bluuebunny/crossref_metadata_2025_split huggingface dataset:
P883 Impaired long-term quantitative cellular response to SARS-COV-2 vaccine in thiopurine-treated IBD patients
Authors: Mayorga Ayala L F , Herrera-deGuise C , Esperalba J , Martinez-Gomez X , Céspedes Martinez E , Serra Ruiz X , Robles V , Lastiri E , Perez Z , Oller E , Fernandez-Naval C , Martinez-Gallo M , Casellas F , Borruel N 
Published: January 2024

Abstract

Background
SARS-CoV-2 mRNA vaccine induces a robust immune response in most patients with inflammatory bowel disease (IBD). However, humoral short-term response appears to be reduced in patients receiving anti-TNF agents or tofacitinib, even after booster doses. Data on long-term immune response is limited. We aimed to assess short and long-term humoral and T-cell response to SARS-CoV-2 mRNA vaccine in IBD patients receiving anti-TNF and/or thiopurines.

Methods
A prospective, longitudinal study was carried out in IBD patients receiving thiopurines, anti-TNF mono, or combo therapy. Patients had received between 2 and 4 doses of mRNA SARS-CoV-2 vaccine. Cellular and humoral response to the vaccine was assessed by serum interferon-gamma release assay (IGRA) and antibody SARS-CoV-2, respectively. We defined short-term response as humoral and T-cell response six weeks after the second vaccine and long-term response 6 to 12 months after that. Primary outcome was to determine if T-cell immune response differs in IBD patients receiving anti-TNF versus thiopurines.

Results
We recruited 148 IBD patients, 57 treated with anti-TNF monotherapy, 53 with anti-TNF combo, and 38 with thiopurines. Short-term T-cell and humoral responses were similar between the three groups. However, long-term T-cell concentration was reduced in thiopurine-treated (median 0.7 UI/mL [0.26-2.35]; p&lt;0.05) and anti-TNF-combo-treated patients (median 0.4 UI/mL [0.22-1.13]; p&lt;0.01) when compared to anti-TNF monotherapy (median 2.2 UI/mL [1-4.15]). Multivariate analysis showed that anti-TNF monotherapy (-0.93, p&lt;0.05) and decreased time between vaccination and T-cell response measurement (0.04 [.00005-.078] p=0.05) were associated with increased T-cell concentration long-term when compared to the other groups of patients.

Conclusion
We found a diminished long-term quantitative cellular response in our cohort of IBD patients vaccinated for SARS-CoV-2 treated with thiopurines or combo therapy compared with anti-TNF monotherapy. These findings highlight the recommendation to receive booster doses in IBD patients, specially those receiving thiopurines.
P965 Ulcerative proctitis treated with biologics: is it too hard to treat?
Authors: Bertani L , Tricò D , Barberio B , Bretto E , Ceccarelli L , Calabrese F , Pasta A , Bertin L , Fabiana Z , Maniero D , Frara S , De Bernardi A , Bodini G , Ribaldone D G , Costa F , Savarino E V 
Published: January 2024

Abstract

Background
Patients with ulcerative proctitis are widely considered a challenging population because the reported reduced response rate to conventional medical treatment. On the other hand, data on the role of biological therapies in this specific cohort are currently scarce

Methods
We retrospectively evaluated all patients with proctitis (defined as the mucosal inflammation of only the rectum with ulcerative colitis confirmed by histology) treated with biologics (infliximab, adalimumab, vedolizumab -VDZ-, ustekinumab -UST) and tofacitinib (TOFA) at four referral centers in the last 5 years. All patients were treated with concomitant topical mesalamine. We included in this study only patients who underwent colonoscopy at baseline and after 52 weeks of treatment, in order to evaluate therapeutic response in terms of mucosal healing (defined as a Mayo Endoscopic Score -MES- &lt;2), besides that clinical remission (defined as a Partial Mayo Score -PMS- &lt;2 without oral or topical corticosteroid therapy). We collect clinical and demographic data, as well as fecal calprotectin (FC) and C-Reactive Protein (CRP) levels at baseline and after the induction of therapy

