Upper GI Tract

Key clinical point: A family history of eczema and a diet lacking allergenic foods, such as milk, increased the risk for incident eosinophilic esophagitis (EoE) in children with aerodigestive dysfunction who underwent triple endoscopy.

Major finding: A family history of eczema increased the odds of a future diagnosis EoE by ~4 times (odds ratio [OR] 4.02; P = .006) whereas a diet containing dairy significantly lowered the risk for incident EoE (OR 0.26, P = .02).

Study details: Findings are from a study including 119 patients with aerodigestive dysfunction who were age 0-21 years and underwent triple endoscopy (flexible bronchoscopy, rigid direct laryngoscopy + bronchoscopy, and esophagoscopy with biopsy), of whom 19 had EoE.

Disclosures: This study was supported by the US National Institutes of Health/National Center for Advancing Translational Science. AM Loizides declared serving as the Medical Director of Clinical Development at Albireo Pharma.

Source: Moran S et al. Factors associated with eosinophilic esophagitis in an urban, tertiary care pediatric aerodigestive population undergoing triple endoscopy. Am J Otolaryngol. 2023;45(1):104096 (Nov 5). doi: 10.1016/j.amjoto.2023.104096

Key clinical point: A family history of eczema and a diet lacking allergenic foods, such as milk, increased the risk for incident eosinophilic esophagitis (EoE) in children with aerodigestive dysfunction who underwent triple endoscopy.

Major finding: A family history of eczema increased the odds of a future diagnosis EoE by ~4 times (odds ratio [OR] 4.02; P = .006) whereas a diet containing dairy significantly lowered the risk for incident EoE (OR 0.26, P = .02).

Study details: Findings are from a study including 119 patients with aerodigestive dysfunction who were age 0-21 years and underwent triple endoscopy (flexible bronchoscopy, rigid direct laryngoscopy + bronchoscopy, and esophagoscopy with biopsy), of whom 19 had EoE.

Disclosures: This study was supported by the US National Institutes of Health/National Center for Advancing Translational Science. AM Loizides declared serving as the Medical Director of Clinical Development at Albireo Pharma.

Source: Moran S et al. Factors associated with eosinophilic esophagitis in an urban, tertiary care pediatric aerodigestive population undergoing triple endoscopy. Am J Otolaryngol. 2023;45(1):104096 (Nov 5). doi: 10.1016/j.amjoto.2023.104096

Key clinical point: A family history of eczema and a diet lacking allergenic foods, such as milk, increased the risk for incident eosinophilic esophagitis (EoE) in children with aerodigestive dysfunction who underwent triple endoscopy.

Major finding: A family history of eczema increased the odds of a future diagnosis EoE by ~4 times (odds ratio [OR] 4.02; P = .006) whereas a diet containing dairy significantly lowered the risk for incident EoE (OR 0.26, P = .02).

Study details: Findings are from a study including 119 patients with aerodigestive dysfunction who were age 0-21 years and underwent triple endoscopy (flexible bronchoscopy, rigid direct laryngoscopy + bronchoscopy, and esophagoscopy with biopsy), of whom 19 had EoE.

Disclosures: This study was supported by the US National Institutes of Health/National Center for Advancing Translational Science. AM Loizides declared serving as the Medical Director of Clinical Development at Albireo Pharma.

Source: Moran S et al. Factors associated with eosinophilic esophagitis in an urban, tertiary care pediatric aerodigestive population undergoing triple endoscopy. Am J Otolaryngol. 2023;45(1):104096 (Nov 5). doi: 10.1016/j.amjoto.2023.104096

Key clinical point: The risk for inflammatory bowel diseases (IBD), particularly Crohn’s disease, was 3.5 times higher in patients with eosinophilic esophagitis (EoE).

Major finding: Compared with control individuals without EoE, patients with EoE were at a ~3.5-fold increased risk for IBD (adjusted hazard ratio [aHR] 3.56; 95% CI 1.79-7.11), particularly Crohn’s disease (aHR 3.39; 95% CI 1.2-9.60). When compared with siblings of patients with EoE, 12 patients with EoE were diagnosed with IBD later in life compared with 11 siblings, which corresponded to an aHR of 2.48 (95% CI 0.92-6.70).

Study details: Findings are from a nationwide cohort study including 1587 patients with histologically verified EoE and 7808 age- and sex-matched control individuals without EoE.

Disclosures: This study was funded by the Consortium of Eosinophilic Gastrointestinal Disease Researcher Training Program and Karolinska Institutet, Sweden. Some authors declared serving as consultants, advisors, or speakers for or receiving financial support, grants, or fees for lectures from Karolinska Institutet and other sources.

Source: Uchida AM et al. Eosinophilic esophagitis is associated with increased risk of later inflammatory bowel disease in a nationwide Swedish population cohort. United European Gastroenterol J. 2023 (Dec 7). doi: 10.1002/ueg2.12493

Key clinical point: The risk for inflammatory bowel diseases (IBD), particularly Crohn’s disease, was 3.5 times higher in patients with eosinophilic esophagitis (EoE).

