bluuebunny/crossref_metadata_2025_split huggingface dataset:
P1070 Comaparison of Effectiveness and Perisitence Anti-TNF drugs on Perianal Fistulizing Crohn’s Disease: A Single Tertiary IBD Referral Center Experience
Authors: Koç Ö , Acehan M F , Yılmaz V , Guvenir S T , Toruner M 
Published: January 2025

Abstract

Background
Perianal Crohn’s disease (CD) is a debilitating and often challenging manifestation of Crohn’s disease that involves the formation of fistulas, abscesses, and other inflammatory lesions around the anus and perineal area. It is associated with significant morbidity, including pain, recurrent infections, and impairment of daily activities. Treatment of perianal CD is complex, requiring a multidisciplinary approach to control disease activity, promote healing, and preserve anal function. Anti-TNF (tumor necrosis factor) biologic agents, such as infliximab and adalimumab, have become a mainstay in the management of perianal Crohn’s disease. However, there is still a debate which anti-TNF agents acts better than other in this subset of patients. Here in this study, we aimed to evaluate the compare the efficacy and persistence of two Anti-TNF agents in perianal Crohn’s disease.

Methods
This was a single center, retrospective cohort analysis of patients with Crohn’s disease either received adalimumab or infliximab as a first line biologic treatment. A total of 396 patients were included to this analysis. Demographic information such as gender, age, Montreal classification, smoking and prior medications were noted from patients electronic medical records. Weighted Kaplan-Meier and Cox models were used to assess the outcomes.

Results
Out of 446 Crohn’s disease patients, 128 patients had perianal Crohn’s disease. Gender, smoking, extraintestinal manifestations presence and family history were not different between patients with and without perianal disease. However, in perianal disease group there was more concomitant immunomodulator use than in patients with no perianal involvement (61.5% vs 49.4%, p&lt;0.05). Anti-TNF drug persistence was significantly higher in patients without perianal involvement when compared to patients with with perianal involvement (Figure 1). There was no significant difference in drug persistence rates in perianal Crohn’s disease between infliximab and adalimumab treatment (Figure 2). The concomitant use of immunomodulator drugs did not make any impact.

Conclusion
In Crohn’s disease patients, anti-TNF medication persistence rates was observed to be significantly lower in those with perianal involvement. However, which anti-TNF agent was chosen as first line biologic did not change medication persistence rates. Concomitant thiopurine use did not make any impact on the results.
P1073 Clinical characteristics and outcomes of patients with Inflammatory Bowel Disease under long term (&gt;10years) anti-TNFa treatment
Authors: Orfanoudaki E , Foteinogiannopoulou K , Theodoraki E , Drygiannakis I , Panayiotou S , Papatzelou I , Koutroubakis I 
Published: January 2025

Abstract

Background
There is limited information in the literature regarding long term effectiveness and safety of anti-TNFa agents in patients with Inflammatory Bowel Disease (IBD). We aimed to study the effectiveness and safety of anti-TNFa agents in IBD patients receiving this treatment beyond 10 years .

Methods
Consecutive IBD patients under anti-TNFa treatment &gt;10 years were prospectively studied. Demographic and clinical characteristics as well as treatment details and outcomes were recorded based on an updated IBD registry. Outcomes included need for treatment optimization [dose escalation or immunosuppressant (IMM) addition], disease related hospitalizations and surgeries, serious infections and malignancies. Drug survival of anti-TNF treatment &gt;10 years was assessed (at 13 and 15 years).

Results
Out of 395 patients being initiated with any anti-TNFa in our department, 56 with at least 10 years of anti-TNFa use [males 32(57%), mean age (±SD) 53.3(±13) years, mean disease duration (±SD) 22.8 (±1.15) years were included. Patients were 82%(46/56) with CD, mean duration of anti-TNFa use (±SD) 162 (±32.93) months, 39 (70%) under infliximab, 17 under adalimumab, while anti-TNFa represented the first biologic in 88% of them. More than half of the patients [54%(30/56)] were under combination treatment with IMM (24 azathioprine, 6 methotrexate) and 45% (25/56) needed dose escalation. During follow up 75% (42/56) remained on the index anti-TNFa, precisely 84% (31/37) at 13 and 55% (16/29) at 15 years after drug initiation respectively (figure 1). Main causes of discontinuation were loss of response (8/14), patient preference 1, malignancy 2, osteonecrosis 1, death of other cause 1 and deep remission 1. During follow up, a total of 30 disease related hospitalizations in 18 patients, 12 serious infections, 6 malignancies (non Hodgkin lymphoma of the liver, prostate carcinoma, thyroid gland carcinoma, hepatocellular carcinoma and two cases of non melanoma skin cancer) and 4 disease related operations were recorded.

