Introduction

Inflammatory bowel disease (IBD) exerts a significant socioeconomic burden in Western nations. Drugs are a consistent driver of direct healthcare costs. However, healthcare utilisation, which varies considerably between individuals, contributes substantially. Predicting the patients who are more likely to be higher utilizers of healthcare is challenging, as symptom burden does not always reflect underlying disease activity.^​

Aims & Methods

We aimed to establish whether model-based clustering could be used to identify novel subgroups, or clusters, of patients with IBD, and if baseline cluster membership could predict adverse disease outcomes during longitudinal follow up. We recruited patients with a diagnosis of Crohn’s disease (CD) or ulcerative colitis (UC) between 2012 and 2015. In addition to baseline demographic data, we collected data regarding somatoform symptom-reporting using the patient health questionnaire-15, anxiety or depression using the hospital anxiety and depression scale, and stool frequency, extracolonic features, and general wellbeing derived from overlapping components of the Harvey Bradshaw Index for patients with CD, and the simple clinical colitis activity index for patients with UC, all of which were used as variables for modelling. Using LatentGOLD version 6.0, we performed latent class analysis (LCA) to establish the novel clusters and select the optimal model. We measured clinical outcomes during longitudinal follow up, including flare or glucocorticosteroid prescription, treatment escalation, hospitalisation, and intestinal resection. We then performed multivariate Cox regression analysis, controlling for all baseline characteristics, to establish if individual cluster membership was an independent predictor for these outcomes, expressing results as hazard ratios (HRs) with 95% confidence intervals (CIs).

Results

Of the 760 patients recruited, 692 (91.1%) provided complete baseline data (mean age 43.6 (age range 17 to 89 years), 382 (55.2%) female, 647 (93.8%) Caucasian, and 394 (56.9%) with CD). The best LCA solution was obtained using a three-cluster model. Cluster 1 was defined by below average gastrointestinal and psychological symptom burden, cluster 2 by average gastrointestinal and psychological symptom burden, and cluster 3 by above average gastrointestinal and psychological symptom burden. Proportions with faecal calprotectin <250mcg/g at baseline were similar between clusters. Compared with cluster 1, patients in cluster 3 were at significantly increased risk of glucocorticosteroid prescription or flare, escalation, a composite of escalation, hospitalization, or intestinal resection, or any of the endpoints of interest (table 1). Effect sizes increased when only including individuals in biochemical remission at baseline. Healthcare utilization was highest in cluster 3.

Table 1- Disease outcomes according to cluster membership at baseline.

Conclusion

It is feasible to derive novel clusters of patients with IBD, based not only on gastrointestinal symptoms, but also on measures of psychological health. The cluster with the highest psychological symptom burden identifies patients at higher risk of adverse disease outcomes who are high volume users of healthcare.

Disclosure

None.

Introduction

In Inflammatory Bowel Disease (IBD), histological assessment of colonic biopsies may detect areas “indefinite for dysplasia” (IND). This definition is used when a definite distinction between non-neoplastic changes and neoplasia is not possible(1). The role of this finding in predicting the endoscopic and histological findings in IBD colitis is currently undefined.

Aims & Methods

Primary aim was to evaluate the outcome of IBD patients(pts) with an initial histological finding of areas IND in random colonic biopsies, followed up for ≥ 3 years. At this purpose, all IBD pts showing areas IND in colonic biopsies taken from March 2018 to March 2022, subsequently followed up for ≥3 years including ≥ 1 control colonoscopy were retrospectively enrolled. All pts were in regular follow up at our referral IBD Unit and underwent colonoscopy with histological assessment in the same center.

