Introduction

There has been an increasing trend in the incidence of Crohn's disease (CD) in the population >60 years of age. Although biological therapies have transformed the management of CD, providing better clinical outcomes, in elderly individuals they are often underutilized due to concerns about their efficacy and safety, as this population presents greater frailty, comorbidities and polypharmacy.

Aims & Methods

This systematic review and meta-analysis aimed to compare the efficacy and safety of ustekinumab (UST) versus vedolizumab (VDZ) in the treatment of elderly patients with CD. We performed a systematic search of the PubMed, Embase, and Cochrane Library databases in January 2025. Article screening was conducted independently by two authors using Rayyan software. Inclusion criteria were studies comparing UST and VDZ in the treatment of CD in patients >60 years, with follow-up >9 months, and that evaluated at least one of the outcomes of interest. The primary outcome was clinical remission, and secondary outcomes included clinical response, general infection, and serious infection. For statistical analysis, we used Review Manager software, applying a random-effects model to calculate the odds ratio (OR) in binary outcomes.

Results

Five studies were included, totaling 404 patients, of whom 209 (51.73%) received treatment with UST and 195 (48.27%) with VDZ. The mean age of the patients was 67.9 years. In the UST group, 145 patients (78.8%) received prior treatment with anti-TNF, while in the VDZ group this number was 88 patients (51.2%). No statistically significant differences were observed regarding clinical remission (OR 0.87; 95% CI 0.51-1.48; I²=0%), clinical response (OR 1.69; 95% CI 0.81-3.53; I²=0%), general infection (OR 1.51; 95% CI 0.76-2.99; I²=0%) and severe infection (OR 2.60; 95% CI 0.54-12.52; I²=50%) between the groups treated with UST and VDZ.

Conclusion

Comparing efficacy and safety outcomes between UST and VDZ treatments in elderly patients with CD, no significant differences were observed between the groups. Randomized clinical trials are needed to confirm these findings.

Introduction

The management of inflammatory bowel disease (IBD) often relies on colonoscopy to evaluate disease activity and detect complications. However, intestinal ultrasound (IUS) has emerged as a non-invasive, accurate alternative, endorsed by ECCO-ESGAR guidelines for use in both Crohn’s disease and ulcerative colitis. This study aimed to evaluate the impact of IUS implementation on the frequency of colonoscopies performed in IBD patients at a tertiary care hospital.

Aims & Methods

We conducted a retrospective analysis comparing two time periods: before IUS implementation (2021–2022) and after its introduction (2023–2024). The number of colonoscopies performed for IBD management in each period was recorded. Screening colonoscopies in IBD patients were not included in the analysis; therefore, the data reflect colonoscopies performed specifically for the clinical management of the disease. The percentage change in colonoscopy utilization was calculated to assess the effect of IUS integration into routine clinical practice.

Results

In the pre-IUS period (2021–2022), a total of 340 colonoscopies were performed for the management of patients with IBD. After the introduction of IUS in 2023, the number of colonoscopies over the subsequent two years decreased to 280, reflecting a 17.6% reduction. This decline suggests a meaningful shift towards non-invasive monitoring facilitated by IUS.

Conclusion

The integration of IUS into the endoscopic workflow was associated with a notable decrease in colonoscopy use among IBD patients. These findings reinforce the role of IUS as a valuable, non-invasive modality for disease monitoring, with the potential to optimize resource utilization and support faster clinical decision-making. Prospective studies are needed to further assess the long-term benefits and cost-effectiveness of widespread IUS adoption in IBD care.

