Introduction

Disease clearance (DC), defined as combined clinical, endoscopic and histologic remission, has been proposed as the ultimate therapeutic target in ulcerative colitis (UC). However, the addition of faecal calprotectin (FC) remission to DC, now proposed as ‘complete disease clearance (CDC)’, in predicting for relapse is unknown. We aimed to explore the use of composite therapeutic endpoints, including DC and CDC, in predicting long-term outcomes for UC patients on vedolizumab (VED).

Aims & Methods

The phase IV Vedolizumab Immunomodulator Enforced Withdrawal Study (VIEWS) prospectively recruited UC patients in steroid-free clinical remission on VED 300mg IV q8w. Baseline evaluation (week 0) included FC, endoscopy, histology, and serum VED trough levels. Remission definitions were FC<150µg/g, centrally-read Mayo endoscopic score (MES)=0 and centrally read Nancy index (NI)=0 by a gastrointestinal pathologist. FC value differentiated DC and CDC. DC was defined as FC≥150µg/g, MES=0 and NI=0. CDC was defined as FC<150µg/g, MES=0 and NI=0. Clinical relapse, defined as partial Mayo score ≥3 and FC≥150µg/g or MES increase of ≥1, was evaluated for 2 years. Cox regression, Kaplan-Meier curves and log rank statistics were performed to assess the time to clinical relapse. Odds ratios (OR) and 95% confidence intervals (CI) were calculated for dichotomous categorial variables. Multivariate logistic regression models were performed to identify predictive factors of relapse. P<0.05 was deemed statistically significant (IBM SPSS Statistics, version 30).

Results

62 consecutively recruited UC patients were followed over 24 months. Of 54 patients with endoscopic assessments at baseline, 80% were in endoscopic remission, 76% histologic remission, 68% had DC, and 63% had CDC. Baseline CDC was associated with significantly lower rates of clinical relapse compared with DC and clinical/endoscopic remission alone (log rank P<0.001; HR: 0.17 [95%CI:0.04-0.64], P=0.009) (Figure 1). Baseline CDC had an OR of 0.16 (95%CI:0.04-0.75, P=0.01) in predicting relapse, versus DC (OR: 0.20 [95%CI:0.05-0.89], P=0.03), endoscopic remission (OR:0.91 (95%CI:0.16-5.15), P=0.92), histologic remission (OR: 0.10 [95%CI:0.02-0.50], P=0.002), and neither endoscopic nor histologic remission (OR:4.44 [95%CI:0.55-35.90], P=0.13). Univariate predictors of CDC at baseline were female sex (P=0.03), UC disease duration < 5 years (P=0.01), smoking status (P=0.004) and serum VED concentrations (P=0.03). On multivariate analysis, only female sex (OR: 7.0 [95%CI: 1.17-42.33], P=0.03) predicted for CDC.

Conclusion

CDC, a novel composite endpoint, predicted for significantly lower rates of relapse compared with DC in UC patients on VED. Female sex was associated with baseline CDC. FC should be incorporated into composite endpoints with endoscopy and histology.

Disclosure

Aviv Pudipeddi has received speaking and consulting fees from AbbVie and Takeda.
Sudarshan Paramsothy has received speaking and consulting fees from AbbVie, Janssen and Takeda.
Craig Haifer has received speaking and consulting fees from Takeda.
Jakob Begun has received speaking and consulting fees from Takeda.
Crispin Corte has received speaking and consulting fees from AbbVie, Takeda, Janssen, Pfizer, Ferring and Celltrion.
Mark Ward has received speaking and consulting fees from AbbVie, Takeda, Janssen and Pfizer.
Peter De Cruz has received speaking and consulting fees from AbbVie, Janssen and Celltrion.
Rupert Leong has received unrestricted funding from Takeda.

Introduction

The increase in life expectancy has led to a more frequent performance of invasive procedures in older patients, including endoscopic retrograde cholangiopancreatography (ERCP). Elderly patients often present with multiple comorbidities and technical challenges, which may lead to the rejection of the procedure due to concerns about morbidity and mortality, as well as the potential futility of treatment. Few series address the safety and efficacy of ERCP in patients aged ≥95 years.

