Introduction

Introduction & Aim: Deficiency of NOD2 (nucleotide-binding oligomerization domain containing protein 2) demonstrates the strongest genetic association to Crohn’s disease (CD). Mounting evidence links NOD2 variants with poor clinical outcome, particularly in pediatric and early onset CD. CD patients with loss-of-function NOD2 polymorphisms, particularly carriers of more than one risk allele, frequently present with an aggressive, fistulizing and fibrostenotic disease, requiring multiple surgical resections, and are more refractory to some available therapies. NOD2 signaling regulates gut innate immunity by sensing bacterial muramyl dipeptide (MDP) and fine-tuning Toll-like and Nod-like receptor (TLR/NLR) responses. NOD2-defective myeloid cells are implicated in CD pathogenesis, where ineffective clearance of bacterial infections drives a dysregulated, granulomatous inflammatory response.

Aims & Methods

Here we present preclinical data on OTL-104, an autologous haematopoietic stem cell gene therapy (HSC-GT) which aims to stably restore NOD2 expression in gut resident macrophages, to correct the dysfunctional immune surveillance linked to NOD2-deficient CD pathogenesis.

Results

We used in vitro and in vivo models of NOD2 deficiency to evaluate the safety and efficacy of OTL-104 to restore NOD2 expression and function. NOD2^KO human myeloid cells differentiated in vitro from CRISPR-generated NOD2^KO CD34⁺ HSCs are unable to mount a proinflammatory cytokine response to MDP stimulation. Similarly, myeloid cells differentiated from CD34⁺ cells obtained from peripheral blood of genetically characterized NOD2 deficient CD patients, are also refractory to MDP stimulation and unable to generate a normal cytokine response profile (IL-8, TNFa, IL-6, CXCL1/2 and IL-10). Transduction with a lentiviral vector (LV) expressing NOD2 under the macrophage-restricted chimeric CathepsinG/cFES promoter fully restores NOD2-mediated IL-8 and TNFa responses in NOD2^KO CD34⁺ derived monocytes. In NOD2-deficient patient cells, LV transduction also restores MDP-induced cytokine responses to levels comparable to those observed in monocytes derived from CD34⁺ cells from healthy donors.
Transplantation of lineage negative (Lin^-) hematopoietic stem/progenitor cells (HSPCs) transduced with the OTL-104 vector in NOD2^KO mice was used as an in vivo model of gene therapy for CD. Compared to wild-type mice, NOD2^KO mice fail to release systemic inflammatory mediators and recruit myeloid cells in response to MDP administration. Transplantation of transduced Lin^- HSPCs restores MDP-induced systemic release of IL-6 and CXCL1 as well as innate mobilization of monocyte/macrophage cells. Transplanted NOD2^KO mice display normal hematopoiesis and stable vector copy numbers in hematopoietic cells. Key to the success of our therapeutic approach, histopathological analysis of intestinal lamina propria from gene therapy treated mice shows a normal biodistribution and physiological NOD2 gene expression is restored in tissue resident hematopoietic cells, detected by in situ RNAScope analysis of endogenous or LV derived NOD2 mRNA.

Conclusion

These results confirm the negative impact of NOD2 deficiency in primary immune activation and support the therapeutic potential of OTL-104 HSC-GT for long-term correction of NOD2-deficient CD.

Disclosure

Orchard Therapeutics is a Biotechnology Company

Introduction

Tissue factor (TF) on cell membranes initiates blood clotting upon vessel trauma and exposure of subendothelial cells to blood flow. The risk of thromboembolic events is increased in patients with ulcerative colitis (UC). Tofacitinib, a JAK1 & 3 inhibitor, recently introduced in UC therapeutics, may further increase the risk¹.

Aims & Methods

To delineate thrombosis pathophysiology in this context, TF expression in primary human colonic mesenchymal cells (PHCMC) of patients with active UC was correlated with clinical, biochemical and endoscopic data. We then treated those PHCMC with tofacitinib, with or without cytokines to better mimic the in vivo milieu they are exposed to.
PHCMC were isolated and set to ex vivo culture from endoscopic biopsies of the inflamed mucosa of 10 UC patients with an endoscopic Mayo score ≥ 2 were treated with each one of all major T helper (Th)1 (TNF-α, IFN-γ), Th2 (IL-4, IL-13) or T regulatory (Treg; TGF-β, IL-10) cytokines with or without tofacitinib. Cells were lysed, RNA was isolated and reverse-transcribed to cDNA. TF and RPL4 (housekeeping) cDNAs were quantified as C_T cycles with real-time, reverse-transcription PCR. Wilcoxon and Mann-Whitney U tests were used to compare TF ΔΔC_T for paired or unpaired values, respectively, and Spearman’s rho to correlate TF ΔΔC_T with scale clinical variables and continuous laboratory values.