Results

The study population included 99 pts with IBD colitis and histological aspects IND detected in random colonic biopsies in 79(79.8%) pts and in target biopsies in 20(20.2%) pts. In the 79 pts, areas IND were detected in random biopsies taken from: rectum in 62(78%), left colon in 29(36%), transverse colon in 6(7.5%), right colon in 5(6.3%), >1 area in 18(22.3%) pts. In the 20 pts with areas IND on target biopsies, these were taken from stenosis (5 pts), polyps (9 pts), lateral spreading tumors (2 pts), flat elevated mucosa (4 pts). For the aim of the study, only the 79 IBD pts (37 females, 46.8%) showing in random colonic biopsies areas IND were considered. These 79 IBD pts (69 UC, 9 CD, 1 unclassified colitis) showed median age of 51 [18-79], long-standing IBD in 54(68.4%), family history of CRC in 11(13.9%), concomitant primary sclerosing cholangitis in 1(1.3%) pt. Random biopsies were taken from colonic mucosa proximal to ulcerations in 54(68.4%) pts, erosions in 19(24%) pts and to mild inflammation in 6(7.6%) pts. The second colonoscopy was performed after a median of 11[1-42] months. In the 79 pts with a first evidence of areas IND on random biopsies, the second colonoscopy detected: dysplasia in 10(12.6%) pts (high grade, HGD in 2[2.5%], low grade dysplasia, LGD in 8[10.1%]pts), areas IND in 12(15.2%) pts, no dysplasia (HGD, LGD or IND) in 38(48.1%) pts, while in the remaining 16(20.3%) pts no reliable histology was available. LGD at second colonoscopy was detected in random biopsies (4pts) or in target biopsies (4pts). Differently, in both pts with HGD it was detected in target biopsies, including one focal area of adenocarcinoma (CRC) in 1(1.3%) pt. Areas IND confirmed at second colonoscopy were detected in the same colonic segment in 11(13.9%) pts and in a different segment in 1(1.3%) pt. After the second colonoscopy, 4 out of the 79 IBD pts required IBD-related colonic surgery, and histology of the surgical specimen detected LGD in 1 pt, CRC in 1 pt and areas IND in 2 pts. During the study period (median 27[2-75] months) 51 out of the 79(64.5%) IBD pts repeated a third colonoscopy detecting: areas IND in 4(7.8%), LGD in 6(11.8%), HGD in 1(2%) pts and no CRC.

Conclusion

Patients with IBD colitis showing areas indefinite for dysplasia deserve careful endoscopic surveillance as dysplasia and CRC may be detected at subsequent colonoscopies.

References

1. Feakins R, Borralho Nunes P, Driessen A, Gordon IO, Zidar N, Baldin P, Christensen B, Danese S, Herlihy N, Iacucci M, Loughrey MB, Magro F, Mookhoek A, Svrcek M, Rosini F. Definitions of Histological Abnormalities in Inflammatory Bowel Disease: an ECCO Position Paper. J Crohns Colitis. 2024 Feb 26;18(2):175-191.

Introduction

Little is now about the natural history and impact of irritable bowel syndrome (IBS)-type symptoms on psychological health and quality of life in inflammatory bowel disease (IBD). We aimed to address this in a one-year longitudinal study of secondary care patients.

Aims & Methods

We collected demographic, Rome III IBS-type symptom, psychological, and quality of life data, with questionnaires at 3-month intervals, over 12 months of follow-up in patients with IBD in clinical remission at baseline. We assessed the natural history of Rome III IBS-type symptoms over the 12 months of the study and compared psychological and quality of life data between those reporting Rome III IBS-type symptoms at each of the points of follow-up with those not reporting such symptoms.

Results

Among 206 patients with IBD in clinical remission at baseline (104 (50.5%) women, mean age 56.9 years (range 18-83 years), 79 (38.3%) Crohn’s disease), 33 (16.0%) reported Rome III IBS-type symptoms at baseline and 72 (35.0%) reported Rome III IBS-type symptoms at one or more time points. Among the 33 patients with Rome III IBS-type symptoms at baseline, symptoms resolved in 6 (18.2%) patients, were present throughout in 6 (18.2%) patients, and fluctuated in the remaining 21 (63.6%) patients. Among the 39 patients with new onset of Rome III IBS-type symptoms after baseline, 24 (65.1%) had symptoms at one point in time only, 10 (25.6%) at two points, four (10.3%) at three points, and one (2.6%) at four points. At each point in time, reporting IBS-type symptoms was associated with significantly higher anxiety, depression, or somatoform symptom-reporting scores, and/or lower quality of life scores.

Conclusion

In this 12-month follow-up study, one-third of patients with IBD reported presence of Rome III IBS-type symptoms at any point in time. Reporting such symptoms was associated with significant impacts on psychological health and/or quality of life.

