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FDA Expands Dupilumab for EoE to Younger Children
The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron/Sanofi) for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. It is the first and only medicine approved to treat these patients.
, as reported by this news organization.
EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.
Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway.
EoE KIDS Trial
The FDA approval of dupilumab for younger children is based on results from the phase 3 randomized, double-blind, placebo-controlled EoE KIDS trial, which had two parts.
Part A was a 16-week double-blind treatment period that evaluated the safety and efficacy of dupilumab in a tiered weight-based dosing schema.
At 16 weeks, 66% of children who received higher dose dupilumab at tiered dosing regimens based on weight achieved histologic disease remission (six or fewer eosinophils/high power field), which was the primary endpoint, compared with only 3% of children who received placebo.
In addition, a greater decrease in the proportion of days with one or more signs of EoE according to the Pediatric EoE Sign/Symptom Questionnaire caregiver version (PESQ-C) was observed in children treated with dupilumab at 16 weeks compared placebo.
Part B was a 36-week extended active treatment period in which eligible children from Part A in the dupilumab group continued to receive their dose level and those in the placebo group in Part A switched to active treatment.
Histologic remission was sustained at week 52 in 53% of children treated with dupilumab in Parts A and B. Histologic remission was also achieved at week 52 in 53% of children who switched to dupilumab from placebo in Part B.
The safety profile of dupilumab observed through 16 weeks in these children was generally in line to that seen through 24 weeks in persons aged 12 years or older with EoE.
The most common adverse events (≥ 2%) more frequently observed with dupilumab than with placebo were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the dupilumab arm.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron/Sanofi) for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. It is the first and only medicine approved to treat these patients.
, as reported by this news organization.
EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.
Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway.
EoE KIDS Trial
The FDA approval of dupilumab for younger children is based on results from the phase 3 randomized, double-blind, placebo-controlled EoE KIDS trial, which had two parts.
Part A was a 16-week double-blind treatment period that evaluated the safety and efficacy of dupilumab in a tiered weight-based dosing schema.
At 16 weeks, 66% of children who received higher dose dupilumab at tiered dosing regimens based on weight achieved histologic disease remission (six or fewer eosinophils/high power field), which was the primary endpoint, compared with only 3% of children who received placebo.
In addition, a greater decrease in the proportion of days with one or more signs of EoE according to the Pediatric EoE Sign/Symptom Questionnaire caregiver version (PESQ-C) was observed in children treated with dupilumab at 16 weeks compared placebo.
Part B was a 36-week extended active treatment period in which eligible children from Part A in the dupilumab group continued to receive their dose level and those in the placebo group in Part A switched to active treatment.
Histologic remission was sustained at week 52 in 53% of children treated with dupilumab in Parts A and B. Histologic remission was also achieved at week 52 in 53% of children who switched to dupilumab from placebo in Part B.
The safety profile of dupilumab observed through 16 weeks in these children was generally in line to that seen through 24 weeks in persons aged 12 years or older with EoE.
The most common adverse events (≥ 2%) more frequently observed with dupilumab than with placebo were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the dupilumab arm.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron/Sanofi) for the treatment of eosinophilic esophagitis (EoE) in children aged 1-11 years and weighing ≥ 15 kg. It is the first and only medicine approved to treat these patients.
, as reported by this news organization.
EoE is a chronic inflammatory disorder driven by type 2 inflammation that damages the esophagus and causes difficulty swallowing and eating.
Dupilumab is a monoclonal antibody that acts to inhibit part of the inflammatory pathway.
EoE KIDS Trial
The FDA approval of dupilumab for younger children is based on results from the phase 3 randomized, double-blind, placebo-controlled EoE KIDS trial, which had two parts.
Part A was a 16-week double-blind treatment period that evaluated the safety and efficacy of dupilumab in a tiered weight-based dosing schema.
At 16 weeks, 66% of children who received higher dose dupilumab at tiered dosing regimens based on weight achieved histologic disease remission (six or fewer eosinophils/high power field), which was the primary endpoint, compared with only 3% of children who received placebo.
In addition, a greater decrease in the proportion of days with one or more signs of EoE according to the Pediatric EoE Sign/Symptom Questionnaire caregiver version (PESQ-C) was observed in children treated with dupilumab at 16 weeks compared placebo.
Part B was a 36-week extended active treatment period in which eligible children from Part A in the dupilumab group continued to receive their dose level and those in the placebo group in Part A switched to active treatment.
Histologic remission was sustained at week 52 in 53% of children treated with dupilumab in Parts A and B. Histologic remission was also achieved at week 52 in 53% of children who switched to dupilumab from placebo in Part B.
The safety profile of dupilumab observed through 16 weeks in these children was generally in line to that seen through 24 weeks in persons aged 12 years or older with EoE.
The most common adverse events (≥ 2%) more frequently observed with dupilumab than with placebo were injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections. In EoE KIDS Part B, one case of helminth infection was reported in the dupilumab arm.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
Etrasimod Appears Effective in Eosinophilic Esophagitis: Phase 2 Study
Etrasimod, an investigational, oral selective sphingosine-1-phosphate (S1P)–receptor modulator, also improved endoscopic features of EoE, overall symptom severity, and dysphagia in some patients, researchers reported.
“These results support further investigation of etrasimod in EoE,” said Evan S. Dellon, MD, MPH, AGAF, of the University of North Carolina at Chapel Hill.
Dr. Dellon presented the results from the phase 2 study at the October 2023 annual scientific meeting of the American College of Gastroenterology in Vancouver, Canada.
VOYAGE Study
In the VOYAGE study, 108 adults were included, with about half female and an average EoE diagnosis for nearly 5 years.
The patients were randomized to once-daily doses of etrasimod 2 mg, etrasimod 1 mg, or placebo for 24 weeks, followed by a 28-week still-ongoing extension period investigating the efficacy and safety of daily oral etrasimod 1 mg and 2 mg, compared with placebo.
After 24 weeks of treatment, there was a 52.4% reduction in peak eosinophil count (PEC) in the group of patients who were given a 2-mg daily dose of etrasimod compared to placebo, Dr. Dellon said.
Among patients given a 1-mg daily dose of etrasimod, there was a 27.4% reduction in PEC.
Meanwhile, there was a 61% increase in PEC for people who were given placebo.
Etrasimod also bested placebo on secondary outcomes in the VOYAGE study, including:
- Comprehensive histologic severity and extent scores, with a change of -0.2 in both etrasimod groups (P < .0001), compared with a slight increase for the placebo group.
- Endoscopic features (EREFS), with a decline of 1.3 for the 2-mg–dose etrasimod group (P = .0303), compared with a slight decline for the placebo group. There was a decline of 1.0 in the 1-mg–dose etrasimod group, but this was not statistically significant.
