Preethi G. Venkat, Jill F. Nehrbas, Pamela Schoppee Bortz, Thomas A. Platts-Mills, Brian W. Behm, Esteban J. Figueroa, Jeffrey M. Wilson
Aims
Ustekinumab, a monoclonal antibody (mAb) used to treat inflammatory bowel disease, has been associated with immediate hypersensitivity reactions during first intravenous infusion. While rare, the mechanism for these reactions is unclear. IgE to the oligosaccharide galactose-α-1,3-galactose (α-gal) is a cause of allergy to mammalian meat and other mammalian products that express α-gal. Given that ustekinumab (Stelara) is produced in murine SP2/0 cells, a cell line known to introduce α-gal during post-translational modification, we hypothesized that α-gal could explain some of these reactions.
Methods and Results
We describe six patients with Crohn's disease who experienced acute reactions during ustekinumab infusion and were found to have IgE specific to α-gal. Serum or cells from a separate group of α-gal IgE-sensitized patients with red meat allergy were used for in vitro experiments to investigate ustekinumab allergenicity. ImmunoCAP binding assays confirmed that IgE from four red meat allergic patients, but not controls, bound to ustekinumab on the solid phase. This binding was inhibited by the α-gal-containing glycoprotein beef thyroglobulin. Basophil activation tests (BAT), carried out to assess functional activity, revealed dose-dependent activation with ustekinumab from four α-gal-sensitized individuals, but not controls. Two other mAbs produced in SP2/0 cells (cetuximab and infliximab) as well as a representative mAb produced in Chinese Hamster Ovary (CHO) cells (vedolizumab) were evaluated as comparators, with the mAbs from SP2/0 but not CHO cells eliciting BAT activity.
Conclusions
Pre-existing IgE to α-gal may account for some first-dose infusion reactions to ustekinumab. Screening for α-gal sensitization in patients with alpha-gal syndrome should be considered prior to ustekinumab infusion.
{"title":"IgE to Galactose-α-1,3-Galactose (α-Gal) and Relevance to Ustekinumab First-Dose Infusion Reactions and Allergenicity","authors":"Preethi G. Venkat, Jill F. Nehrbas, Pamela Schoppee Bortz, Thomas A. Platts-Mills, Brian W. Behm, Esteban J. Figueroa, Jeffrey M. Wilson","doi":"10.1002/jgh3.70374","DOIUrl":"https://doi.org/10.1002/jgh3.70374","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Ustekinumab, a monoclonal antibody (mAb) used to treat inflammatory bowel disease, has been associated with immediate hypersensitivity reactions during first intravenous infusion. While rare, the mechanism for these reactions is unclear. IgE to the oligosaccharide galactose-α-1,3-galactose (α-gal) is a cause of allergy to mammalian meat and other mammalian products that express α-gal. Given that ustekinumab (Stelara) is produced in murine SP2/0 cells, a cell line known to introduce α-gal during post-translational modification, we hypothesized that α-gal could explain some of these reactions.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods and Results</h3>\u0000 \u0000 <p>We describe six patients with Crohn's disease who experienced acute reactions during ustekinumab infusion and were found to have IgE specific to α-gal. Serum or cells from a separate group of α-gal IgE-sensitized patients with red meat allergy were used for in vitro experiments to investigate ustekinumab allergenicity. ImmunoCAP binding assays confirmed that IgE from four red meat allergic patients, but not controls, bound to ustekinumab on the solid phase. This binding was inhibited by the α-gal-containing glycoprotein beef thyroglobulin. Basophil activation tests (BAT), carried out to assess functional activity, revealed dose-dependent activation with ustekinumab from four α-gal-sensitized individuals, but not controls. Two other mAbs produced in SP2/0 cells (cetuximab and infliximab) as well as a representative mAb produced in Chinese Hamster Ovary (CHO) cells (vedolizumab) were evaluated as comparators, with the mAbs from SP2/0 but not CHO cells eliciting BAT activity.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Pre-existing IgE to α-gal may account for some first-dose infusion reactions to ustekinumab. Screening for α-gal sensitization in patients with alpha-gal syndrome should be considered prior to ustekinumab infusion.</p>\u0000 </section>\u0000 </div>","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jgh3.70374","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147299990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura E. Lavette, Mary S. McGrath, Sahil Khanna, Matthew K. Schliep, Taylor M. Horgan, Mira Sridharan, Brian J. Wentworth
Background and Aims
Optimal steroid induction therapy in autoimmune hepatitis (AIH) is unclear. We aimed to investigate the relationship between steroid dosing, route of administration, and time to biochemical response to help standardize AIH practice patterns and reduce excess steroid exposure.
Methods
We conducted a retrospective cohort study of adult patients with non-severe AIH receiving induction steroid therapy. Patients were stratified into three treatment groups: (1) low-dose oral steroids (n = 39; prednisone < 40 mg/day or budesonide 9 mg/day), (2) high-dose oral steroids (n = 32; prednisone 40 mg/day), and (3) intravenous steroids (n = 21; methylprednisolone 1 g/day). Time to biochemical response and predictors of biochemical response were compared at 6- and 12-month intervals.
Results
Rates of biochemical response were similar between the low- and high-dose oral steroid groups at 6 months (72% vs. 78%, p = 0.54) and 12 months (92% vs. 91%, p = 1.00). Regarding high-dose oral versus IV steroid induction, rates of biochemical response were similar between groups at 6 months (78% vs. 86%, p = 0.72) and 12 months (91% vs. 90%, p = 1.00). Time to biochemical response was not significantly different across all groups at both 6 and 12 months (log-rank test, p = 0.23 and p = 0.42, respectively). Initial biomarkers of disease severity were not predictive of time to biochemical response across groups.
