bluuebunny/crossref_metadata_2025_split huggingface dataset:
P0953 Real world effectiveness and safety of filgotinib in Ulcerative Colitis: 1 year follow-up results of the ICC registry
Authors: Naber M , van der Meulen A , Voorneveld P , van Bodegraven A , Duijvestein M , Pierik M , Verleye L , Bodelier A , Bouwknegt D , Visschedijk M , West R , van der Marel S , Mensink P , de Vries A , Römkens T , Oldenburg B , Löwenberg M , van Schaik F ,   The Dutch Initiative on Crohn and Colitis (ICC) Registry
Published: January 2025

Abstract

Background
Filgotinib is a preferential JAK1-inhibitor approved for the treatment of ulcerative colitis (UC). The ICC registry was developed to evaluate the effectiveness and safety of advanced therapies in inflammatory bowel disease (IBD). Here, we report the one-year follow-up results of filgotinib in patients with UC.

Methods
Fourteen hospitals prospectively enrolled UC patients initiating filgotinib in the Dutch ICC registry. Treatment persistence was assessed by Kaplan-Meier survival analysis. Clinical remission (i.e. Simple Clinical Colitis Activity Index [SCCAI] ≤ 2) and corticosteroid-free clinical remission rates were assessed at 12, 24 and 52 weeks for all patients who were not in remission at baseline, based on SCCAI score, faecal calprotectin and/or endoscopy. Patients lost to follow up were considered as treatment failure. Reasons for treatment discontinuation and adverse events were recorded.

Results
Eighty-three UC patients (47% females) were enrolled between January 2022 and October 2023. Mean age and disease duration at baseline were 41 [sd ± 16] and 12 years [sd ± 9], respectively. A total of 49 (59%) patients had used up to two advanced therapies and 34 (41%) patients had used three or more. At baseline, 75 patients (90%) had active disease of whom 24 (32%) used oral corticosteroids. After one year of follow-up, 58.8% of patients still used filgotinib (Figure 1). At week 12, 24 and 52, corticosteroid-free clinical remission rates were 57.1%, 32.7% and 34.6% respectively (Figure 2). Reasons for treatment discontinuation were primary non-response (n=17), secondary loss of response (n=13), side effects (n=3) or other reasons (n=4). Fifty-seven adverse events were recorded (19 infections). Ten infections required treatment with antibiotics or antiviral therapy, none of them led to hospitalization or therapy discontinuation. No thromboembolic events were reported.

Conclusion
The results of this real world study show that, even in a therapy-refractory UC population with an average disease duration of 12 years, more than half of the patients still used filgotinib and one third of patients was in corticosteroid-free clinical remission after one year of follow-up. No new safety signals were found.
P0958 Curcumin-QingDai combination for active ulcerative colitis: A cost-effectiveness analysis
Authors: Yanai H , Choi D , Ben-Horin S , Salomon N , Loebstein R , Leshno M , Rubin D T 
Published: January 2025

Abstract

Background
A combination of two herbal compounds, curcumin and QingDai (CurQD), was recently proposed as an effective treatment for patients with active ulcerative colitis (UC) based on randomized controlled and real-world evidence, but no cost-effectiveness analysis for this nutraceutical is currently available

Methods
A Markov model was generated to simulate the progression of patients with moderate-to-severe UC, by separate analysis for a cohort of advanced therapy-naïve and advanced therapy-experienced patients. Medications costs were derived from published average wholesale price (AWP) in the US. Efficacy data was modeled by synthesis of efficacy reports of randomized placebo-controlled trials and real-world cohort studies of all FDA-approved drugs for UC, and each compared with CurQD. The model used a time horizon of 54 weeks. The threshold of 50,000$/quality adjusted life-year (QALY) was chosen, and a one-way sensitivity analysis was performed for testing analysis robustness.

Results
The comparison of CurQD with the FDA approved advanced therapies for UC yielded an estimated incremental cost-effectiveness ratio (ICER) of over 200,000$/QALY for all comparisons. Differences ranged from -0.05 to a slight gain of 0.07 QALY in bio-experienced patients and from -0.1 to 0.04 QALY in bio-naïve patients. The one- way sensitivity analysis proved the robustness of the analysis.