Higher Dose Arm, Better Results
In the email exchange with GI & Hepatology News, Dr. Dellon said this appears to be “a dose-response where the 2-mg dose is needed to see more prominent response, but the EREFS response is in the right direction with the 1-mg dose.”
The study found a statistically significant decrease in only one segment of the trial participants, those who took the 2-mg dose and had a history of dilation, as measured by the Dysphagia Symptom Questionnaire (DSQ). In that group, there was a reported decrease of 21.6 points from baseline.
“The average scores at baseline are in the low 30s. The range for DSQ (which is a composite score of daily measurements over 14 days) is from 0 to 84,” Dr. Dellon wrote. “A score in the 30s over 2 weeks is quite symptomatic, so a decrease of 21.6 points is substantial.”
Dr. Dellon and co-authors said etrasimod appeared to be well tolerated with a safety profile consistent with use of the drug in patients with ulcerative colitis.
In treatment-emergent adverse events, elevation of liver transaminases was reported among 4 of 39 patients (10.3%) in the 1-mg etrasimod group and 3 of the 41 patients (7.3%) in the 2-mg etrasimod group, compared with none in the placebo group.
Bilirubin elevation was reported in 2 patients (5.1%) in the 1-mg etrasimod group and none in the 2-mg etrasimod or placebo groups.
Prospect of Another EoE Treatment
In an interview with GI & Hepatology News, Scott Gabbard, MD, a gastroenterologist at Cleveland Clinic, said, “For so many years, there was no FDA approved therapy [for EoE]. Now, we do have an FDA approved therapy.”
The FDA approved the first treatment for EoE — dupilumab (Dupixent) — last year.
“It’s exciting to suddenly have the prospect of more options for patients with EoE. We can see multiple other options for our patients who sorely need therapy coming down the pipeline,” Dr. Gabbard said.
The data support further investigation, with only about one potential concern drawing attention during the presentation, he added.
“Overall, there were no serious adverse events,” Dr. Gabbard said. “There was clearly a change in baseline and overall symptom scores.”
In an email exchange with GI & Hepatology News, Jennifer Horsley-Silva, MD, of the Mayo Clinic, said the VOYAGE study was important because it serves as a proof of concept that targeting S1P receptors can affect EoE.
“A limitation of the study is it was conducted in a specific group of patients with EoE: a substantial number were refractory to corticosteroids, and over half had prior esophageal dilations,” she wrote.
Pfizer sponsored the VOYAGE trial. Dr. Dellon indicated no relevant financial relationships. Dr. Horsley Silva has research funding from Regeneron/Sanofi, Allakos, Celgene, Bristol Myers Squibb, and has participated in an advisory board for Sanofi Genzyme. No disclosures were included for Dr. Gabbard and no recent paper is available in PubMed for Dr. Horsley-Silva.
Etrasimod, an investigational, oral selective sphingosine-1-phosphate (S1P)–receptor modulator, also improved endoscopic features of EoE, overall symptom severity, and dysphagia in some patients, researchers reported.
“These results support further investigation of etrasimod in EoE,” said Evan S. Dellon, MD, MPH, AGAF, of the University of North Carolina at Chapel Hill.
Dr. Dellon presented the results from the phase 2 study at the October 2023 annual scientific meeting of the American College of Gastroenterology in Vancouver, Canada.
VOYAGE Study
In the VOYAGE study, 108 adults were included, with about half female and an average EoE diagnosis for nearly 5 years.
The patients were randomized to once-daily doses of etrasimod 2 mg, etrasimod 1 mg, or placebo for 24 weeks, followed by a 28-week still-ongoing extension period investigating the efficacy and safety of daily oral etrasimod 1 mg and 2 mg, compared with placebo.
After 24 weeks of treatment, there was a 52.4% reduction in peak eosinophil count (PEC) in the group of patients who were given a 2-mg daily dose of etrasimod compared to placebo, Dr. Dellon said.
Among patients given a 1-mg daily dose of etrasimod, there was a 27.4% reduction in PEC.
Meanwhile, there was a 61% increase in PEC for people who were given placebo.
Etrasimod also bested placebo on secondary outcomes in the VOYAGE study, including:
- Comprehensive histologic severity and extent scores, with a change of -0.2 in both etrasimod groups (P < .0001), compared with a slight increase for the placebo group.
- Endoscopic features (EREFS), with a decline of 1.3 for the 2-mg–dose etrasimod group (P = .0303), compared with a slight decline for the placebo group. There was a decline of 1.0 in the 1-mg–dose etrasimod group, but this was not statistically significant.
Higher Dose Arm, Better Results
In the email exchange with GI & Hepatology News, Dr. Dellon said this appears to be “a dose-response where the 2-mg dose is needed to see more prominent response, but the EREFS response is in the right direction with the 1-mg dose.”
The study found a statistically significant decrease in only one segment of the trial participants, those who took the 2-mg dose and had a history of dilation, as measured by the Dysphagia Symptom Questionnaire (DSQ). In that group, there was a reported decrease of 21.6 points from baseline.
“The average scores at baseline are in the low 30s. The range for DSQ (which is a composite score of daily measurements over 14 days) is from 0 to 84,” Dr. Dellon wrote. “A score in the 30s over 2 weeks is quite symptomatic, so a decrease of 21.6 points is substantial.”
Dr. Dellon and co-authors said etrasimod appeared to be well tolerated with a safety profile consistent with use of the drug in patients with ulcerative colitis.
In treatment-emergent adverse events, elevation of liver transaminases was reported among 4 of 39 patients (10.3%) in the 1-mg etrasimod group and 3 of the 41 patients (7.3%) in the 2-mg etrasimod group, compared with none in the placebo group.
Bilirubin elevation was reported in 2 patients (5.1%) in the 1-mg etrasimod group and none in the 2-mg etrasimod or placebo groups.
Prospect of Another EoE Treatment
In an interview with GI & Hepatology News, Scott Gabbard, MD, a gastroenterologist at Cleveland Clinic, said, “For so many years, there was no FDA approved therapy [for EoE]. Now, we do have an FDA approved therapy.”
The FDA approved the first treatment for EoE — dupilumab (Dupixent) — last year.
“It’s exciting to suddenly have the prospect of more options for patients with EoE. We can see multiple other options for our patients who sorely need therapy coming down the pipeline,” Dr. Gabbard said.
The data support further investigation, with only about one potential concern drawing attention during the presentation, he added.
“Overall, there were no serious adverse events,” Dr. Gabbard said. “There was clearly a change in baseline and overall symptom scores.”
