bluuebunny/crossref_metadata_2025_split huggingface dataset:
P1029 Janus Kinase Inhibitors for the Management of Acute Severe Ulcerative Colitis: A Multicentre Study
Authors: Gilmore R , Fernandes R , Chin S , Con D , De Cruz P , Demase K , Sparrow M , Thin L , Baker J , Venugopal K , Lucas S , Garg M , Loebenstein M , Nguyen A , Moore G , Tandon B , Bryant R , MacFarlane K , Lynch K , Abdul S , Subhaharan D , Mohsen W , Haig A , Day M , White L , Begun J , An Y K 
Published: January 2025

Abstract

Background
Acute Severe Ulcerative Colitis (ASUC) is a medical emergency, with limited therapeutic options available for medical management. Tofacitinib and Upadacitinib are novel Janus Kinase inhibitors (JAKi), with proven efficacy for ulcerative colitis (UC). This study aimed to examine the outcomes of patients treated with JAKi for ASUC in a real-world population.

Methods
A retrospective multi-centre study was conducted including patients (≥18 years) with ASUC commenced on Tofacitinib or Upadacitinib from April 2021 to April 2024. ASUC was defined according to Truelove and Witt’s criteria. Demographic and clinical data were recorded at admission, JAK induction, discharge, week 8, week 16 and 1 year post-induction. The primary outcome was need for colectomy. We further evaluated adverse events and drug-specific response.

Results
A total of 124 patients were included from 11 Australian Inflammatory Bowel Disease (IBD) centers. Tofacitinib was used in 49%, while Upadacitnib was used in the remainder. 58% of patients received JAKi as first line salvage therapy, while the remainder received JAKi sequentially after failure of first line infliximab therapy.
The rate of colectomy during admission was 17% and 40% by 1 year. There was no significant difference between rate of colectomy during index admission (p=0.38), or 1 year post induction (p=0.24) between Tofacitinib and Upadacitinib.
There was a significantly increased risk of inpatient colectomy for those receiving sequential salvage compared to initial JAKi salvage (p=&lt;0.01). However, there was no significant difference in the rate of colectomy in either cohort up to 1 year post induction (p=0.19).
Clinical response was observed in 45% of patients by day 3 of induction and 65% by day 7. Clinical remission rates were 40% by week 8 and 65% by week 16. Biochemical remission was achieved in 51% by week 16. Mucosal healing was achieved in 47% of patients who underwent repeat endoscopy within 16 weeks of induction.
Adverse events occurred in 16% of patients, all of which were minor and did not require hospitalisation. The most common events noted were acne (7%) and nasopharyngitis (6%).

Conclusion
Jaki demonstrate effectiveness and safety for the management of ASUC. There was no significant difference in the inpatient colectomy rate between Tofacitinib and Upadacitinib. There was a significantly higher rate of inpatient colectomy for patients requiring sequential salvage therapy, but no significance when patients were followed up to 1 year. There is variability in prescribing practice between dosage of Tofacitinib and Upadacitinib, duration and dosage of corticosteroid wean, and the use of prophylactic PJP and VTE prophylaxis.
P1034 Prognostic value of short-term endo-histological outcomes in moderate-to severe ulcerative colitis patients on tofacitinib treatment – prospective cohort study
Authors: Resál T , Bacsur P , Farkas B , Ivány E , Bálint A , Bősze Z , Fábián A , Bor R , Tóth T , Szepes Z , Farkas K , Molnár T 
Published: January 2025

Abstract

Background
Data are scarce on the deep remission of tofacitinib (TOFA) in moderate-to severe ulcerative colitis (UC), however, it can fundamentally change disease course and behaviour.

Methods
This was a prospective cohort study, assessing the short-term effectiveness of TOFA in UC patients. Baseline was the day of induction of TOFA. Clinical, biochemical, endoscopic and histological activities were assessed at baseline and at week 8 and 12, and we collected one-year treatment persistence. Primary outcome was week 12 histological remission (HR), defined as Nancy score&lt;1 and endoscopic Mayo score (eMayo)≤1. Secondary outcomes were week 12 corticosteroid-free remission (CSFR), defined as clinical remission (CR; partial Mayo score [pMayo]&lt;2 with a rectal bleeding subscore of 0) and C-reactive protein (CRP) ≤5 mg/L and endoscopic remission (eMayo score ≤1), furthermore, one-year treatment persistence were assessed. Data was handled by intention to treat analysis. We performed multivariable logistic, Cox-regression and linear regression models to control potential confounders and to reduce bias. The most reliable models were selected based on ROC analyzes with highest area under the curve (AUC).