Conclusions
Lower dose prednisone may be an effective initial induction regimen in outpatients with AIH. Similarly, oral steroids may be non-inferior to IV steroids. Together, these results favor a more conservative approach for non-severe AIH induction therapy.
{"title":"Dosing and Route of Steroid Induction Therapy in Non-Severe Autoimmune Hepatitis Do Not Affect Time to Biochemical Response","authors":"Laura E. Lavette, Mary S. McGrath, Sahil Khanna, Matthew K. Schliep, Taylor M. Horgan, Mira Sridharan, Brian J. Wentworth","doi":"10.1002/jgh3.70371","DOIUrl":"10.1002/jgh3.70371","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background and Aims</h3>\u0000 \u0000 <p>Optimal steroid induction therapy in autoimmune hepatitis (AIH) is unclear. We aimed to investigate the relationship between steroid dosing, route of administration, and time to biochemical response to help standardize AIH practice patterns and reduce excess steroid exposure.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We conducted a retrospective cohort study of adult patients with non-severe AIH receiving induction steroid therapy. Patients were stratified into three treatment groups: (1) low-dose oral steroids (<i>n</i> = 39; prednisone < 40 mg/day or budesonide 9 mg/day), (2) high-dose oral steroids (<i>n</i> = 32; prednisone 40 mg/day), and (3) intravenous steroids (<i>n</i> = 21; methylprednisolone 1 g/day). Time to biochemical response and predictors of biochemical response were compared at 6- and 12-month intervals.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Rates of biochemical response were similar between the low- and high-dose oral steroid groups at 6 months (72% vs. 78%, <i>p</i> = 0.54) and 12 months (92% vs. 91%, <i>p</i> = 1.00). Regarding high-dose oral versus IV steroid induction, rates of biochemical response were similar between groups at 6 months (78% vs. 86%, <i>p</i> = 0.72) and 12 months (91% vs. 90%, <i>p</i> = 1.00). Time to biochemical response was not significantly different across all groups at both 6 and 12 months (log-rank test, <i>p</i> = 0.23 and <i>p</i> = 0.42, respectively). Initial biomarkers of disease severity were not predictive of time to biochemical response across groups.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Lower dose prednisone may be an effective initial induction regimen in outpatients with AIH. Similarly, oral steroids may be non-inferior to IV steroids. Together, these results favor a more conservative approach for non-severe AIH induction therapy.</p>\u0000 </section>\u0000 </div>","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12932122/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147311272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vedolizumab, a gut-selective α4β7 integrin antagonist, is widely used for the treatment of ulcerative colitis (UC) and is generally considered to have a favorable systemic infection safety profile. During routine clinical practice, we observed an unexpected clustering of urinary tract infections (UTIs) among patients initiating vedolizumab in an Iranian cohort, prompting further evaluation.
Methods
This single-center, observational case series included 15 adult patients with moderate-to-severe UC treated with vedolizumab and followed prospectively for 12 weeks for the occurrence of UTIs. A contemporaneous comparator cohort of 30 UC patients treated with infliximab (n = 15) or tofacitinib (n = 15) was followed over the same period. The primary outcome was symptomatic, culture-proven UTI, defined as > 105 CFU/mL of a single uropathogen.
Results
Patients treated with vedolizumab demonstrated significant clinical improvement, with a mean Mayo score reduction from 8.2 to 3.5 during follow-up. An unexpectedly high number of early symptomatic UTIs was observed in the vedolizumab group, including cases caused by non-typhoidal Salmonella species, whereas no UTIs were detected in the small comparator cohorts. Given the limited sample size and observational design, reliable estimation of relative risk was not possible.
Conclusions
In this small, single-center cohort, an unusual clustering of early symptomatic UTIs was observed among patients initiating vedolizumab. These findings are observational and hypothesis-generating, and no causal relationship can be inferred. They highlight the importance of real-world pharmacovigilance and the need for larger, multicenter studies to clarify whether such infection patterns reflect contextual clustering or reproducible safety signals influenced by regional epidemiological factors.
{"title":"An Unusual Cluster of Urinary Tract Infections, Including Salmonella spp., in an Iranian Ulcerative Colitis Cohort Treated With Vedolizumab: A Case Series and Comparative Analysis","authors":"Yousef VatanParast","doi":"10.1002/jgh3.70355","DOIUrl":"10.1002/jgh3.70355","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Vedolizumab, a gut-selective α4β7 integrin antagonist, is widely used for the treatment of ulcerative colitis (UC) and is generally considered to have a favorable systemic infection safety profile. During routine clinical practice, we observed an unexpected clustering of urinary tract infections (UTIs) among patients initiating vedolizumab in an Iranian cohort, prompting further evaluation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This single-center, observational case series included 15 adult patients with moderate-to-severe UC treated with vedolizumab and followed prospectively for 12 weeks for the occurrence of UTIs. A contemporaneous comparator cohort of 30 UC patients treated with infliximab (<i>n</i> = 15) or tofacitinib (<i>n</i> = 15) was followed over the same period. The primary outcome was symptomatic, culture-proven UTI, defined as > 10<sup>5</sup> CFU/mL of a single uropathogen.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Patients treated with vedolizumab demonstrated significant clinical improvement, with a mean Mayo score reduction from 8.2 to 3.5 during follow-up. An unexpectedly high number of early symptomatic UTIs was observed in the vedolizumab group, including cases caused by non-typhoidal Salmonella species, whereas no UTIs were detected in the small comparator cohorts. Given the limited sample size and observational design, reliable estimation of relative risk was not possible.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>In this small, single-center cohort, an unusual clustering of early symptomatic UTIs was observed among patients initiating vedolizumab. These findings are observational and hypothesis-generating, and no causal relationship can be inferred. They highlight the importance of real-world pharmacovigilance and the need for larger, multicenter studies to clarify whether such infection patterns reflect contextual clustering or reproducible safety signals influenced by regional epidemiological factors.</p>\u0000 </section>\u0000 </div>","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12929186/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147311219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The first-choice treatment for immune checkpoint inhibitor (ICI)-induced colitis is steroids; however, side effects may occur and survival may be reduced. Sulfasalazine (SSZ) is primarily used for inflammatory bowel disease but studies on ICI-induced colitis are scarce. This study examined the efficacy and safety of SSZ for ICI-induced colitis while testing SSZ as a steroid-sparing agent.