Aims & Methods

To compare the clinical characteristics, techniques, complications, and short- and long-term outcomes of super-elderly (≥95 years) and elderly (65-70 years) patients undergoing ERCP at La Paz University Hospital. A retrospective study was conducted, including all ERCP performed in super-elderly patients between 2018 and 2024. For the elderly group, an equal number of procedures performed during the same period were randomly selected and matched by sex. Data on demographics, comorbidities, indications, technical characteristics, complications, technical success rates and mortality at 30 days, 6 months and 12 months were collected and compared.

Results

A total of 92 procedures were included in each group, with 78.3% women in both groups. Super-elderly patients had a higher frequency of comorbidities, such as hypertension, heart failure, atrial fibrillation, chronic kidney disease and dementia (p<0.01). In terms of frailty, they had a significantly lower Barthel index compared to the elderly (p<0.001). ERCP indications were predominantly urgent in the super-elderly (cholangitis and biliary colic), while the elderly had a higher proportion of elective procedures such as planned choledocholithiasis and tumor-related causes (p<0.01). Most procedures in the super-elderly were performed in a hospital setting, while in the elderly, outpatient procedures predominated (p<0.001). Although no differences were observed in average hospital stay (p=0.59), the elderly had a higher proportion of procedures with 24-hour observation (p<0.001). In terms of techniques performed, the elderly group underwent more complex procedures such as cholangioscopy and radiofrequency ablation than the super-elderly. Technical success and procedure completion rates were similar (95.65% in the elderly and 96.74% in the super-elderly, p>0.05). Globally, immediate complications were slightly more frequent in the super-elderly (32.6%), although without significant differences compared to the elderly (25%, p=0.33); similarly for late complications. Regarding technique-related complications, despite the rates being comparable, the types of complications varied between the groups. In the elderly, mild pancreatitis predominated, whereas the super-elderly experienced a broader range of complications, including moderate pancreatitis, severe cholangitis and perforations, with a tendency towards greater severity, suggesting higher fragility in this group. Despite this, no statistically significant differences were observed in short- or long-term mortality. In the elderly, most deaths at 6 and 12 months were due to biliary causes (77.8% and 70%, respectively), primarily due to tumor-related processes. In the super-elderly, only 26.3% of deaths at 6 months and none at 12 months were due to biliary causes, reflecting the influence of additional comorbidities in this group.

Conclusion

Although super-elderly patients have a higher burden of comorbidities and frailty, the technical success and procedure completion rates are similar to those of 65-70-years-old. The indications and therapeutic approaches vary significantly between the two groups, with a higher proportion of urgent procedures in the super-elderly and a greater frequency of advanced techniques in the elderly. Despite differences in clinical characteristics, no significant differences in short- and long-term mortality were observed, suggesting that ERCP is safe and effective in both age groups, highlighting the importance of not rejecting the indication solely due to advanced age.

References

Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20. PMID: 31863440.

Introduction

No data exist on the relationship between serum and tissue infliximab (IFX) concentrations and outcomes in acute severe ulcerative colitis (ASUC).

Aims & Methods

In hospitalized patients (pts) with ASUC treated with IFX rescue therapy, we assessed relationships between longitudinal serum and tissue IFX concentrations and pt outcomes. In an open-label, prospective study, hospitalized ASUC pts treated with IFX rescue therapy were followed for 22 weeks (wks) at 2 centers. Inclusion criteria: (A) hospitalized ASUC (partial Mayo score [PMS] > 7, baseline Mayo endoscopic score [MES] ≥ 2 and met Truelove/Witts criteria) (B) receiving either standard or accelerated rescue IFX. From IFX initiation until wk 22, clinical scores (PMS) and serum sampling were performed at multiple induction and maintenance timepoints (hospital/outpatient). Colonoscopy scores (MES) and biopsies were collected on day 2-5 post first infusion (early inpatient) and wk 16-22 (maintenance). Outcomes: Median area under the curve (AUC) of serum IFX concentration during early induction (wk 0-2), induction (wk 0-14) and maintenance (wk 15-22) were compared between wk 22 endoscopic remitters (ERs) (MES 0 or 1 without UC-related hospitalization or colectomy) and non-remitters (NRs). Tissue IFX concentrations were compared between groups.