Results
A total of 75 moderate-to severe UC patients (mean age 38.4 ± 12.1; male/female ratio 32/44) were involved in our prospective cohort study. In total, 7 patients (9.2%) achieved histological remission, while 20 patients (26.7%) achieved endoscopic remission. We found, that one-year treatment persistence was strongly influenced by week 12 endoscopic remission (β=3.79 [95% CI: 1.21 – 6.37]), but not by HR (β=1.58 [95% CI: -0.74 – 3.89]). In total, 34 patients (44.7%) were in CSFR at week 12, and higher baseline pMayo score decreased (OR=0.64 [95% CI: 0.43 – 0.94]), while albumin increased (OR=1.33 [95% CI: 1.01 – 1.76]) the chance of achieving the outcome (AUC = 0.93).

Conclusion
Based on our prospective cohort study, short-term HR is still a hard-to-reach endpoint in moderate-to-severe UC on TOFA. We found, that one-year treatment persistence is influenced by endoscopic mucosal healing, but not by HR, however, it should be enhanced, that as only a few patients achieved HR, the necessary statistical power was lacking.
P1040 Steroid use and dependency in South Indian Inflammatory Bowel Disease patients- A multi-center clinical audit
Authors: Mandapati C S P , Kuriakose Kuzhiyanjal A , Musunuri B , Desai G , Anasosalu S , Tantry B V , A k Satheesh R , Hajare S , Shetty S , Limdi J K 
Published: January 2025

Abstract

Background
Corticosteroids are effective induction agents for Inflammatory Bowel Disease (IBD) but are ineffective for maintenance. Their judicious use and steroid-sparing strategies are advocated by societal guidelines, but data from India are scarce.

Methods
An audit of steroid use in the last 12 months was conducted in unselected IBD outpatients from 4 large centres in South India using the steroid assessment tool (1). Cases that met the ECCO criteria for steroid dependency or excess were assessed to see whether steroid prescriptions were definitely avoidable, probably avoidable or unavoidable (2). Definitely avoidable and probably avoidable steroid uses were termed as inappropriate steroid excess. Categorical data were reported in proportions. Chi-square and Fischer test (expected count &lt;5) was used to assess the association of factors associated with outcomes. Statistical significance was determined at 5% level of significance.

Results
Of 400 patients (61% male) enrolled in the study, 279 (70%) patients had ulcerative colitis (UC) and 121 (30%) patients had Crohn’s disease (CD). Baseline characteristics are outlined in Table 1. Among these, steroids were given to 208 (52%) IBD patients, and 127 (32%) patients were identified as having steroid excess or dependence:84 (66%) with UC and 43 (34%) with CD. CD patients with mild-inactive disease tended to have more steroid dependency (p&lt;0.001), although rates of steroid use (P=0.123) and dependency were similar in overall CD (35.5%) and UC (30%) patients. Inappropriate “steroid excess” was noted in 48% of IBD patients (UC (52%) and CD (40%)) (p=0.226) (Fig. 1). The annual incidence of inappropriate steroid excess was 15.25 % (Percentage of inappropriate excess to the total cohort). Notably, 12.5% (n=26) patients commenced steroids without any biochemical or endoscopic evaluation and 128 (61%) patients did not receive any concomitant bone protection.

Conclusion
In this first study from India, steroid dependency or excess was observed in 32% of IBD patients with inappropriate steroid excess seen in 15.2%. Despite limitations posed by cost, access and logistical challenges, these observations are sobering and have triggered a quality improvement programme to improve quality of care for our patients.

References
1.Selinger CP, Parkes GC, Bassi A, et al. A multi-centre audit of excess steroid use in 1176 patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2017
2.Raine T, Bonovas S, Burisch J et al. ECCO Guidelines on Therapeutics in Ulcerative Colitis: Medical Treatment. J Crohns Colitis. 2022
P1052 Ustekinumab for refractory intestinal Behçet’s Disease
Authors: Yang H , Li M , Huang Z , Gao X 
Published: January 2025

Abstract

Background
Intestinal Behçet’s disease (BD) is typically treated with a limited number of empirical medications. There is a continuing need for more effective and safer treatment options, particularly for refractory cases. This study reports the first use of ustekinumab in the treatment of refractory intestinal BD.