In an email exchange with GI & Hepatology News, Jennifer Horsley-Silva, MD, of the Mayo Clinic, said the VOYAGE study was important because it serves as a proof of concept that targeting S1P receptors can affect EoE.
“A limitation of the study is it was conducted in a specific group of patients with EoE: a substantial number were refractory to corticosteroids, and over half had prior esophageal dilations,” she wrote.
Pfizer sponsored the VOYAGE trial. Dr. Dellon indicated no relevant financial relationships. Dr. Horsley Silva has research funding from Regeneron/Sanofi, Allakos, Celgene, Bristol Myers Squibb, and has participated in an advisory board for Sanofi Genzyme. No disclosures were included for Dr. Gabbard and no recent paper is available in PubMed for Dr. Horsley-Silva.
Etrasimod, an investigational, oral selective sphingosine-1-phosphate (S1P)–receptor modulator, also improved endoscopic features of EoE, overall symptom severity, and dysphagia in some patients, researchers reported.
“These results support further investigation of etrasimod in EoE,” said Evan S. Dellon, MD, MPH, AGAF, of the University of North Carolina at Chapel Hill.
Dr. Dellon presented the results from the phase 2 study at the October 2023 annual scientific meeting of the American College of Gastroenterology in Vancouver, Canada.
VOYAGE Study
In the VOYAGE study, 108 adults were included, with about half female and an average EoE diagnosis for nearly 5 years.
The patients were randomized to once-daily doses of etrasimod 2 mg, etrasimod 1 mg, or placebo for 24 weeks, followed by a 28-week still-ongoing extension period investigating the efficacy and safety of daily oral etrasimod 1 mg and 2 mg, compared with placebo.
After 24 weeks of treatment, there was a 52.4% reduction in peak eosinophil count (PEC) in the group of patients who were given a 2-mg daily dose of etrasimod compared to placebo, Dr. Dellon said.
Among patients given a 1-mg daily dose of etrasimod, there was a 27.4% reduction in PEC.
Meanwhile, there was a 61% increase in PEC for people who were given placebo.
Etrasimod also bested placebo on secondary outcomes in the VOYAGE study, including:
- Comprehensive histologic severity and extent scores, with a change of -0.2 in both etrasimod groups (P < .0001), compared with a slight increase for the placebo group.
- Endoscopic features (EREFS), with a decline of 1.3 for the 2-mg–dose etrasimod group (P = .0303), compared with a slight decline for the placebo group. There was a decline of 1.0 in the 1-mg–dose etrasimod group, but this was not statistically significant.
Higher Dose Arm, Better Results
In the email exchange with GI & Hepatology News, Dr. Dellon said this appears to be “a dose-response where the 2-mg dose is needed to see more prominent response, but the EREFS response is in the right direction with the 1-mg dose.”
The study found a statistically significant decrease in only one segment of the trial participants, those who took the 2-mg dose and had a history of dilation, as measured by the Dysphagia Symptom Questionnaire (DSQ). In that group, there was a reported decrease of 21.6 points from baseline.
“The average scores at baseline are in the low 30s. The range for DSQ (which is a composite score of daily measurements over 14 days) is from 0 to 84,” Dr. Dellon wrote. “A score in the 30s over 2 weeks is quite symptomatic, so a decrease of 21.6 points is substantial.”
Dr. Dellon and co-authors said etrasimod appeared to be well tolerated with a safety profile consistent with use of the drug in patients with ulcerative colitis.
In treatment-emergent adverse events, elevation of liver transaminases was reported among 4 of 39 patients (10.3%) in the 1-mg etrasimod group and 3 of the 41 patients (7.3%) in the 2-mg etrasimod group, compared with none in the placebo group.
Bilirubin elevation was reported in 2 patients (5.1%) in the 1-mg etrasimod group and none in the 2-mg etrasimod or placebo groups.
Prospect of Another EoE Treatment
In an interview with GI & Hepatology News, Scott Gabbard, MD, a gastroenterologist at Cleveland Clinic, said, “For so many years, there was no FDA approved therapy [for EoE]. Now, we do have an FDA approved therapy.”
The FDA approved the first treatment for EoE — dupilumab (Dupixent) — last year.
“It’s exciting to suddenly have the prospect of more options for patients with EoE. We can see multiple other options for our patients who sorely need therapy coming down the pipeline,” Dr. Gabbard said.
The data support further investigation, with only about one potential concern drawing attention during the presentation, he added.
“Overall, there were no serious adverse events,” Dr. Gabbard said. “There was clearly a change in baseline and overall symptom scores.”
In an email exchange with GI & Hepatology News, Jennifer Horsley-Silva, MD, of the Mayo Clinic, said the VOYAGE study was important because it serves as a proof of concept that targeting S1P receptors can affect EoE.
“A limitation of the study is it was conducted in a specific group of patients with EoE: a substantial number were refractory to corticosteroids, and over half had prior esophageal dilations,” she wrote.
Pfizer sponsored the VOYAGE trial. Dr. Dellon indicated no relevant financial relationships. Dr. Horsley Silva has research funding from Regeneron/Sanofi, Allakos, Celgene, Bristol Myers Squibb, and has participated in an advisory board for Sanofi Genzyme. No disclosures were included for Dr. Gabbard and no recent paper is available in PubMed for Dr. Horsley-Silva.
FROM ACG 2023
Psychosocial burdens significant in EoE pediatric patients
Key clinical point: Diagnosis of eosinophilic esophagitis (EoE) leads to psychosocial burdens in pediatric patients, especially in patients with neurodevelopmental disorders.
Major finding: Patients with shorter disease duration (6-12 months) had a higher symptom burden (P = .03). Patients with neurodevelopmental disorders had significantly greater somatic symptoms and anxiety, lower quality of life scores, and greater sleep disordered breathing (P < .01 for all)
Study details: This study included 87 patients (age 8-18 years, mean age 12.8 years, 26% girls) who completed validated assessments of EoE symptoms, quality of life, somatization, and sleep disordered breathing during regular clinic visits. Of these, 14% had been diagnosed with a neurodevelopmental disorder.
Disclosures: The authors reported no conflicts of interest.
Source: Jensen T et al. Sleep, anxiety, somatization, quality of life, and resilience in pediatric patients with eosinophilic esophagitis. Clin Transl Gastroenterol. 2024 (Jan 11). doi: 10.14309/ctg.0000000000000672
Key clinical point: Diagnosis of eosinophilic esophagitis (EoE) leads to psychosocial burdens in pediatric patients, especially in patients with neurodevelopmental disorders.