Results
Among 64 patients enrolled (age 50.8±16.5 years, 29 [45.3%] women), 33 (51.6%) were treated with anti-TNF), 15 with VDZ, 13 with UST, and 3 with TOFA. Globally, 51 (79.7%) patients achieved clinical remission and 37 (57.8%) patients achieved endoscopic remission at 52 weeks. There were no group differences in age, sex, BMI, disease duration, PMS, MES, drug, or baseline CRP levels between patients achieving or not either clinical or endoscopic remission. Baseline calprotectin levels were lower in patients who achieved endoscopic remission (median [IQ range] 297 [158, 475] versus 442 [230, 1545] µg/mL, p=0.036), but not in those who achieved clinical remission. After the induction phase, lower calprotectin levels were observed in patients achieving clinical (46 [15, 166] versus 553 [72, 1649] µg/mL, p=0.001) and endoscopic remission (38 [15, 112] versus 328 [52, 2171] µg/mL, p=0.0002), compared with non-responders. The effects of post-induction calprotectin levels on clinical remission (β= -0.001, p=0.020) and endoscopic remission (β= -0.007, p=0.006) remained significant in multivariable models adjusted for age, sex, BMI, disease duration, and biological treatment. A cut point of 200 µg/mL post-induction was identified to predict endoscopic remission (sensitivity 92%, specificity 64%, ROC AUC 0.781)

Conclusion
High rates of clinical and endoscopic remission with biological therapies could be achieved in patients with ulcerative proctitis. Fecal calprotectin levels after the induction of biological therapies seem to predict the therapeutic response in patients with ulcerative proctitis
P970 Iatrogenic adrenal insufficiency on discontinuation of glucocorticoid treatment in children and adolescent patients with inflammatory bowel disease: to screen or not to screen?
Authors: Chadokufa S N , Huggett B , Lashley C , Buckingham R , Sawney T , Kiparissi F , Gaynor E , Huggett Bonita 
Published: January 2024

Abstract

Background
Glucocorticoids are a mainstay of inflammatory bowel disease (IBD) treatment, with oral tapering courses frequently used to induce remission or limit flares. Iatrogenic adrenal insufficiency (AI), due to suppression of the hypothalamic-pituitary-adrenal (HPA) axis is an established side effect of exogenous glucocorticoids. The rate of AI in this population is unknown. There is no standard guidance to suggest routine screening in paediatric IBD (pIBD). This study aimed to better understand the rates of AI with a screening and management protocol developed for pIBD patients given glucocorticoid therapy (GT)

Methods
All patients with IBD under 18 years treated with GT (prednisolone) for 3 weeks or longer from March 2022 to August 2023 were identified. Patients on other GT were excluded. Patients were screened for AI by serum early morning cortisol (Vitros Ortho Clinical Diagnostics immunoassay) and ACTH, and if indicated underwent standard short synacthen(SST) testing. Adrenal axis function was divided into normal allowing cessation of GT, or impaired response requiring hydrocortisone maintenance therapy (see figure1). A serum morning cortisol &gt;250nmol/l indicated a normal adrenal axis; whereas dynamic adrenal axis testing was recommended for cortisol of 175-249 nmol/l. Those with cortisol &lt;175nmol were diagnosed with AI and started on maintenance hydrocortisone. Repeat testing with SST was performed 3 monthly to reassess the adrenal-axis. Patients with an abnormal SST at the 6-month mark were referred to endocrinology

Results
14 subjects were identified (8 male),7 with Ulcerative colitis, 4 with Crohn’s disease, 1 with IBD-U,2 with early-onset IBD. Median age at diagnosis was 10 years (range 8 months -14 years). Duration of GT was for an average 3 months (range 6 - 16 weeks). 42%(n=6) initiated GT with IV methylprednisolone before switching to 2mg/kg oral prednisolone (maximum 40mg) for 2 weeks, weaning 5mg every week. At the end of initial GT, morning cortisol was deficient in 42% (n=6), insufficient in 35% (n=5) requiring SST. Of those undergoing a SST at this stage, 60% (n=3) had a normal response, 40% (n=2) demonstrating AI. Overall, 57% (n=8) had significant AI at the end of initial treatment. Repeat adrenal axis testing was offered at 3 months (5 of 8) and at 6 months (4 of 4). AI was noted in 100% and 75% at 3 and 6-month respectively. No child suffered an adrenal crisis during the study period

Conclusion
AI following glucocorticoid therapy is common in this small cohort. Screening for AI should be considered in pIBD patients receiving conventional doses of glucocorticoids longer than 3 weeks, with appropriate advice given. The incidence and risks of iatrogenic adrenal insufficiency (AI) requires further investigation
P973 Real-world data on the effectiveness on IBD of anti-IL23 drugs prescribed for psoriasis indication
Authors: Ribaldone D G , Palumbo A , Cariti C , Susca S , Merli M , Saracco G M , Quaglino P , Dapavo P , Vernero M 
Published: January 2024

Abstract

Background
There is a significant association between psoriasis and IBD, which share the pathogenic role of IL-23. In the dermatological field, drugs targeting the p19 subunit of IL-23, such as risankizumab, guselkumab, and tildrakizumab, have been approved for the treatment of moderate to severe psoriasis. However, there are still no real-life data on the efficacy and safety profile of IL-23 inhibitors in patients with IBD.