Methods
This was a retrospective review of medical records. The primary outcome was clinical remission at 12 weeks. Secondary outcomes included endoscopic remission (defined as the absence of ulcers) and normalization of C-reactive protein (CRP) levels.

Results
Five patients with refractory or intolerant intestinal BD, previously treated with corticosteroids and/or immunomodulators, received ustekinumab. All had previously been exposed to anti-TNFα monoclonal antibodies. The median follow-up duration after the first ustekinumab infusion was 12 months. Clinical remission rates were 80% (4/5) at 12 weeks, 75% (3/4) at 6 months, and 50% (2/4) at 12 months. CRP normalization rates were 60% (3/5) at 12 weeks, 50% (2/4) at 6 months, and 33% (1/3) at 12 months. Endoscopic remission rates were 50% (2/4) at 6 months and 50% (1/2) at 12 months. One patient required surgery due to refractory disease.

Conclusion
Ustekinumab appears to be a potentially effective treatment for refractory intestinal BD and represents a promising treatment option for refractory intestinal BD, especially in patients with limited therapeutic choices. Further studies are needed to confirm these findings and explore its broader applicability.
P1058 Trajectories of response in patients with moderately-to-severely active Crohn’s disease treated with mirikizumab based on biofailed status: Post hoc results from the VIVID-1 study
Authors: Schreiber S W , Clemow D B , Yu G , Keefer L A , Ananthakrishnan A N , D’Haens G , Deepak P , Kochhar G S , Melmed G Y , Chen Y F , Moses R E 
Published: January 2025

Abstract

Background
Mirikizumab, an anti-IL-23p19 antibody, demonstrated robust efficacy in improving clinical and endoscopic endpoints with an acceptable safety profile1. We explored the trajectory of response to treatment in patients with moderate-to-severely active Crohn’s disease (CD), in patients treated with mirikizumab based on biofailed status at study baseline.

Methods
Biofailed was defined as patients with demonstrated intolerance, inadequate response, or loss of response to an approved biologic therapy for CD (BF, N=275) and Not Biofailed (NBF, N=297) patients described previously1 were assessed via Growth Mixture Model to identify distinct clusters based on individual patient response trajectories. Change from baseline in Crohn’s Disease Activity Index total score was used in the Growth Mixture Model to identify trajectories. Modified baseline observation carried forward imputation used.

Results
There were four clusters identified for both the BF and NBF groups. Mirikizumab trajectory groups by baseline biofailed status: Super Responder (BF/NBF: 18.9%/17.8%), Responder (BF/NBF: 19.3%/25.3%), Delayed Responder (BF/NBF, 29.8%/29.3%), and Non/Incomplete Responder (BF/NBF, 32.0%/27.6%) (Figure 1). The overall response rate across responder groups for BF patients was 68.0% and for NBF patients was 72.4%.

Conclusion
Mirikizumab clinical response groups (Super Responder, Responder, Delayed Responder, and Non/Incomplete Responder) were similar for BF and NBF patients suggesting mirikizumab works consistently for BF and NBF patients, and prior biofailed status is not associated with the speed or magnitude of a MIRI-triggered clinical response.

References
1.M Ferrante, S Danese, M Chen, et al. OP05 Primary efficacy and safety of mirikizumab in moderate to severe Crohn’s Disease: results of the treat-through VIVID 1 study, Journal of Crohn’s and Colitis, Volume 18, Issue Supplement_1, January 2024., Pages i7–i9, https://doi.org/10.1093/ecco-jcc/jjad212.0005.
P1060 Exploring The Relationship Between Hormonal Contraceptive Use And Ulcerative Colitis Flares: A Longitudinal Analysis
Authors: Frutos C , Benítez J M , Soto P , Marín Pedrosa S , Iglesias-Flores E , Gros B 
Published: January 2025

Abstract

Background
Numerous studies have implicated hormonal contraceptive therapy (HCT) as a potential trigger for IBD onset. However, data regarding disease flares in hormonal contraceptive users are limited in ulcerative colitis (UC). This study aims to explore this association.

Methods
Female patients who were diagnosed with UC after 1st January 2014, and born between 1966-2008 were included. The Andersen-Gill extension of the Cox proportional hazards model was used to account for recurrent events within the same subjects. Two models were employed: M1: the first included each patient corresponding to only one cohort, while in the second M2: one those who initiated HCT after diagnosis, were included twice, one from diagnosis to HCT as non-exposed and as exposed thereafter.