Major finding: Patients with shorter disease duration (6-12 months) had a higher symptom burden (P = .03). Patients with neurodevelopmental disorders had significantly greater somatic symptoms and anxiety, lower quality of life scores, and greater sleep disordered breathing (P < .01 for all)
Study details: This study included 87 patients (age 8-18 years, mean age 12.8 years, 26% girls) who completed validated assessments of EoE symptoms, quality of life, somatization, and sleep disordered breathing during regular clinic visits. Of these, 14% had been diagnosed with a neurodevelopmental disorder.
Disclosures: The authors reported no conflicts of interest.
Source: Jensen T et al. Sleep, anxiety, somatization, quality of life, and resilience in pediatric patients with eosinophilic esophagitis. Clin Transl Gastroenterol. 2024 (Jan 11). doi: 10.14309/ctg.0000000000000672
Key clinical point: Diagnosis of eosinophilic esophagitis (EoE) leads to psychosocial burdens in pediatric patients, especially in patients with neurodevelopmental disorders.
Major finding: Patients with shorter disease duration (6-12 months) had a higher symptom burden (P = .03). Patients with neurodevelopmental disorders had significantly greater somatic symptoms and anxiety, lower quality of life scores, and greater sleep disordered breathing (P < .01 for all)
Study details: This study included 87 patients (age 8-18 years, mean age 12.8 years, 26% girls) who completed validated assessments of EoE symptoms, quality of life, somatization, and sleep disordered breathing during regular clinic visits. Of these, 14% had been diagnosed with a neurodevelopmental disorder.
Disclosures: The authors reported no conflicts of interest.
Source: Jensen T et al. Sleep, anxiety, somatization, quality of life, and resilience in pediatric patients with eosinophilic esophagitis. Clin Transl Gastroenterol. 2024 (Jan 11). doi: 10.14309/ctg.0000000000000672
February 2024 – ICYMI
Gastroenterology
October 2023
El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.
Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.
Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.
November 2023
Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.
Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.
December 2023
Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.
Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.
Clinical Gastroenterology and Hepatology
October 2023
Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.
Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.
November 2023
Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.
Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.
Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.
December 2023
Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.
Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.
Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.
Techniques and Innovations in Gastrointestinal Endoscopy
Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.
Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003
Gastro Hep Advances
Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.
Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.
Gastroenterology
October 2023
El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.
Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.
Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.
November 2023
Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.
Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.
December 2023
Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.
Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.
Clinical Gastroenterology and Hepatology
October 2023
Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.
Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.
November 2023
Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.
Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.
Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.
December 2023
Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.
Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.
Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.
Techniques and Innovations in Gastrointestinal Endoscopy
Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.
Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003
Gastro Hep Advances
Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.
Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.
Gastroenterology
October 2023
El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.
Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.
Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.
November 2023
Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.
Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.
December 2023
Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.
Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.
Clinical Gastroenterology and Hepatology
October 2023
Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.
Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.
November 2023
Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.
Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.
Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.
December 2023
Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.
Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.
Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.
Techniques and Innovations in Gastrointestinal Endoscopy
Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.
Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003
Gastro Hep Advances
Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.
Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.
Vitamin D levels are lower in patients with eosinophilic esophagitis
Key clinical point: The serum levels of vitamin D are significantly lower in patients with newly diagnosed eosinophilic esophagitis (EoE) than in control individuals without EoE; however, vitamin D levels are not strongly linked with the clinical, endoscopic, or histologic features of EoE.
Major finding: Mean serum 25-hydroxy-vitamin D3 levels were lower by 10.8 ng/mL in patients with EoE vs control individuals (95% CI −19.0 to −2.51). However, these levels were neither associated with differences in clinical or endoscopic features of EoE nor did they significantly correlate with EoE Endoscopic Reference Scores and eosinophil counts (Pearson’s R −0.28, P = .08; and −0.01, P = .93, respectively).
Study details: This secondary analysis of a prospective cohort study used the data of adults who underwent endoscopy and biopsy for upper gastrointestinal symptoms, of whom 40 were diagnosed with EoE and 40 were control individuals without EoE.
Disclosures: This study was supported by the US National Institutes of Health. The authors declared no conflicts of interest.
Source: Cameron BA et al. Vitamin D levels as a potential modifier of eosinophilic esophagitis severity in adults. Dig Dis Sci. 2024 (Jan 6). doi: 10.1007/s10620-023-08264-x
Key clinical point: The serum levels of vitamin D are significantly lower in patients with newly diagnosed eosinophilic esophagitis (EoE) than in control individuals without EoE; however, vitamin D levels are not strongly linked with the clinical, endoscopic, or histologic features of EoE.
Major finding: Mean serum 25-hydroxy-vitamin D3 levels were lower by 10.8 ng/mL in patients with EoE vs control individuals (95% CI −19.0 to −2.51). However, these levels were neither associated with differences in clinical or endoscopic features of EoE nor did they significantly correlate with EoE Endoscopic Reference Scores and eosinophil counts (Pearson’s R −0.28, P = .08; and −0.01, P = .93, respectively).
Study details: This secondary analysis of a prospective cohort study used the data of adults who underwent endoscopy and biopsy for upper gastrointestinal symptoms, of whom 40 were diagnosed with EoE and 40 were control individuals without EoE.
Disclosures: This study was supported by the US National Institutes of Health. The authors declared no conflicts of interest.
Source: Cameron BA et al. Vitamin D levels as a potential modifier of eosinophilic esophagitis severity in adults. Dig Dis Sci. 2024 (Jan 6). doi: 10.1007/s10620-023-08264-x
Key clinical point: The serum levels of vitamin D are significantly lower in patients with newly diagnosed eosinophilic esophagitis (EoE) than in control individuals without EoE; however, vitamin D levels are not strongly linked with the clinical, endoscopic, or histologic features of EoE.
Major finding: Mean serum 25-hydroxy-vitamin D3 levels were lower by 10.8 ng/mL in patients with EoE vs control individuals (95% CI −19.0 to −2.51). However, these levels were neither associated with differences in clinical or endoscopic features of EoE nor did they significantly correlate with EoE Endoscopic Reference Scores and eosinophil counts (Pearson’s R −0.28, P = .08; and −0.01, P = .93, respectively).
Study details: This secondary analysis of a prospective cohort study used the data of adults who underwent endoscopy and biopsy for upper gastrointestinal symptoms, of whom 40 were diagnosed with EoE and 40 were control individuals without EoE.
Disclosures: This study was supported by the US National Institutes of Health. The authors declared no conflicts of interest.
Source: Cameron BA et al. Vitamin D levels as a potential modifier of eosinophilic esophagitis severity in adults. Dig Dis Sci. 2024 (Jan 6). doi: 10.1007/s10620-023-08264-x
Allergic phenotypes may predict low response to proton-pump inhibitors in eosinophilic esophagitis
Key clinical point: Patients with eosinophilic esophagitis (EoE) who test positive for food and environmental allergens may report a lower response to proton-pump inhibitor (PPI) treatment, a first-line treatment for EoE.