Methods
A prospective, single center observational study was conducted on patients with IBD and psoriasis from April 2021 to March 2023 at the gastroenterological-dermatological outpatient clinic at “Città della Salute e della Scienza of Turin”, Italy. Patients received a dermatological indication to start drug therapy with IL-23 inhibitors according to the dermatological dosing schedule. They were treated either with guselkumab subcutaneously at a dose of 100 mg every 8 weeks, or with risankizumab subcutaneously at a dose of 150 mg every 12 weeks, or with tildrakizumab 100 mg every 12 weeks subcutaneously. Objectives of this study included evaluating the achievement of clinical remission at 3, 6, and 12 months, defined as disease activity with Harvey-Bradshaw Index (HBI) &lt; of 5 in CD and pMAYO &lt; of 2 in UC.

Results
At 3 months after the start of drug treatment, clinical remission was achieved by 73.3% of patients (p=0.006). This number also remained almost constant at 6 (62.4%, p=0.008) and 12 months (60.3%, p=0.04). In addition, there was a statistically superior steroid-free clinical remission compared to T0 at 3 (15.3% vs 73.3%, p=0.006) and 6 months (7.1% vs 54.1%, p=0.04). No major side effects were reported. Two cases of arthralgias (11.8%) and one case of fever with chills (5.9%) were reported. IL-23 inhibitors appear to be effective in maintaining the steroid-free clinical remission. In addition, there was a reduction in fecal calprotectin values to a median value at 6 months of 81.0 (95%IC= 28.2-249.8; p=0.03) from a median value at T0 of 343.1 (95%IC= 44.8-869.7). The maintenance rate of IL-23 inhibitors therapy at the end of follow-up was 75.8%.

Conclusion
In this study risankizumab, guselkumab, and tildrakizumab appear to be effective in inducing clinical remission and steroid-free clinical remission in patients with IBD. In addition, they appear to be effective in maintaining steroid-free clinical remission. IL-23 inhibitors demonstrated a good safety profile in patients with IBD. Despite the limitations of the study with the need to publish further real-world data on a larger scale and with higher dosing of IL-23 inhibitors, the results obtained are promising as they, for the first time, provide real-life support for the clinical potential of these drugs as treatment for IBD in addition to psoriasis.
P977 Combined F18-FDG-PET-MRI-imaging can predict clinical remission in small bowel Crohn’s disease
Authors: Mattila J , Kallio J , Nuutila P , Koffert J 
Published: January 2024

Abstract

Background
Diagnostics and follow-up of small bowel Crohn’s disease (CD) can be difficult. Combined PET-MRI enterography (MRE) can be used to evaluate intestinal inflammation. Lack of standardized methods and diagnostic thresholds has limited its clinical use in diagnostics and monitoring of small bowel CD. There is no previous data on the use of PET-MRI in follow-up of small bowel CD.

Methods
34 patients with suspected CD in small bowel were recruited from Turku University Hospital’s outpatient clinic. A static PET-MRE was obtained with [18F]-FDG (fluorodeoxyglucose) tracer. CD diagnosis was confirmed with small bowel capsule endoscopy. Patients diagnosed with CD were started with appropriate treatment chosen by clinicians. Endoscopic findings including histopathology, laboratory results (Hb, CRP, serum albumin (Alb) and fecal calprotectin (FC)) and medication data were collected. Patients diagnosed with CD (N=16) went through control PET-MRE median 105 days after initial imaging. Highest SUVmax (standardized uptake value) in small intestine was measured and MRE-images with diffusion weighted imaging (DWI) were analyzed by an experienced abdominal radiologist and severity of inflammation was graded from 1-4. Hb, CRP, Alb and FC were measured from the patients at the time of imaging.

Results
Median SUVmax was significantly lower after three months of medical treatment (3.2 vs. 2.1) (p=0.016). FC was significantly lower at the time of control imaging (p=0.030) (median 725 ug/g vs. 141 ug/g). 10 patients had FC &lt;250 ug/g at the time of control imaging. Using this as a cut- off for clinical response, ROC-curve showed AUC 0.73 for SUVmax and AUC 0.65 for MRE-grading. Sensitivity and specificity were highest at SUVmax 2.4 (83% and 80%).

