Introduction

In complex perianal fistulizing Crohn’s disease (PFCD), rectal involvement is associated with worse outcomes, likely due to persistent inflammation at fistula internal openings. It is linked to lower remission rates and higher failure rates after anti-TNF-alpha induction, and current guidelines consider it a contraindication to surgical repair. However, its predictive value for secondary loss of response (LOR) to anti-TNF-alpha therapy remains unclear. While endoscopy and MRI can assess rectal disease, the former is limited to mucosal findings, whereas MRI provides comprehensive evaluation of transmural and pelvic inflammation.

Aims & Methods

This study aimed to assess the predictive value of rectal involvement for secondary LOR using both modalities. We conducted a longitudinal study (2000–2023) at a tertiary inflammatory bowel disease center. Included were PFCD patients naïve to anti-TNF-alpha therapy who achieved response or remission after induction. Patients with inadequate follow-up or poor adherence were excluded. Rectal involvement was defined as wall thickening >3 mm on MRI, and mucosal inflammation, a single ulcer >5 mm, or ≥3 ulcers <5 mm on endoscopy. Patients were stratified by MRI findings. Logistic regression identified predictors of secondary LOR, and Kaplan–Meier analysis assessed recurrence-free survival (RFS).

Results

A total of 80 patients were included (male-to-female ratio: 1.33). MRI-detected rectal wall thickening was present in 49 patients (61.3%). The two groups were comparable in baseline demographics and disease phenotype. Mean age at Crohn’s disease diagnosis was 28.9 years in the thickening group and 27.4 years in the non-thickening group; mean age at PFCD onset was 32.5 and 31.5 years, respectively. Most patients were treated with infliximab (88%), and the remainder received adalimumab (12%). Endoscopic rectal involvement was documented in 37 patients (46.3%). Secondary LOR occurred in 64.3% of patients overall, with a mean time to LOR of 17.8 months. Notably, MRI-defined rectal thickening was independently associated with increased odds of LOR (OR = 6.35, p = 0.002), whereas endoscopic assessment did not show a significant association. Patients without MRI-defined thickening had significantly higher RFS at 12, 36, and 60 months (86%, 72%, 57%) compared to those with rectal thickening (57%, 35%, 28%; p < 0.001).

Conclusion

Baseline MRI-detected rectal thickening is a strong, independent predictor of secondary LOR and reduced RFS in PFCD. MRI should be integrated into early disease assessment to identify high-risk patients who may benefit from intensified therapy and close monitoring. Resolution of rectal inflammation may restore eligibility for surgical repair. Further prospective studies comparing MRI and endoscopic markers are warranted to guide tailored treatment strategies.

Introduction

Despite robust quality indicators such as adenoma detection rate (ADR) in patients without IBD, such indicators for quality in colonoscopy are so far lacking in IBD. The European Society of Gastrointestinal Endoscopy currently recommends a dysplasia detection rate (DDR) of >8%, but evidence base for this is limited.

Aims & Methods

To examine whether existing quality indicators such ADR correlate with endoscopists’ IBD specific quality indicators such as dysplasia detection rate (DDR) and dysplastic lesions per colonoscopy (DPC). Data from consecutive colonoscopies performed by gastroenterologists across 11 tertiary IBD centres were collected, selected if at least 150 non-IBD colonoscopies and 40 IBD-surveillance colonoscopies were performed over a 5-year period. Non-IBD colonoscopies were for patients aged ≥50y, and IBD-colonoscopies for patients meeting national and international criteria for eligibility for dysplasia surveillance. Colonoscopies were excluded if the patient had known dysplasia, a known or suspected familial CRC syndrome, previous colonic resection or severe inflammation in Crohn’s or UC. Correlation between endoscopists’ ADR, adenomas per colonoscopy (APC) in non-IBD colonoscopies with their DDR and DPC in IBD colonoscopies. Secondarily, detection of sessile serrated lesions (SSLs) in patients with and without IBD were analysed.