References

1. Panés J, Bouzas R, Chaparro M, et al., Imaging techniques for assessment of inflammatory bowel disease: Joint ECCO and ESGAR evidence-based consensus guidelines. Journal of Crohn's and Colitis. 2013;7(7):556–585. doi: 10.1016/j.crohns.2013.01.206
2. Smith RL, Taylor SA, Horsthuis K, et al., Reduction in the use of endoscopy after implementing an intestinal ultrasound service: A retrospective single-centre study. Journal of Crohn’s and Colitis. 2024;18(Suppl 1):i1344. doi: 10.1093/ecco-jcc/jjad212.1124
3. Kucharzik T, Wittig BM, Helwig U, et al., Intestinal ultrasound for monitoring of Crohn's disease activity: A prospective multicenter study. Clinical Gastroenterology and Hepatology. 2023;21(6):1397–1406. doi: 10.1016/j.cgh.2022.12.005
4. Bryant RV, Jairath V, Kucharzik T, et al., AGA Clinical Practice Update on the Role of Intestinal Ultrasound in the Management of Inflammatory Bowel Disease: Expert Review. Clinical Gastroenterology and Hepatology. 2024. [In press] doi: 10.1016/j.cgh.2024.03.014
5. Zorzi F, Bezzio C, Mazza S, et al., The role of intestinal ultrasound in ulcerative colitis: A systematic review. World Journal of Gastrointestinal Endoscopy. 2023;12(3):97210. doi: 10.4253/wjge.v12.i3.97210

Introduction

Bowel urgency (BU) is a common, debilitating symptom among patients with ulcerative colitis (UC).¹ LUCENT-URGE is a Phase 3b, open-label, single-arm 28-week (W) study in adults with moderately-to-severely active UC and BU (Urgency Numeric Rating Scale [UNRS] ≥3) at baseline treated with mirikizumab (MIRI). Here, we report W28 results from LUCENT-URGE (NCT05767021).

Aims & Methods

Patients were treated with intravenous MIRI 300 mg at W0, 4 and 8, followed by 200 mg subcutaneous at W12, 16, 20, and 24. The primary objective was to assess improvement in UNRS at W12. Key secondary objectives included evaluating the improvement in UNRS at W28, the improvement in Stool Deferral Time (SDT) and Bowel Urgency Frequency (BUF) at W12 and W28, the proportion of participants achieving clinical remission and an UNRS score of ≤1 (BU remission) at W12 and W28, and the proportion of participants achieving clinical response and an improvement in UNRS score ≥3 (clinically meaningful improvement [CMI] of UNRS) at W12 and W28. UNRS and BUF was measured using a daily diary where patients recorded the number of times they experienced BU in the past 24 hours and was averaged over a 7-day period. SDT was reported in minutes (min), and the shortest weekly SDT was used. Baseline observation carried forward was used as the endpoint for the corresponding visit for all missing observations. Missing continuous data were treated as no change from baseline and binary endpoints were treated as nonresponse for participants that discontinue prior to the time point of interest.

Results

172 patients were enrolled from 8 countries. Baseline modified Mayo score (MMS; mean± standard deviation [SD]) was 6.8±1.3, and 64.0% patients had severe disease activity (MMS 7-9). Baseline mean duration of UC was 8.0 years, mean UNRS score was 6.9 and mean BUF was 6.9 times/day. Mean UNRS and BUF improved from baseline to W28 by 3.6 and 3.8, respectively. The proportion of patients with SDT defined as “≥15 min or no urgency” was 4.1% at baseline and improved to 29.7% at W28 (Table 1). At W12, 36 (20.9%) patients achieved clinical remission, 54 (31.4%) achieved endoscopic remission, and 92 (53.5%) achieved CMI of UNRS. At W28, 62 (36.1%) patients achieved clinical remission, 76 (44.2%) achieved endoscopic remission, and 100 (58.1%) achieved CMI of UNRS. 76 (44.2%) patients achieved both clinical response and CMI of UNRS at W12, and 86 (50.0%) patients at W28. At W12 and W28, 8 patients (4.7%) and 28 patients (16.3%) achieved both clinical remission and BU remission, respectively. The safety profile of MIRI observed in LUCENT-URGE was consistent with previous studies, with no death reported and similar frequency of treatment-emergent adverse events (TEAEs). Most common TEAEs were ulcerative colitis exacerbation (5.2%) and upper respiratory tract infection (5.2%).