Results

110 serum samples over 22 wks (mean 7.9 samples/pt) with 54 samples between wk 0- 2 (mean= 3.9/pt) were collected. Biopsies at early inpatient (n=17) and maintenance colonoscopies (n=15) were collected from 14 pts. Mean age was 38 years, 50% were female, mean disease duration was 7.8 years and 69% had pancolitis. One NR needed colectomy and another was re-hospitalized. 50% achieved endoscopic remission at wk 22. ERs had numerically higher baseline CRP (49 [±28] vs. 31 [±24] mg/dL), immunomodulator use (71% vs. 43%) and clinical response (86% vs. 43%) to NRs, while albumin (3.3 [±0.9] vs. 2.9 [±0.6] g/dL) and total IFX dose between wk 0-2 (16 [±1] vs. 12 [±6] mg/kg) were more similar. Mean BMI was 23.8 kg/m². Between wk 0-2, the mean number of IFX infusions per pt was 1.5 (±0.7), and median dose per infusion was 11.4 mg/kg (IQR 25-75: 11-19). Median serum IFX concentration AUC was higher in ERs than NRs in early induction (wk 0-2: 568 ug*day/mL [528-1627] vs. 293 [145- 423], p=0.004), all induction (wk 0-14: 3036 [2742-3199] vs. 1768 [1375-2468] p=0.004) and in maintenance (wk 15-22: 841 [309-3295] vs. 405 [295-718] p=0.002). Findings were similar for dose normalized AUC. Peak concentration 2 hrs post first infusion was numerically higher in ERs vs. NRs (median 365 ug/mL [200-484] vs. 187 [140-355] p=0.15) overall and dose-adjusted. Anti- IFX antibodies were detected in one NR maintenance sample. Baseline clearance inversely correlated with AUC (r=-0.7, p=0.03) or dose-normalized induction AUC (r=-0.8, p=0.01). Tissue IFX concentrations were similar in inflamed/non-inflamed tissue and were similar between ERs/NRs in early induction (median 104 ng/mg [89-114] vs. 107 [76-133], p=1.0), and maintenance (10 [4-69] vs. 26 [3-87], p=0.99). Percent of drug in tissue vs. serum was similar between ERs/NRs (induction: median 7% vs 8%; maintenance: 8% vs 6%).

Conclusion

Intense serum and tissue sampling of ASUC pts receiving IFX showed higher serum drug exposure at all timepoints in endoscopic remitters whereas tissue concentrations were similar regardless of outcome. Tissue IFX may be required but not sufficient for achievement of outcomes in ASUC.