Disclosure

none

Introduction

Psychological co-morbidity, including anxiety and depression, is highly prevalent in inflammatory bowel disease (IBD), and associated with worse disease outcomes and increased healthcare utilization. This complex relationship likely arises due to gut-brain axis communication. Treatments targeting this pathway, including psychological therapies, may provide a means of improving psychological health in IBD. However, randomised control trials (RCTs) examining effect of psychological therapies in IBD are conflicting, and a previous meta-analysis demonstrated only short-term improvements in quality of life.

Aims & Methods

To assess whether psychological therapies positively impact psychological health of patients with IBD, we updated our previous systematic review and meta-analysis. RCTs examining the effects of psychological therapies vs. control in adults with IBD were identified by searching MEDLINE, EMBASE, EMBASE Classic, PsychINFO, and the Cochrane central register of controlled trials. Two investigators assessed eligibility of potential studies and extracted data from eligible studies independently. Continuous outcomes assessed included the effect of psychological therapies on measures of psychological health, including depression, anxiety, stress, and quality of life scores. Where data were available, outcomes were assessed both upon completion of therapy, and again at the final point of follow-up. The effect of psychological therapies was summarised using a standardised mean difference (SMD) with 95% confidence intervals (CIs).

Results

In total 25 RCTs were included, reporting data from 2,227 patients with IBD. Nine studies examined effects of psychological therapies in specific populations, including patients with reduced quality of life, elevated stress scores, fatigue, or presence of depressive symptoms. The remaining studies were conducted in unselected patients. In four RCTs, for patients with clinically active IBD, upon completion of treatment, quality of life scores were significantly higher in patients assigned to psychological therapies (SMD = 0.68; 95% CI 0.09 to 1.26, p=0.02), but there was no improvement in anxiety scores (SMD = -1.04; 95% CI -2.46 to 0.39). The effects of psychological therapies for patients with quiescent disease in 21 RCTs are summarized in table 1; psychological therapies led to significantly lower anxiety, depression, and stress scores, and significantly higher quality of life scores at treatment completion. This benefit persisted to final follow-up in trials for depression scores. Effect was strongest with third wave therapies, and in RCTs recruiting selected patients.

Table 1- Effect of Psychological Therapy on measures of psychological health in patients with quiescent IBD.

Conclusion

Psychological therapies exert short-term benefits on all aspects of psychological health for patients with quiescent IBD and improve quality of life in patients with clinically active disease. Future RCTs should examine the effects of these therapies in selected groups of patients with evidence of psychological distress, where benefit is likely to be greatest.

Introduction

Inflammatory bowel disease (IBD) and endometriosis are immuno-mediated chronic inflammatory diseases observed in young women, sharing some of the clinical manifestations (i.e. abdominal pain). The possible association and the relationship between endometriosis and IBD is undefined.

Aims & Methods

In a multidisciplinary approach, we aimed to assess in patients with IBD and concomitant endometriosis, the clinical outcome in terms of abdominal pain and endometriosis-related symptoms at 6 and 12 months and characteristics of endometriosis. All female IBD pts in childbearing age referring symptoms compatible with endometriosis were enrolled and referred to dedicated gynecologists for transvaginal ultrasonography (TVS). Inclusion criteria: 1) female gender; 2) age ≥18 and ≤55 years; 3)well-defined diagnosis of IBD; 4) symptoms compatible with endometriosis; 6) consent. Exclusion criteria: 1) pregnancy; 2) menopause; 3) suspected pelvic malignancy at TVS. Characteristics of IBD, endometriosis and adenomyosis were classified according to standard criteria. Data were expressed as median [range]. The Student-t Test and χ2 test were used for comparisons.

