Introduction

Due to the diverse symptoms experienced by patients living with Crohn's Disease (CD) and Ulcerative Colitis (UC), it can be challenging to understand how best to assess the benefit of new therapeutics for these conditions. Identifying priority symptoms that significantly impact patient’s well-being and functioning is essential to inform the development of new therapies that truly improve their quality of life. Qualitative interviews with patients are a fundamental step in collecting this critical data, ensuring patient-focused drug development. This study aimed to identify the most pertinent concepts (signs, symptoms, and impacts) from the patient perspective to provide an in-depth understanding of what aspects of their condition they prioritize.

Aims & Methods

A total of 24 qualitative interviews were conducted with US adult patients with UC or CD. Concept elicitation was conducted remotely using an IRB-approved, semi-structured guide. Participants rated the bothersomeness on a 10-point scale from 0 (no bother) to 10 (greatly bothersome); the average rating of bothersomeness for each symptom was calculated and combined with the total number of incidence reports to assess the saliency of each identified concept. Data were analyzed in Atlas.ti and then visualized in a graphical format using Microsoft Excel. Salience was assessed for the present time ('at the interview') and at worst.

Results

Twelve UC adults (mean age: 39.5 years, 7 female, 7 white, 4 with only high school education) participated. The average time since UC diagnosis was 5.3 years, with 10 receiving one UC treatment at the time of the interview. Patients with UC most frequently reported rectal bleeding (N=12), fatigue (n=9/12), abdominal pain (n=9/12bowel urgency (n=9/12), and diarrhea (n=8/12). The symptoms identified as most bothersome in a ranking task were abdominal pain (n=7/12), bowel urgency (n=5/12), rectal bleeding (n=4/12), and diarrhea (n=4/12). In symptom salience tasks 'at its worst', rectal bleeding (bothersomeness, 8.7/10) and bowel urgency (bothersomeness, 9.3/10) were identified as most salient. Most frequently reported UC impacts were diet change (N=12, worrying (n=10/12) and increased need for rest (n=10/12).  
 
Twelve CD adults (mean age: 40.3 years, 8 female, 10 white, 4 with only high school education) participated. The average time since CD diagnosis was 10.3 years, with 11 receiving one CD treatment at the time of the interview. Patients with CD most frequently reported fatigue (n=11/12bowel urgency (n=9/12), abdominal pain (n=8/12), and diarrhea (n=7/12). The symptoms identified as one of the most bothersome to patients in a ranking task were fatigue (n=8/12%), frequent bowel movements (n=6/12), diarrhea (n=4/12), bowel urgency (n=4/12) and abdominal pain (n=8/12). In symptom salience tasks 'at its worst', fatigue (bothersomeness, 8.3/10) was identified as most salient. Most frequently reported CD impacts were inability to leave home (n=10/12), low mood (n=10/12) and planning around bathroom use (n=10/12).

Conclusion

The UC and CD patients reported priorities and concerns that may not be adequately assessed by the Mayo score (fatigue, abdominal pain and bowel urgency are not assessed) and CD Activity Index (CDAI) (fatigue, bowel urgency and diarrhea are not assessed) currently used in UC and CD clinical trials, respectively. This underlines a need to increase patient experience data collection and to investigate whether inflammatory bowel disease (IBD) drugs in development (as well as those already approved) adequately address patients’ priorities.

Introduction

Patients enrolled in randomised controlled trials (RCT) of advanced therapeutics in inflammatory bowel disease (IBD) may differ from the target population of patients given these same drugs in routine practice. Prior research from 2012 indicated that only approximately a third of patients would theoretically qualify for enrolment in an RCT (1). We aimed to re-evaluate the overlap between patients in routine practice and those in contemporary RCTs.

Aims & Methods

We evaluated all patients with active IBD at our institution who were considered for treatment with a biologic or small molecule (both de novo and switching). Their characteristics were compared against inclusion and exclusion criteria of recently completed or ongoing RCTs: ozanimod, upadacitinib, risankizumab, golimumab-guselkumab, guselkumab (Crohn’s disease [CD] only), filgotinib, mirikizumab, and etrasimod (ulcerative colitis [UC] only for the latter three drugs). We calculated the percentage of patients ineligible for all evaluated trials and identified the commonest criteria for ineligibility.

Results

We evaluated 286 patients (155 CD, 131 UC); 16 additional patients with IBD unclassified were ineligible for trial participation by default. Among patients with CD, 34.2% (53/155) would have been eligible for participation in at least one RCT; among patients with UC, 47.3% (62/131) would have been eligible for participation in at least one RCT (Table 1). Patients with CD would have been excluded mainly due to the presence of stricturing or penetrating disease, the presence of ostomies, comorbidities, including history of malignancy, and insufficient symptoms despite endoscopic activity. Patients with UC would have been excluded mainly due to insufficient symptoms despite endoscopic activity, ulcerative proctitis, newly diagnosed disease, and comorbidities, including history of malignancy.