Results
Among 2359 patients in our local database, 545 were women with UC, of whom 131 met the inclusion criteria for analysis. The majority had UC proctitis 57 (43.2%) with 24 (18.2%) were smokers. The median age was 32.5 (23.3-42) years. Of the cohort, 52 (39.1%) women exposed HCT, with a median exposure duration of 1.5 (0.5-5.0) years. Of these, 33 (25%) were exposed to HCT during follow-up.
Over 518 person-years of follow up, 173 flares and 196 courses of steroids were observed with 54 admissions, differences were observed among the hospitalization rates between groups Table 1. Additionally, there were 24 pregnancies documented in our cohort.
No differences in time to first flare (log-rank test p=0.83). However, the Cox proportional hazard model showed that HCT was associated with higher cumulative risk of flares in both models (M1: aHR 1.53, 95%CI 1.05-2.22, p=0.029) and (M2: aHR 1.47, 95%CI 1.019-2.11, p=0.039), Figure 1A and 1B. No adverse events associated to HCT occurred during follow-up.

Conclusion
Our study suggests that HCT is associated with an increased cumulative risk of flares and hospitalization rates in patients with UC. Furthermore, no safety signals were observed with the use of HTC in this cohort.
P1066 Effectiveness and safety of vedolizumab in real-world studies in Asian patients with inflammatory bowel disease: a systematic review and meta-analysis
Authors: Gu Y , Zhang X , Gu L , Zou D 
Published: January 2025

Abstract

Background
Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic gastrointestinal disorders with rising prevalence in Asia. Vedolizumab (VDZ) is a humanized monoclonal antibody targeting α4β7 integrin, selectively blocking gut lymphocyte trafficking. Despite numerous real-world studies on VDZ use in Asian patients with IBD over recent years, a comprehensive analysis summarizing its effectiveness and safety is still lacking. This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of VDZ in Asian patients with IBD.

Methods
A literature search was conducted to identify real-world studies evaluating intravenous VDZ in Asian patients with IBD from inception to 20th December 2023. Meta-analyses were performed separately for CD and UC patients to pool clinical and endoscopic remission and response rates across induction (6-14 weeks), medium term (22-30 weeks), and long term (over 48 or 52 weeks) using a random-effects model in R software. The incidence of adverse events (AE), serious AE (SAE), and serious infection were assessed for safety.

Results
Twenty-nine studies (15 CD and 25 UC) with 2,395 patients (827 CD, 1,568 UC) were analysed (Figure 1). In the induction phase, clinical response and remission were achieved in 57.48% and 61.15% of CD patients, and 64.72% and 40.07% of UC patients. In the medium term, clinical response and remission were 64.32% and 60.72% for CD, and 64.87% and 43.51% for UC. In the long term, the clinical response and clinical remission rate were 44.55% and 45.83% in CD patients, 61.35% and 56.14% in UC patients. Moreover, corticosteroid-free clinical remission was achieved by 36.58% of that in CD and 49.03% of that in UC for the long-term observation.
Endoscopic response was achieved by 41.37% of CD patients and 48.57% of UC patients during induction phase. Endoscopic remission rates for CD were 11.11%, 18.41%, and 36.42%, and for UC 43.19%, 54.27%, and 66.72% in induction, medium, and long term, respectively. The pooled complete endoscopic remission rates for UC were 27.98% (induction), 47.87% (medium term), and 50.61% (long term) (Table 1).
AEs occurred in 6.67% to 61.54% of CD patients and 29.69% to 75.38% of UC patients. SAEs and serious infection rates were 0.00% to 1.56% and 0.00% to 2.70% in UC patients, and 0.00% to 0.75% for serious infections in CD, with no SAEs reported in CD studies.

Conclusion
VDZ demonstrated effective clinical outcomes with a favourable safety profile in Asian patients with IBD.
P1069 Impact of Unmet Needs on Quality of Life in Patients with Short Bowel Syndrome in Japan
Authors: Ogino T , Watanabe K , Nakano H , Hayashi A 
Published: January 2025

Abstract

Background
Inflammatory bowel disease (IBD) is a major cause of short bowel syndrome (SBS). Patients with SBS face numerous challenges throughout their lives, leading to a reduced quality of life (QoL). Addressing unmet needs (UMNs) to improve QoL is critical; however, research on the UMNs of SBS patients remains limited. This study aimed to identify the UMNs of SBS patients with IBD (SBS-IBD) and without IBD (SBS-non-IBD) and clarify how these UMNs affect their QoL.