Conclusion
The present analysis suggests that the markedly reduced cost and demonstrated efficacy of CurQD provides a significant cost-effectiveness benefit over advanced therapies for active UC, including over anti-TNF biosimilars.

References
1.Yanai, H., et al., Real-world experience with Curcumin-QingDai combination for patients with active ulcerative colitis: A retrospective multicentre cohort study. Aliment Pharmacol Ther, 2023. 58(2): p. 175-181.
2.Ben-Horin, S., et al., Curcumin-QingDai Combination for Patients With Active Ulcerative Colitis: A Randomized, Double-Blinded, Placebo-Controlled Trial. Clin Gastroenterol Hepatol, 2024. 22(2): p. 347-356 e6.
3.Ben-Horin, S., et al., Letter: Change in bowel urgency in active ulcerative colitis patients treated with Curcumin-QingDai (CurQD): A post-hoc analysis of a randomized placebo-controlled trial. J Crohns Colitis, 2024.
P0969 Treat to Target strategy in IBD: A real world multicentre experience
Authors: Tan Y Y , Tey T T , Thia T J K , Yan Z H , Qiu T Y , Leong W H J , Chowdhury S , Liew I Y , Lin H , Tan T K M , Lim C T T , Tay S W , Salazar E 
Published: January 2025

Abstract

Background
Suboptimal control of inflammatory bowel disease (IBD) can lead to clinical relapse and disease progression. The STRIDE-II consensus in 2021 encompasses recommendations for short term, intermediate, and long-term targets involving clinical, biochemical and endoscopic remission respectively in a ‘Treat to Target’ strategy to improve IBD-related clinical outcome . We aim to assess the rates of biochemical and endoscopy assessments in our cohort.

Methods
This was a multi-center retrospective study involving four hospitals in Singapore. Between 1 January 2021 to 1 June 2022, we included patients who were initiated on or had a change in advanced therapies and followed up for up to 18 months. Clinical remission was defined as per STRIDE-II treatment targets for Patient Reported Outcomes 2. Biochemical remission defined as CRP &lt;5mg/L or fecal calprotectin (FC) levels &lt;250μg/g. Complications were defined as IBD-related hospitalisation or surgery.

Results
A total of 107 patients were included. The median age was 37 years, 75 (69.4%) were male and 69 (64.4%) had Crohn’s disease (CD). Seventy-three (68.2%) patients had a history of steroid use and 62 (57.9%) were on immunomodulators (Table 1). Eighty-seven (81.3%) were biologics naïve. Ninety-one (85.1%) required new initiation and 16 (14.9%) required a switch of advanced therapy. Eighty-three (76.6%) were started/switched to anti-TNF.
During study period, CRP, FC and endoscopic evaluation was done in 64 (59.8%), 79 (73.9%) and 67 (62.6%) patients respectively. By end of follow up, 100 (93.4%) patients had at least one assessment done. The median time to CRP evaluation was 51 (24-126) days, 92 (49-197) days for FC, 363 days (218-463) for endoscopy. Eighty-one patients (75.7%) were in clinical remission at the end of follow up.
Assessment of CRP within 90 days of treatment change was associated with CRP &lt;5mg/L (p=0.037) but not clinical remission or complication rates. Assessment of FC within 90 days was also associated with clinical remission (p=0.02) only.
Sub-analysis of UC patients demonstrated association of timely CRP and FC assessment with biochemical remission (p=0.02) and reduction in complications (p=0.05). Sub-analysis of CD patients did not show any significant associations.

Conclusion
Around 60% of patients had biochemical and endoscopic assessment within the first 18 months from change in therapy. Timely biochemical assessments within 90 days was associated with clinical remission.
P0973 Early infliximab use is associated with less disease progression in luminal Crohn’s disease: a real-world tertiary centre experience
Authors: Gordon H , Pakpoor J , Radia C , FurtadoOMahony L , Sanford J , Azzu H , Valentine C , Al-Allawee M , Gupta T , Brain O 
Published: January 2025

Abstract

Background
The PROFILE study demonstrated clear benefits of early advanced therapy in luminal Crohn’s disease (CD) in the trial setting. We retrospectively evaluated the relationship between timing of onset of infliximab as first advanced therapy and disease outcomes in a real-world single centre cohort at Oxford University Hospitals NHS Trust.