Table 1. Change in Bowel Urgency Measures from Baseline at Week 12 and Week 28, BOCF

Conclusion

MIRI showed an early and sustained improvement on BU severity, frequency and stool deferral time through W28 in LUCENT-URGE. MIRI consistently improved clinical outcomes in patients with moderately-to-severely active UC.

References

Dubinsky M, et al. Bowel Urgency in Ulcerative Colitis: Current Perspectives and Future Directions. AJG 2023; 118(11): 1940-53.

Disclosure

SD reports consultancy fees from AbbVie, Alimentiv, Allergan, Amgen, Applied Molecular Transport, AstraZeneca, Athos Therapeutics, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Dr Falk Pharma, Eli lilly and company, Enthera, Ferring Pharmaceuticals Inc., Gilead, Hospira, Inotrem, Janssen, Johnson & Johnson, Morphic, MSD, Mundipharma, Mylan, Pfizer, Roche, Sandoz, Sublimity Therapeutics, Takeda, Teladoc Health, TiGenix, UCB Inc., Vial, Vifor; lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals Inc., Gilead, Janssen, Mylan, Pfizer, Takeda.
AD reports fees for participation in clinical trials, review activities such as data monitoring boards, statistical analysis and end point committees from Abivax, AbbVie, Bristol Myers Squibb, Dr Falk Foundation, Galapagos, Gilead, Janssen, and Pfizer; consultancy fees from AbbVie, Alfasigma, Amgen, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Dr Falk Foundation, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Sandoz, Stada, Takeda, Tillotts, and Vifor Pharma; payment from lectures including service on speakers bureaus from AbbVie, Alfasigma, Biogen, CED Service GmbH, Celltrion, Falk Foundation, Ferring, Galapagos, Gilead, High5MD, Janssen, Materia Prima, MedToday, MSD, Pfizer, Streamed-Up, Takeda, Tillotts, and Vifor Pharma; payment for manuscript preparation from Abbvie, Falk Foundation, J & J, Takeda, Thieme, and UniMed Verlag.
DL declares counselling, boards, and transport or fees from AbbVie, Amgen, Biogen, Celltrion, Ferring, Alphasigma, Janssen, Lilly, MSD, Pfizer, Prometheus, Roche, Sandoz and Takeda.
JKL has received consultancy and speaker fees from AbbVie, Abivax, Arena, AlfaSigma, Bristol Myers Squibb, Biohit, Celltrion, Eli Lilly and Company, Ferring, Galapagos, Janssen, MSD, Pfizer, Takeda and Tillotts and research grants from AbbVie, Galapagos and Takeda.
RK reports lecture fees from Aboca S.p.A. Società Agricola, Ferring, AbbVie, and Eli Lilly and Company.
JDL consulted or served on an advisory board or data monitoring committee for Amgen, Arena Pharmaceuticals, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, Gilead, Janssen Pharmaceuticals, Merck, Pfizer, Protagonist Therapeutics, Sanofi. He has had research funding or in kind support from Nestle Health Science, Takeda, Janssen Pharmaceuticals, AbbVie and Eli lilly and company. He has had educational grants from Janssen. He has performed legal work on behalf of manufacturers of generic ranitidine and 3M. He owns stock in Dark Canyon Labs.
ZY has received research support from AbbVie, Axcella, Bristol Myers Squibb, CymaBay, Galectin, Intercept, Inventiva, Madrigal, NGM, Novo Nordisk, NST, Poxel, and Sagimet; has acted as a speaker for AbbVie, Intercept, and Bristol Myers Squibb; and as a consultant for Intercept and Madrigal.
EC reports advisory board and consultant for Pfizer, Takeda, and PRIME Education; speaker for AbbVie, Eli Lilly and Company, Janssen, and Takeda.
KA, WJE, TT, IR are employees and minor shareholders of Eli Lilly and Company.
DR reports grant support from Takeda and has served as a consultant for AbbVie, AltruBio, Arena Pharmaceuticals, Bristol Myers Squibb, Eli Lilly and Company, Genentech, Gilead Sciences, Iterative Scopes, Janssen, Pfizer, Prometheus Biosciences, Roche, Takeda, and Techlab.
MD reports consulting fees from AbbVie, Arena Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Genentech (Roche), Gilead Sciences, Janssen, Pfizer, Prometheus Biosciences, Roche, Takeda Pharmaceuticals, and UCB; contracted research from AbbVie and Janssen; stock interest in Trellus Health; and licensing fees from Takeda Pharmaceuticals.