Table 1. Number of patients (n, %) with inflammatory bowel disease eligible for participation in a randomized clinical trial.

Conclusion

Only a minority of patients with IBD from routine practice would be eligible for participation in contemporary RCTs, although the percentage has increased for patients with UC compared to past studies.

References

1. Ha C et al. Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population. Clin Gastroenterol Hepatol 2012;10:1002-7.

Disclosure

JH received speaker’s fees from Abbvie, Janssen, and Takeda; consulting fees from Alimentiv Inc.
EH declares no conflict of interest.
TK declares no conflict of interest.
TV declares no conflict of interest.
DD has served as a speaker, consultant, and/or advisory board member for MSD, Abbvie, Takeda, Pfizer, Janssen, Krka, Eli Lilly, Oktal Pharma, Roche, Novartis, Amgen, and Lek.

Introduction

Current treatments for Crohn’s disease (CD) and ulcerative colitis (UC) are associated with loss of treatment response. However, studies assessing the real-world burden of non-response in Canada are scarce and the clinical and humanistic burden remains unknown. We aimed to describe the burden of active disease on symptom prevalence and work impairment by describing patients with CD and UC according to remission status.

Aims & Methods

Data were drawn from the Adelphi Real World Inflammatory Bowel Disease Specific Programme™, a real-world, cross-sectional survey of gastroenterologists (GEs) and their consulting patients with CD and UC in Canada from June 2023 to January 2024. Data included physician-reported patient demographics and clinical characteristics. Descriptive analyses were conducted.

Results

19 physicians reported data for 144 patients (73 with CD and 71 with UC). Physicians reported 20% of patients not to be in clinical or endoscopic remission (non-remitters), 31% to be in clinical remission only and 49% in both clinical and endoscopic remission. Mean (standard deviation) age was 44.5 (20.5) years among non-remitting patients, 33.5 (13.3) years among those in clinical remission only and 40.4 (17.4) years among patients in those with clinical and endoscopic remission. Among non-remitting patients, 38% were an ex-smoker, versus 14% of clinical remission and 18% of clinical and endoscopic remission patients. The most reported comorbid conditions included anxiety (24% non-remitters, 14% clinical remitters, 18% clinical and endoscopic remitters), depression (14% non-remitters, 0% in clinical remitters, and 14% in clinical and endoscopic remitters) and hypertension (14% non-remitters, 9% clinical remitters, and 14% clinical and endoscopic remitters). Top three current symptoms included fatigue (52% non-remitters, 32% clinical remitters, 15% clinical and endoscopic remitters), abdominal pain (69% non-remitters, 14% clinical remitters, 7% clinical and endoscopic remitters), and non-bloody diarrhea (48% non-remitters, 7% clinical remitters, 6% clinical and endoscopic remitters). Regarding employment, 38% of non-remitters were working full-time versus 48% of clinical remitters, and 58% of clinical and endoscopic remitters.

Conclusion

Patients with CD/UC that had not achieved or maintained remission experienced more symptom burden, comorbid conditions, and were often not in full-time employment than those in disease remission. Notably, non-remitters experienced a high symptom burden, including fatigue, abdominal pain, and diarrhea, which impacted daily living. Patients with both clinical and endoscopic remission experienced fewer symptoms and full-time employment. This highlights the importance of, and significant unmet need for, effective treatment in IBD to manage disease symptoms and decrease inflammation.

Disclosure

Janssen Global Services funded the research and I am an employee of Janssen

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

Despite new therapeutic strategies, substantial proportion of patients with ulcerative colitis (UC) undergo colectomy at some point. Restorative proctocolectomy with ileal pouch ano anastomosis (IPAA) is regarded as intervention of choice in these patients. However, the disease conversion to Crohn´s disease (CD) is reported in up to one third of these patients who necessitate immune suppressive treatment after IPAA. Considering the life-long need for immune suppressive therapy in these patients, ileo-rectal anastomosis (IRA) would represent a good alternative to IPAA in this specific group of patients. Todate, no data are available to predict the UC-CD conversion. One of the possibility to reduce the risk of performing IPAA in patients developing CD in pouch is to use the modified two-stage proctocolectomy approach and identify patients who develop CD endoscopically between colectomy and the restoration of continuity.