Methods
A pharmacy database was searched to identify patients who received infliximab as first advanced therapy in CD. Electronic patient records (Cerner) were searched to capture the following: demographics, Montreal classification, timing of onset of infliximab, biochemical, endoscopic and radiological parameters. The primary outcome was persistence on therapy. Secondary outcomes were survival without surgery or hospitalisation, progression of disease phenotype and steroid use. Data was analysed using GraphPad Prism.

Results
247 patients prescribed infliximab as first advanced therapy were identified (F:M = 112:135). Median duration (IQR) from diagnoses to first infliximab dose was 2.83 (0.25 – 10.02) years. 117 patients had inflammatory luminal disease at therapy onset (Montreal B1P0), with median first therapy from diagnosis of 2.67 (0.25 – 9.91) years.
When reviewing all cases, and those with exclusively inflammatory luminal disease, persistence on therapy, survival without surgery and survival without hospitalisation did not vary with time to first advanced therapy (p&gt;0.05 all comparisons, figure 1). However, in patients with luminal inflammatory CD who started therapy within 2 years of disease onset there was less disease progression, defined as extension in location, behaviour or new perianal disease (2/52 vs 10/65 chi sq 4.18 p=0.04), and a trend towards less systemic corticosteroid use (4/52 vs 13/65 chi sq 3.53 p=0.06).

Conclusion
Early infliximab therapy in luminal CD is associated with less disease progression and less use of systemic corticosteroids. The lack of variation in other outcomes may be due to historical case selection for advanced therapies.

References
Noor NM et al. PROFILE. Gastro Lancet Hep 2024

Figure 1: Persistence on therapy, surgery and hospitalisation free survival, categorised by duration from diagnosis until first infliximab dose. *luminal = Montreal B1P0
P1007 Influence of pharmacokinetic-pharmacodynamic failure mechanisms on outcomes in biologic therapy sequencing in inflammatory bowel disease
Authors: Steenholdt C , Lorentsen R D , Henneberg J , Petersen P , Brynskov J 
Published: January 2025

Abstract

Background
Increasing therapeutic options for inflammatory bowel disease (IBD) calls for tools to aid choice of sequencing. We investigated if pharmacokinetic (PK) and pharmacodynamic (PD) failure mechanisms prompting therapy change influenced subsequent outcomes when switching to a different biologic drug class.

Methods
Retrospective cohort study at a tertiary, Danish IBD center including all patients treated with first TNF-inhibitors, followed by vedolizumab, and then ustekinumab, as defined by national treatment regulations at time of study. Clinical and objective disease remission were defined by validated indices (HBI, SCCAI, Mayo, SES-CD). Treatment failure was defined by the treating physician and supported by clinical disease activity scorings and objective disease activity evaluations. Drug trough levels and anti-drug antibodies were measured at manifest treatment failure in routinely collected biobanked samples. PK-PD failure was defined according to maintenance drug concentrations: infliximab 8.0 µg/mL, adalimumab 12.0, golimumab 1.4, vedolizumab 15. Primary treatment failure despite dose intensification was ascribed to PD. Primary endpoints were steroid-free treatment persistence and one-year remission.

Results
The study included 112 patients switching from TNF-inhibitors to vedolizumab (infliximab n=61, adalimumab n=32, golimumab n=16, certolizumab pegol n=3) and 31 subsequently to ustekinumab. Treatment persistence on vedolizumab did not differ between patients discontinuing TNF-inhibitors due to PK (n=28, 31%) or PD (n=63, 69%) (mean 989 days [554-1,424] vs. 951 [659-1,242], p=0.93). One-year steroid-free clinical and objective remission rates on VDZ were also comparable between PK-PD groups (29% vs 35%, p=0.63 and 35% vs. 43%, p=0.48, respectively). Furthermore, treatment persistence on ustekinumab was neither different between patients having initially discontinued TNF-inhibitors due to PK or PD (1,553 [997-2,110], n=11) vs. 1,200 [762-1,639], n=14; p=0.42), nor later discontinued vedolizumab due to PK or PD (1,305 [832-1,778], n=11 vs. 1,323 [785-1,862], n=15; p=0.43). Clinical and objective remission on ustekinumab was also similar between these groups. Sensitivity analysis using other thresholds to define PK or PD failure were congruent to the above findings. Sensitivity analyses with exclusion of primary non-responders and multivariate analyses correcting for potential confounders also supported the findings.