Conclusion
More than half of the patients under long-term anti-TNFa treatment (&gt;10 years) continue to receive the agent for an additional 5 years. Rates of serious infections and malignancies are no negligible and close monitoring is needed in these patients.
P1076 Improvement of Work Productivity and Activity Impairment (WPAI) in patients with moderate to severe UC using Biologics therapy; the MOSAIK cohort study
Authors: Seong G , Park Y , Lee K M , Jung S A , Park Y S 
Published: January 2025

Abstract

Background
The patients with ulcerative colitis (UC) can have low quality of life and their work productivity can be also impaired. The aim of this study is to investigate the work productivity and activity impairment (WPAI) of moderate to severe UC patients with biologics treatment, using the MOSAIK cohort (ClinicalTrials.gov: NCT02229344).

Methods
In this cohort, we enrolled patients with moderate to severe UC diagnosed for the first time and collected their WPAI questionnaires annually from the time of diagnosis. WPAI questionnaires scored overall work impairment and social activity impairment from 0 to 10. We compared the scores between the patients treated with biologics and without biologics.

Results
In a total 346 patients, 69 (19.9%) patients started biologics during 5 years of observation period. 43 (12.43%) patients started biologics within 1 year from diagnosis. At baseline, mean score of overall work impairment (10 points scale) in biologics group was higher than that of non-biologics group (4.8 and 3.8, respectively). During the treatment, both groups showed numerical improvement of work productivity and social activity. At 1 year, the difference in scores of work productivity impairment between the two groups decreased to 2.6 and 1.8, respectively. Finally at 5 year, the scores of work productivity impairment were similar in the biologics and non-biologics group (1.5 and 1.4, respectively).

Conclusion
In moderate to severe UC, the patients receiving biologics due to their high disease activity can experience impaired work productivity. However, work productivity and social activity can be improved in biologics group as much as in the non-biologics group. Therefore, it is important to start biologics timely to control the disease activity and eventually restore the patients’ daily work and life.

References
1.A new opportunity for innovative inflammatory bowel disease research: the moderate-to-severe ulcerative colitis in Korea (MOSAIK) cohort study. Intest Res. 2019;17(1):1-5. Published online January 25, 2019
P1077 Early detection of non-response to non-anti-TNF treatment in Inflammatory Bowel Disease patients using neutrophil-to-lymphocyte ratio as a biomarker
Authors: Rellou S , Kordalis L , Spyrantis A , Lamprou S , Efstathiou S , Pagoni A , Manou D , Sdonas T , Tasovasili A 
Published: January 2025

Abstract

Background
The neutrophil-to-lymphocyte ratio (NLR) has been proposed as a potential marker of subclinical inflammation. Previous studies suggest NLR may predict therapeutic response to anti-tumor necrosis factor (anti-TNF) drugs1,2. However, there is a lack of published data investigating the role of NLR as a predictor for non-anti-TNF treatments.

Methods
In this retrospective analysis, medical records of 55 patients followed in the inflammatory bowel disease (IBD) outpatient department from January 1, 2020, to July 1, 2024, were reviewed. All patients initiated non-anti-TNF biologic treatment during this period. NLR was measured at week 4 of treatment, and non-response (NR) was assessed at week 16. Patients were divided into two groups: Group A (n = 11)/non-responders and Group B (n = 44)/responders. Statistical analysis of NLR measurements was performed using R. Logistic regression was conducted to evaluate the relationship between NR and ln(NLR).