Conclusion
Decreased SUVmax measured after starting CD medication seems to predict clinical remission and a cut-off level 2.4 could be used in diagnostics. Diagnostic yield was higher for SUVmax compared to MRE-grading. Here we have shown for the first time that PET-MRE can be used for disease activity monitoring in small bowel CD.
P1001 Predictive factors of colectomy in patients admitted with Acute Severe Ulcerative Colitis
Authors: Karpavičiūtė V , Kiudelis G , Kupčinskas J , Kupčinskas L 
Published: January 2024

Abstract

Background
Acute severe ulcerative colitis (ASUC) is a life-threatening condition which requires quick decision making and urgent treatment. To facilitate this process, it is essential to identify patients at a high risk of emergency colectomy. The aim of this study is to identify predictors for emergency colectomy in patients with ASUC.

Methods
A retrospective study of 121 patients admitted with ASUC to a single gastroenterology centre between 2010 and 2020 was performed. Clinical and demographic data, laboratory and endoscopic examinations results were analysed as potential predictors of colectomy. Albumin and C-reactive protein (CRP) levels were recorded at baseline and at the 3rd day after intravenous steroids (IVS) initiation.

Results
119 patients initially received IVS, while 2 patients with suspected intestinal perforation underwent emergency colectomy on the first day. 64 (53%) were women, with a median age of all patients of 33 (IQR 27-49) yrs. 15 (12.4%) patients admitted with ASUC underwent colectomy, while mortality rate during hospitalization was 1.7%. During the entire follow-up period, with a median duration of 46.5 months (23-88.25), colectomy was performed in 19 (15.7%) patients. Overall, in the study group, colectomy rate at 1 month, 3 months and 2 years were 12.4%, 12.4%, and 14.0%, respectively. Assessing further outcomes after colectomy, during the follow-up period, 13 (68.4%) achieved clinical remission, 1 died during the operation, and 5 (26.3%) patients still have an active course of the disease requiring immunosuppressive treatment.
When comparing patients in the colectomy group (n=13) with patients who avoided colectomy during this hospitalization (n=105), no significant differences were found in age, sex, duration of illness, body mass index, endoscopic activity, the use of prednisolone or azathioprine prior to admission or previous treatment with biologics. The presence of cytomegalovirus and Clostridium difficile infection was also not associated with a higher risk of colectomy. Significant differences between the groups were found comparing the laboratory findings: the strongest predictor of colectomy was the CRP/albumin ratio at day 3 after IVS initiation (median value was 1.26 (0,81-3,26) in colectomy group vs. 0,64 (0,25-1,36) in non-colectomy group, p&lt;0.001). The difference was also observed when comparing albumin (median 26 (24-28) vs. 29 (27-32), p=0.012) and CRP (median 33 (25-83) vs. 16 (8-37), p=0.003) levels separately on the 3rd day, while at baseline there was no significant differences in laboratory findings.

Conclusion
A low serum albumin level, higher CRP and CRP/albumin ratio are predictive factors of emergency colectomy in ASUC patients.
P1010 Guselkumab improves abdominal pain and bowel urgency symptoms in patients with moderately to severely active ulcerative colitis: Results from the phase 3 QUASAR induction study
Authors: Rubin D , Panés J , Feagan B , Yarandi S , Huang K H , Germinaro M , Han C , Miao Y , Zhang H , Qiu Y , Klopocka M , Duvall G , Lichtenstein G , Hisamatsu T , Bressler B , Peyrin-Biroulet L 
Published: January 2024

Abstract

Background
Abdominal pain and bowel urgency are prevalent, burdensome symptoms experienced by patients (pts) with ulcerative colitis (UC) that impact daily life, including social activities. In this study, we use data from the Phase 3 QUASAR Induction Study to assess efficacy of guselkumab (GUS) on abdominal pain, bowel urgency, and the impact of bowel urgency on pts’ lives.

Methods
Pts were randomized 3:2 to receive IV GUS 200mg or placebo (PBO) at Weeks (Wks) 0, 4, and 8. Abdominal pain and bowel urgency were evaluated at baseline and Wk12 using items from the Inflammatory Bowel Disease Questionnaire, where pts rated trouble with abdominal pain, symptoms of bowel urgency, and the impact of bowel urgency over the past 2 wks using 7-point scales (1=all of the time to 7=none of the time). A ≥2 point increase from baseline was clinically meaningful improvement. All analyses were prespecified but not multiplicity controlled; all p-values are nominal.