Major finding: Positive food allergen testing predicted lower odds of histologic response (adjusted odds ratio [aOR] 0.15; P = .0006) and symptom response (aOR 0.22; P = .03) to PPI therapy. Patients with a higher number of positive environmental allergens detected on skin-prick testing (≥10 vs <10) were less likely to respond to PPI (21.0% vs 53.9%; P = .03).
Study details: Findings are from a retrospective study including 61 adults with newly diagnosed EoE who underwent formal allergy testing for food and environmental allergens and received PPI therapy twice daily after EoE diagnosis.
Disclosures: The corresponding author WW Chan declared serving on the scientific advisory board for a several pharmaceutical companies.
Source: Muftah M et al. Allergic phenotype identified on allergen testing is associated with proton pump inhibitor nonresponse in eosinophilic esophagitis. J Gastroenterol Hepatol. 2024 (Jan 7). doi: 10.1111/jgh.16469
Key clinical point: Patients with eosinophilic esophagitis (EoE) who test positive for food and environmental allergens may report a lower response to proton-pump inhibitor (PPI) treatment, a first-line treatment for EoE.
Major finding: Positive food allergen testing predicted lower odds of histologic response (adjusted odds ratio [aOR] 0.15; P = .0006) and symptom response (aOR 0.22; P = .03) to PPI therapy. Patients with a higher number of positive environmental allergens detected on skin-prick testing (≥10 vs <10) were less likely to respond to PPI (21.0% vs 53.9%; P = .03).
Study details: Findings are from a retrospective study including 61 adults with newly diagnosed EoE who underwent formal allergy testing for food and environmental allergens and received PPI therapy twice daily after EoE diagnosis.
Disclosures: The corresponding author WW Chan declared serving on the scientific advisory board for a several pharmaceutical companies.
Source: Muftah M et al. Allergic phenotype identified on allergen testing is associated with proton pump inhibitor nonresponse in eosinophilic esophagitis. J Gastroenterol Hepatol. 2024 (Jan 7). doi: 10.1111/jgh.16469
Key clinical point: Patients with eosinophilic esophagitis (EoE) who test positive for food and environmental allergens may report a lower response to proton-pump inhibitor (PPI) treatment, a first-line treatment for EoE.
Major finding: Positive food allergen testing predicted lower odds of histologic response (adjusted odds ratio [aOR] 0.15; P = .0006) and symptom response (aOR 0.22; P = .03) to PPI therapy. Patients with a higher number of positive environmental allergens detected on skin-prick testing (≥10 vs <10) were less likely to respond to PPI (21.0% vs 53.9%; P = .03).
Study details: Findings are from a retrospective study including 61 adults with newly diagnosed EoE who underwent formal allergy testing for food and environmental allergens and received PPI therapy twice daily after EoE diagnosis.
Disclosures: The corresponding author WW Chan declared serving on the scientific advisory board for a several pharmaceutical companies.
Source: Muftah M et al. Allergic phenotype identified on allergen testing is associated with proton pump inhibitor nonresponse in eosinophilic esophagitis. J Gastroenterol Hepatol. 2024 (Jan 7). doi: 10.1111/jgh.16469
Histological categories do not help in predicting treatment response in eosinophilic esophagitis
Key clinical point: Budesonide orodispersible tablet (BOT) induces clinicohistological remission irrespective of the distribution of esophageal eosinophilia. Histological categories are not predictors of treatment response in patients with eosinophilic esophagitis (EoE).
Major finding: Histological categories were not found to be significantly associated with treatment outcome (mid: adjusted odds ratio [aOR] 1.75; 95% CI 0.588-5.25; distal: aOR 1.42; 95% CI 0.535-3.60; diffuse: aOR 0.910; 95% CI 0.358-2.19).
Study details: This post hoc analysis of the phase 3 EOS-1 and EOS-2 trials included 263 patients with EoE having either proximal, mid, or distal esophagus predominant disease or diffuse disease who received a 6-week induction treatment with BOT.
Disclosures: This study was supported by the Swiss National Science Foundation and others. Some authors declared serving as consultants for or receiving speaker or consulting fees or travel grants from various sources.
Source: Godat A et al on behalf of the EoE eosinophil distribution research group. Eosinophil distribution in eosinophilic esophagitis and its impact on disease activity and response to treatment. Clin Gastroenterol Hepatol. 2023 (Dec 15). doi: 10.1016/j.cgh.2023.12.003
Key clinical point: Budesonide orodispersible tablet (BOT) induces clinicohistological remission irrespective of the distribution of esophageal eosinophilia. Histological categories are not predictors of treatment response in patients with eosinophilic esophagitis (EoE).
Major finding: Histological categories were not found to be significantly associated with treatment outcome (mid: adjusted odds ratio [aOR] 1.75; 95% CI 0.588-5.25; distal: aOR 1.42; 95% CI 0.535-3.60; diffuse: aOR 0.910; 95% CI 0.358-2.19).
Study details: This post hoc analysis of the phase 3 EOS-1 and EOS-2 trials included 263 patients with EoE having either proximal, mid, or distal esophagus predominant disease or diffuse disease who received a 6-week induction treatment with BOT.
Disclosures: This study was supported by the Swiss National Science Foundation and others. Some authors declared serving as consultants for or receiving speaker or consulting fees or travel grants from various sources.
Source: Godat A et al on behalf of the EoE eosinophil distribution research group. Eosinophil distribution in eosinophilic esophagitis and its impact on disease activity and response to treatment. Clin Gastroenterol Hepatol. 2023 (Dec 15). doi: 10.1016/j.cgh.2023.12.003
Key clinical point: Budesonide orodispersible tablet (BOT) induces clinicohistological remission irrespective of the distribution of esophageal eosinophilia. Histological categories are not predictors of treatment response in patients with eosinophilic esophagitis (EoE).
Major finding: Histological categories were not found to be significantly associated with treatment outcome (mid: adjusted odds ratio [aOR] 1.75; 95% CI 0.588-5.25; distal: aOR 1.42; 95% CI 0.535-3.60; diffuse: aOR 0.910; 95% CI 0.358-2.19).
Study details: This post hoc analysis of the phase 3 EOS-1 and EOS-2 trials included 263 patients with EoE having either proximal, mid, or distal esophagus predominant disease or diffuse disease who received a 6-week induction treatment with BOT.
Disclosures: This study was supported by the Swiss National Science Foundation and others. Some authors declared serving as consultants for or receiving speaker or consulting fees or travel grants from various sources.