Methods
This study (iRECSA) was a single-arm, multicenter exploratory study from November 2021 to December 2024 that evaluated the efficacy and safety of SSZ for mild-to-moderate ICI-induced colitis. SSZ was given at 4 g/day orally for 2 weeks. The primary outcome was clinical response (a ≥ 1-point reduction from baseline partial Mayo score or partial Mayo score < 1). Secondary endpoints included clinical responses in the Simple Clinical Colitis Activity Index (SCCAI), Lichtiger Index, and Common Terminology Criteria for Adverse Events (CTCAE) grade, plus SSZ-related adverse event incidence.
Results
Ten patients were enrolled. The median partial Mayo score decreased from 4 (range 3–5) to 2 (range 0–4), with 80% of patients achieving a clinical response. Similar response rates were observed with the Lichtiger Index and CTCAE grade. Defecation urgency was present in 70% of patients at baseline but resolved in all after treatment. Nine adverse events occurred in six patients; three patients discontinued SSZ because of hypersensitivity-related adverse events. Three patients required systemic steroids after the study treatment.
Conclusions
This exploratory study suggests that SSZ may be a useful option for mild-to-moderate ICI-induced colitis, but caution is warranted against SSZ-related hypersensitivity.
{"title":"Exploratory Clinical Study to Evaluate the Efficacy and Safety of Sulfasalazine for Immune Checkpoint Inhibitor (ICI)-Induced Colitis","authors":"Mariko Kobayashi, Takeshi Yamada, Shunsuke Ueyama, Yoshiyuki Yamamoto, Akinori Sugaya, Yoshinori Hiroshima, Takashi Mamiya, Junji Hattori, Shintaro Akiyama, Bryan J. Mathis, Kiichiro Tsuchiya","doi":"10.1002/jgh3.70365","DOIUrl":"10.1002/jgh3.70365","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>The first-choice treatment for immune checkpoint inhibitor (ICI)-induced colitis is steroids; however, side effects may occur and survival may be reduced. Sulfasalazine (SSZ) is primarily used for inflammatory bowel disease but studies on ICI-induced colitis are scarce. This study examined the efficacy and safety of SSZ for ICI-induced colitis while testing SSZ as a steroid-sparing agent.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This study (iRECSA) was a single-arm, multicenter exploratory study from November 2021 to December 2024 that evaluated the efficacy and safety of SSZ for mild-to-moderate ICI-induced colitis. SSZ was given at 4 g/day orally for 2 weeks. The primary outcome was clinical response (a ≥ 1-point reduction from baseline partial Mayo score or partial Mayo score < 1). Secondary endpoints included clinical responses in the Simple Clinical Colitis Activity Index (SCCAI), Lichtiger Index, and Common Terminology Criteria for Adverse Events (CTCAE) grade, plus SSZ-related adverse event incidence.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Ten patients were enrolled. The median partial Mayo score decreased from 4 (range 3–5) to 2 (range 0–4), with 80% of patients achieving a clinical response. Similar response rates were observed with the Lichtiger Index and CTCAE grade. Defecation urgency was present in 70% of patients at baseline but resolved in all after treatment. Nine adverse events occurred in six patients; three patients discontinued SSZ because of hypersensitivity-related adverse events. Three patients required systemic steroids after the study treatment.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This exploratory study suggests that SSZ may be a useful option for mild-to-moderate ICI-induced colitis, but caution is warranted against SSZ-related hypersensitivity.</p>\u0000 </section>\u0000 </div>","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jgh3.70365","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146217236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Haziq Hasnol, Joel Tan, Tarun Jain, Kavitha Subramaniam
<p>In Inflammatory Bowel Disease (IBD), adipose tissue is postulated to be a source of pro-inflammatory cytokines and adipokines, which may affect disease outcomes. In patients with treatment refractory IBD, abdominal body composition is often characterized by excessive fat deposition and skeletal muscle deficits [<span>1</span>]. The accumulation of hypertrophic mesenteric adipose tissue and the phenomenon of “creeping fat” in both the small and large bowel are recognized as unique characteristics of Crohn's Disease (CD).</p><p>Several aspects of body composition have been investigated to assess outcomes in IBD including body mass index (BMI), visceral adipose tissue, subcutaneous adipose tissue, and muscle mass [<span>2</span>]. BMI, as an anthropometric measure, is non-specific and not a reliable predictor of visceral or subcutaneous adiposity. Imaging modalities such as computed tomography (CT) or magnetic resonance imaging (MRI) have been used in studies to provide more accurate assessments of fat distribution.</p><p>The aim of this study was to assess the role of adiposity, particularly visceral adipose tissue, in predicting clinical relapse in patients with IBD.</p><p>This retrospective study evaluated anthropometric measures of adiposity, including abdominal body composition using routinely acquired CT scans of the abdomen from patients with a confirmed clinical, endoscopic, histological, and radiological diagnosis of IBD between 2014 and 2020 at the local tertiary IBD centre. The study was approved by the local ethics committee.