Results
At baseline, percentages of pts with abdominal pain (GUS 77.7% and PBO 77.9%), symptoms of bowel urgency (GUS 86.0% and PBO 83.2%), and impact of bowel urgency (GUS 70.8% and PBO 70.4%) at least a little of the time (score ≤5) were similar between groups. GUS-treated pts showed greater improvements at Wk12 in these outcomes compared with PBO (Table 1). For abdominal pain, 52.0% of GUS-treated pts had clinically meaningful improvements from baseline at Wk12 vs 33.0% in the PBO group (p&lt;0.001), and 21.1% vs 12.3%, respectively, of those with abdominal pain at baseline had resolution at Wk12 (p=0.004; Fig. 1A). For symptoms of bowel urgency, 58.6% vs 33.0%, respectively, had clinically meaningful improvements (p&lt;0.001; Fig. 1B), and 24.0% vs 9.8%, respectively, of those with symptoms of bowel urgency at baseline had resolution at Wk12 (p&lt;0.001). Similarly, 57.7% vs 33.0%, respectively, had clinically meaningful improvements in the impact of bowel urgency (p&lt;0.001; Fig. 1B), and 32.4% vs 13.1%, respectively, of those impacted at baseline had resolution at Wk12 (p&lt;0.001). Symptoms and impact of bowel urgency were combined into a bowel urgency score; of pts with symptoms or impact scores ≤6 at baseline, 19.7% versus 8.2%, respectively, had resolution of both at Wk12 (p&lt;0.001; Fig. 1B).

Conclusion
Pts receiving GUS showed clinically meaningful improvements in health-related quality of life measures related to abdominal pain and bowel urgency, including both the symptoms of bowel urgency and impact on pts’ lives.
P1030 Inflammatory Bowel Disease helpline contact trends in a real-world Australasian cohort: Crohn’s Colitis Cure (CCC) data insight’s program
Authors: Pipicella J L , Wilson W , Ghaly S , Antoniades S , Kate L , Grafton R , Ng W , Sechi A , Somes K , Arnold K , Connor S J , Andrews J M 
Published: January 2024

Abstract

Background
For optimal outcomes, Inflammatory Bowel Disease (IBD) necessitates lifelong engagement in care. Specialized-IBD-nurse-led helplines improve access to care and reduce associated costs1,2. Despite this evidence, IBD nurses and helplines receive variable funding and little is known about their use across care sites. We therefore analysed IBD-helpline usage in a large, multi-site real-world Australasian cohort.

Methods
Crohn’s Colitis Care (CCCare), is a cloud-based IBD-specific electronic medical record used in Australia and New Zealand. It includes a "Helpline" tab to support helpline encounter documentation during the point of contact. All entered data feed into an associated, de-identified clinical quality registry (CQR). Helpline-associated data fields, including contact reason and type, were extracted from CCCare’s CQR in November 2023. Data from 6 large adult care sites across Australia and New Zealand were analysed.

Results
In 2022, a total of 6,717 helpline encounters were documented. There was a roughly equal split in contact type; phone accounting for 50.9% (n=3,416) and email for 49.1% (n=3301). The most common reasons for contact were related to medications (n=2,577; 38.4%), investigations (n=1,719; 25.6%) and clinical (n=1,060; 15.8%).
More encounters were seen in 2023 (to date of data extract), with 7,540 helpline entries to date (Figure 1). In 2023, the most common form of patient contact was email (70.3%), with phone contact accounting for only (29.8%). The most common reasons for contact were again related to medications (n=2,577; 31.1%), investigations (n=1,162; 22.0%) and clinical (n=1,439; 19.1%). In both years, helpline activity was lowest in January and February, perhaps corresponding to the Holiday season (southern hemisphere summer).

Conclusion
A number of helpline entries were recorded across these 2 years, with activity lowest each summer. The data show a shift in the predominant mode of contact from phone to email in 2023, reflecting evolving communication preferences and making scheduling of helpline support easier.
1 - Nicolaides S, Vasudevan A, Van Langenberg D. Inflammatory Bowel Disease Helpline Reduces Subsequent Inpatient Admission Rates. J Crohns Colitis. 2020 Feb 10;14(2):281. doi: 10.1093/ecco-jcc/jjz141. PMID: 31374121.
2 - Karimi N, Sechi AJ, Harb M, Sawyer E, Williams AJ, Ng W, Connor SJ. The effect of a nurse-led advice line and virtual clinic on inflammatory bowel disease service delivery: an Australian study. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e771-e776. doi: 10.1097/MEG.0000000000002249. PMID: 34402467.