Conclusion
Our study does not show evidence for inferior outcomes during subsequent sequencing to biologics with different modes of action in patients switching due to PK failures as compared to those with PD failure. Choice of sequencing may thus take into account other aspects such as efficacy, safety and costs.
P1024 Switching to subcutaneous infliximab in week 6 – the effect on mucosal healing and treatment persistence
Authors: Brinar M , Zlopasa L , Kodvanj I , Jelakovic M , Turk N , Grgic D , Cukovic Cavka S , Kunovic A , Krznaric Z 
Published: January 2025

Abstract

Background
Infliximab remains a cornerstone in managing inflammatory bowel disease (IBD) patients. The recent introduction of subcutaneous (SC) infliximab offers a potential alternative to intravenous (IV) administration. However, the optimal timing of the switch is still unclear. We aimed to investigate the difference in mucosal healing rates and therapy persistence in patients switched to SC infliximab at week 6 as opposed to those maintained on IV therapy.

Methods
All patients starting infliximab treatment from January 2023 to April 2024 were included. Patients with primary non-response to IV infliximab and those starting treatment for prophylaxis of postoperative disease recurrence were excluded from the analysis. At week 6, patients were stratified into two groups: SC (n = 48) and IV (n = 77). The primary outcomes included mucosal healing and persistence on therapy. Mucosal healing was defined as a Mayo endoscopic score of 0 or 1 for ulcerative colitis patients, a simple endoscopic score for Crohn’s disease (SES-CD) ≤ 3, or a modified Rutgeerts score ≤ i2a. Drug concentrations were measured, and odds ratios were calculated for comparative efficacy. Statistical analyses were performed using R version 4.3.1

Results
A total of 125 IBD patients starting infliximab for active disease with were included (71 with Crohn’s disease, 54 with ulcerative colitis). No significant differences in gender, age at diagnosis, age at infliximab initiation and concomitant immunomodulator use were found between the IV and SC treatment groups. Patients in the IV group had a significantly shorter disease duration compared to SC group (median 2, interquartile range (IQR) [1-11] years vs median 7, IQR [3-14] years; p=0.009). In 86% of the cohort, infliximab was the first-line biologic. No significant difference in mucosal healing rates was found between the IV and SC treatment groups (p = 0.06). Therapy discontinuation rates were similar between groups: 24% (18/77) for IV versus 22% (11/48) for SC. Median infliximab concentrations measured at week 14 were significantly higher in the SC group (median 12.0, IQR [10,9-12] µg/mL) compared to the IV group (median 6.2, IQR [4,1-9,3] µg/mL; p = 0.004). No therapy optimization was observed in the SC group, whereas 32% (n = 23) of patients in the IV group required dose optimization.

Conclusion
Switching to subcutaneous infliximab at week 6 is equally effective, with similar treatment persistence compared to IV maintenance therapy. Furthermore, SC application is preferred by patients and is cost-effective, with significant proportion of patients on iv maintenance therapy requiring treatment optimization during follow-up. These findings support SC infliximab as a viable alternative in IBD management.
P1026 Rectal stump surveillance in the IBD population
Authors: Clark J , de Silva S , King D 
Published: January 2025

Abstract

Background
Patients with inflammatory bowel disease (IBD) may require surgical resection, including subtotal colectomy, to manage symptoms and improve quality of life. However, there remains a risk of colorectal cancer (CRC) within the retained rectal stump. Although robust national and international guidelines exist for CRC surveillance in IBD patients with an intact colon, there is a significant gap in guidance for those with a retained rectal stump. We examined the current surveillance practices for the rectal stump in IBD patients, aiming to clarify current practice and optimise long-term surveillance strategies.