Disclosure

PC, SS, and LE report no conflicts of interest.
PL, MR, MS, MF and WT are employees of Alimentiv Inc
RB Speaker/consulting/moderator: Bristol Myers Squibb, Janssen, AbbVie, Takeda, Ferring, Celltrion, Pfizer, Merck, Eli Lilly. Advisory boards: Celltrion, AbbVie, Pfizer, Janssen, Bristol Myers Squibb, Takeda, Merck, Eli Lilly. Educational grants and educational sponsorships: Abbvie, Johnson and Johnson Innovative Medicine, Pfizer, Eli Lilly, Amgen, Pendopharm, Merck, Celltrion, Organon. Travel support: Pfizer, Celltrion, Johnson and Johnson Innovative Medicine, Abbvie.
WA reports consulting fees and participation on advisory board from Johnson & Johnson and Takeda Pharmaceuticals, Inc.
BB reports consulting fees and participation on advisory board from Bristol Myers Squibb, Abbvie, Merck and has grant funding from Merck, Mirador, Prometheus, and Gilead.
PD reports consulting fees from Alimentiv.
MD M. Duijvestein reports speaking fee from Bristol Meyers Squibb, Takeda, Galapagos, Janssen, Dr. Falk, advisory board feest form Abbvie, Bristol Meyers Squibb, Celltrion, Galapagos/Alfasigma, Janssen, Takeda and grant/Research support: Pfizer, Bristol Meyers Squibb, Galapagos Alfasigma, Janssen
MSS Speaker for Abbvie, Janssen, Takeda, Pfizer, Ferring, Novartis, and Lilly. Advisor for Abbvie, Janssen, Takeda, Pfizer, Ferring, Gilead, Amgen, Merck, and Lilly. Research for Abbvie, Janssen, Takeda, Pfizer, and Gilead. Consults for Abbvie, Janssen, Takeda, Pfizer, and Lilly.
RL Consultant for Xencor, Sanofi. SAB member for CJ Biosciences, Ancilia, and Montage Bio.
DL consulting: Abbvie, AltruBio, BMS, Boehringer Ingelheim, Eli Lilly, Johnson & Johnson, PSI, Palatin, Pfizer, Prime, Takeda, Vedanta. Speaking fees: Abbvie, Johnson & Johnson; Grants: Boehringer Ingelheim, Johnson & Johnson.
ES has obtained grant/research support from Abbott (AbbVie), AstraZeneca, CCFA, Janssen Research &Development, Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney (NIDDK), National Institute of Health (NIH), New York Crohn’s Foundation, Pfizer, UCB, UCSF–CCFA Clinical Research Alliance, Genentech. Seres Therapeutics, Celgene Corporation. Consulting fees are reported for AbbVie, Crohn’s and Colitis Foundation of America (CCFA), Entera Health, Evidera, GI Health Foundation, Janssen, Protagonist Therapeutics, Seres Health, Takeda Pharmaceuticals, Bristol Myers Squibb. Stock shareholder of Gilead, and honoraria of GIHealth Foundation for non-branded speaker’s bureau, Janssen for non-branded speaker’s bureau.
BGF reports consulting fees from AbbVie,Abivax,Adiso,AgomAB Therapeutics,Allianthera,Amgen,AnaptysBio,Arena Pharma,Avoro Capital Advisors,Atomwise,,BioJamp,Biora Therapeutics,Blackbird Laboratories,Boehringer-Ingelheim,Boxer Capital,Celsius Therapeutics,Celgene/BMS,Connect BioPharma,Cytoki,Disc Medicine,Duality,EcoR1,Eli Lilly,Equillium,Ermium,First Wave,Forbion,Galapagos,Galen Atlantica,Genentech/Roche,Gilead,Gossamer Pharma,GSK,Hinge Bio,Index Pharma,Imhotex,Immunic Therapeutics,Intercept,JAKAcademy,Janssen,Japan Tobacco Inc.,Kaleido Biosciences,Klick Health,Landos Biopharma,Lenczner Slaght,LifeSci Capital,Lument AB,Mage Biologics,Mestag,Millennium,MiroBio,Monte Rose Tx,Morgan Lewis,Morphic Therapeutics,Mylan,Nexys Therapeutics,Nimbus Therapeutics,OM Pharma,OrbiMed Origo BioPharma,Orphagen,Pandion Therapeutics,Pendopharm,Pfizer,Prometheus Therapeutics and Diagnostics (Merck),Progenity,Protagonist,PTM Therapeutics,Q32 Bio,Rebiotix,REDX,Roche,Roivant/Televant,Sandoz,Sanofi,Seres Therapeutics,Silverback Therapeutics,Sobi,Spyre Therapeutics,Surrozen Inc.,Synedgen,Takeda,Teva,Thelium,Tigenix,Tillotts,Triastek,Ventyx; lecture fees from Takeda,Janssen,and AbbVie; participation on advisory board for AbbVie,AnaptysBio,Boehringer-Ingelheim,Celgene/BMS,Eli Lilly,Genentech/Roche,Janssen,Merck,MiroBio,Origo BioPharma,Pfizer,REDX Pharma,Sanofi,Takeda,Teva,Ecor1Capital,Morphic,GSK; stock or stock options from Evida,EnGene,and Connect Biopharma.
WS reports consulting fees from Alimentiv, Eli Lilly, Forbion, Prometheus Biosciences, Prometheus Laboratories, Shoreline Biosciences, Ventyx Biosciences; stock or stock options from Eli Lilly, Prometheus Biosciences, Prometheus Laboratories, Shoreline Biosciences, Mirador Therapeutics, Ventyx Biosciences; and employee at Mirador Therapeutics and Ventyx Biosciences. Spouse: Eli Lilly – stock, Merck - employee; Prometheus Laboratories – stock, stock options; Ventyx Biosciences – stock, stock options
VJ reports consulting fees and participation on advisory board for AbbVie, Alimentiv, Altrubio, Amgen, AnaptysBio, Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, BiomeBank, Boehringer Ingelheim, Bristol Myers Squibb, Calluna Pharma, Celltrion, Eli Lilly, Endpoint Health, Ensho Therapeutics, Enthera, Exeliom Biosciences, Ferring, Flagship Pioneering, Fresenius Kabi, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, MRM Health, Nxera Therapeutics, Pandion, Pendopharm, Pfizer, Protagonist, Reistone Biopharma, Roche, Roivant, Sandoz, Sanofi, Second Genome, Sorriso, Spyre Therapeutics, Takeda, Teva, Tillotts, Ventyx, Vividion; speaker fees from AbbVie, Ferring, Bristol Myers Squibb, Galapagos, Janssen, Pfizer, Takeda, Tillotts, and Fresenius Kabi.
NVC reports research grants from R-Biopharm and consulting fees from AcelaBio, Alimentiv, Pfizer, ProciseDX, Prometheus Biosciences, and Spyre Therapeutics. NVC is a current employee of Mirador Therapeutics.