Results

Endometriosis was diagnosed in 25 (71%) out of 35 IBD patients with compatible symptoms. These 25 IBD pts included 12 (48%) Crohn’s Disease (CD) and 13 (52%) Ulcerative Colitis (UC). CD and UC patients were comparable in terms of age (38 [28-47] vs 39 [25-53]; p=0.75). IBD characteristics included: IBD duration: 11.5 [1-35], CD 11 [1-25] vs UC 12 [1-35] years; p=0.8, CD localization: ileum 4 (33.3%), colon 1 (8.4%), ileum-colon 7 (58.3%), CD behavior: non-stricturing non-penetrating 6 (50%), stricturing in 3 (25%), penetrating in 3 (25%) pts, UC extent: proctitis 3 (23%), left-sided 5 (38.5%), pancolitis in 5 (38.5%) pts. Other IBD characteristics did not differ between CD and UC pts with endometriosis. In IBD patients with endometriosis, a comparable frequency of dysmenorrhea (9 [75%] vs 13 [100%] pts; p=0.47), dyschezia (5 [41.7%] vs 6 [46.1%] pts; p=0.85), dyspareunia (9 [75%] vs 10 [76.9%] pts; p=0.72), dysuria (0 [0%] vs 3 [23.1%] pts; p=0.24) was observed between CD and UC. At transvaginal ultrasonography, deep infiltrating endometriosis was observed in all thr 25 patients with IBD and endometriosis. Moreover, a high frequency of rectal endometriosis was detected in these 25 IBD pts (6 [24%]). Adenomyosis was observed in 19 (76%) IBD pts with endometriosis, with no differences between CD and UC (8 [66.6%] vs 11 [84.6%]; p=0.56).
Among the 25 IBD pts with endometriosis, 10 (40%) underwent dienogest or estroprogestinic treatment. At 6 months, gynecological follow up was available in 9 pts, of whom 7 were on dienogest or estroprogestinic treatment. Among these 7 pts, 4 reported no endometriosis-related symptoms and 5 no abdominal pain. At 12 months, gynecological clinical follow-up currently includes 6 pts (25%), all on progestinic treatment. Of these, only 2 pts reported abdominal pain while 3 pts reported recurrence of endometriosis-related symptoms.

Conclusion

In the tested population, endometriosis was present in half of IBD pts with compatible symptoms, particularly DIE, with a high rate of rectal endometriosis. After endometriosis treatment, a lower proportion of patients referred abdominal pain. Endometriosis, often mimicking IBD, should be searched and treated in IBD young patients in order to avoid ineffective treatments.

Introduction

Inflammatory bowel disease (IBD) management faces significant care gaps, particularly in areas such as diet and mental health support. Digital health applications provide remote support to patients with IBD to improve health, however few digital applications have published evidence of efficacy.

Aims & Methods

The purpose of this randomized controlled trial (RCT) was to identify if use of the LyfeMD digital health platform results in significant changes in health behaviours among patients in remission with Crohn’s Disease (CD) and Ulcerative Colitis (UC). LyfeMD is an integrated digital and human platform designed to improve physical and mental health. Patients over the age of 18 with UC or CD in remission were recruited in Calgary, Alberta. Participants were randomly assigned to the LyfeMD intervention (n=10) or the standard care control (n=10) group. The intervention group was given access to the LyfeMD mobile app for 8 weeks and assigned a health coach. Self-reported validated measures were collected at baseline and week 8 including demographics, leisure-time physical activity (LTPA), stress score (SS), depression and anxiety risk, sleep, screen-time outside of work, and sitting time. Diet intake was collected using 2 consecutive 24-hour recalls (ASA-24) at baseline and week 12. Intake data was used to calculate the healthy eating index (HEI). Independent and paired sample t-tests were used to identify significant differences between and within groups.

Results

Twenty people were recruited for this study (N=10 per group); 65% were female, with a mean age of 45.3 years (standard deviation) [SD] =9.9). Mean body mass index was 28.1kg/m2 (7.0) and 80% of the participants had CD. After 8 weeks the intervention group showed significant improvements in risk of anxiety (mean = -1.9/21 [2.3]) screen time (mean = -7.2/168 hours/week [11.3]), sitting hours (-10.6/168 hours/week, [12.9], and overall well-being (mean = +12.5/100 [21.2]) (p<0.05). At week 12 the intervention group also showed significant improvements in both overall diet quality (mean = +12.2/100 [16.6]) and moderation scores (mean= +5.6/50 [5.0]). Between the groups we see significant differences for both sitting time and for the moderation component of the HEI (p<0.05).

Conclusion

The LyfeMD digital health platform is a safe option for patients with IBD, providing accessible lifestyle therapy thus, reducing current gaps in the healthcare system. Future studies should focus on an increased sample size and targeting remote populations where this program may be even more valuable to healthcare providers and patients.

Disclosure

Lorian Taylor, Puneeta Tandon and Maitreyi Raman are cofounders of LyfeMD. Vidya Rajagopalan at the time of this study worked for the University of Calgary and presently works for LyfeMD.