Aims & Methods

The aim of the present study was to assess the UC-CD conversion rate identified prior IPAA via ileoscopy.
All patients with UC operated in one tertiary IBD center between 2016 and 2021 were identified in medical records. The main outcome was CD detected at ileoscopy between the first stage operation, i.e. total colectomy with terminal ileostomy and the restoration of continuity either via IPAA or IRA. The ileoscopy was performed between three to six months after colectomy. The secondary outcome was the rate of conversion to CD after IPAA or IRA.

Results

Sixty patients underwent total colectomy (mean age 41 years, range 22-77; 62% were men); seven patients were lost to follow-up, finally the data from 53 patients were analysed. The majority of these patients (36 - 68%) underwent colectomy for therapy resistent chronically active UC, 9 (17%) patients for acute severe UC, 2 patients had benign colonic stenosis, 5 had high-grade dysplasia or colorectal cancer detected at surveillance colonoscopy and one patient had extensive pseudopolyposis.
All resection specimen were reviewed and no histopathological features of CD were found. Three out of the 53 (6%) ileoscopically assessed patients prior IPAA or IRA were diagnosed with CD in prestomal terminal ileum. During the further follow-up, additional 4 patients developped CD, two after IPAA, one with definitive ileostomy in prestomal ileum and one in neoterminal ileum after IRA.
In total 7 out of 53 patients in this cohort developped CD (13%). Using the two stage approach with ileoscopy between colectomy and restoration of continuity, three out of these seven patients with CD convertion in this cohort were detected prior the decision on the type of second-stage operation.

Conclusion

The conversion from ulcerative colitis to Crohn`s disease occurs in a significant proportion of IBD patients after colectomy. Ileoscopy performed between the two stages of restorative proctolectomy is helpfull in detecting these patients and guiding the decision on the type of surgical intervention to restore continuity.

Disclosure

Nothing to disclose.

Introduction

Acute severe colitis (ASC) is a medical-surgical emergency that can occur at any time during the course of chronic inflammatory bowel disease. It most commonly affects UC.

Aims & Methods

Aims: The aim of our work is to describe the particularities of GCA management during Crohn's disease (CD).
Materials and methods: This is a retrospective descriptive and analytical study spread over a 5-year period from January 2018 to January 2023. All patients who developed GAC during the course of Crohn's disease, whether inaugural or progressive, were included in our study.Data collected included age, sex, Crohn's disease location and phenotype, Lichtiger score before and after coticotherapy, second-line treatment, and use of surgery. SPSS 2.0 software was used for the statistical study. A binary logistic regression model was used for univariate analysis.

Results

Of the 424 IBD cases, 267 were being followed for Crohn's disease, of whom 38 (14.2%) patients presented with GAC. Mean age was 44.21 ±12.7 years (range 19-72 years). The F/H sex ratio was 1.9 (25 women to 13 men).The location of Crohn's disease was pancolic in 28 patients, ileocolic in 9, and ileocolic with high involvement in 1 patient. GCA was inaugural in 10 patients (26.3%), and complicated known Crohn's disease in 28 patients (73.7%). The mean Lichtiger score calculated at D0 was 11.84±1.8. The mean CRP value on admission was 89.8±47. Mean albumin was 27.9±3.6. Emergency abdomino-pelvic CT scans showed no complications such as colectasis, perforation or abscess in our series. All patients received IV methylprednisolone corticosteroids at a dose of 0.8 mg/kg/d, not to exceed 40 mg/d, with close clinico-biological monitoring. 21 patients (55.2%) were corticosensitive. The mean Lichtiger score calculated at D5 in corticosensitive patients was 8.7, with a mean CRP value at D3 of 36.8±12.

In univariate analysis, CRP >45 (on admission) and hypoalbuminemia were predictive factors for failure of IV corticosteroid therapy, with [OR=3.2 [1.3-5.2]; p=0.0005] and [OR = 1.31 [1.015-7,] p=0.002] respectively.Of the 17 (44.8%) cortico-resistant patients, 3 (7.9%) received emergency second-line treatment with Infliximab, and 15 (39.47%) underwent subtotal colectomy with ileostomy. Of these patients, one was scheduled after failure of second-line treatment. Good outcome was noted in 36 patients (94.7%). 2 cases of death (5.3%) were reported postoperatively. On discharge, 23 patients (63.9%) were treated with immunosuppressive agents or 13 (36.1%) with biotherapy.

Conclusion

Acute severe colitis can reveal or complicate Crohn's disease at any stage of its evolution. Management must be urgent, and requires medical-surgical coordination. The first-line medical treatment is intravenous corticosteroid therapy. Colectomy should be discussed at every stage of management.