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

Despite the increase in the therapeutic armamentarium of the treatment of Crohn’s disease (CD), historically less than 50% of patients achieve partial response after induction, and less than 20% achieve clinical remission. It remains unknown how response to biologic induction therapy influences disease behavior, treatment patterns, and health-care utilization in those patients who are maintained on biologic therapy for the treatment of their CD.

Aims & Methods

Aims: To determine the impact of achieving clinical remission after induction therapy for CD on post-induction outcomes.
Methods: A retrospective chart review of all persons with CD, age 18 or above, followed at Mount Sinai Hospital, Canada who were dispensed an approved biologic therapy for IBD between April 1^st, 1996, and June 30^th, 2021, and completed a complete course of induction was conducted. We stratified patients into those were in clinical remission as per the physician global assessment at completion of biologic induction (“remitters”) and those who were not (“non-remitters”). The start of follow-up was the completion date of biologic induction and patients were followed until end of last follow-up date. We extracted data on IBD symptoms, decisions on biologic therapy (such as discontinuation), healthcare utilization such as hospitalizations and emergency department (ED) visits, need for CD surgery, and endoscopic assessments. Endoscopic remission was defined based on a SES-CD score of £ 4 when available, or on the endoscopists’ impression of absence of mucosal inflammation.

Results

A total of 160 patients were eligible for data extraction; 60.0% were male, 35.6% and 25.0% had stricturing and penetrating complications respectively, 28.9% had perianal disease and 34.3% had a history of a CD surgery. The index biologic included Infliximab in 24.4% patients, adalimumab in 32.5% patients, vedolizumab in 25.0% patients, and ustekinumab in 11.9% patients. Fifty-five (34.4%) patients were remitters and 105 (65.6%) were non-remitters after completion of biologic induction. Those in clinical remission at induction were less likely to have upper gastrointestinal CD (3.6% vs. 10.5%), have penetrating complications (18.2% vs. 28.6%), and perianal disease (16.4% vs. 35.2%) at time of biologic start. Remitters were more likely to be in sustained clinical remission throughout follow-up compared to non-remitters (47.2% vs. 27.6%, p=0.01), be in clinical remission at last follow-up date (87.2% vs. 69.5%, p=0.04), and appeared to have a lower likelihood of discontinuing the index biologic (7.2% vs. 16.1%, p=0.06). Similarly, remitters were less likely to undergo a CD-related intestinal resection during follow-up (3.6% vs. 13.3%, p=0.05). There appeared to be no significant differences between remitters and non-remitters in proportion of patients being hospitalized for IBD (10.9% vs. 19.0%, p=0.14) or non-IBD (5.4% vs. 7.6%, p=0.62) reasons and visiting the emergency department (7.2% vs. 13.3% p=0.26). Of the 160 patients, 117 (73.1%) underwent a colonoscopy or sigmoidoscopy during follow-up. There were no differences in the rates of ulcer persistence (51.6% vs. 53.5%, p=0.63) or achievement of endoscopic remission (58.9% vs. 48.7%, p=0.76) between remitters and non-remitters at induction.

Conclusion

Achieving clinical remission after biologic induction is associated with sustained clinical remission in follow-up but not endoscopic remission.

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

Severe acute ulcerative colitis (ASUC) is a life-threatening medical emergency of colonic inflammatory bowel disease (IBD), most often in ulcerative colitis (UC) but also in Crohn's disease (CD).

Aims & Methods

The aim of our study was to compare the epidemioclinical and evolutionary profiles of ASUC in UC and in CD.
We conducted a retrospective, descriptive and comparative study including patients who presented with ASUC over a 10-year period [January 2010 - December 2019]. The diagnosis of ASUC was established on Truelove and Witts criteria and supported by endoscopic findings. Group 1 included patients with UC and group 2 included patients with CD. Patients followed for CD with anoperineal manifestations or upper gastrointestinal tract involvement were excluded. Data were entered and analyzed by SPSS software version 26.

