bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0719 The SAPHIR study: Assessment of Fresenius Kabi adalimumab biosimilar persistence in patients with inflammatory chronic diseases: Descriptive analysis of patients baseline characteristics
Authors: Peyrin-Biroulet L , Bouguen G , Becheur H , Cambon A , Bouhnik Y 
Published: January 2025

Abstract

Background
Biosimilar treatment initiation is based on a shared decision-making process, in which the patient’s acceptability to the treatment plays a major role. Indeed, negative perception of the biosimilar by the patient can generate a nocebo effect, which interferes with treatment results, leading to subjective worsening of the disease or poor tolerability. The SAPHIR study aimed to evaluate baseline patients’ characteristics predictive of biosimilar treatment persistence.

Methods
The SAPHIR study is a prospective, multicentre, observational cohort study. All patients with inflammatory rheumatic diseases and inflammatory bowel diseases were included after initiating treatment with Idacio® (adalimumab biosimilar) and were to be followed over a period of one year with assessments at 1, 6 and 12 months.
We present here the patients baseline characteristics and their acceptability to treatment.

Results
Of the 582 patients enrolled, 18 presented a protocol deviation and were not analysed. The 564 patients analysed were divided into two groups based on the circumstances of the Adalimumab biosimilar prescription: the "initiation" group (n=318) not previously treated with biotherapy and the "switch" group (n=246) previously treated with originator adalimumab. Disease severity was assessed globally on a Likert scale. According to this evaluation, 61% (n=185) of patients in the "initiation" group versus 10% (n=25) in the "switch" group were considered markedly or severely ill.
Baseline data from these patients are summarised in Table 1.
Patients were questioned about chronic treatment in general: 38% (n=61) of patients in the "initiation" group and 13.5% (n=25) in the "switch" group do not know if their medications are effective or even doubt their benefit. The perception of the biosimilar was assessed by a serie of affirmations (self-completion questionnaire on the acceptability of switching to a biosimilar), summarised in Table 2.

Conclusion
Biosimilars still meet with reluctance from patients. This situation seems linked to a lack of information on the concept of biosimilarity. Numerous guidelines have been published to promote and facilitate the transition from biotherapy to its biosimilar. These preliminary results show that difficulties with treatment acceptability also exist and seem more pronounced in patients initiating biological treatment with a biosimilar.
Table 1: Baseline data: BMI, Body Mass Index; SF-12, 12-Items Short Form Survey; HAD Scale, Hospital Anxiety and Depression Scale.

Table 2: Perception of the biosimilar by the patient
P0726 The Moderating Role of Adverse Childhood Experiences in the Relationship between Crohn's Disease Activity and the Development of PTSD Symptoms
Authors: Di Vincenzo F , Spagnolo G , Vecchione M , D'Onofrio A M , Camardese G , Sani G , Gasbarrini A , Cammarota G , Chieffo D P R , Ferrarese D , Scaldaferri F 
Published: January 2025

Abstract

Background
Crohn's disease (CD) is a type of inflammatory bowel disease (IBD) characterized by transmural granulomatous inflammation, skip lesions, and a relapsing-remitting course, potentially affecting the entire gastrointestinal tract. Patients with chronic illness are at an increased risk for traumatic stress because of the medical trauma. Previous evidence suggests that many patients perceive the chronic nature of the disease and related diagnostics and therapeutic procedures as traumatic events. Initial studies on post-traumatic stress (PTS) in patients with IBD have found that approximately one-third of patients may experience significant PTS symptoms, including flashbacks, nightmares, hypervigilance, disrupted sleep, and low mood, potentially leading to the development of post-traumatic stress disorder (PTSD).
This study aims to explore the moderating role of adverse childhood experiences (ACEs) in the link between CD activity and PTSD symptoms.

Methods
In a cross-sectional design, the revised Impact of Event Scale (IES-R) and the ACEs Questionnaire were administered to consecutive CD outpatients at Policlinico A. Gemelli in Rome. Disease activity was assessed with the Harvey-Bradshaw Index (HBI). Data were analyzed using Pearson correlation coefficients and moderated regression models in SPSS (version 27).