Introduction

Crohn’s disease (CD) is a chronic condition characterized by a relapsing-remitting course, often requiring intestinal resection. Postoperative management primarily aims to maintain clinical remission. The advent of biologic therapies has undoubtedly improved disease prognosis following initial surgery. However, access to this therapeutic class remains limited in lower-middle income countries such as Tunisia, necessitating the use of alternative agents, notably azathioprine (AZA), which has been widely used for this indication, albeit with controversial results.

Aims & Methods

This study aimed to evaluate the effectiveness of AZA in maintaining remission after a first intestinal resection in patients with ileal or ileocolonic Crohn’s disease, and to identify factors associated with treatment failure.
​We conducted a retrospective, descriptive, and analytical study in the gastroenterology department of Sahloul University Hospital in Sousse (Tunisia) over a 4-year period (2020–2024). We included all patients with ileal or right ileocolonic CD who underwent intestinal resection and received AZA in the postoperative period.

Results

A total of 66 patients were included, with a mean age at diagnosis of 31.50 ± 12.24 years and a male-to-female ratio of 1.06. The median interval between diagnosis and surgery was 21.5 months. During follow-up, AZA failure occurred in 63.6% of patients (n=42), with a mean time from surgery to failure of 44.71 ± 37.74 months. In univariate analysis, ileocolonic disease location (p=0.042), the total number of flares (p=0.007), and the number of severe flares (p<0.001) prior to surgery were significantly associated with AZA failure. Failure rates were also significantly higher in patients who underwent emergency surgery (p=0.007). Inflammatory resection margins (p<0.001) and severe inflammatory activity (p=0.007) were also significantly associated with treatment failure. In multivariate analysis, three independent risk factors were identified: the number of severe flares before surgery (p=0.031), preoperative inflammatory syndrome (p=0.008), and histopathological evidence of disease at the resection margins (p=0.004).

Conclusion

Our findings suggest that thiopurines remain a valuable therapeutic option in the management of Crohn’s disease, particularly in our setting, where access to alternative therapies is limited and associated with high costs.

Introduction

Vedolizumab (VDZ) is approved for moderate-to-severe inflammatory bowel disease (IBD; ulcerative colitis [UC] & Crohn’s disease [CD]).^1,2 While the subcutaneous (SC) formulation of VDZ is effective as maintenance treatment (mTx) in patients (pts) responding to intravenous (IV) VDZ induction treatment (Tx),^1,3 real-world data on Tx patterns of pts switching mTx from VDZ IV to SC or initiating mTx VDZ SC after IV induction are limited.

Aims & Methods

This prospective, non-interventional, multicentre (NCT05384080) study (conducted under the umbrella VARIETY protocol) enrolled adults with UC or CD initiating/undergoing induction with VDZ IV or continuing VDZ IV mTx, with the option to switch to VDZ SC mTx. The primary endpoint was real-world Tx patterns with VDZ, including Tx persistence. Additional endpoints assessed pt characteristics, pt-reported outcomes, and safety (adverse events [AEs]). Data were descriptively analysed.