</p><p>Demographic variables included were age, sex, BMI, and smoking history. Clinical variables included IBD type, prior surgery, corticosteroid use, biologic therapy (specifically anti–tumor necrosis factor alpha [TNF-α] agents), anti-TNF drug levels, disease behavior (classified using Montreal and Vienna classifications), disease location (Montreal classification), disease duration, and disease complications.</p><p>Abdominal body composition was assessed via CT measurements, including cross-sectional areas of total fat, subcutaneous fat, visceral fat, and skeletal muscle at the level of the third lumbar vertebra (L3) in the supine position. Image segmentation and measurement were performed using ImageJ/Fiji software (National Institutes of Health, Bethesda, MD, USA). Measurements were calculated by pixel count and expressed in square centimeters. Sarcopenia was defined as a skeletal muscle index (SMI), determined by CT imaging, two standard deviations below the mean for healthy young adults—specifically < 55 cm<sup>2</sup>/m<sup>2</sup> in men and < 39 cm<sup>2</sup>/m<sup>2</sup> in women.</p><p>The primary outcome measure was clinical relapse within 12 months of current therapy. Clinical relapse was defined as an acute flare of symptoms and/or worsening biochemical markers and/or endoscopic recurrence requiring dose intensification of current therapy or surgical resection. Statistical analyses included
{"title":"Visceral Obesity as a Predictor of Clinical Relapse in Inflammatory Bowel Disease","authors":"Haziq Hasnol, Joel Tan, Tarun Jain, Kavitha Subramaniam","doi":"10.1002/jgh3.70354","DOIUrl":"10.1002/jgh3.70354","url":null,"abstract":"<p>In Inflammatory Bowel Disease (IBD), adipose tissue is postulated to be a source of pro-inflammatory cytokines and adipokines, which may affect disease outcomes. In patients with treatment refractory IBD, abdominal body composition is often characterized by excessive fat deposition and skeletal muscle deficits [<span>1</span>]. The accumulation of hypertrophic mesenteric adipose tissue and the phenomenon of “creeping fat” in both the small and large bowel are recognized as unique characteristics of Crohn's Disease (CD).</p><p>Several aspects of body composition have been investigated to assess outcomes in IBD including body mass index (BMI), visceral adipose tissue, subcutaneous adipose tissue, and muscle mass [<span>2</span>]. BMI, as an anthropometric measure, is non-specific and not a reliable predictor of visceral or subcutaneous adiposity. Imaging modalities such as computed tomography (CT) or magnetic resonance imaging (MRI) have been used in studies to provide more accurate assessments of fat distribution.</p><p>The aim of this study was to assess the role of adiposity, particularly visceral adipose tissue, in predicting clinical relapse in patients with IBD.</p><p>This retrospective study evaluated anthropometric measures of adiposity, including abdominal body composition using routinely acquired CT scans of the abdomen from patients with a confirmed clinical, endoscopic, histological, and radiological diagnosis of IBD between 2014 and 2020 at the local tertiary IBD centre. The study was approved by the local ethics committee.</p><p>Demographic variables included were age, sex, BMI, and smoking history. Clinical variables included IBD type, prior surgery, corticosteroid use, biologic therapy (specifically anti–tumor necrosis factor alpha [TNF-α] agents), anti-TNF drug levels, disease behavior (classified using Montreal and Vienna classifications), disease location (Montreal classification), disease duration, and disease complications.</p><p>Abdominal body composition was assessed via CT measurements, including cross-sectional areas of total fat, subcutaneous fat, visceral fat, and skeletal muscle at the level of the third lumbar vertebra (L3) in the supine position. Image segmentation and measurement were performed using ImageJ/Fiji software (National Institutes of Health, Bethesda, MD, USA). Measurements were calculated by pixel count and expressed in square centimeters. Sarcopenia was defined as a skeletal muscle index (SMI), determined by CT imaging, two standard deviations below the mean for healthy young adults—specifically < 55 cm<sup>2</sup>/m<sup>2</sup> in men and < 39 cm<sup>2</sup>/m<sup>2</sup> in women.</p><p>The primary outcome measure was clinical relapse within 12 months of current therapy. Clinical relapse was defined as an acute flare of symptoms and/or worsening biochemical markers and/or endoscopic recurrence requiring dose intensification of current therapy or surgical resection. Statistical analyses included","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jgh3.70354","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146217530","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarcopenia is commonly observed in patients with periampullary cancer. Even in early-stage cases, it is associated with higher morbidity and poor postoperative outcomes. In this study, we aimed to evaluate the impact of sarcopenia on overall survival in patients with resectable periampullary cancer.
Methods
We retrospectively analyzed data from all patients with resectable periampullary cancer who met the inclusion criteria and underwent curative surgery at Songklanagarind Hospital between 2013 and 2023. All eligible patients had preoperative abdominal computed tomography scans, and we calculated the skeletal muscle index (SMI) at the L3 vertebral level. Patients were categorized into sarcopenia and non-sarcopenia groups based on SMI thresholds. We compared baseline characteristics, laboratory parameters, and overall survival using Kaplan–Meier analysis.