Results

Increased TF mRNA abundance in PHCMC was associated with increased partial Mayo score (Spearman's rho 0.661, p < 0.044), reduced serum albumin (Spearman's rho -0.723, p < 0.05) and more severe endoscopic lesions (endoscopic Mayo score 3). No association with CRP was found (p > 0.999). Cells originating from UC patients of an endoscopic Mayo score 3 expressed 20 times more TF than those from an endoscopic Mayo score 2 (p < 0.017). Furthermore, PHCMC from difficult-to-treat patients, defined as requiring > 1 biologics, expressed 9 times more TF than those from patients requiring ≤ 1 biologics.
Interestingly, treatment of PHMC with tofacitinib did not upregulate TF. PHCMC expressed receptors and responded to treatment with all major Th1 (TNF-α, IFN-γ), Th2 (IL-4, IL-13) or Treg (TGF-β, IL-10) cytokines by further upregulating TF by 5.5-7.5 times (p 0.001 - 0.035). IL-13 had the maximal effect. Even when tofacitinib was added together with the aforementioned cytokines, it did not further upregulate TF. Instead, it tended to partially inhibit their effects; for example, it decreased upregulation of TF by IL-13 by 40%.

Conclusion

The expression of TF mRNA in active UC is significantly associated with clinically and endoscopically severe disease and resistance to treatment. Tofacitinib per se does not increase TF. Instead, it may limit the upregulating effect of pro-inflammatory cytokines.

References

1. Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076.

Disclosure

Procurement of reagents and consumables for this project was partially supported by Pfizer Inc. with competitive grant # 64132481.

Introduction

Not all patients with ulcerative colitis (UC) respond initially to treatment with biologic agents, and predicting their efficacy prior to treatment is difficult. Vedolizumab, a humanized monoclonal antibody against alpha 4 beta 7 (α4β7) integrin, suppresses immune cell migration by blocking the interaction between α4β7 integrin and mucosal addressin cell adhesion molecule 1, and is used to treat patients with UC with moderate-to-severe activity. Reports about histological features that predict vedolizumab efficacy are scarce.

Aims & Methods

We evaluated the infiltration of inflammatory cells in the colonic mucosa prior to the induction of vedolizumab and examined the association between histological features and vedolizumab efficacy.
This was a multicenter, retrospective study. Patients with UC who were treated with vedolizumab between November 2018 and April 2021 were enrolled in this study. All eligible patients had moderate-to-severe disease activity at the time of the initial treatment with vedolizumab. Biopsy specimens taken from the colonic mucosa prior to vedolizumab induction were used, and the areas positively stained for CD4, CD68, and CD45 per unit area of the lamina propria were calculated. Clinical and histological features were compared between those with and without remission at week 22, and the factors associated with clinical outcomes were identified.

Results

A total of 42 patients were included in this study. 17 (40.5%) patients achieved clinical remission at week 22. Significantly more CD4+ cells were found in the colonic mucosal tissues of patients with remission than in those without remission (odds ratio [OR]=1.44, P=0.014). In contrast, the CD68-positive area and the CD45-positive were not significantly different between the two groups. The concomitant use of corticosteroids and high Mayo scores had a negative association with the vedolizumab response (OR=0.11, P=0.008 and OR=0.50, P=0.009, respectively).

Conclusion

A high CD4+ infiltration in the colonic mucosa was associated with remission after vedolizumab treatment. Histological evaluation for CD4+ cell infiltration may be helpful in selecting patients who can benefit from vedolizumab.

Introduction

The healthcare sector generates millions of tonnes of waste worldwide each year and GI endoscopy is one of the largest contributors (1).
Despite the proven negative health and environmental impacts of incineration, many European public health agencies and national governments still require incineration as the only safe waste management solution for hospitals’ waste (2).
In November 2022, we started a project around waste management in our endoscopy unit. Until then we did not segregate any of our waste except dangerous medical material such as needles, medication and potentially infectious and toxic products. Moreover, even this segregation, seemed to have different interpretation rules in different hospital departments. This lack of segregation and separate waste streams causes that the quantity of waste categorised as hazardous is unnecessarily much higher than it needs to be, increasing not only the environmental impact of disposal methods, but also the financial costs of disposal and treatment. The large majority of waste produced by the healthcare sector (approximately 85%), however, is actually non-hazardous and similar to domestic waste i.e. much of it can be easily recycled. Over 50% of non-hazardous waste from hospitals is paper, cardboard, and plastics, while the rest comprises discarded food, metal, glass, textiles, and wood (3).