Results
The study included 55 IBD patients (27 with ulcerative colitis [UC] and 28 with Crohn’s disease [CD]), with a mean age of 49.81 years. The cohort comprised 23 females and 32 males. Treatment distribution was as follows: ustekinumab (n = 26), vedolizumab (n = 22), upadacitinib (n = 6) and tofacitinib (n = 1).The non-parametric Wilcoxon test revealed statistically significant differences in median NLR between Group A and Group B (P = 0.01464 &lt; 0.05). Logistic regression demonstrated a significant relationship between NR and ln(NLR) (P = 0.024844 &lt; 0.05). The ROC curve analysis yielded an area under the curve (AUC) of 0.7407, with a threshold achieving a sensitivity of 0.9091 and a specificity of 0.5227.

Conclusion
NLR shows promise as a non-invasive, accessible, and cost-effective biomarker for the early detection of non-response to non-anti-TNF biologic therapy in IBD patients.

References
1.Langley BO, Guedry SE, Goldenberg JZ, Hanes DA, Beardsley JA, Ryan JJ. Inflammatory Bowel Disease and Neutrophil-Lymphocyte Ratio: A Systematic Scoping Review. J Clin Med. 2021;10(18):4219. Published 2021 Sep 17. doi:10.3390/jcm10184219
2.Qian G, Hongxia D, Jin LI. Nan Fang Yi Ke Da Xue Xue Bao. 2020;40(4):453-458. doi:10.12122/j.issn.1673-4254.2020.04.01
P1084 Safety of tofacitinib and upadacitinib compared to other advanced therapies in ulcerative colitis: a large real-world comparison
Authors: Fiorino G , Allocca M , D’Amico F , Rusconi F , Hernandez G , Zilli A , Parigi T , Furfaro F , Cosintino R , Faggiani R , Jairath V , Peyrin-Biroulet L , Danese S 
Published: January 2025

Abstract

Background
Whether adverse events of special interest[1] related to JAK inhibitors (JAKi) are a concern compared to other drugs used in ulcerative colitis (UC) needs investigation.
We aimed to assess and compare the frequency of adverse events of special interest by JAKi within the class, and with other advanced therapies, on a large real-world population of UC patients.

Methods
This was a non-interventional, retrospective study conducted with data obtained from TriNetX from patients with diagnosis of adult UC, exposed to advanced therapies (range 1-1095 days). The final cohort included 866 patients over 444,424 UC patients available in the database who matched the query criteria.
Adverse events (any), herpes zoster, cardiovascular events, thromboembolic events, cancer (any), non-melanoma skin cancer were investigated. We compared each JAKi with TNF, IL-23 antagonists, and vedolizumab, and within the class by survival analyses and log-rank test. Propensity score matching and adjustment for confounders, such as age, sex, first or second line advanced therapy, smoking habit and other known baseline risk factors, was done. Statistical significance was set as a p value &lt; 0.05.

Results
Only tofacitinib and upadacitinib were included, as data on filgotinib were not available. Tofacitinib was associated with statistically significant lower rates of thromboembolic events than anti-TNFs (HR 0.61, 95% CI 0.38-098, p=0.04), and lower rates of cancer than vedolizumab (HR 0.63, 95% CI 0.41-0.96, p=0.03), but higher rates of herpes zoster than anti-IL23 (p=0.001). Upadacitinib showed lower rates of thromboembolic events (p=0.001), but higher rates of herpes zoster reactivation than IL-23 (p=0.001). Similar safety profile was found between tofacitinib and upadacitinib when they were directly compared.

Conclusion
Anti-JAK show a similar safety profile than all the other drug classes used in UC. Herpes zoster infection/reactivation remains the only adverse event of note for both JAKi.

References
1.European Medicine Agency. EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders. 2022 [cited 2024 Jun 12]; Available from: https://www.ema.europa.eu/en/news/ema-recommends-measures-minimise-risk-serious-side-effects-janus-kinase-inhibitors-chronic-inflammatory-disorders.
P1085 Early and sustained improvement in patient-reported outcomes and biomarker concentrations with tulisokibart induction in patients with moderately to severely active ulcerative colitis: A post-hoc analysis from ARTEMIS-UC
Authors: Peyrin-Biroulet L , Yen M , Zhou W , Dong B , Danese S , Feagan B G , Sands B E 
Published: January 2025

Abstract

Background
In the phase 2, double-blind, placebo-controlled, multicenter ARTEMIS-UC trial, 12 weeks of induction treatment with the anti-tumor necrosis factor-like cytokine 1A (TL1A) monoclonal antibody tulisokibart led to significant rates of clinical remission, endoscopic improvement and mucosal healing, and improvement in patient-reported outcome (PRO) measures and disease surrogate biomarkers in patients with moderately to severely active ulcerative colitis (UC).1 This post-hoc analysis from ARTEMIS-UC examined the time course of improvement from baseline in patient-reported symptoms (PRO-2 score [combined Mayo stool frequency and rectal bleeding subscores]) and biomarkers (fecal calprotectin and high-sensitivity C-reactive protein [hs-CRP]) with tulisokibart.