Results
A total of 139 patients were included, with 71 in the sarcopenia group and 68 in the non-sarcopenia group. Patients with sarcopenia were older (66.1 ± 10 vs. 60.2 ± 11 years, p = 0.001). The 5-year survival rate was lower in the sarcopenia group (50.2%) than in the non-sarcopenia group (53.0%); however, the difference was not statistically significant (p = 0.161). Significant survival outcomes were observed in patients with postoperative improved SMI (58.8% vs. 44.5%, p = 0.019).
Conclusion
Preoperative sarcopenia is a key negative prognostic factor for overall survival and postoperative outcomes in patients with resectable periampullary cancer. Enhancing postoperative SMI through exercise and nutritional intervention should be integrated in postoperative care to improve survival outcomes in this population.
背景与目的：肌少症常见于壶腹周围癌患者。即使在早期病例中，它也与较高的发病率和较差的术后预后有关。在这项研究中，我们旨在评估肌肉减少症对可切除壶腹周围癌患者总生存率的影响。方法：回顾性分析2013年至2023年Songklanagarind医院所有符合纳入标准并接受根治性手术的可切除壶腹周围癌患者的数据。所有符合条件的患者术前进行腹部计算机断层扫描，我们计算了L3椎体水平的骨骼肌指数（SMI）。根据SMI阈值将患者分为肌肉减少组和非肌肉减少组。我们使用Kaplan-Meier分析比较基线特征、实验室参数和总生存率。结果：共纳入139例患者，其中肌肉减少组71例，非肌肉减少组68例。肌肉减少症患者年龄较大（66.1±10岁比60.2±11岁，p = 0.001）。肌少症组5年生存率（50.2%）低于非肌少症组（53.0%）；但差异无统计学意义（p = 0.161）。术后SMI改善患者的生存结果显著（58.8% vs. 44.5%, p = 0.019）。结论：术前肌肉减少是影响可切除壶腹周围癌患者总体生存和术后预后的关键不良预后因素。通过运动和营养干预加强术后重度精神障碍患者应纳入术后护理，以改善该人群的生存结果。
{"title":"Impact of Sarcopenia on Overall Survival in Patients With Resectable Periampullary Cancer: A Retrospective Study","authors":"Kontee Wongseree, Tanawat Pattarapuntakul, Tanawat Jongraksak, Thanawin Wong, Nisa Netinatsunton, Wisitsak Pakdee, Pramot Tanutit, Natee Ina, Thakerng Pitakteerabundit, Pimsiri Sripongpun","doi":"10.1002/jgh3.70366","DOIUrl":"10.1002/jgh3.70366","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background and Aim</h3>\u0000 \u0000 <p>Sarcopenia is commonly observed in patients with periampullary cancer. Even in early-stage cases, it is associated with higher morbidity and poor postoperative outcomes. In this study, we aimed to evaluate the impact of sarcopenia on overall survival in patients with resectable periampullary cancer.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We retrospectively analyzed data from all patients with resectable periampullary cancer who met the inclusion criteria and underwent curative surgery at Songklanagarind Hospital between 2013 and 2023. All eligible patients had preoperative abdominal computed tomography scans, and we calculated the skeletal muscle index (SMI) at the L3 vertebral level. Patients were categorized into sarcopenia and non-sarcopenia groups based on SMI thresholds. We compared baseline characteristics, laboratory parameters, and overall survival using Kaplan–Meier analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 139 patients were included, with 71 in the sarcopenia group and 68 in the non-sarcopenia group. Patients with sarcopenia were older (66.1 ± 10 vs. 60.2 ± 11 years, <i>p</i> = 0.001). The 5-year survival rate was lower in the sarcopenia group (50.2%) than in the non-sarcopenia group (53.0%); however, the difference was not statistically significant (<i>p</i> = 0.161). Significant survival outcomes were observed in patients with postoperative improved SMI (58.8% vs. 44.5%, <i>p</i> = 0.019).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Preoperative sarcopenia is a key negative prognostic factor for overall survival and postoperative outcomes in patients with resectable periampullary cancer. Enhancing postoperative SMI through exercise and nutritional intervention should be integrated in postoperative care to improve survival outcomes in this population.</p>\u0000 </section>\u0000 </div>","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12914076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146229185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Catherine Emerson, Anna Klas, Peter R. Gibson, Lisa Olive, Matthew Fuller-Tyszkiewicz, Antonina Mikocka-Walus
Aims
Fatigue in IBD is pervasive, with very few intervention options available to patients. Research has indicated that psychological therapies are a promising strategy for managing IBD fatigue. However, no such intervention is available to date. This study aimed to evaluate the opinion of patients and health professionals on a potential psychological intervention for IBD fatigue.
Methods and Results
A total of seven patients (Crohn's disease = 5, ulcerative colitis = 2) and seven health professionals participated in semi-structured interviews. Results were derived by using a template analysis, revealing four key themes and associated subthemes: (1) it's a trade-off; (2) buy-in, trust and credibility; (3) accountability; and (4) accessibility and equity. Important factors identified were a self-led online intervention, where patients can converse with other patients. Patients determined a facilitator with IBD-specific knowledge to be important. Health professionals were concerned with the cost-effectiveness and duration of an intervention, whereas patients were less concerned about the financial cost if there is perceived benefit to the intervention.
Conclusion
Findings indicate the need to balance support with accessibility for patients. The lack of consensus of who can deliver an intervention by health professionals is significant and underscores the need for mental health care to be integrated into IBD health services. Nurses were recommended as an alternative to mental health professionals. However, the nurses interviewed emphasized the impact this would pose on their workloads. As such, there needs to be a diversity of supporting staff in IBD health care teams to ensure that future psychological interventions are feasible.