Aims & Methods

We want to raise awareness about the amount of waste produced in a GI endoscopy room and its environmental impact. Moreover, we want to investigate whether most non-hazardous waste from our department is potentially recyclable or compostable. Finally, we would like to promote practices that reduce the volume of waste generated and ensure we can do a proper waste segregation in our endoscopy rooms.
We planned on measuring the amount of residual waste during 3 months in 3 different endoscopy rooms and kept track of the procedures that were done during that period. After these 3 months, we would start to segregate waste and measure again our different bins. To make this segregation possible we placed in every endoscopy room 3 different bins: 1 for residual waste, 1 for plastics and 1 for non-confidential paper and cardboard.
By measuring and calculating the difference, we would like to motivate our medical and nursing staff to continue doing this small effort with enormous results.

Results

In December 2022, January 2023 and February 2023 we collected 205,98 kg, 197,3 kg and 205,22 kg for 606, 583 and 545 endoscopies, respectively. We have now closed our first segregation month, March 2023 and we measured 190,8 kg for 565 endoscopies from which 144,78 kg was residual waste, 38,7 kg were plastics and 7,32 kg was non-confidential paper and cardboard.
The biggest problem we encountered was the training of our staff how to choose the right bin since there is a big difference between munipicial and hospital waste. We will continue to measure for another 3 months and provide training and workshops to our staff.

Conclusion

After one month of segregation, we found that we were able to lower residual waste by 24%. Problems we encountered during our process were the training of our staff and the different segregation policies we have, in combination with the fact that certain categories of waste require specific approaches. The current sustainability metrics and guidelines, though confusing sometimes, offer a unique opportunity to take the first step to the so needed sustainability transformation. Sustainability reporting allows a company to first observe its environmental footprint and then improve its business model and operations.

References

1. Enrique Rodríguez de Santiago*, Mario Dinis-Ribeiro*, Heiko Pohl, Deepak Agrawal, Marianna Arvanitakis, Robin Baddeley, Elzbieta Bak, Pradeep Bhandari, Michael Bretthauer, Patricia Burga, Leigh Donnelly, Axel Eickhoff, Bu'Hussain Hayee, Michal F. Kaminski, Katarina Karlović, Vicente Lorenzo-Zúñiga, Maria Pellisé, Mathieu Pioche, Keith Siau, Peter D. Siersema, William Stableforth, Tony C. Tham, Konstantinos Triantafyllou, Alberto Tringali, Andrew Veitch, Andrei M. Voiosu, George J. Webster, Ariane Vienne, Ulrike Beilenhoff, Raf Bisschops, Cesare Hassan, Ian M. Gralnek, Helmut Messmann. Reducing the environmental footprint of gastrointestinal endoscopy: European Society of Gastrointestinal endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) Position Statement. Endoscopy 2022; 54: 797-826
2. Sustainable healthcare waste management in the EU Circular Economy model. November 2020. www.noharm-europe.org
3. WHO (2014). Safe management of wastes from health-care activities, 2nd ed. www.who.int/water_sanitation_health/publications/safe-management-of-wastes-fromhealthcare-activities/en/ HCWH Europe Page 2 of 7

Introduction

In contrast to ulcerative colitis (UC), the impact of bowel urgency (BU) in patients with moderate-to-severe Crohn’s disease (CD) is unclear. The Communicating Needs and Features of IBD Experiences (CONFIDE) survey aims to understand the experience and impact of symptoms on lives of patients with UC or CD worldwide (United States [US], Europe [EU], and Japan). This survey also explores the communication gaps between healthcare professionals (HCPs) and patients. Previously reported CONFIDE data suggested that BU was the second most reported symptom among US and EU5 (France, Germany, Italy, Spain, and UK) patients with moderate-to-severe UC.¹ Persistent BU was reported in 46% US and 28% EU5 patients receiving advanced therapies for UC and 45% US and 37% EU5 patients reported wearing diapers/pads/protection at least once every week.¹ Here, we present patient and HCP perspectives on the experiences and impact of CD-related symptoms.