Source: Godat A et al on behalf of the EoE eosinophil distribution research group. Eosinophil distribution in eosinophilic esophagitis and its impact on disease activity and response to treatment. Clin Gastroenterol Hepatol. 2023 (Dec 15). doi: 10.1016/j.cgh.2023.12.003
Eosinophil-derived neurotoxin can help diagnose eosinophilic esophagitis in exclusive distal eosinophilia
Key clinical point: The levels of eosinophil-derived neurotoxin (EDN) may be used to track disease activity in patients with eosinophilic esophagitis (EoE) patients and may aid the diagnosis of EoE in patients with challenging conditions, such as distal eosinophilia.
Major finding: The average endoscopic reference score (EREFS; 3.4 vs 0.4; P < .001) and EDN concentrations (135.8 µg/mL vs 3.2 µg/mL; P < .001) were significantly higher in patients with active EoE vs control individuals. In patients with exclusive distant eosinophilia, positive (≥10 µg/mL) vs negative EDN concentrations correlated with significantly higher EREFS (3.33 vs 1.35, P < .001), which indicated a diagnosis of EoE.
Study details: Findings are from a retrospective study that included children and young adults who underwent routine endoscopy with biopsy and EDN esophageal epithelial brushings, of whom 140 had EoE and 91 were control individuals without EoE.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Thomas J et al. Addressing diagnostic dilemmas in eosinophilic esophagitis using esophageal epithelial eosinophil-derived neurotoxin. J Pediatr Gastroenterol Nutr. 2023 (Dec 27). doi: 10.1002/jpn3.12054
Key clinical point: The levels of eosinophil-derived neurotoxin (EDN) may be used to track disease activity in patients with eosinophilic esophagitis (EoE) patients and may aid the diagnosis of EoE in patients with challenging conditions, such as distal eosinophilia.
Major finding: The average endoscopic reference score (EREFS; 3.4 vs 0.4; P < .001) and EDN concentrations (135.8 µg/mL vs 3.2 µg/mL; P < .001) were significantly higher in patients with active EoE vs control individuals. In patients with exclusive distant eosinophilia, positive (≥10 µg/mL) vs negative EDN concentrations correlated with significantly higher EREFS (3.33 vs 1.35, P < .001), which indicated a diagnosis of EoE.
Study details: Findings are from a retrospective study that included children and young adults who underwent routine endoscopy with biopsy and EDN esophageal epithelial brushings, of whom 140 had EoE and 91 were control individuals without EoE.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Thomas J et al. Addressing diagnostic dilemmas in eosinophilic esophagitis using esophageal epithelial eosinophil-derived neurotoxin. J Pediatr Gastroenterol Nutr. 2023 (Dec 27). doi: 10.1002/jpn3.12054
Key clinical point: The levels of eosinophil-derived neurotoxin (EDN) may be used to track disease activity in patients with eosinophilic esophagitis (EoE) patients and may aid the diagnosis of EoE in patients with challenging conditions, such as distal eosinophilia.
Major finding: The average endoscopic reference score (EREFS; 3.4 vs 0.4; P < .001) and EDN concentrations (135.8 µg/mL vs 3.2 µg/mL; P < .001) were significantly higher in patients with active EoE vs control individuals. In patients with exclusive distant eosinophilia, positive (≥10 µg/mL) vs negative EDN concentrations correlated with significantly higher EREFS (3.33 vs 1.35, P < .001), which indicated a diagnosis of EoE.
Study details: Findings are from a retrospective study that included children and young adults who underwent routine endoscopy with biopsy and EDN esophageal epithelial brushings, of whom 140 had EoE and 91 were control individuals without EoE.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Thomas J et al. Addressing diagnostic dilemmas in eosinophilic esophagitis using esophageal epithelial eosinophil-derived neurotoxin. J Pediatr Gastroenterol Nutr. 2023 (Dec 27). doi: 10.1002/jpn3.12054
Eosinophil levels may predict concomitant non-EoE diseases in patients with EoE
Key clinical point: Patients with eosinophilic esophagitis (EoE) may also present with non-EoE eosinophilic gastrointestinal diseases (EGID) with esophageal involvement (EI; EGID + EI) if they have high levels of peripheral blood eosinophils.
Major finding: Patients with EGID + EI vs EoE were more likely to have eczema (P = .003), food allergy (P < .001), abdominal pain (60.9% vs 45.0%; P = .002), and higher peripheral blood eosinophil levels (0.44 × 103/µL vs 0.38 × 103/µL; P = .027).
Study details: Findings are from an observational cohort study including 592 patients with isolated EoE and 190 patients with EGID + EI.
Disclosures: This study was supported by a grant from the US National Institutes of Health. ME Rothenberg and corresponding author T Shoda declared serving as a consultant or being inventors or co-inventors of patents.
Source: Sato H et al. Eosinophil involvement outside the esophagus in eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2023 (Dec 14). doi: 10.1016/j.cgh.2023.12.004
Key clinical point: Patients with eosinophilic esophagitis (EoE) may also present with non-EoE eosinophilic gastrointestinal diseases (EGID) with esophageal involvement (EI; EGID + EI) if they have high levels of peripheral blood eosinophils.
Major finding: Patients with EGID + EI vs EoE were more likely to have eczema (P = .003), food allergy (P < .001), abdominal pain (60.9% vs 45.0%; P = .002), and higher peripheral blood eosinophil levels (0.44 × 103/µL vs 0.38 × 103/µL; P = .027).
Study details: Findings are from an observational cohort study including 592 patients with isolated EoE and 190 patients with EGID + EI.
Disclosures: This study was supported by a grant from the US National Institutes of Health. ME Rothenberg and corresponding author T Shoda declared serving as a consultant or being inventors or co-inventors of patents.
Source: Sato H et al. Eosinophil involvement outside the esophagus in eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2023 (Dec 14). doi: 10.1016/j.cgh.2023.12.004
Key clinical point: Patients with eosinophilic esophagitis (EoE) may also present with non-EoE eosinophilic gastrointestinal diseases (EGID) with esophageal involvement (EI; EGID + EI) if they have high levels of peripheral blood eosinophils.
Major finding: Patients with EGID + EI vs EoE were more likely to have eczema (P = .003), food allergy (P < .001), abdominal pain (60.9% vs 45.0%; P = .002), and higher peripheral blood eosinophil levels (0.44 × 103/µL vs 0.38 × 103/µL; P = .027).
Study details: Findings are from an observational cohort study including 592 patients with isolated EoE and 190 patients with EGID + EI.
Disclosures: This study was supported by a grant from the US National Institutes of Health. ME Rothenberg and corresponding author T Shoda declared serving as a consultant or being inventors or co-inventors of patents.