{"title":"A Qualitative Template Analysis to Understand Patient and Practitioner Perspectives on a Psychological Intervention for Fatigue in Inflammatory Bowel Disease","authors":"Catherine Emerson, Anna Klas, Peter R. Gibson, Lisa Olive, Matthew Fuller-Tyszkiewicz, Antonina Mikocka-Walus","doi":"10.1002/jgh3.70363","DOIUrl":"10.1002/jgh3.70363","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Fatigue in IBD is pervasive, with very few intervention options available to patients. Research has indicated that psychological therapies are a promising strategy for managing IBD fatigue. However, no such intervention is available to date. This study aimed to evaluate the opinion of patients and health professionals on a potential psychological intervention for IBD fatigue.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods and Results</h3>\u0000 \u0000 <p>A total of seven patients (Crohn's disease = 5, ulcerative colitis = 2) and seven health professionals participated in semi-structured interviews. Results were derived by using a template analysis, revealing four key themes and associated subthemes: (1) it's a trade-off; (2) buy-in, trust and credibility; (3) accountability; and (4) accessibility and equity. Important factors identified were a self-led online intervention, where patients can converse with other patients. Patients determined a facilitator with IBD-specific knowledge to be important. Health professionals were concerned with the cost-effectiveness and duration of an intervention, whereas patients were less concerned about the financial cost if there is perceived benefit to the intervention.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Findings indicate the need to balance support with accessibility for patients. The lack of consensus of who can deliver an intervention by health professionals is significant and underscores the need for mental health care to be integrated into IBD health services. Nurses were recommended as an alternative to mental health professionals. However, the nurses interviewed emphasized the impact this would pose on their workloads. As such, there needs to be a diversity of supporting staff in IBD health care teams to ensure that future psychological interventions are feasible.</p>\u0000 </section>\u0000 </div>","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12907766/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146213713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ali Emre Bardak, Ceren Yazkac, Zulal Istemihan, Kanan Nuriyev, Asli Cifcibasi Ormeci, Bilger Cavus
<p>Von Hippel Lindau (VHL) disease is an autosomal dominant genetic disorder, which is characterized by the development of benign and malignant tumors and cysts in multiple organs. Most commonly affected organs are cerebellum, eyes, spinal cord, kidneys, adrenal glands, and pancreas [<span>1</span>]. Pancreatic manifestations range from simple cysts and serous cystadenomas to potentially malignant pancreatic neuroendocrine tumors (PNETs) [<span>2, 3</span>]. This study describes the clinical features and pancreatic manifestations of VHL patients with pancreatic involvement managed at our center.</p><p>This is a retrospective observational study conducted at the Department of Gastroenterology and Hepatology, Istanbul University, Istanbul Medical Faculty. All patients with genetically or clinically confirmed VHL disease were screened. 15 patients with confirmed pancreatic involvement were included in the study. Written informed consent was obtained from each patient.</p><p>Data regarding demographic characteristics, family history, age at VHL diagnosis, and pancreatic and extra-pancreatic organ involvement were extracted from electronic health records. This study was descriptive in nature. Categorical variables were summarized using counts and percentages, while continuous variables were reported as means with ranges. No inferential statistical analyses were performed due to the small sample size.</p><p>Our cohort of 15 VHL patients with pancreatic involvement is from five distinct families with a distribution of 6, 5, 2, 1, and 1 patient per family. Four patients are index cases within their families. One patient died from necrotizing pneumonia at age 51. The remaining 14 patients have a mean age of 40.4 years (Table 1).</p><p>13 patients had multiple cysts in the pancreas, while one patient had two cysts, and the other had one PNET. Pancreatic cysts were evaluated through a combination of clinical assessment, imaging studies, biochemical, and cytological cyst fluid analysis.</p><p>Body and neck were the most frequently involved parts, each with 13 patients, followed by the head with 12 patients. Tail was the least involved part with 11 patients. 10 patients had cysts in all parts of the pancreas. The largest cyst in each patient was analyzed according to its size (based on MRI), the part of the pancreas where it was located, and its radiological features (Table 1). The largest pancreatic cysts were most located in the head of the pancreas (<i>n</i> = 4, 28.6%). All cysts except one cyst appeared hypointense on T1-weighted imaging and hyperintense on T2-weighted imaging without a solid component or a contrast enhancement on the post-contrast dynamic series. In one cyst, post-contrast dynamic series revealed an 8 mm polypoid lesion within the cyst, connected to the cyst wall by a stalk and demonstrating contrast enhancement during the arterial phase. This lesion exhibited mild contrast uptake in the portal and venous phases and showed washout chara
{"title":"Pancreatic Involvement in von Hippel Lindau Disease: A Single-Center Experience","authors":"Ali Emre Bardak, Ceren Yazkac, Zulal Istemihan, Kanan Nuriyev, Asli Cifcibasi Ormeci, Bilger Cavus","doi":"10.1002/jgh3.70360","DOIUrl":"10.1002/jgh3.70360","url":null,"abstract":"<p>Von Hippel Lindau (VHL) disease is an autosomal dominant genetic disorder, which is characterized by the development of benign and malignant tumors and cysts in multiple organs. Most commonly affected organs are cerebellum, eyes, spinal cord, kidneys, adrenal glands, and pancreas [<span>1</span>]. Pancreatic manifestations range from simple cysts and serous cystadenomas to potentially malignant pancreatic neuroendocrine tumors (PNETs) [<span>2, 3</span>]. This study describes the clinical features and pancreatic manifestations of VHL patients with pancreatic involvement managed at our center.</p><p>This is a retrospective observational study conducted at the Department of Gastroenterology and Hepatology, Istanbul University, Istanbul Medical Faculty. All patients with genetically or clinically confirmed VHL disease were screened. 15 patients with confirmed pancreatic involvement were included in the study. Written informed consent was obtained from each patient.