Methods
Adults with moderately to severely active UC were randomized 1:1 to receive i.v. placebo or tulisokibart (1000 mg on Day 1 and 500 mg at Weeks 2, 6, and 10). The study population consisted of 2 cohorts based on a genetic diagnostic test (Dx) assessing likelihood for responding to anti-TL1A treatment. Cohort 1 included participants stratified by Dx results while Cohort 2 included only Dx positive participants. Cohort 1 is the population used in this post-hoc analysis. Participants recorded stool frequency and rectal bleeding scores daily using an e-diary. Fecal calprotectin was assessed at baseline and Weeks 6 and 12, and hs-CRP was assessed at baseline and Weeks 2, 6, 10, and 12. Symptomatic response was defined as a reduction from baseline in PRO-2 score ≥ 1 point. A mixed model repeated measures approach was used to compare tulikisobart to placebo for the difference in PRO-2 score for the first 14 days of treatment and the fold change from baseline in fecal calprotectin and hs-CRP at each timepoint.

Results
Among 135 randomized participants in Cohort 1, 60/67 (89.6%) receiving placebo and 68/68 (100%) receiving tulisokibart completed the 12-week induction period. The numerical difference in improvement of PRO-2 started as early as Day 2 and achieved significant improvement with tulisokibart compared to placebo at Day 9, with a sustained improvement persisting from the latter part of Week 2 through Week 12 (Figure 1, Table 1). Significant improvements with tulikisobart compared to placebo in fecal calprotectin and hs-CRP were observed by Weeks 6 and 2 (the first time point when these biomarkers were measured), respectively, which were maintained through Week 12 (Table 1).

Conclusion
In patients with moderately to severely active UC, induction with tulisokibart led to early and sustained improvement in patient-reported outcomes. Induction with tulisokibart also led to early and persistent improvement in biomarkers.

References
1. Sands BE, et al. N Engl J Med 2024;391:1119-29.
P1086 Achieving early symptom resolution and endoscopic outcomes is associated with improved long-term outcomes in ulcerative colitis: A post-hoc analysis of INSPIRE and COMMAND studies
Authors: Tinoco da Silva Torres J , Danese S , Tanida S , Dulai P S , Xuan S , Kalabic J , Morisset P , Vladea R , Sharma D , Panes J 
Published: January 2025

Abstract

Background
Early disease control, which includes symptom remission with mucosal healing (endoscopic and histological remission) is emerging as a potential therapeutic goal in ulcerative colitis, which may be achieved by effective therapeutic intervention.1 This post-hoc analysis examined the impact of achieving individual symptom resolution, endoscopic improvement (EI) or endoscopic remission (ER) post 12 Weeks (Wk) of risankizumab (RZB; a specific inhibitor of interleukin-23) induction treatment on achieving long-term clinical, endoscopic, and quality of life (QoL) outcomes at maintenance Wk 52.

Methods
This analysis included patients (pts) who achieved a clinical response after 12 wks of intravenous RZB in Phase 2b and Phase 3 INSPIRE induction studies and received subcutaneous RZB 180 or 360 mg in COMMAND maintenance study. The frequency and proportions of pts achieving maintenance Wk 52 outcomes (clinical remission [CR], EI, ER, or meaningful change in QoL) between pts who achieved the absence of symptoms (abdominal pain, bowel urgency [BU], tenesmus, fecal incontinence [FI], sleep interruption [SI], nocturnal bowel movements [NBM]), achieved fatigue normalization, or achieved EI/ER at end of induction vs those who did not was determined. Adjusted predictive analyses assessed the relationship between achieving outcomes at induction Wk 12 and maintenance Wk 52, reported as logistic regression-derived odds ratios (ORs) and 95% confidence intervals.