Results

Overall, 162 enrolled pts (August 2022–June 2023; UC, n=103; CD, n=59) were included in the interim analysis. At enrolment, 127 (78.4%) received VDZ mTx (UC, n=78; CD, n=49) and 35 (21.6%), VDZ induction (UC, n=25; CD, n=10). The mean (SD) age was 38.2 (12.3) yrs, and time since IBD diagnosis was 10.7 (11.1) yrs. Majority of pts were male (96 [59.3%]), currently employed (124 [76.5%]), had never smoked (109 [67.3%]), and reported previous biologic therapy (95 [58.6%]). Demographic and IBD Tx history data were consistent across cohorts. At baseline, in pts with UC, the mean (SD) partial Mayo score was 1.8 (2.7); in pts with CD, the mean (SD) Crohn’s Disease Activity Index (CDAI) score was 90.6 (70.1). During the 1-yr study period, 20.0% (n=7; UC, n=2; CD, n=5) of pts in the induction and 51.2% (n=65; UC, n=40; CD, n=25) in the mTx cohort switched to VDZ SC. At week (W) 52, Tx persistence was 40.0% (n=14; UC, n=11; CD, n=3) and 77.2% (n=98; UC, n=61; CD, n=37) in the induction and mTx cohorts, respectively, and highest overall in mTx pts who switched to VDZ SC (86.2%; n=56; Table). The most common reason for Tx discontinuation was investigator decision (64.7%; n=33). For VDZ IV and SC, the mean (SD) number of doses per pt was 10.5 (7.6) and 23.8 (15.0), respectively. The median time from VDZ Tx initiation to SC Tx was 383 days (induction: 98 days; mTx: 434 days). In the induction cohort, the mean (SD) Work Productivity & Activity Impairment (WPAI) scores improved from 32.7 (24.1) at baseline (n=21) to 21.5 (31.2) at W52 (n=11), and the Short IBD Questionnaire (SIBDQ) scores improved from 44.1 (10.0) at baseline (n=34) to 51.0 (12.9) at W52 (n=15). In the mTx cohort, WPAI and SIBDQ results remained consistent over time. Fifty-three AEs were reported, including 4 serious AEs (malignancy, IBD flare requiring hospitalization, abdominal abscess, and unconsciousness). One AE of special interest (hypersensitivity reaction) was considered VDZ-related.

Conclusion

In this Polish real-world study, high Tx persistence was reported, especially in pts who switched to VDZ SC. No new safety signals were noted. Overall, the results were consistent with those from other VARIETY cohorts,⁴ although lower persistence was observed during induction. The small size of the induction cohort was a limitation of this study.

References

1. Sandborn WJ, et al. Gastroenterology. 2020;158:562–72.e12.
2. Loftus EV Jr, et al. Aliment Pharmacol Ther. 2020;52:1353–65.
3. Vermeire S, et al. J Crohns Colitis. 2022;16:27–38.
4. Novacek G, et al. J Crohns Colitis. 2024;18(suppl 1):i1506–7

Disclosure

Conflicts of interest: Agata Michalak received lectures fees and/or travel grants from AbbVie, Bayer, Biocodex and Takeda. Katarzyna Karłowicz received lecture fees, consultancy fees or travel educational grants from Bristol Myers Squibb, AbbVie, Polpharma, Takeda and Pfizer. Renata Talar-Wojnarowska received lecture fees and/or travel grants from AbbVie, Astellas, Ferring, Janssen and Takeda. Adam Fabisiak received fees and/or travel grants from Bristol Myers Squibb, Pro. Med. CS, Pfizer and Polpharma. Magdalena Achtenberg received lecture fees from Ferring. Piotr Eder received lecture fees and/or travel grants from Takeda, Ferring, Astellas, Pfizer and Janssen. Maria Kłopocka received payment for lectures from Janssen, Takeda, Ferring, Alfasigma and Pharmabest and travel/accommodation/meeting expenses from Ferring, Janssen, Takeda, Alfasigma and Pharmabest. Maciej Gonciarz received compensation and/or research/educational grants from Pfizer, Polfarma, Abbvie, BMS, Ewoppharma, Ferring, Astellas, Takeda, Jansen-Cilag, Celtrion, Johnson & Johnson, and Sanofi. Grażyna Rydzewska received speaker and consultant fees from AbbVie, AlfaSigma, AstraZeneca, Bayer, Biocodex, Bristol Myers Squibb, Ferring, Janssen, Lilly, Pro. Med. Pl., Recordati, Sanprobi, SOBI and Takeda and travel/accommodation meeting expenses from AbbVie, Ferring and Takeda. Eliza Majewska is a permanent employee of Takeda Pharma Sp. z o.o. Maria Kopertowska-Majchrzak, Tomasz Romańczyk, Halina Cichoż-Lach, Małgorzata Zwolińska-Wcisło, and Elżbieta Poniewierka declare no conflicts of interest.
Funding: The study was funded by Takeda Pharma Sp. z o.o.
Acknowledgements: Medical writing support was provided by Michelle Rebello, PhD, of Cactus Life Sciences (part of Cactus Communications) and funded by Takeda Pharma Sp. z o.o.