Source: Sato H et al. Eosinophil involvement outside the esophagus in eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2023 (Dec 14). doi: 10.1016/j.cgh.2023.12.004
More comprehensive testing needed to characterize esophageal dysphagia
The current approach to esophageal function testing is insufficient to characterize esophageal motility disorders, as many patients with esophageal dysphagia have abnormalities that are undetectable with routine tests, according to investigators.
More nuanced assessments of esophageal motility disorders could potentially lead to more accurate diagnoses, and more effective treatments, reported Ravinder K. Mittal, MD, and Ali Zifan, PhD, of the University of California San Diego.
Esophageal motility disorders are currently divided into major and minor variants based on the contraction phase of peristalsis, Dr. Mittal and Dr. Zifan wrote in their report in Gastro Hep Advances. Yet the reason for dysphagia in many of these patients remains a puzzle, particularly in patients with supernormal contraction during peristalsis, like those with nutcracker esophagus. What’s more, up to half of patients with dysphagia have normal findings on high-resolution manometry impedance (HRMZ), the typical diagnostic modality, leaving many with the broad label of functional dysphagia.
This lack of clarity “suggests that the etiology in many patients remains unknown,” according to the investigators, which prompted them to publish the present review article.
After describing the shortcomings of current test methods, the investigators provided an overview of the physiology of esophageal peristalsis, then dove deeper into available data concerning luminal cross section measurements, esophageal distension during peristalsis, bolus flow, and distension contraction patterns in normal patients versus those with various kinds of dysphagia.
They highlighted two key findings.
First, in patients with functional dysphagia, esophagogastric junction outflow obstruction (EGJOO), and high amplitude esophageal peristaltic contractions (HAEC), the bolus must travel through a narrow esophageal lumen. Second, in patients with nonobstructive dysphagia and type 3 achalasia, the bolus moves against distal luminal occlusion.
“These findings indicate a relative dynamic obstruction to bolus flow and reduced distensibility of the esophageal wall in patients with several primary esophageal motility disorders,” the investigators wrote. “We speculate that the dysphagia sensation experienced by many patients may result from a normal or supernormal contraction wave pushing the bolus against resistance.”
Yet routine esophageal function testing fails to capture these abnormalities, Dr. Mittal and Dr. Zifan noted.
“[C]urrent techniques used to measure esophageal distension during peristalsis are not adequate,” they wrote. “The high-resolution manometry and current scheme of classifying esophageal motor disorders in the current format emphasize only half of the story of peristalsis, probably the less important of the two halves, i.e., the contraction phase of peristalsis.”
More focus is needed on esophageal distension, they suggested, noting that relaxation is first needed to accommodate a bolus before contraction, no matter how powerful, can push it down the esophagus.
“A simple analogy is that of a car — it cannot get through a roadway that is smaller than its own width, irrespective of the horsepower of its engine,” they wrote.
The solution may lie in a more comprehensive approach to esophageal function testing.
“Integrating representations of distension and contraction, along with objective assessments of flow timing and distensibility, complements the current classification of esophageal motility disorders that are based on the contraction characteristics,” the investigators wrote, predicting that these efforts could improve diagnostic accuracy.
What to do about those diagnoses is another mystery.
“The question though remains regarding the optimal treatment for the impaired distension function of the esophagus, and whether improvement in the distension function will lead to improvement in dysphagia symptoms,” the investigators concluded.
The review was supported by the National Institutes of Health. The investigators reported copyright/patent protection for the computer software (Dplots) used to evaluate the distension contraction plots.
Medicine is strewn with diseases first labeled as functional or psychologically induced that have been recategorized into clear non-sensory disorders of which functional dysphagia is one.
In this review article, Dr. Mittal and Dr. Zifan discuss a summary and new paradigm for esophageal motility disorders and the origin of functional dysphagia (FD). As with other functional disorders, the predominance of research has suggested that functional dysphagia is in large part a sensory disorder in which patient are sensing normally sub-threshold events of normal bolus transit interpreted as dysphagia.
Will this lead to recategorization of all functional dysphagia as a perturbation in motor function and the discovery of new therapies? Certainly, to some degree, though sensory dysfunction will likely remain a prominent mechanism in some patients. Nevertheless, it is always exciting when a new approach to an old disorder emerges. With the work from Dr. Mittal’s laboratory and many others, functional dysphagia may soon drop the functional!
David A. Katzka, MD, is a gastroenterologist at New York–Presbyterian/Columbia University Irving Medical Center, New York, where he leads the Esophagology and Swallowing Center. He has performed research for Medtronic, but has no other relevant disclosures.
Medicine is strewn with diseases first labeled as functional or psychologically induced that have been recategorized into clear non-sensory disorders of which functional dysphagia is one.
In this review article, Dr. Mittal and Dr. Zifan discuss a summary and new paradigm for esophageal motility disorders and the origin of functional dysphagia (FD). As with other functional disorders, the predominance of research has suggested that functional dysphagia is in large part a sensory disorder in which patient are sensing normally sub-threshold events of normal bolus transit interpreted as dysphagia.
Will this lead to recategorization of all functional dysphagia as a perturbation in motor function and the discovery of new therapies? Certainly, to some degree, though sensory dysfunction will likely remain a prominent mechanism in some patients. Nevertheless, it is always exciting when a new approach to an old disorder emerges. With the work from Dr. Mittal’s laboratory and many others, functional dysphagia may soon drop the functional!
David A. Katzka, MD, is a gastroenterologist at New York–Presbyterian/Columbia University Irving Medical Center, New York, where he leads the Esophagology and Swallowing Center. He has performed research for Medtronic, but has no other relevant disclosures.
Medicine is strewn with diseases first labeled as functional or psychologically induced that have been recategorized into clear non-sensory disorders of which functional dysphagia is one.
In this review article, Dr. Mittal and Dr. Zifan discuss a summary and new paradigm for esophageal motility disorders and the origin of functional dysphagia (FD). As with other functional disorders, the predominance of research has suggested that functional dysphagia is in large part a sensory disorder in which patient are sensing normally sub-threshold events of normal bolus transit interpreted as dysphagia.
Will this lead to recategorization of all functional dysphagia as a perturbation in motor function and the discovery of new therapies? Certainly, to some degree, though sensory dysfunction will likely remain a prominent mechanism in some patients. Nevertheless, it is always exciting when a new approach to an old disorder emerges. With the work from Dr. Mittal’s laboratory and many others, functional dysphagia may soon drop the functional!
David A. Katzka, MD, is a gastroenterologist at New York–Presbyterian/Columbia University Irving Medical Center, New York, where he leads the Esophagology and Swallowing Center. He has performed research for Medtronic, but has no other relevant disclosures.