Introduction

Patients with inflammatory bowel disease (IBD) require long-term, intensive care. To optimise future healthcare delivery, identifying patients suitable for remote monitoring is crucial. Patient-reported outcome measures integrated within eHealth systems, such as the 4-item Mobile Health Index (mHI)¹, offer potential for predicting disease activity. This study explores the predictive value of the mHI within the e-health system DEARhealth² at a Dutch university medical centre.

Aims & Methods

This multi-centre prospective cohort study tracked IBD patients within the e-health system. Patients were categorised into high-, intermediate-, and low-risk groups based on current and past biochemical disease activity. High-risk patients had current biochemical disease activity (FCP > 150 µg/g and/or CRP > 5 mg/L), intermediate-risk patients were in remission but experienced a biochemical flare within the last three years, while low-risk patients had been in biochemical remission for at least three years. A personalised care pathway, considering both risk group and medication usage, dictated the frequency of outpatient visits and lab tests. Over a 24-month period, patients are monitored according to standard of care (biochemical disease activity; endoscopic disease activity) and with mHI scores at both pre-defined time points and patient-initiated moments. These preliminary results focus on assessing the predictive value of the mHI, above a validated cut-off value¹, at baseline for predicting a flare within six months. Sensitivity, specificity, and predictive values are calculated alongside simple logistic regression and Kaplan-Meier analyses.

Results

Out of 319 patients (56.7% Crohn’s Disease (CD), median age 43 years, median disease duration 15 years), 89 exhibited biochemical disease activity at baseline and were excluded from the current analysis. Among the 230 patients in remission at baseline, 51 (21.3%) scored above the mHI cut-off point at baseline and 79 (34.3%) experienced a biochemical flare-up within six months of follow-up. The relative risk of experiencing a disease flare in Ulcerative Colitis (UC) patients with a baseline mHI score above the cut-off point was 2.44 (p = 0.04) with sensitivity of 42.1%, specificity of 82.4%, positive predictive value of 40.0%, and negative predictive value of 83.6%. In CD patients, this relative risk was 1.62 (p = 0.39) with sensitivity of 38.5%, specificity of 73.4%, positive predictive value of 14.7%, and a negative predictive value of 90.9%. Logistic regression analysis revealed a significant association between a mHI score above the cut-off point and disease flares in UC patients (OR = 3.394, 95% CI: 1.110-10.330, p = 0.03), whereas in CD patients, such an association was not significant (OR = 1.724, 95% CI: 0.487-5.603, p = 0.37). Similarly, Kaplan-Meier analysis demonstrated a longer flare-free survival in UC patients with a baseline mHI score below the cut-off point (p = 0.03), while no significant difference was observed in CD patients (p = 0.14).

Conclusion

This study indicates that the mHI could be a valuable tool for predicting disease activity, and particularly quiescent disease, in UC patients. However, this predictive capability was not observed in patients with CD. These results underscore the potential utility of mHI in enhancing the management of IBD patients, with implications for personalised care and resource allocation within healthcare systems. Further research should explore repeated mHI measurements in combination with biomarkers like calprotectin for a more comprehensive approach.

References

¹ Van Deen, W. K., van der Meulen-de, A. E., Parekh, N. K., Kane, E., Zand, A., DiNicola, C. A., ... & Hommes, D. W. (2016). Development and validation of an inflammatory bowel diseases monitoring index for use with mobile health technologies. Clinical gastroenterology and hepatology, 14(12), 1742-1750.

² DEARhealth: Software as a medical device using Dynamic & Risk-based care pathways and Smart Decision Support Recommendations. DEARhealth. (n.d.). https://dearhealth.com/hospital/

Disclosure

PWJM reports consulting fees from Abbvie and Takeda, and payment for presentations from Galapagos and Takeda. PWV reports consulting fees from Abbvie, Galapagos, BMS, Janssen, Lilly, and Takeda, and payment for presentations from Galapagos and Takeda. AEvdMdJ received research grants from Nestle, Norgine, Cablon, Galapagos, and ZonMw, including speaker’s fees from, Tramedico, Janssen Pharmaceuticals, Takeda, Galapagos, Vedanta, Ferring, and AbbVie. These are not related to this work. All other authors have no conflicts of interest to declare.
This study has received funding from Galapagos/Alfasigma