Introduction

Older adults with ulcerative colitis (UC) have greater morbidity than younger adults, yet there is paucity of data on the management and outcomes of those who present with acute severe ulcerative colitis (ASUC) in this patient population. This study aims to investigate differences in the management and outcomes between older and younger patients hospitalised with ASUC.

Aims & Methods

We conducted a retrospective study on all ASUC presentations to a Quaternary Sydney hospital over a 10-year period. A modified True-love Witts’ Criteria was used to identify ASUC as ≥6 bloody bowel motions daily and presence of at least one systemic feature, including heart rate >90 bpm, temperature >37.8°C, haemoglobin <105 g/L, and C-reactive protein (CRP) ≥30 mg/L. Older patients who presented with ASUC was defined as those ≥65 years old at time of presentation. Data collected on management included rates of rescue therapy, colectomy and TPN requirement. Data collected on outcomes included hospital length of stay and rates of ICU admission, 30- and 90-day readmission, and 30- and 90-day mortality.

Results

A total of 172 presentations met criteria for ASUC. Of these presentations, 148 patients (86.1%) were <65 years old and 24 patients (13.9%) were ≥65 years old. Median age at presentation in older adults was 73.6 years old and in younger adults was 32.0 years old. Older adults had similar rates of need for rescue therapy (37.5% vs 35.1%, p=0.08), colectomy (12.5% vs 9.5%, p=0,64) and TPN (12.5% vs 10.1%, p=0.73), as their younger counterparts. Older adults (n=6, 25.0%) had significantly higher rates of ICU admission (p<0.01) compared to those <65 years old (n=3, 2.0%). Older adults also had significantly higher 30- and 90-day mortality rates (n=3, p<0.01). There was no mortality observed in adults <65 years old. There was no significant difference in 30- and 90-day readmission rates between older adults and those <65 years old at time of ASUC presentation. Table 1 compares management and outcomes in adults <65 years old and ≥65 years old who presented with ASUC.

Table 1. Comparison of management and outcomes in adults <65 years old and ≥65 years old who presented with ASUC

Conclusion

Despite similar rates of need for rescue therapy and colectomy, older patients who present with ASUC are more likely to have poorer outcomes, with increased requirement of ICU admission and higher mortality rates compared to patients <65 years old. The higher morbidity and mortality observed in our study in older adults who present with ASUC highlights the need for further research to optimise care pathways and improve outcomes in this patient population.

Introduction

Patients with ulcerative colitis (UC) are at increased risk of developing colorectal cancer (CRC), and this is assumed to be due to chronic inflammation of the colorectal mucosa.

Aims & Methods

To identify risk factors for the development of dysplasia or CRC in patients with UC. Retrospective observational cohort study. Clinical data and colonoscopy findings were collected from medical records. A 1:2 Propensity Score Matching (PSM) was performed to balance covariates adjusting for disease extension, age, gender, smoking habit and disease duration. An Andersen-Gill model was used to account for multiple colonoscopies per patient and time-varying risk of dysplasia or CRC, allowing for recurrent events and intra-individual correlation.

Results

A total of 571 UC patients were identified, median age at diagnosis was 39.5 (27.3-54.2), and 304 (53.2%) were men. At diagnosis, 147 (25.7%) had proctitis, 203 (35.6%) left side colitis and 191 (33.5%) extensive colitis. During a median follow-up of 7.1 years (IQR 3.7– 13.3), 51 patients (9.8%) developed dysplasia/CRC. This was more frequent in males (72.9% vs. 27.1%, p=0.004) and in older patients [48.1 years (36.7–60.2) vs. 38.5 years (26.5–53.8), p=0.004].
After PSM adjustment, 123 patients were included, 41 of whom had dysplasia/CRC, with a total of 381 colonoscopies over a follow-up period of 14.6 years (IQR 8.0–22.4). Macroscopic inflammatory activity was present in 283 (74.3%) colonoscopies and microscopic involvement in 5 (1.3%). Older age at diagnosis (aHR 1.03, 95% CI 1.04–1.10, p<0.001) and higher degree of macroscopic inflammation (aHR 1.44, 95% CI 1.02–2.03, p=0.041) were associated with an increased risk of dysplasia/CRC development; advance therapy, family history of CRC, disease extension and microscopic inflammation were not associated with an increased risk.