</p><p>Data regarding demographic characteristics, family history, age at VHL diagnosis, and pancreatic and extra-pancreatic organ involvement were extracted from electronic health records. This study was descriptive in nature. Categorical variables were summarized using counts and percentages, while continuous variables were reported as means with ranges. No inferential statistical analyses were performed due to the small sample size.</p><p>Our cohort of 15 VHL patients with pancreatic involvement is from five distinct families with a distribution of 6, 5, 2, 1, and 1 patient per family. Four patients are index cases within their families. One patient died from necrotizing pneumonia at age 51. The remaining 14 patients have a mean age of 40.4 years (Table 1).</p><p>13 patients had multiple cysts in the pancreas, while one patient had two cysts, and the other had one PNET. Pancreatic cysts were evaluated through a combination of clinical assessment, imaging studies, biochemical, and cytological cyst fluid analysis.</p><p>Body and neck were the most frequently involved parts, each with 13 patients, followed by the head with 12 patients. Tail was the least involved part with 11 patients. 10 patients had cysts in all parts of the pancreas. The largest cyst in each patient was analyzed according to its size (based on MRI), the part of the pancreas where it was located, and its radiological features (Table 1). The largest pancreatic cysts were most located in the head of the pancreas (<i>n</i> = 4, 28.6%). All cysts except one cyst appeared hypointense on T1-weighted imaging and hyperintense on T2-weighted imaging without a solid component or a contrast enhancement on the post-contrast dynamic series. In one cyst, post-contrast dynamic series revealed an 8 mm polypoid lesion within the cyst, connected to the cyst wall by a stalk and demonstrating contrast enhancement during the arterial phase. This lesion exhibited mild contrast uptake in the portal and venous phases and showed washout chara","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jgh3.70360","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146217267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Remimazolam is a benzodiazepine receptor agonist intravenous anesthetic. This study aimed to evaluate the efficacy and safety of remimazolam for sedation during gastrointestinal endoscopy using real-world clinical data.
Methods
This retrospective observational study included 352 patients who underwent esophagogastroduodenoscopy or colonoscopy sedated with remimazolam between January and February 2024 at our institution. Outcomes included the incidence of awakening during procedures, the sedation completion rate, and the incidence and severity of adverse events. Multivariate logistic regression analyses identified factors associated with hypoxia and hypotension.
Results
Median patient age was 67 years (IQR: 58–74), and 62.2% were male. Median initial and additional doses were 3 (IQR: 2–3 mg) and 1 mg (IQR: 0–2 mg). Awakening occurred in 19.0% of patients. The sedation completion rate was 100%. Adverse events included hypotension (7.8%), hypoxia (13.1%), and bradycardia (4.0%), and no serious adverse events were observed. The only risk factor for hypoxia was advanced age (Odds ratio 1.04, 95% confidence interval: 1.01–1.08, p = 0.03), and the dose of remimazolam itself was not an independent risk factor for either hypoxia or hypotension.
Conclusions
Remimazolam usage for gastrointestinal endoscopic sedation showed a favorable safety profile. Advanced age was associated with an increased risk of hypoxia, suggesting that careful monitoring and individualized sedation protocols are especially necessary for elderly patients. On the other hand, there are still issues regarding the duration of sedation. During long procedures, it is necessary to frequently check the depth of sedation to avoid undersedation.
{"title":"Real-World Evaluation of Remimazolam for Sedation During Gastrointestinal Endoscopy: Efficacy, Safety, and Risk Factors","authors":"Hinako Sakurai, Kurato Miyazaki, Atsushi Nakayama, Motoki Sasaki, Mai Oowada, Misaki Sugawara, Yuki Kubo, Rei Mizobe, Ai Katsumi, Maya Ishizawa, Yuri Imura, Shoma Murata, Daisuke Minezaki, Kentaro Iwata, Anna Tojo, Teppei Masunaga, Kumiko Kirita, Mari Mizutani, Michiko Nishikawa, Yusaku Takatori, Teppei Akimoto, Shintaro Kawasaki, Noriko Matsuura, Hideomi Tomida, Tomohisa Sujino, Kaoru Takabayashi, Kanai Takanori, Naohisa Yahagi, Motohiko Kato","doi":"10.1002/jgh3.70351","DOIUrl":"10.1002/jgh3.70351","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background and Aim</h3>\u0000 \u0000 <p>Remimazolam is a benzodiazepine receptor agonist intravenous anesthetic. This study aimed to evaluate the efficacy and safety of remimazolam for sedation during gastrointestinal endoscopy using real-world clinical data.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This retrospective observational study included 352 patients who underwent esophagogastroduodenoscopy or colonoscopy sedated with remimazolam between January and February 2024 at our institution. Outcomes included the incidence of awakening during procedures, the sedation completion rate, and the incidence and severity of adverse events. Multivariate logistic regression analyses identified factors associated with hypoxia and hypotension.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Median patient age was 67 years (IQR: 58–74), and 62.2% were male. Median initial and additional doses were 3 (IQR: 2–3 mg) and 1 mg (IQR: 0–2 mg). Awakening occurred in 19.0% of patients. The sedation completion rate was 100%. Adverse events included hypotension (7.8%), hypoxia (13.1%), and bradycardia (4.0%), and no serious adverse events were observed. The only risk factor for hypoxia was advanced age (Odds ratio 1.04, 95% confidence interval: 1.01–1.08, <i>p</i> = 0.03), and the dose of remimazolam itself was not an independent risk factor for either hypoxia or hypotension.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Remimazolam usage for gastrointestinal endoscopic sedation showed a favorable safety profile. Advanced age was associated with an increased risk of hypoxia, suggesting that careful monitoring and individualized sedation protocols are especially necessary for elderly patients. On the other hand, there are still issues regarding the duration of sedation. During long procedures, it is necessary to frequently check the depth of sedation to avoid undersedation.</p>\u0000 </section>\u0000 </div>","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jgh3.70351","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146217261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hayley Logan, Katherine Rimmer, James Doecke, Desmond Patrick
Background and Aims
Therapeutic drug monitoring (TDM) of non anti-TNF biologics is not well established in clinical practice. We aimed to clarify the association between VTL and remission in our cohort of maintenance vedolizumab patients using objective markers of disease activity to see if this could aid in decision making.