Methods
A survey on patients’ UMNs was conducted between February and May 2024 in Japan, involving adult patients with SBS, both those receiving parenteral support (PS) and those not. The survey included 54 items addressing patient concerns and consultations with healthcare professionals (HCPs). A comparison was made between adult-onset SBS-IBD and SBS-non-IBD. UMNs were defined as the discrepancy between the level of concerns and the frequency of consultations with HCPs, measured on a 7-point Likert scale. UMNs related to disease/treatment and daily life aspects were evaluated separately. QoL was assessed using the SBS-Quality of Life scale (SBS-QoL). Multiple regression analysis was performed to assess the factors influencing UMNs and their impact on QoL.

Results
Ninety-four patients had SBS-IBD, the majority of whom had Crohn’s disease, while fifty-eight had SBS-non-IBD. The mean ages were 47.4 years and 46.0 years, respectively. Among those with SBS-IBD, approximately half had a stoma, with a significantly higher proportion compared to the SBS-non-IBD group. Additionally, 68% of the SBS-IBD group received PS, compared to 52% in the SBS-non-IBD group (p=0.04), and the duration of PS dependence was longer in the SBS-IBD group (7.3 years vs 4.6 years, p=0.02). Regarding disease/treatment UMNs, the most common issue in the SBS-IBD group was depression or anxiety (33%). For daily life UMNs, concerns about the future (38%), financial situation (31%), and work/school (30%) were identified. Similar trends were observed in the SBS-non-IBD group. Multiple regression analysis showed that QoL was impacted by disease/treatment UMNs (p=0.02), daily life UMNs (p=0.01), PS volume (p=0.02), and hospitalization due to catheter-related bloodstream infection (p&lt;0.01) in patients with SBS-IBD.

Conclusion
For both SBS-IBD and SBS-non-IBD patients, depression or anxiety had the highest discrepancy level in disease/treatment UMNs. It is essential for doctors to prioritize these UMNs by actively engaging in discussions with patients about their individual needs and treatment goals, staying informed about the latest research and emerging trends in holistic management of SBS.

Funding
This study was supported by Takeda Pharmaceutical Co., Ltd.
P1071 Trajectories of response in patients with moderately-to-severely active ulcerative colitis treated with mirikizumab: Results from the LUCENT-1 study
Authors: Schreiber S W , Clemow D B , Keohane A , Zhu B , Ritter T , Regueiro M , Hudesman D , Chen Y F , Owen C 
Published: January 2025

Abstract

Background
Mirikizumab, an anti-IL-23p19 antibody, demonstrated robust efficacy in improving clinical and endoscopic endpoints with an acceptable safety profile1. We explored the trajectory of response to mirikizumab treatment in patients with moderate-to-severely active ulcerative colitis.

Methods
Mirikizumab patients described previously1 were assessed via Growth Mixture Model (GMM) to identify distinct clusters based on individual patient response trajectories. The sum of stool frequency and rectal bleeding modified Mayo subscores was used in the GMM to identify trajectories. Week 12 clinical endpoints were assessed by trajectory group. Modified baseline observation carried forward imputation was used.

Results
Trajectory groups were identified as Super Responder (N=223; 25.7%), Responder (N=409; 47.1%), and Delayed or Non/Incomplete Responder (N=236; 27.2%) (Figure 1). At week 12, a different proportion of patients achieved efficacy endpoints by Super Responder, Responder, and Delayed or Non/Incomplete Responder trajectory groups, respectively: symptomatic remission: 70%/58%/0%; bowel urgency improvement: 72%/51%/22%; clinical response: 95%/75%/14%; clinical remission: 36%/32%/0% (Figure 2).

Conclusion
Three response trajectory groups were identified for mirikizumab treatment of ulcerative colitis: Super Responder, Responder, and Delayed or Non/Incomplete Responder. At week 12 of treatment, the proportion of patients achieving efficacy endpoints in general was greatest in Super Responders followed by Responders and then Delayed or Non/Incomplete Responders, with an overall response rate of 72.8%. Efficacy was similarly robust across both the Super Responder and Responder groups.

References
1.D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940. Erratum in: N Engl J Med. 2023 Aug 24;389(8):772. doi: 10.1056/NEJMx230004.