Results
In total, 179 and 186 pts received RZB 180 and 360 mg during maintenance, respectively. After adjusting for pt characteristics, pts who achieved absence of symptoms at Wk 12 had significantly greater odds of achieving CR, EI, or ER at Wk 52; specifically, absence of BU, FI, and NBM were significantly associated with CR (OR 1.793, 1.722, 1.645), absence of BU and NBM were significantly associated with EI (OR 1.557, 1.563), and absence of FI, NBM, and SI were significantly associated with ER (OR 2.337, 2.318, 2.355). Similarly, pts who achieved endoscopic outcomes of EI/ER at induction Wk 12 had a significantly greater odds of achieving CR (OR 2.011/3.332) and maintaining EI (OR 2.278/5.974) and ER (OR 3.222/7.426) at Wk 52 (Figure). Pts achieving absence of BU, tenesmus, NBM, and ER at Wk 12 had significantly greater odds of achieving meaningful within-person change in QoL outcomes such as work time missed, impairment while working, and overall work and activity impairment at Wk 52 (Table).

Conclusion
Achieving early disease control with RZB treatment through symptom and specifically endoscopic outcome improvements at Wk 12 was generally associated with greater odds of achieving improved long-term clinical, endoscopic, and QoL outcomes at Wk 52.

References
1. Solitano V, et al. J Clin Med. 2020;9(8):2646.
P1095 Switching from Ustekinumab to Risankizumab Improves Outcomes in Crohn’s Disease: A Single-Centre Real-World Data Analysis
Authors: Qazi U , Padley J , Colwill M , Mehta S , Donovan F , Francisco Alves A M , Pollok R , Poullis A , Patel K , Honap S 
Published: January 2025

Abstract

Background
Ustekinumab is a mainstay of treatment for Crohn’s disease (CD) and has been shown to be effective and safe. The SEQUENCE(1) trial found risankizumab is superior to ustekinumab at inducing endoscopic remission and non-inferior with respect to clinical remission. However, there is a lack of real-world data investigating the effectiveness of risankizumab in ustekinumab-exposed patients with active CD and we therefore aimed to assess this.

Methods
A retrospective, observational study was performed at a tertiary inflammatory bowel disease centre. We included all patients diagnosed with CD whose treatment was switched from ustekinumab to risankizumab between December 2023 to November 2024. Electronic patient records were used to collect anonymised data on demographics, disease phenotype and previous advanced therapy. Clinical and biochemical markers of disease activity were assessed at baseline (prior to treatment switch to risankizumab), and at 3 and 6 months after switching. Statistical significance was assessed using a one-sided paired t-test.

Results
Patient demographics are summarised in table 1. 52 patients were included in the study; mean age 45 years, age range 19-82 years, mean disease duration 12.7 years. 10 patients were switched due to primary loss of response to ustekinumab, 41 due to secondary loss of response and 1 due to side effects. The mean duration of follow-up was 178 days. All patients had clinical (Harvey Bradshaw Index (HBI)), biochemical (faecal calprotectin (FCP) or C-reactive protein (CRP)), radiological or endoscopic evidence (Simple Endoscopic Score for CD (SESCD) of active disease at baseline. The mean HBI at baseline was 3.4 which significantly improved at 3 months to 2.6 (n=40, p=0.02) and 6 months (n=13, p=0.03). The mean FCP at baseline was 530, which significantly decreased at 3 months to 211 (n=26, p=0.04). The mean albumin at baseline was 37.3g/L which significantly increased to 38.3g/L at 3 months (n=44, p=0.01). Changes in CRP, FCP and albumin at 6 months were not statistically significant. SESCD was available for 3 patients at 6 months of which 1 improved, 1 worsened and 1 was unchanged. No new safety signals were identified.

Conclusion
This real-world study demonstrates that in patients with active CD switching from ustekinumab to risankizumab can, at least in the short term, significantly improve symptoms and biochemical markers of disease activity. Larger studies with longer-term outcomes are needed to understand the impact of switching to anti-IL23p19 therapies in ustekinumab-exposed patients.

References
1.Peyrin-Biroulet L, Chapman JC, Colombel JF, Caprioli F, D’Haens G, Ferrante M, et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Crohn’s Disease. N Engl J Med. 2024 Jul 18;391(3):213–23