Results

We included 71 patients with a sex ratio M/F of 0.65. The mean age at diagnosis of IBD was 31.08 years with extremes ranging from 12 to 58 years. Twenty-one percent of the patients had a body mass index greater than 25kg/m2. Thirty-three patients had UC, while 38 patients had CD. Patients in group 2 had a significantly lower mean age of occurrence of ASUC (30.84 vs. 37.33 years; p=0.02). The two groups were comparable for sex(p=0.62), smoking (p=0.71) and family history of IBD (p=0.94). ASUC was inaugural in 36.6% of the patients with no difference between the 2 groups (p=0.3). Twenty-six patients in group 1 were previously on treatment (p=0.03), mainly with Pentasa. For the diagnosis of ASUC, the median number of bloody stools was 7 with no difference between the 2 groups (p=0.56). The mean CRP level was significantly higher in group 2 (121mg/l vs 74.49mg/l;p=0.004). Severity signs on endoscopy were similar between the 2 groups (p=0.17). There was also no difference in the presence of colonic infection between the 2 groups (p=0.66). The response to the first line treatment with corticosteroids was found in 61.2% (n=38) and was significantly higher in group 2 (p=0.02). The mean number of bloody stools was significantly lower in group 2 at day 3 and day 5 of the treatment (p=0.003 and p=0.005 respectively). The decrease in mean CRP level at day 3 and day 5 of the treatment was comparable between the 2 groups (p=0.15 and p=0.12 respectively). Thus, the use of second-line therapy was more important in group 1 (p=0.017). There was no difference between the 2 groups regarding the occurrence of complications during the course of the disease, mainly colectasia, perforation and digestive bleeding (p=1, p=0.13 and p=1 respectively). Surgical treatment was required in 26.7% of the patients (n=19) without a difference between the 2 groups (p=0.53). It was significantly associated with an early occurrence of the ASUC (p=0.009), the need for second-line treatment (p<0.001) and the number of bloody stools at day 3 and day 5 of the follow-up (p<0.001 and p<0.001 respectively). There was no difference between the 2 groups regarding the occurrence of postoperative complications, mainly abscess (p=1) and rectal stump inflammation (p=0.6). The occurrence of a second ASUC under maintenance treatment was more important in group 1 without a significant difference (37.5 vs 14.7% p=0,08).

Conclusion

ASUC is the most severe complication of colonic IBD and is prone to an overall outcome independent of the type of the underlying IBD.

Disclosure

No conflict of interest

Clinical Case Summary

Cryptosporidiosis is a gastrointestinal infection caused by the protozoan Cryptosporidium spp. It is typically self-limited in immunocompetent patients. However, in immunocompromised individuals, it can lead to moderate to severe diarrhea and significant morbidity and mortality.¹
We present the case of a 31-year-old woman with a history of Crohn’s disease in remission, who presented with a one-week history of diarrhea (up to 10 bowel movements daily), abdominal pain, and fever (38°C). Laboratory tests revealed an elevated C-reactive protein (CRP), and intestinal ultrasound showed bowel wall thickening, hyperemia and wall disruption, suggestive of an active flare. However, routine stool culture isolated Cryptosporidium, and based on her clinical background, oral paromomycin and azithromycin were initiated, resulting in complete clinical remission.
Cryptosporidiosis is a common parasitic cause of diarrhea, particularly affecting immunocompromised patients, such as those with HIV, cancer or solid organ transplants.²
Although few cases have been described in inflammatory bowel disease (IBD), the immunosuppressive state of these patients may increase the risk of infection. Diagnosing cryptosporidiosis in this population can be challenging, as stool tests detect only about 30% of cases, and the clinical presentation often mimics an IBD flare.³
Treatment is generally supportive and reserved for severe or refractory cases. Nitazoxanide is the drug of choice, and in non-responders, it can be combined with fluoroquinolones or azithromycin. In IBD patients, the decision to initiate specific antiparasitic treatment depends on the degree of immunosuppression and the clinical scenario.⁴
A clear association between IBD and cryptosporidiosis has not been established, but it is crucial to rule out opportunistic gastrointestinal infections in suspected flare-ups before starting specific therapies.
image "Bowel wall thickening, hyperemia, and disruption of the normal layer pattern."

References

(1) Janssen B, Snowden J. Cryptosporidiosis. 2023 Jul 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan–. PMID: 28846353.
(2) Liu B, Schnider A, DeArmond M, Banach DB, Haubrich BA. Cryptosporidiosis in individuals with inflammatory bowel disease: a scoping review protocol. BMJ Open. 2024 Oct 15;14(10):e086529. doi: 10.1136/bmjopen-2024-086529. PMID: 39414295; PMCID: PMC11481120.
(3) Ferreira J, Baden R, Magge S, Cheifetz A. Cryptosporidiosis masquerading as a Crohn's flare. Inflamm Bowel Dis. 2011 Oct;17(10):E133-4. doi: 10.1002/ibd.21811. Epub 2011 Jul 7. PMID: 21739536.
(4) Manthey MW, Ross AB, Soergel KH. Cryptosporidiosis and inflammatory bowel disease. Dig Dis Sci 1997;42:1580–6.

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

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.