Results

21 endoscopists (Table 1) met inclusion criteria, who performed 3207 non-IBD colonoscopies and 902 IBD (515 ulcerative colitis [UC] and 387 Crohn’s disease [CD]) colonoscopies. Of the non-IBD colonoscopies, patients’ median age was 65 (IQR 58-73) years, with 1556 (49%) female. Of the IBD-colonoscopies, patients’ median age was 48 (IQR 36-59) years, with 412 (45.7%) female, median disease duration of 14 (IQR 10-21) years. Chromoendoscopy was used in 234 (26%) of IBD colonoscopies. Nontargeted segmental biopsies were performed in 854 IBD colonoscopies, of which 12 (1.42%) detected dysplasia. No cancers were detected in all 902 IBD surveillance colonoscopies.
Key quality indicators for endoscopists are outlined in table 1. ADR correlated with both DDR (Pearson r = 0.44, p = 0.047) and DPC (r = 0.51, p = 0.018). Of the 17 endoscopists with ADR ≥35%, 13 (76%) endoscopists had DDR of ≥ 8%, 6 (35%) had DDR ≥ 12%, and 9 (53%) had a DPC rate of ≥ 0.15. Sessile serrated lesion detection rate (SSLDR) and SSL per colonoscopy (SSLPC) were strongly correlated in both IBD and non IBD endoscopies.

Table 1. Characteristics of 21 endoscopists included for study

Conclusion

Individual endoscopists’ ADRs in patients without IBD correlate with their DPC and DDR in patients with IBD. Further studies are required to assess whether these indicators are correlated with post-colonoscopy colorectal cancer in patients with IBD.

Disclosure

No conflicts of interest to disclose

Introduction

With the expanding array of therapeutic options in Crohn’s disease and ulcerative colitis, it is important to understand patient priorities regarding disease management goals in addition to those of healthcare professionals (HCPs). Views on Inflammatory Bowel Disease (IBD) Expectations and Well-being - Patients and Treatment providers (VIEW-PT): an analysis based on the IBD Disease Specific Programme (DSP)™, previously identified features of optimal disease control, with inclusion of patient and HCP perspectives¹. In order to aid with development of IBD management plans, this study aims to assess the prevalence of optimal disease control and associated factors in a real-world setting.

Aims & Methods

Features of optimal disease control identified in VIEW-PT¹ were used to evaluate prevalence and factors associated with IBD disease control. Data were drawn from the IBD DSP, a cross-sectional survey, with retrospective data collection, of HCPs and their patients with IBD in EU5 (France, Germany, Italy, Spain, the United Kingdom), and the United States of America, collected 2020-21 and 2023-24. Patients with a history of moderate-to-severe disease were included. HCPs reported patient demographics, clinical characteristics, treatment history, healthcare resource utilisation and whether treatment targets were set and subsequently achieved. Patients self-reported sex, symptoms, involvement in their current treatment decision and health-related quality of life via Visual Analogue Scale (EQ-VAS). Patients without key symptoms (bleeding, bowel urgency, fecal incontinence, abdominal pain, fatigue), and with restored bowel movement frequency, extraintestinal manifestations control, complete mucosal healing, no steroid use, no sleep disturbance, and EQ-VAS ≥80^2,3 were considered to have optimal disease control. Logistic regression was performed to determine association of factors with optimal disease control, with odds ratios (OR) and p-values reported.

Results

Of 2614 patients with IBD, just 10.0% had optimal disease control aligned with features identified in VIEW-PT¹. Patient demographics are in Table 1a. Logistic regression analysis included 1833 patients with complete data (Table 1b). Patients involved in treatment decisions (OR=4.82, p<0.001) and patients who achieved their set treatment targets (OR=2.17, p=0.002) had higher odds of achieving optimal disease control, while patients who had not achieved their set treatment targets (OR=0.31, p=0.002) had lower odds of achieving optimal disease control. Other factors associated with optimal disease control included a previous history of smoking (OR=2.13, p=0.004) or having never smoked (OR=1.91, p=0.013), having a psychological comorbidity (OR=0.27, p=0.002), not receiving advanced therapy (OR=0.54, p=0.005), and having >4 HCP visits in the past 12 months (OR=0.42, p<0.001).

Conclusion

Patient involvement in treatment decisions and achievement of treatment targets were most strongly associated with optimal disease control in patients with IBD. Other significantly associated factors included no psychological comorbidities, none or ex-smoking status, and advanced therapy prescription. This real-world evidence suggests that involving patients in treatment decisions and setting and reaching targets may support achievement of optimal disease control in patients with IBD.

References

1. Rubin et al. J Crohn’s Colitis. 2025 Jan 1;19(1): i1376-i1377.
2. Jiang et al. Qual Life Res. 2021; 30(3):803-816.
3. Janssen et al. Eur J Health Econ. 2021;22(9):1467-1475.

Disclosure

MD has received consultant and advisory fees from Abbvie, Abivax, Astra Zeneca, Boehringer Ingelheim International GmbH, Bristol-Meyer Squibb, Celltrion, Eli Lilly and Company, Genentech , Janssen Pharmaceuticals, Johnson and Johnson, Merck, Pfizer Inc, Prometheus Labs, Sanofi, Spyre, Takeda Pharmaceuticals.