Results
A total of 172 CD patients were included in the study, of whom 152 completed the IES and 148 also completed the ACEs questionnaire. Forty-eight patients (31.2%) exhibited a score of 33 or more on the IES-R, suggestive of PTSD. Correlation analyses revealed that ACEs scores correlated significantly with all subscales of the IES-R: intrusion (r=.405, p&lt; .001), avoidance (r=.348, p&lt; .001), and hyperarousal (r= .363, p&lt; .001). Moreover, patients with higher ACEs had significantly more severe disease activity (r= .272, p&lt; .001). Notably, the highest scores of ACEs were observed for the items related to feeling undervalued and ignored by one’s family. Further results from a hierarchical regression analysis demonstrated that the relationship between CD activity and the overall IES- R score was significantly stronger among patients with high ACEs scores (b= .21, p &lt; .001) compared to those with medium (b= .12, p= .005) or low scores (b=.06, p =.291).

Conclusion
Our study revealed that ACEs play a moderating role in the relationship between CD disease activity and the development of PTS symptoms. Patients with higher PTS symptoms and more ACEs are less likely to achieve remission and may require increased use of gastroenterology services. These findings underscore the importance of a psychological assessment to enhance the management of these patients. Intervention trials to mitigate PTS symptoms in patients with IBD are warranted.
P0727 Effectiveness and Safety of ustekinumab in the Treatment of Penetrating Crohn’s Disease: A Prospective Real-World Study
Authors: Wu Y , Huang Z , Deng X , Chao K ,   Yan-Hui WU Zhao-Peng HUANG Xiao-Xia DENG Min-Zhi LIN Zi-Cheng HUANG Xiang GAO Kang CHAO
Published: January 2025

Abstract

Background
Ustekinumab (UST) has been proved to be effective in the treatment of Crohn's disease (CD). However, data on the efficacy of UST in treating CD patients with penetrating complications are limited. The objective of this study was to evaluate the efficacy and safety of UST in the treatment of penetrating CD.

Methods
In this single-center, prospective, observational real-world study, we enrolled patients with penetrating CD who were undergoing UST treatment. The primary endpoint was the rate of transmural healing at week 26 and 52 evaluated by computerized tomography enterography or magnetic resonance enterography. Secondary endpoints included radiologic response rates and surgery-free survival rates at week 26 and 52, as well as surgery-free survival duration and safety. Statistical analysis was conducted using the Kaplan-Meier method.

Results
The study included 134 patients, among whom 26.8% had complex intestinal fistula. Transmural healing rates at week 26 and 52 were 11.9% and 17.8%, respectively. Radiologic response rates were 60% and 50.6% at week 26 and 52. Surgery-free survival rates were 90.5% and 87.1% at week 26 and 52, respectively. After a median follow-up period of 55.57 weeks, 17 patients required abdominal surgery. The median surgery-free survival duration was 164.5 weeks (95% CI 145.6-183.5 weeks). During the follow-up period, only one patient developed erythema, with no serious adverse events reported.

Conclusion
UST demonstrates promising efficacy and safety profiles for treating penetrating CD.
P0728 Interventions for ocular extraintestinal manifestations in inflammatory bowel disease: an umbrella review of systematic reviews
Authors: Estevinho M M , Solitano V , Magro F , Yuan Y , Jairath V 
Published: January 2025

Abstract

Background
A significant proportion of patients with inflammatory bowel disease (IBD) develop extraintestinal manifestations (EIM). Ocular involvement occurs in an estimated 12–25% of ulcerative colitis cases and 25–50% of Crohn’s disease cases, making it the third most common EIM after rheumatological and dermatological manifestations. There is limited information on treatment options for ocular EIM. To address this gap, we reviewed all systematic reviews (SRs) evaluating drug interventions for ocular EIM.

Methods
We searched three databases (MEDLINE, Embase, and the Cochrane Database of Systematic Reviews) from inception to May 2024 to identify SRs addressing therapeutic interventions for ocular EIM. The exclusion criteria ruled out studies that were not systematic reviews, did not focus on patients with IBD, or were unrelated to ocular interventions. Screening, selection, and data extraction were performed independently by two authors, with a third author consulted when necessary. The quality of SRs was assessed using the AMSTAR-2 tool.