Table 1. Baseline characteristics of the complete cohort and after Propensity Matching Score.

Conclusion

Older age at diagnosis and the presence of macroscopic involvement on successive colonoscopies are associated with an increased risk of developing dysplasia or CRC in patients with UC.

Disclosure

Beatriz Gros has worked as an advisor for Abbvie, Pfizer, Alphasigma and Roche and has served as an speaker for Abbvie, Pfizer, Alphasigma, Roche, Janssen, Takeda and Gilead.

Introduction

Intestinal ultrasound is a noninvasive and inexpensive tool to assess disease activity in patients with inflammatory bowel disease, such as Crohn's and ulcerative colitis by monitoring the disease activity in real time.

Aims & Methods

Intestinal ultrasound is a non-invasive, cost-effective imaging tool for routine clinical evaluations. This study examines its role in monitoring Crohn’s disease, comparing it with CT Enterography.
This is a prospective, descriptive, comparative study including patients with crohn's disease aged over 16, between March 2023 and March 2024. Every patient had a colonoscopy, enteroscan, and digestive ultrasonography; the delay between each test was limited to one month by the same operator. Patients with ileal or recto-colic resections or pregnant women were not included. We develope a form to collect clinical, therapeutic, and epidemiological informations as well as the outcomes of CT, colonoscopy, and ultrasounds. Between ultrasound, CT scan and colonoscopy, we asked our patients to choose the most widely accepted para-clinical test. Ultrasonography's sensitivity (Se) and specificity (Sp) were determined, and data from enteroscanner and ultrasound were analyzed, with a focus on the wall's thickness, vascularization, damage extent, and peridigestive environment. The statistical study was carried out using SPSS 21.0 software. Quantitative variables were expressed as medians and qualitative variables as numbers and percentages. The McNemar test and the Wilcoxon test for associated samples were applied. The significance level was set at 0.05.

Results

Forty-nine patients were included, with a male-to-female ratio of 0.53 and a median age of 32 years. US detected digestive thickening in 81.6% of cases, mainly in the terminal ileum. CT Enterography detected thickening in the proximal small bowel and rectum in 2.2% of cases, which US missed. US sensitivity was 84.4%, with specificity of 50%. No significant difference was found between US and CT for thickening detection. Mesenteric infiltration detected by US was similar to CT (Se = 86.5%, Sp = 100%). For adenopathy, Se was 75% (Sp = 97%). US showed a 60% sensitivity for detecting complications, with a significant difference compared to CT (p = 0.002). There was no correlation between thickening on US and ulcers on endoscopy.

Conclusion

Despite limitations in examining the proximal intestine and rectum, intestinal ultrasonography is a sensitive, accessible method for monitoring Crohn’s disease and detecting complications.

Introduction

Aim: To report on the efficacy and safety of elective switching from intravenously (IV) to subcutaneously (SC) administered Vedolizumab in Inflammatory Bowel Disease (IBD) patients in clinical remission.

Aims & Methods

Retrospective analysis of IBD patients in clinical remission who were receiving Vedolizumab IV for treatment of their disease in a single tertiary center and were switched to SC, based on their physician’s choice. The primary endpoint was disease deterioration during the follow-up period, according to the disease specific composite measures. In CD, clinical remission was defined as Crohn's Disease Activity Index (CDAI) <150 and in UC as Simple Clinical Colitis Activity Index (SCCAI) <2.

Results

Between December 2023 and February 2025, 86 patients (Crohn’s disease = 17, Ulcerative colitis = 69) were consulted in order to switch from IV to SC vedolizumab administration. Five patients (5,8%) did not want to change and therefore, 81 patients (94,2%) were finally switched. All patients were in clinical remission. After a mean (SD) follow up period of 8 (4) months, 9 patients (11,1%) experienced worsening of their disease, and were either switched back to IV VDZ (n=4, 4,9%) or to another agent (n=5, 6,2%). The remaining 72 patients (88,8%) showed favorable response, none of them requested an unscheduled visit, or developed an adverse event (clinical or laboratory) or needed escalation of treatment.

Conclusion

Elective switching from IV to SC Vedolizumab seems to be an effective and safe approach in real-world every day clinical practice in IBD patients in clinical remission.