Aims & Methods

Online, quantitative, cross-sectional surveys were conducted separately among HCPs and patients with CD from US and EU5 between May and October 2021. Moderate-to-severe CD was defined using criteria based on previous treatment, steroid use, and/or hospitalization. Data are presented as descriptive statistics.

Results

Surveys were completed by 215 US (male [M]=55%, mean age 41 years) and 547 EU5 (M=55%, mean age 38 years) patients. Of these, 58% US and 63% EU5 patients were receiving advanced therapies (biologic/novel oral) and 66% and 63% were receiving steroids at the time of survey completion, respectively. Most patients in the US (61%) and EU5 (62%) reported moderate CD, followed by severe (25% and 10%), and mild CD (14% and 28%).
In both US and EU5 populations, top three symptoms currently (past month) experienced by patients were diarrhoea (US: 55%, EU5: 55%), BU (US: 42%, EU5: 38%), and increased stool frequency (US: 40%, EU5: 37%). Among the patients receiving advanced therapies (US: 58%, EU5: 63%), 46% US and 39% EU5 patients experienced BU and 27% US and 19% EU5 patients reported fistula-related symptoms around the anus/rectum. Of the patients who had experienced BU, only 40% US and 27% EU5 patients were completely comfortable discussing BU with their HCPs and only 27% US and 23% EU5 patients felt comfortable discussing BU-related accidents. Embarrassment was the most common reason for discomfort associated with discussing BU (US: 73%, EU5: 64%) and BU-related accidents (US: 72%, EU5: 66%) with HCPs.
A total of 200 US (M=78%) and 503 EU5 (M=71%) HCPs completed the surveys, of which 92% were gastroenterologists or specialists in internal medicine and 7% were non-physicians. According to HCPs, the top three patient-reported symptoms were diarrhoea (US: 67%, EU5: 66%), blood in stool (US: 44%, EU5: 24%), and increased stool frequency (US: 32%, EU5: 28%). BU was reported among the top three symptoms only by 19% US and 16% EU5 HCPs. Many HCPs (US: 34%, EU5: 40%) reported not proactively discussing BU, with the most common reason being that they “expect the patient to bring this up if this is an issue” (US: 34%, EU5: 42.0%).

Conclusion

Similar to the findings in UC patients¹, bowel urgency was the second most reported symptom among patients with CD, but not among the HCP-perceived top three symptoms. A large proportion of patients with moderate-to-severe CD receiving advanced therapies continued to experience bowel urgency. These results indicate a communication gap between HCPs and patients with CD, highlighting the underappreciation of the impacts of bowel urgency on patients’ daily lives.

References

1. Rubin, D. T. et al. (2021) P028 Communicating Needs and Features of IBD Experiences (CONFIDE) Survey: Patient and Healthcare Professional Perspectives on Experience of Ulcerative Colitis Symptoms. The American Journal of Gastroenterology, 116:p S7. https://doi.org/10.14309/01.ajg.0000798712.28363.8b