Results
Of 1,436 studies, six met the inclusion criteria. The ocular EIMs most commonly reported included uveitis, iritis, scleritis, and episcleritis. The number of studies reporting ocular EIM within each SR varied from two (Guillo, 2021) to 22 (Peyrin-Biroulet, 2017). Therapeutic interventions differed: two SRs evaluated vedolizumab (Zheng, 2024; Chateau, 2019), one focused on ustekinumab (Guillo, 2021), while the others assessed different advanced therapies. Quality assessment using AMSTAR-2 rated the reviews from high to low confidence, with most achieving moderate confidence due to some non-critical weaknesses.
The incidence of new ocular EIM after treatment was 1% for both vedolizumab and ustekinumab in two SRs. For existing EIM, ocular symptoms improved in 55–59% of cases with ustekinumab (data from two SRs). However, there was no consistent evidence supporting vedolizumab for treating established ocular EIM. Anti-tumor necrosis factor (TNF) drugs were evaluated in two SRs, showing benefits for most patients with ocular manifestations without notable differences in the effectiveness among the different anti-TNF agents. No SRs focused on the risk of new ocular EIM after starting anti-TNF therapy.

Conclusion
Infliximab, adalimumab, certolizumab and ustekinumab appear effective for ocular EIM. There is no strong evidence that vedolizumab is effective for treating existing ocular EIM, though it may reduce the occurrence of new EIM. Further research with clear definitions and systematic assessments of ocular manifestations is needed. A multidisciplinary approach remains crucial.

References
Licona Vera E, Betancur Vasquez C, Peinado Acevedo JS, Rivera Bustamante T, Martinez Redondo JM. Ocular Manifestations of Inflammatory Bowel Disease. Cureus. 2023;15(6):e40299
P0730 Inflammatory Bowel Disease Lifestyle Food and Exercise (IBDLiFE) study: a randomized controlled trial to investigate the effectiveness of a personalised diet and physical activity intervention for adults with inactive IBD in Aotearoa, New Zealand
Authors: Yap J , Wall C L , Meredith-Jones K , Iosua E , Osborne H , Schultz M 
Published: January 2025

Abstract

Background
People with inflammatory bowel disease (IBD) are at higher risk of metabolic diseases that may respond to changes in diet and physical activity. Whether these lifestyle changes are possible and effective in IBD is unclear. This study aims to investigate the effectiveness of personalised diet and physical activity advice on metabolic disease risk factors in adults with inactive IBD.

Methods
A randomised controlled trial was conducted at three hospitals in New Zealand (NZ) from May 23 to August 24. Eligible participants (aged &gt;18 years, body mass index (BMI) ≥ 25 kg/m2, low fibre intake (&lt;25g/day), stable medical therapy, and could exercise) were randomised to one of two 6-month interventions: dietitian-delivered generic or personalised physical activity and heart-healthy diet advice. The primary outcome was body fat change and secondary outcomes included disease activity, faecal calprotectin, self-reported physical activity, and dietary intake (3-day food diaries). Multivariable regression models investigated between group differences adjusted for age, sex, and baseline values (significance p&lt;0.05). Dietary intake and physical activity were adjusted for seasonality and disease activity. The study was approved by the NZ Health and Disability Ethics Committee (ref 2022 EXP 13602).

Results
A total of 64 participants were randomised and 51 (80%) completed the 6-month intervention and had complete datasets. Participants were median age 47 (LQ, UQ 37, 55), 59% female, 91% NZ European ethnicity, 61% had Crohn’s disease, 75% had faecal calprotectin &lt; 100µg/g, 80% were non-smokers, and 81% on maintenance medical therapy including 44% on biologics. The intervention group had a non-significant decrease in fat mass (-188g; 95%CI: -1606, 1230) compared to the control group and statistically significant changes in dietary intake: increased fruit (0.5 serves/day; 95%CI: 0.1, 1.0) and dietary fibre (3.1 g/1000kcal/day; 95%CI: 1.1, 5.1), and reduced discretionary food and drink (-1.7 serves/day; 95%CI: -3.0, -0.3) and sodium (-911 mg/day; 95%CI: -1783, -40). Physical activity increased non-significantly by 188 total MET-mins/week (95%CI: -3336, 3711). Disease activity indices and faecal calprotectin did not significantly alter.