ST has received grants/research support from AbbVie, Celgene, Celsius, ECCO, Galapagos, GSK, Helmsley Trust, IOIBD, Janssen, Eli Lilly and company, Pfizer, Takeda, UKIERI, Vifor, and Norman Collisson Foundation;
consulting fees from Alimentiv, Apexian, Apollo, Arcturis, AstraZeneca, BMS, Clario, Cosmo, Endpoint Health, EQrX, Equillium, Ferring, Galapagos, Genentech/Roche, Gilead, GSK, Janssen, Iterative Health, Eli Lilly and company, Mestag, Microbiotica, ONO, Pfizer, Phesi, Protagonist, Sanofi, Satisfai, Sensyne Health, Spyre, Takeda, Teva, Theravance, Tr1X Bio; has received speaker fees from BMS, Ferring, GSK, Janssen, Eli Lilly and company, Pfizer, Sun Pharma, Takeda; and has share options from Satisfai Health Inc.

APB, EK and SF are employees of Eli Lilly and Company and may hold stock or stock options.

GM is part of the speaker bureau for Lilly- 2023-present, Omvoh (mirikizumab); and Pfizer, 2018-present, Xeljanz (tofacitinib), Velsipity (etrasimod)

NA has no conflict of interest to disclose.

LW has no conflict of interest to disclose.

CO is a former employee and shareholder of Eli Lilly and Company.

XZ has no conflict of interest to disclose.

VP and GC are employees of Adelphi Real World.

RP is a consultant for Abbott, AbbVie, Abbivax, Alimentiv,Amgen, AnaptysBio, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly and company, Ferring, Galapagos, Inviva, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Janssen, Merck, Mirador, Novartis, Oppilan Pharma, Odyssey, Organon, Pandion.

Introduction

Mirikizumab is a humanized IgG4 monoclonal, anti-interleukin-23p19 antibody. VIVID-2 (NCT04232553), an ongoing open-label study, has demonstrated sustained clinical and endoscopic efficacy at 2 years of treatment of mirikizumab for Crohn’s disease (CD).¹ Here we present the long-term quality of life (QoL) up to 2 years from VIVID-2.

Aims & Methods

Patients enrolled in the phase 3 VIVID-1 study who achieved an endoscopic response to mirikizumab continued maintenance treatment in VIVID-2, while endoscopic non-responders received mirikizumab induction therapy followed by maintenance treatment. Quality of life was assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ). The proportion of patients who achieved IBDQ response/remission, as well as mean changes from VIVID-1 baseline in IBDQ total scores at W64 and104 were reported. EQ-5D-5L Visual Analog Scale (VAS) scores (range 0-100, with 100 being best imaginable health state) were assessed at W64. Work productivity was assessed at W64 using Work Productivity and Activity Impairment Questionnaire in Crohn's Disease (WPAI:CD) (4 scores including absenteeism, presenteeism, work productivity loss and activity impairment are derived as percentages with higher values indicating greater impairment). Modified non-responder imputation (mNRI) was used for binary missing data imputation, and modified baseline observation carried forward (mBOCF) was used for continuous missing data imputation. Estimates of mean changes from baseline were calculated with analysis of covariance (ANCOVA).

Results

Analysis of endoscopic responders showed IBDQ response and IBDQ remission were maintained through W104 (85.0% and 71.3%, respectively) while endoscopic non-responders also maintained IBDQ response and remission through the same time (72.6% and 60.8%, respectively). (Table 1) Mean change from baseline in IBDQ total score was maintained through W104 for endoscopic responders and non-responders (least squares mean (standard error); 57.2 (2.1) and 46.8 (2.4), respectively). Similarly, EQ-5D-5L VAS improvement was observed for both groups at W64 (27.0 (1.0) and 22.3 (1.2), respectively). WPAI:CD improvements in both groups ranged from −13.9 (1.8) to −34.3 (1.5) for the different scores collected at W64.

Conclusion

Patients continuing mirikizumab maintenance and those receiving reinduction achieved meaningful long-term QoL improvement that was maintained at 2 years of treatment.

References

1. Barnes E, Sands B, D'Haens G, et al. Long-term efficacy and safety of mirikizumab following 104 weeks of continuous treatment for Crohn's disease: results from the VIVID-2 open-label extension study. Gastroenterology. 2025;168(3 Suppl):S14-S15. doi:10.1053/j.gastro.2025.01.073.