Disclosure

• Simon Travis, Grants: AbbVie, ECCO, Eli Lilly and Company, Helmsley Trust International, Organization for the Study of Inflammatory Bowel Disease, Norman Collision Foundation, Pfizer, Takeda, UCB Pharma, UKIERI, Vifor Pharma; Consultancy fees: AbbVie, Allergan, Amgen, Apexian, Asahi Kasei Pharma, Bioclinica, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, ChemoCentryx, Cosmo Pharmaceuticals, Eli Lilly and Company, Enterome, Equillium, Ferring Pharmaceuticals, Genentech/Roche, GlaxoSmithKline, Giuliani SpA, Immunocore, Immunometabolism, Janssen, Merck, Merck Sharp & Dohme, Mestag Therapeutics, Neovacs, Novartis, Novo Nordisk, NPS Pharmaceuticals/Nycomed, Pfizer, Protagonist Therapeutics, Proximagen, Receptos, Roche, Satisfai Health, Sensyne Health, Shire, Sigmoid Pharma, Sorriso Pharmaceuticals, Takeda, UCB Pharma, VHsquared, Vifor Pharma, and Zeria Pharmaceutical.
• Marla C. Dubinsky, Consultancy fees: AbbVie, Arena Pharmaceuticals, Boehringer Ingelheim International GmbH, Bristol Myers Squibb, Celgene Corporation, Eli Lilly and Company, F. Hoffman-La Roche Ltd, Genentech Inc., Gilead Sciences, Janssen, LLC, Pfizer, Prometheus Biosciences, Takeda Pharmaceuticals USA, Inc., and UCB; Stockholder: Trellus Health Inc.; Research support: AbbVie, Janssen, LLC, Pfizer, and Prometheus Biosciences; Licensing fees: Takeda.
• Toshifumi Hibi, Consultancy fees/grant/research support/speaker: AbbVie GK and Mitsubishi-Tanabe Pharma; Grant/Lecture/speaker fees: JIMRO, Mochida Pharmaceutical, Takeda Pharmaceutical, and Zeria Pharmaceutical; Consultancy/ Lecture/speaker fees: Pfizer, EA Pharma; Grants: Kyorin, Otuska Holdings; Consultancy fees: Bristol-Myers Squibb, Eli Lilly and company, Gilead Sciences, Janssen, Nichi-Iko Pharmaceutical; Lecture/speaker fees: Sondoz K.K.
• David T. Rubin, Consultancy fees: Abbvie, Alimentiv Inc., Altrubio, Arena Pharmaceuticals, Aslan Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals, Boehringer Ingelheim Ltd., Bristol-Myers Squibb, Celgene Corp/Syneos, ClostraBio, Connect BioPharma, EcoR1, Genentech/Roche, Gilead Sciences, Ironwood Pharmaceuticals, Iterative Scopes, Janssen Pharmaceuticals, Kaleido Biosciences, Eli Lilly and company, Materia Prima, Pfizer, Prometheus Biosciences, Reistone, Seres Therapeutics, Takeda, Target RWE, Techlab Inc., and Trellus Health; Stockholder: Altrubio, Alike, and Iterative Scopes.
• Remo Panaccione, Consultancy/speaker fees and/or advisory board member: AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Ferring, Fresenius Kabi, Gilead Sciences, Janssen, Merck, Organon, Pfizer, Roche, Sandoz, Shire, and Takeda; Consultancy fees and/or advisory board member: Alimentiv, AstraZeneca, Biogen, Boehringer Ingelheim, Genentech, Glaxo-Smith Kline, JAMP Bio, Mylan, Novartis, Oppilan Pharma, Pandion Pharma, Progenity, Protagonist Therapeutics, Sublimity Therapeutics, Ventyx; Consultancy fees: Abbivax, Abbott, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Galapagos, JAMP Bio, Pendopharm, Satisfai Health, Theravance Biopharma, Trellus, Viatris, and UCB.
• Stefan Schreiber, Consultancy fees: AbbVie, Arena, Biogen, Bristol-Myers Squibb, Celgene, Celltrion, Falk, Fresenius, Gilead Sciences, IMAB, Janssen, Eli Lilly and Company, MSD, Mylan, Pfizer Inc, Protagonist, Provention Bio, Takeda, and Theravance
• Christian Atkinson, Employee: Adelphi Real World
• Theresa H. Gibble, Cem Kayhan, Alison P. Bleakman, Tommaso Panni, and Angelo Favia are employees and stockholders of Eli Lilly and Company.

Introduction

Although CADe/x systems increase colorectal polyp detection, their ability to predict histological diagnosis is limited.

Aims & Methods

The aim of this study is to determine which factors related to morphology, histology and the image characteristics are associated with histology prediction by PolyDeep, a CADe/x system.
For this analysis, 5546 still images of colorectal polyps collected in PIBAdb database (https://www.iisgaliciasur.es/home/biobanco/colorectal-polyp-image-cohort-pibadb/?lang=en) were used. The images were obtained from videos recorded by endoscopist. Each image was associated with the endoscopy description (morphology, size), the final histology diagnosis and the characteristics (size, area) related with the Red, Green and Blue model (RGB model) and the Hue, Saturation and Value model (HSV model). Finally, the Convolutional Neural Network (CNN) determined the probability a polyp was classified as neoplastic lession (adenomatous, Traditional Serrated Adenoma,TSA, Sessile Serrated Lession, SSL). We determined Polydeep classified lesions as neoplastic if the probability was ≥0.5. We performed three analysis: (1) linear multiple regression in order to determine which variables are associated with the probability of classification as neoplastic lesions. (2). A multivariate logistic regresion analysis to define the variables associated with the classification as a neoplastic lesions. (3) A multivariate logistic regression to establish which variables are associated with missclassification of polyps. We use the R software for statistical computing.