The current approach to esophageal function testing is insufficient to characterize esophageal motility disorders, as many patients with esophageal dysphagia have abnormalities that are undetectable with routine tests, according to investigators.
More nuanced assessments of esophageal motility disorders could potentially lead to more accurate diagnoses, and more effective treatments, reported Ravinder K. Mittal, MD, and Ali Zifan, PhD, of the University of California San Diego.
Esophageal motility disorders are currently divided into major and minor variants based on the contraction phase of peristalsis, Dr. Mittal and Dr. Zifan wrote in their report in Gastro Hep Advances. Yet the reason for dysphagia in many of these patients remains a puzzle, particularly in patients with supernormal contraction during peristalsis, like those with nutcracker esophagus. What’s more, up to half of patients with dysphagia have normal findings on high-resolution manometry impedance (HRMZ), the typical diagnostic modality, leaving many with the broad label of functional dysphagia.
This lack of clarity “suggests that the etiology in many patients remains unknown,” according to the investigators, which prompted them to publish the present review article.
After describing the shortcomings of current test methods, the investigators provided an overview of the physiology of esophageal peristalsis, then dove deeper into available data concerning luminal cross section measurements, esophageal distension during peristalsis, bolus flow, and distension contraction patterns in normal patients versus those with various kinds of dysphagia.
They highlighted two key findings.
First, in patients with functional dysphagia, esophagogastric junction outflow obstruction (EGJOO), and high amplitude esophageal peristaltic contractions (HAEC), the bolus must travel through a narrow esophageal lumen. Second, in patients with nonobstructive dysphagia and type 3 achalasia, the bolus moves against distal luminal occlusion.
“These findings indicate a relative dynamic obstruction to bolus flow and reduced distensibility of the esophageal wall in patients with several primary esophageal motility disorders,” the investigators wrote. “We speculate that the dysphagia sensation experienced by many patients may result from a normal or supernormal contraction wave pushing the bolus against resistance.”
Yet routine esophageal function testing fails to capture these abnormalities, Dr. Mittal and Dr. Zifan noted.
“[C]urrent techniques used to measure esophageal distension during peristalsis are not adequate,” they wrote. “The high-resolution manometry and current scheme of classifying esophageal motor disorders in the current format emphasize only half of the story of peristalsis, probably the less important of the two halves, i.e., the contraction phase of peristalsis.”
More focus is needed on esophageal distension, they suggested, noting that relaxation is first needed to accommodate a bolus before contraction, no matter how powerful, can push it down the esophagus.
“A simple analogy is that of a car — it cannot get through a roadway that is smaller than its own width, irrespective of the horsepower of its engine,” they wrote.
The solution may lie in a more comprehensive approach to esophageal function testing.
“Integrating representations of distension and contraction, along with objective assessments of flow timing and distensibility, complements the current classification of esophageal motility disorders that are based on the contraction characteristics,” the investigators wrote, predicting that these efforts could improve diagnostic accuracy.
What to do about those diagnoses is another mystery.
“The question though remains regarding the optimal treatment for the impaired distension function of the esophagus, and whether improvement in the distension function will lead to improvement in dysphagia symptoms,” the investigators concluded.
The review was supported by the National Institutes of Health. The investigators reported copyright/patent protection for the computer software (Dplots) used to evaluate the distension contraction plots.
The current approach to esophageal function testing is insufficient to characterize esophageal motility disorders, as many patients with esophageal dysphagia have abnormalities that are undetectable with routine tests, according to investigators.
More nuanced assessments of esophageal motility disorders could potentially lead to more accurate diagnoses, and more effective treatments, reported Ravinder K. Mittal, MD, and Ali Zifan, PhD, of the University of California San Diego.
Esophageal motility disorders are currently divided into major and minor variants based on the contraction phase of peristalsis, Dr. Mittal and Dr. Zifan wrote in their report in Gastro Hep Advances. Yet the reason for dysphagia in many of these patients remains a puzzle, particularly in patients with supernormal contraction during peristalsis, like those with nutcracker esophagus. What’s more, up to half of patients with dysphagia have normal findings on high-resolution manometry impedance (HRMZ), the typical diagnostic modality, leaving many with the broad label of functional dysphagia.
This lack of clarity “suggests that the etiology in many patients remains unknown,” according to the investigators, which prompted them to publish the present review article.
After describing the shortcomings of current test methods, the investigators provided an overview of the physiology of esophageal peristalsis, then dove deeper into available data concerning luminal cross section measurements, esophageal distension during peristalsis, bolus flow, and distension contraction patterns in normal patients versus those with various kinds of dysphagia.
They highlighted two key findings.
First, in patients with functional dysphagia, esophagogastric junction outflow obstruction (EGJOO), and high amplitude esophageal peristaltic contractions (HAEC), the bolus must travel through a narrow esophageal lumen. Second, in patients with nonobstructive dysphagia and type 3 achalasia, the bolus moves against distal luminal occlusion.
“These findings indicate a relative dynamic obstruction to bolus flow and reduced distensibility of the esophageal wall in patients with several primary esophageal motility disorders,” the investigators wrote. “We speculate that the dysphagia sensation experienced by many patients may result from a normal or supernormal contraction wave pushing the bolus against resistance.”
Yet routine esophageal function testing fails to capture these abnormalities, Dr. Mittal and Dr. Zifan noted.
“[C]urrent techniques used to measure esophageal distension during peristalsis are not adequate,” they wrote. “The high-resolution manometry and current scheme of classifying esophageal motor disorders in the current format emphasize only half of the story of peristalsis, probably the less important of the two halves, i.e., the contraction phase of peristalsis.”
More focus is needed on esophageal distension, they suggested, noting that relaxation is first needed to accommodate a bolus before contraction, no matter how powerful, can push it down the esophagus.
“A simple analogy is that of a car — it cannot get through a roadway that is smaller than its own width, irrespective of the horsepower of its engine,” they wrote.
The solution may lie in a more comprehensive approach to esophageal function testing.
“Integrating representations of distension and contraction, along with objective assessments of flow timing and distensibility, complements the current classification of esophageal motility disorders that are based on the contraction characteristics,” the investigators wrote, predicting that these efforts could improve diagnostic accuracy.
What to do about those diagnoses is another mystery.
“The question though remains regarding the optimal treatment for the impaired distension function of the esophagus, and whether improvement in the distension function will lead to improvement in dysphagia symptoms,” the investigators concluded.
The review was supported by the National Institutes of Health. The investigators reported copyright/patent protection for the computer software (Dplots) used to evaluate the distension contraction plots.
FROM GASTRO HEP ADVANCES