Introduction

The prevalence of IBD is rising in racial and ethnic minorities and in countries with previous low prevalence. There are limited studies of this disease in Latin America and the Caribbean.

Aims & Methods

This cross-sectional, retrospective study used de-identified insurance claims from commercial health insurers in PR. Cases identified had ICD-10 codes for IBD and at least one of the following criteria: 2 hospitalizations for IBD, 4 IBD-related physician visits, one IBD drug claim plus one of the former, or 2 ambulatory center IBD claims plus one of the former .Variables include age, gender, insurance type (Medicare Advantage or commercial insurance), IBD diagnosis, IBD-related physician visits, endoscopies, emergency room visits, hospitalizations and surgery. Point prevalence was defined as a new and pre-existing case during a 12-month period over the average number of insured population for each year of the study period. Estimates are presented as the number of cases per 100,000 insured individuals with 95% confidence intervals (CI) using Poisson regression. The study was approved by the MSC-IRB. We aim to estimate the point prevalence of IBD in an insured population in Puerto Rico (PR) from 2018 to 2022.

Results

The average insured population for the study period was 1,764,543. IBD was identified in 6,293 individuals; 35.6% had Crohn’s disease (CD), 61% had ulcerative colitis (UC), and 3.4% were undetermined IBD. The overall prevalence of IBD was 356.6/100,000; prevalence was 127.1/100,000 for CD, and 217.5/100,000 for UC. Yearly prevalence rates showed an upward trend from 2018 to 2021 and a slight decrease in 2022. In 2018, the prevalence was 147.0/100,000 (95% CI: 145.33-148.68), increasing to 175.4/100,000 (95% CI: 173.45-177.35) in 2019 and 188.8/100,000 (95% CI: 186.77-190.89) in 2020. The peak prevalence occurred in 2021 at 215.0/100,000 (95% CI: 212.8-217.23), followed by a decrease to 199.9/100,000 (95% CI: 197.83-201.93) in 2022.

Conclusion

The increase in IBD prevalence in PR from 2018 to 2021, peaking at 215.0/100,000, aligns with previous studies suggesting an increasing disease burden on the island. An analysis for 2013 reported 181.5/100,000 across all insurance types including Medicaid. The peak in 2021 may reflect improved diagnosis, increased disease awareness, or better access following pandemic-related healthcare disruptions. The slight decline in 2022 prevalence may reflect a shift in insurance status, immigration, or a decrease in healthcare access. Continued monitoring of IBD prevalence is essential to track long-term trends, given the considerable rise since the early 2000s. Our findings place PR within the recent rising global trends of this disease and underscores the need for ongoing research and targeted healthcare strategies. The Medicaid insured population is being studied and should provide a more complete vision of IBD in PR.

References

Torres EA, Torres-Cintron M, Velazquez S, Vendrell R, Del Valle A, Pérez C M. Prevalence of Inflammatory Bowel Diseases in Puerto Rico: A Health Care Claims Analysis of  an Insured Population. PR Health Sci J 2021;40(3):103–109.
Ye Y, Manne S, Treem WR, Bennett D. Prevalence of Inflammatory Bowel Disease in Pediatric and Adult Populations: Recent Estimates From Large National Databases in the United States, 2007–2016. Inflamm Bowel Dis 2020;26:619-625.
Vendrell R, Venegas HL, Perez CM, Morell C, Roman RV, Torres EA. Differences in prevalence of Inflammatory Bowel Disease in Puerto Rico between commercial and government-sponsored managed health care insured individuals. Bol Asoc Med PR 2013;105(2) :15-19.