Methods
A retrospective cross-sectional cohort study was performed on 83 consecutive moderate–severe inflammatory bowel disease (IBD) patients. VTL measurement immediately prior to infusion was paired with clinical and objective markers of disease activity. Objective disease assessment was undertaken using fecal calprotectin, magnetic resonance imaging, intestinal ultrasound, or sigmoidoscopy/colonoscopy.
Results
Eighty-three patients on maintenance vedolizumab were evaluated (59% UC and 41% CD). The median age at diagnosis was 40 years. Median trough vedolizumab levels were comparable in patients who achieved steroid-free clinical remission (12.65 μg/mL vs. 8.89 μg/mL p = 0.771) or objective remission (15.22 μg/mL vs. 8.89 μg/mL p = 0.073) versus those who had not. Quartile analysis (Q1: < 6.9 μg/mL, Q2: 6.9–12.2 μg/mL, Q3: 12.2–18.6 μg/mL, and Q4: > 18 ug/mL) showed no difference between quartiles of vedolizumab levels and clinical or objective remission (p = 0.65).
Conclusion
Vedolizumab trough levels were not associated with clinical or objective remission during maintenance therapy, and in our real-world cohort, do not appear to be a clinically relevant target for TDM.
背景与目的：非抗肿瘤坏死因子生物制剂的治疗性药物监测（TDM）在临床实践中尚未得到很好的建立。我们的目的是利用疾病活动的客观标记物来澄清维多单抗维持性患者队列中VTL和缓解之间的关系，看看这是否有助于决策。方法：对83例连续中重度炎症性肠病（IBD）患者进行回顾性横断面队列研究。在输注前立即进行VTL测量，与疾病活动的临床和客观标志物配对。使用粪便钙保护蛋白、磁共振成像、肠道超声或乙状结肠镜/结肠镜进行客观疾病评估。结果：83例维持性维多单抗患者被评估（59% UC和41% CD）。诊断时的中位年龄为40岁。获得无类固醇临床缓解（12.65 μg/mL vs. 8.89 μg/mL p = 0.771）或客观缓解（15.22 μg/mL vs. 8.89 μg/mL p = 0.073）的患者的vedolizumab中位谷水平与未获得缓解的患者相当。四分位数分析（Q1: 18 ug/mL）显示，vedolizumab水平与临床或客观缓解的四分位数之间没有差异（p = 0.65）。结论：Vedolizumab谷底水平与维持治疗期间的临床或客观缓解无关，并且在我们的现实世界队列中，似乎不是TDM的临床相关靶点。
{"title":"Therapeutic Drug Monitoring of Vedolizumab Levels During Maintenance in Inflammatory Bowel Disease (MOVE-IBD)","authors":"Hayley Logan, Katherine Rimmer, James Doecke, Desmond Patrick","doi":"10.1002/jgh3.70320","DOIUrl":"10.1002/jgh3.70320","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background and Aims</h3>\u0000 \u0000 <p>Therapeutic drug monitoring (TDM) of non anti-TNF biologics is not well established in clinical practice. We aimed to clarify the association between VTL and remission in our cohort of maintenance vedolizumab patients using objective markers of disease activity to see if this could aid in decision making.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A retrospective cross-sectional cohort study was performed on 83 consecutive moderate–severe inflammatory bowel disease (IBD) patients. VTL measurement immediately prior to infusion was paired with clinical and objective markers of disease activity. Objective disease assessment was undertaken using fecal calprotectin, magnetic resonance imaging, intestinal ultrasound, or sigmoidoscopy/colonoscopy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Eighty-three patients on maintenance vedolizumab were evaluated (59% UC and 41% CD). The median age at diagnosis was 40 years. Median trough vedolizumab levels were comparable in patients who achieved steroid-free clinical remission (12.65 μg/mL vs. 8.89 μg/mL <i>p</i> = 0.771) or objective remission (15.22 μg/mL vs. 8.89 μg/mL <i>p</i> = 0.073) versus those who had not. Quartile analysis (Q1: < 6.9 μg/mL, Q2: 6.9–12.2 μg/mL, Q3: 12.2–18.6 μg/mL, and Q4: > 18 ug/mL) showed no difference between quartiles of vedolizumab levels and clinical or objective remission (<i>p</i> = 0.65).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Vedolizumab trough levels were not associated with clinical or objective remission during maintenance therapy, and in our real-world cohort, do not appear to be a clinically relevant target for TDM.</p>\u0000 </section>\u0000 </div>","PeriodicalId":45861,"journal":{"name":"JGH Open","volume":"10 2","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12907250/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146214224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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