Conclusion
Dietitian-delivered personalised compared to generic advice, led to significant changes in dietary intake associated with reduced metabolic disease risk in patients with inactive IBD. However, the lack of significant changes in fat mass between groups is likely due to the absence of increased physical activity or reduced energy intake. Nonetheless, this study shows that adults with inactive IBD can make lifestyle changes without worsening disease activity.
P0731 Analysis of the short-term efficacy and risk factors of ustekinumab combined with surgical intervention in the management of perianal fistulizing Crohn's Disease: a single center real-world result
Authors: Ma K , Li Y , Weng F , Yao Y , Wang C 
Published: January 2025

Abstract

Background
The aim of this study was to evaluate the short-term clinical efficacy and identify potential risk factors for Ustekinumab (UST) in conjunction with surgical intervention among patients diagnosed with perianal fistulizing Crohn's Disease (pfCD), utilizing MRI healing as the gold standard.

Methods
The study was conducted retrospectively from July 2021 to July 2024, including all patients diagnosed with pfCD who underwent surgical intervention combined with UST treatment and completed a 24-week follow-up. The clinical data of patients and perianal fistula characteristics, were collected. The primary efficacy evaluation indicator is the clinical healing rate and MRI healing rate after treatment. The secondary efficacy indicators included the CDAI, PDAI, CRP, ESR, and FC. Additionally, the SES-CD and Van Assche score were utilized, along with Wexner incontinent score, to evaluate effectiveness prior to treatment and at 24 weeks post-treatment. The independent risk factors induced MRI healing after treatment were determined through multivariate analysis using binary logistic regression analysis.

Results
A total of 66 patients were included in this study. According to the Montreal classification, group A1, A2 and A3 consisted of 3 patients (4.5%), 59 patients (89.4%), and 4 patients (6.1%) respectively. In terms of disease location, 26 patients (39.4%) were classified as L1, 9 patients (13.6%) as L2, and 31 patients (47.0%) as L3. Additionally, 50 patients (75.8%) presented with B1 while the remaining 16 patients (24.2%) had B2. Four patients (6.1%) presented with simple anal fistulas, while complex anal fistulas were observed in 62 cases (93.9%). At 24-week follow-up, the clinical healing rate was 95.5% (63/66) with an average healing time of 8.58 ± 4.27 weeks. The MRI healing rate demonstrated a significant outcome of 68.2% (45/66). Additionally, there was a notable reduction in patients' CDAI and PDAI scores, as well as CRP, ESR, FC concentrations, Van Assche scores, SES-CD and Wexner scores at 24-week compared to baseline levels (p &lt; 0.001). The multivariate logistic regression analysis revealed that the presence of perianal abscess (OR = 0.05, 95%CI: 0.004~0.052, p = 0.014) and a high baseline Van Assche score (OR = 0.48, 95%CI: 0.252~0.901, p = 0.023) were identified as independent risk factors for MRI healing in patients with pfCD. Meanwhile, no instances of anal function problems were reported during the follow-up period.

Conclusion
The combination of UST and surgical intervention demonstrates favorable short-term clinical efficacy and safety in the management of patients with pfCD. Notably, the presence of perianal abscess and a high Van Assche score independently contribute to the risk of incomplete MRI healing.
P0738 Apulian Network for Inflammatory Bowel Disease (AN-IBD) safety profile: Pilot data
Authors: Ditonno I , Contaldo A , Dell'Aquila P , Suriano V , Bossa F , Annese M , Perri F , Mazzuoli S , Guglielmi F W , Bringiotti R , Palmisano C M , Pranzo G , Albano F , Neve V , Tonti P , Stasi E , Facciorusso A , Marzo M , Paiano P , Gatti F , Di Lorenzo M P , Fanigliulo L , Panarese A , Allegretta L , Bucci A , Hadad Y , Pisani A , Sacco R , Tursi A , Principi M 
Published: January 2025

Abstract

Background
The Apulian Network for Inflammatory Bowel Disease (AN-IBD) is a prospective observational regional database recently approved by the Ethics Committee in Apulia (Italy), enrolling all IBD patients with an established diagnosis and focusing on the safety and effectiveness of all licensed therapies. We aimed to evaluate the safety profile of IBD therapies registered in patients enrolled in the participating centres and to record the occurring adverse events.