Methods
We performed a single centre, retrospective observational study. Patients with IBD undergoing surgical resection were identified using the local surgical IBD database, between January 2012 and September 2023. Cases without a rectal stump were excluded. Data was collected regarding age, sex, date of IBD diagnosis, date of surgery, frequency of surveillance, endoscopic appearance at surveillance, histology at surveillance and histological appearance at resection – this was used to assess initial risk. The British Society of Gastroenterology (BSG) guidelines for surveillance frequency of IBD were used as a comparator.

Results
Of the 53 patients (median age = 52 (IQR = 32), 34% female, 66% male) included, 30.2% underwent surveillance following the BSG guidelines, according to their risk at formation of the rectal stump, determined by BSG guidelines. 39.6% of patients underwent surveillance but not in accordance with the BSG guidelines and 30.2% had no surveillance documented. 51.4% of patients had their risk reclassified at first surveillance, 48.6% had no change to their risk. No patients developed colorectal cancer on surveillance. 85% of patients underwent subtotal colectomy within 10 years of diagnosis.

Conclusion
Conclusion IBD patients with a retained rectal stump are susceptible to adjustment of their risk based on histological and endoscopic appearance at surveillance, when using risk at initial resection as a baseline. This implies close monitoring is required, to ensure any dysplasia or CRC is adequately identified. Surveillance was inconsistent, and many patients had no surveillance documented. This study highlights the need for surveillance guidelines for patients with IBD with a retained rectal stump. The BSG guidelines suggest a screening colonoscopy 10 years post-diagnosis, yet most patients underwent initial resection before this could take place. This raises the question whether patients should undergo surveillance 10-years post-resection, or if this would be required earlier, dependant on risk following resection. The answer to this requires further research, to ensure uniformity in practice.
P1102 Albumin predicts post-operative complications in Acute Severe Ulcerative Colitis
Authors: Hodges P , Phillips J , King H , Creamer J , Kitchin A , Carter O , Tyrrell-Price J ,   Severn and Peninsula Research in Gastroenterology Trainee Network (SPRinG)
Published: January 2025

Abstract

Background
Acute severe ulcerative colitis (ASUC), defined by the modified Truelove and Witts criteria, is a potentially life-threatening condition. Randall et al showed over a decade ago that prolonged medical therapy prior to surgery was associated with a higher rate of major post-operative complications.(1) We undertook a retrospective cohort study with the aim of identifying other clinical parameters that could predict adverse outcomes following colectomy in the setting of ASUC.

Methods
We identified patients who had undergone colectomy for ASUC across 5 UK hospitals forming part of a trainee research network (the South West and Peninsula Research in Gastroenterology (SPRinG) network) over a 10-year period. We undertook a notes review for all these patients and compared pre-operative biomarkers (CRP, albumin) as well as length of stay prior to surgery in those who had a post-operative complication with those who did not.

Results
We identified 126 patients who had undergone colectomy for ASUC. 57% were male and 43% female. Median age was 44. 47% patients (n=59) received rescue therapy (ciclosporin n=17, infliximab n=40, Ustekinumab n=1, unclear from documentation n=1), 37% did not receive rescue therapy (n=46) and documentation was not found in 16% (n=21). Pre-operative albumin level was significantly lower in those who developed a post-operative complication up to 30 days (p=0.04, 95% CI 0.13, 4.68) (Figure1). It was not possible to identify a specific albumin level below which the risk of post-operative complications increases. There was no difference in length of stay prior to surgery, number of days of intravenous corticosteroid treatment, or pre-operative CRP between those who developed post-operative complications up to 30 days and those who did not. Of those who had complications within 30 days (66/126), the most common complications were abscess or wound infection (n=14) and ileus (n=12). Death occurred in 2 patients within 30 days.

Conclusion
We have shown that pre-operative albumin is associated with post-operative complications in ASUC. Our findings do not support the previous observation that prolonged medical therapy (either measured by length of stay or by number of days of intravenous corticosteroid treatment) prior to surgery increases the risk of post-operative complications.

References
1.Randall J, Singh B, Warren BF, Travis SP, Mortensen NJ, George BD. Delayed surgery for acute severe colitis is associated with increased risk of postoperative complications. Br J Surg. 2010;97(3):404-9.
Table 1 Comparison of clinical parameters between patients with and without complications up to 30 days

Figure 1 Pre-operative albumin in those with and without complications up to 30 days