mL versus IFX sc with thiopurines: mean:, 11.8 +/-, 4.6 µg/mL, p=0.54). Finally, residual IFX IV levels before switch did not influence the results of IFX sc serum concentrations (p=NS).

Conclusion
Measure of IFX levels for IFX SC can be proposed at any time between two injections. No residual levels were found. These data are important for our clinical practice.
P467 Therapeutic drug monitoring of biologics in Inflammatory Bowel Disease: Nordic survey on implementation and barriers in clinical practice
Authors: Bjørlykke K , Jahnsen J , Brynskov J , Molander P , Eberhardson M , Davidsdottir L G , Sipponen T , Hjortswang H , Langholz E , Jørgensen K K , Steenholdt C 
Published: January 2022

Abstract

Background
Therapeutic drug monitoring (TDM) is a useful tool to optimise biologic treatments of patients with inflammatory bowel disease (IBD). Albeit broadly recommended by gastrointestinal societies, it is, however, currently unknown how TDM has been adopted and is being used in everyday clinical practice. The aim of the study was to investigate how TDM has been taken up by physicians including barriers for implementation.

Methods
A web-based survey on TDM was distributed to all gastroenterology consultants in the Nordic countries via national gastroenterology- and IBD societies.

Results
Out of 377 physicians responding, 297 handled IBD patients on biologic therapies and were thus eligible for inclusion (NO 118 (40%), DK 86 (29%), SE 50 (17%), FI 33 (11%), IS 10 (3%)). The vast majority were consultant gastroenterologists (n=252, 85%), 152 (51%) were employed at university hospitals, 136 (46%) at community hospitals, and 9 (3%) in private practice. Overall, 257 (87%) used TDM during biologic therapies; 231 (90%) used reactive TDM and 163 (63%) proactive TDM. Common indications were to improve efficacy (70%), aid treatment decisions (62%), improve safety (36%), and improve cost-effectiveness (32%). Notably, Danish physicians used TDM to a significantly lesser extent than all others (58% vs 98%; odds ratio (OR) 0.03 [95%CI 0.01- 0.09], p&lt;0.001); in particular outside the capital region (OR 0.15 [0.05–0.46], p=0.001). Reactive TDM was applied both at primary (74%) and secondary treatment failure (99%) and predominantly for TNF-inhibitors (90–98%) (vedolizumab 63%, ustekinumab 46%). Proactive TDM was used by 80% during maintenance therapy and 56% during induction, and mostly for TNF-inhibitors (79–97%) (vedolizumab 70%, ustekinumab 54%). Proactive TDM was more commonly used in NO, SE, and FI (p&lt;0.001), and by physicians managing &gt;10 IBD patients per week (OR 2.71 [1.34–5.48], p=0.005), but was not associated with employment at university hospital, size of hospital catchment area, or seniority. Main barriers to the use of TDM were lack of guidelines (51%), long response time from the laboratory (49%), lack of knowledge regarding how to use and interpret test results (42%), costs (38%), and currently available evidence (31%). Among physicians using TDM, only 66% reported awareness of TDM guidelines or recommendations.

Conclusion
TDM, and in particular reactive TDM of TNF-inhibitors, has been broadly adopted into clinical practice in the Nordic countries to improve efficacy and assist treatment decisions. Across the Nordic countries, IBD physicians call for improved test response times and, notably, TDM guidelines detailing indications for TDM and interpretation of test results.
P473 Real world experience with the Crohn’s Disease Exclusion Diet (CDED) in a tertiary IBD clinic
Authors: Fliss Isakov N , Anbar R , Cooperstein A , Helbert G , Hirsch A , Ron Y , Thurm T , Maharshak N 
Published: January 2022

Abstract

Background
The Crohn’s Disease Exclusion Diet (CDED) is a whole-food diet designed to reduce exposure to dietary components, hypothesized to negatively affect the microbiome, intestinal barrier, and immune response. In a clinical study in adults with mild-moderate CD (&lt;5 years duration), an inflammatory phenotype involving the terminal ileum, it induced clinical, biochemical and endoscopic disease remission. We aimed to describe our real-world experience with the CDED, in a clinically diverse CD population.

Methods
A retrospective cohort study of CD patients prescribed with the CDED, between 1.2018 and 11.21. Patients’ medical background, medical therapy, nutritional status and clinical disease activity as well as adherence and clinical outcomes were documented from patients’ medical files.

Results
The CDED was recommended to 218 CD patients. Of these, 62 were excluded from the analysis due to lack of medical information (n=11), prior personal experience with the CDED (n=23), patient’s refusal (n=24), and stoma patients (n=4).
The CDED was initiated in 155 patients (age 37.7±16.3, 66% men, disease duration 7.8±9.6), 35.3% had colonic/ileo-colonic disease, 23.7% and 25% had a stricturing and penetrating disease respectively, 27.5% had a history of intestinal resection, 19.9% had extra-intestinal involvement, and 7.7% had a severe endoscopic disease at diet initiation.
Indications for therapy included patient’s will (44.7%), adjunctive therapy (23.7%), bridge with biologic induction (20.4%), rescue therapy (3.9%), exhaustion/contraindication of other advanced therapy options (1.4%), de-escalation of biologics (0.7%), preparation for surgery (0.7%), and others (3.9%). Upon initiation, 67.3% (n=105) had an active disease [Harvey Bradshaw index (HBI) ≥5 / Calprotectin ≥250 g/l] and 32.7% were in remission.
Physician and dietician follow-up at the end of phase 1 was documented in 89 (57.4%) and 74 (47.7%) of patients with an active disease (mean follow-up period 14.6±9.3 weeks).
Fifty-eight percent of patients with dietary follow-up (n=43) were fairly-fully compliant to the CDED.
Clinical response (drop in HBI&gt;2 points) and remission (HBI&lt;5) at the end of phase 1, were achieved by 58.9% (n=62) and 57.5% (n=60) of patients who were treated for an active disease (n=105). Clinical remission rate at the end of phase 1 was lower among patients with higher baseline HBI score (P for trend=0.028), lower dietary adherence (P for trend&lt;0.001) and a surgical history (P=0.033).

Conclusion
The CDED may have efficacy across different clinical scenarios. Adherence is reasonable, and is associated with higher remission rates among patients treated for an active disease.