Methods
The AN-IBD involves 19 centres across Apulia, selected based on their capacity to prescribe advanced IBD therapies. In the six months following the ethical approval, we recorded unselected patients in the database and stratified them by disease type, age, sex and type of treatment. The occurrence of infusion reactions (local and systemic), infections, IBD-related hospitalization, need for colectomy, malignancies, thromboembolic events, and laboratory alterations were recorded. Their severity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Results
A total of 420 patients were enrolled, consisting of 251 males (59,76%) and 169 females (40,24%), with a median age of 44 years. Among them, 243 (57,86%) were diagnosed with ulcerative colitis, 156 (37,14%) with Crohn’s disease and 21 (5%) with unclassified colitis. Overall, 341 patients (81,19%) were treated with advanced therapy, including biologic therapy and small molecules. A total of 33 (7,85%) adverse events were recorded comprehensively, and most of them were graded as moderate according to the CTCAE. Twenty-three patients were treated with biologic therapy (70%), seven with small molecules (21%), one with immunomodulators (3%) and two with conventional therapy (6%). The most common adverse events were infusion reactions, with fourteen cases recorded (42%), followed by eight cases of infective complications (24%), predominantly due to cytomegalovirus reactivation. Other recorded adverse events included IBD-related surgery (15%), malignancies (9%) and altered liver enzymes (9%).

Conclusion
These preliminary findings evaluate the real-world prevalence and nature of adverse events among the population enrolled in our newly developed multicentre regional cohort. The establishment of this new database, given the absence of a national registry, will allow for closer monitoring of IBD patients undergoing conventional and advanced therapies and will increase awareness of the safety of these treatments.
P0742 Real-world efficacy and safety of Upadacitinib in IBD patients. Preliminary data from the Apulian Network for Inflammatory Bowel Disease (AN-IBD)
Authors: Bossa F , Principi M B , Marzo M , Stasi E , Mazzuoli S , Pranzo G , Sacco R , Fanigliulo L , Neve V , Tursi A , Rizzi M , Bringiotti R , Bucci A , Allegretta L , Contaldo A , Mastronardi M , De Tullio N , Hadad Y , Annese M , Delll'Aquila P , Palmisano C M , Paiano P , Facciorusso A , Rima R , Guglielmi F W , Sgarro C , Perri F 
Published: January 2025

Abstract

Background
Upadacitinib is a selective Jak-1 inhibitor approved for treating Inflammatory Bowel disease (IBD). Its efficacy and safety have been assessed in pivotal trials. Few real-world experiences of Upadacitinib in IBD patients have been published so far. We aimed to investigate the effectiveness and safety of Upadacitinib in a cohort of IBD patients in clinical practice.

Methods
This multicenter, observational study was performed among the Apulian Network for Inflammatory Bowel Disease (AN-IBD). All consecutive patients with IBD starting Upadacitinib from its introduction were included.

Results
We enrolled 68 patients with Ulcerative Colitis (UC) and 9 with Crohn’s Disease (CD. The mean age of the patients was 40.2 ± 14.2 (range 19 - 74) and 45.3 ± 11.8 (range 26 - 62) for UC and CD, respectively. Regarding gender, 51 patients were male (66.2%). The mean disease duration was 11.8 ± 8.4 (range 3 - 31) for UC patients and 11.4 ± 8.6 (range 2 - 26) for CD patients. As for disease extension, patients with UC were divided into three groups: pancolitis (n=31, 45.5%), distal colitis (n=33, 48.5%), and proctitis (n=4, 6%). In CD patients, 5 had ileitis (55.6%), 2 colitis (22%), 1 ileocolitis (11.2%) and 1 jejunoileitis (11.2%). The response and remission rates after 8 weeks were 39% and 52% in UC patients. The response and remission rates after 12 weeks were 66% and 16% in CD patients. The primary non-response rate was 9.5% and 16% in UC and CD, respectively. Regarding safety, two cases of herpes reactivation were observed (1 herpes zoster in a non-vaccinated patient, and 1 herpes simplex infection, both managed with antiviral therapy). One patient experienced mild anemia, rapidly corrected after switching to 15 mg/day. One non-responder underwent an urgent colectomy.

Conclusion
These preliminary data confirm the efficacy of upatacitinib in inducing responses in IBD patients (both UC and CD) with a very low rate of primary failure. No new safety issues were identified.