Results

PolyDeep classified 84,51% of the lesions as neoplastic lession and managed to correctly classify 85.02% of the evaluated polyps (92.8% adenomas, 82.5% TSA, 84.2% SSL and 51.6% hyperplastic). The R² in the multiple linear regression is the 0.3655. The model associated to the neoplastic diagnosis has an Akaike Information Criterion (AIC) of 3363.3 and the model associated with missclassification, has an AIC of 3547.5. The variables associated to each regression model showed in the attached table.

Conclusion

The results obtained in this study allow us to establish strategies to improve Polydeep predicted histological diagnosis.

Introduction

Vedolizumab is a humanised monoclonal antibody whose mechanism of action is inhibition of the α4β7 integrin of T leukocytes. It is indicated for moderate or severe flare of inflammatory bowel disease. Subcutaneous (SC) vedolizumab, a new formulation recently approved, is a major advantage for patients for home administration.

Aims & Methods

Analyse the percentage of clinical and biochemical remission in patients on treatment with intravenous (IV) vedolizumab after switching to SC vedolizumab. In addition, the relationship between a treatment with intensified IV vedolizumab and subsequent drug levels versus patients without intensification.
Single-center, descriptive, observational, and retrospective study of a cohort of all of 19 patients diagnosed with ulcerative colitis (UC) and crohn disease (CD) teatred with IV vedolizumab in January 2022, who underwent a switch to SC vedolizumab. Analyse of clinical and analytical parameters (faecal calprotectin (FC), concomitant treatment, vedolizumab levels during follow-up, need for intensified intravenous treatment, ocurrence of adverse effects or loss of response) in patients on IV vedolizumab treatment and subsequent switch to SC vedolizumab with follow-up during weeks 4, 12, and 24.

Results

Ten patients (22.6%) were diagnosed with UC and 9 patients (47.3%) with CD. The baseline characteristics of the patients are described in table 1. 68% of patients were exposed to anti-TNF when initiating IV Vedolizumab due to loss of response, and 15,7% had been exposed to >1 anti-TNF. 31% (6 patients) were naive to Anti-TNF, 4 patients (21%) IV vedolizumab was started as the first line of treatment due to the increased risk of infections and a previous history of neoplasia and in 2 patients with CD (10.5%) vedolizumab was started as prevention of recurrence. Up to 8 patients (42.1%) were on an intensified IV vedolizumab prior to switching to SC vedolizumab. Biochemical remission (FC < 150 µg/g) was achieved in 14 patients (77.7%) at week 24 of follow-up. All 19 patients (100%) achieved clinical remission. It was noted that biochemical remission was not achieved in up to 50% of patients on the intensified regimen with IV vedolizumab. Mean baseline intravenous vedolizumab levels were 12.1 μg/ml. After switching to SC vedolizumab, the mean levels were 13.1 μg/ml at week 4, 19.9 μg/ml at week 12 and 22.9 μg/ml at week 24 (p= 0.001). There was no statistically significant difference in biochemical remission between patients who received an intensive IV vedolizumab regimen and those who did not. One adverse event (paraesthesia) was described in one patient (5.2%) in relation to IV vedolizumab.

Table 1. Baseline characteristics.

Conclusion

78% of patients after switching from IV vedolizumab to SC vedolizumab, reached clinical and biochemical remission at 6 months of follow-up. In addition, vedolizumab levels increased progressiively after switching IV vedolizumab to SC treatment. These findings confirm that SC vedolizumab is a good therapeutic option for long-term maintenance.

References

• Ventress E, Young D, Rahmany S, Harris C, Bettey M, Smith T, Moyses H, Lech M, Gwiggner M, Felwick R, Cummings JRF. Transitioning from Intravenous to Subcutaneous Vedolizumab in Patients with Inflammatory Bowel Disease [TRAVELESS]. J Crohns Colitis. 2022 Jul 14;16(6):911-921. doi: 10.1093/ecco-jcc/jjab224.
• Vermeire S, D'Haens G, Baert F, Danese S, Kobayashi T, Loftus EV, Bhatia S, Agboton C, Rosario M, Chen C, Zhang W, Kisfalvi K, Sandborn WJ. Efficacy and Safety of Subcutaneous Vedolizumab in Patients With Moderately to Severely Active Crohn's Disease: Results From the VISIBLE 2 Randomised Trial. J Crohns Colitis. 2022 Jan 28;16(1):27-38. doi: 10.1093/ecco-jcc/jjab133.
• Bergqvist V, Holmgren J, Klintman D, Marsal J. Real-world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease. Aliment Pharmacol Ther. 2022 Jun;55(11):1389-1401. doi: 10.1111/apt.16927.