Major finding: Compared with control individuals without EoE, patients with EoE were at a ~3.5-fold increased risk for IBD (adjusted hazard ratio [aHR] 3.56; 95% CI 1.79-7.11), particularly Crohn’s disease (aHR 3.39; 95% CI 1.2-9.60). When compared with siblings of patients with EoE, 12 patients with EoE were diagnosed with IBD later in life compared with 11 siblings, which corresponded to an aHR of 2.48 (95% CI 0.92-6.70).

Study details: Findings are from a nationwide cohort study including 1587 patients with histologically verified EoE and 7808 age- and sex-matched control individuals without EoE.

Disclosures: This study was funded by the Consortium of Eosinophilic Gastrointestinal Disease Researcher Training Program and Karolinska Institutet, Sweden. Some authors declared serving as consultants, advisors, or speakers for or receiving financial support, grants, or fees for lectures from Karolinska Institutet and other sources.

Source: Uchida AM et al. Eosinophilic esophagitis is associated with increased risk of later inflammatory bowel disease in a nationwide Swedish population cohort. United European Gastroenterol J. 2023 (Dec 7). doi: 10.1002/ueg2.12493

Key clinical point: The risk for inflammatory bowel diseases (IBD), particularly Crohn’s disease, was 3.5 times higher in patients with eosinophilic esophagitis (EoE).

Major finding: Compared with control individuals without EoE, patients with EoE were at a ~3.5-fold increased risk for IBD (adjusted hazard ratio [aHR] 3.56; 95% CI 1.79-7.11), particularly Crohn’s disease (aHR 3.39; 95% CI 1.2-9.60). When compared with siblings of patients with EoE, 12 patients with EoE were diagnosed with IBD later in life compared with 11 siblings, which corresponded to an aHR of 2.48 (95% CI 0.92-6.70).

Study details: Findings are from a nationwide cohort study including 1587 patients with histologically verified EoE and 7808 age- and sex-matched control individuals without EoE.

Disclosures: This study was funded by the Consortium of Eosinophilic Gastrointestinal Disease Researcher Training Program and Karolinska Institutet, Sweden. Some authors declared serving as consultants, advisors, or speakers for or receiving financial support, grants, or fees for lectures from Karolinska Institutet and other sources.

Source: Uchida AM et al. Eosinophilic esophagitis is associated with increased risk of later inflammatory bowel disease in a nationwide Swedish population cohort. United European Gastroenterol J. 2023 (Dec 7). doi: 10.1002/ueg2.12493

Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.

Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.

Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.

Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948

Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.

Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.

Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.

Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948

Key clinical point: Budesonide oral suspension (BOS) significantly improved most of the efficacy outcomes in adolescents with eosinophilic esophagitis (EoE) over 12 weeks.

Major finding: At week 12, a significantly higher number of adolescents receiving BOS vs placebo achieved histologic (≤6, ≤1, and <15 eosinophils/high-power field; all P < .001) and clinicopathologic (P = .003) responses. BOS vs placebo led to greater reductions in the EoE histology scoring system grade (P < .001) and total EoE endoscopic reference scores (P = .021). Treatment-emergent adverse events were mild or moderate in severity.

Study details: This post hoc analysis of pooled data from a phase 2 and a phase 3 study included 76 adolescents with EoE (age 11-17 years) who were randomly assigned to receive 2 mg BOS twice daily or placebo.

Disclosures: These studies were funded by Shire ViroPharma, Inc., a Takeda company, and Meritage Pharma, Inc. (now part of Shire). Some authors declared serving as consultants for or receiving research funding, etc., from Meritage, Shire, and others. Four authors declared being employees and stockholders of Takeda.

Source: Mukkada VA et al. Pooled phase 2 and 3 efficacy and safety data on budesonide oral suspension in adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2023;77(6):760-768 (Sep 18). doi: 10.1097/MPG.0000000000003948

Key clinical point: In adolescents and adults with eosinophilic esophagitis (EoE), 300 mg dupilumab per week was effective and well-tolerated regardless of prior exposure to swallowed topical corticosteroids (STC).

Major finding: At week 24, a significantly higher proportion of patients receiving dupilumab vs placebo with (>50% vs ≤5%; P < .0001) or without (>45% vs ≤25%; P < .05) prior exposure to STC achieved a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field, with the improvements being maintained till week 52. No new adverse events were reported.

Study details: This sub-group analysis of the phase 3 LIBERTY EoE TREET study included 321 patients with EoE who were randomly assigned to receive dupilumab or placebo for 24 weeks, after which 304 patients received dupilumab for 28 weeks additionally.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Seven authors declared being employees or stockholders of Regeneron Pharmaceuticals or Sanofi. The other authors declared ties with various sources, including Sanofi and Regeneron.

Source: Bredenoord AJ et al. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: A subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2023 (Nov 27). doi: 10.1136/gutjnl-2023-330220

Key clinical point: In adolescents and adults with eosinophilic esophagitis (EoE), 300 mg dupilumab per week was effective and well-tolerated regardless of prior exposure to swallowed topical corticosteroids (STC).

Major finding: At week 24, a significantly higher proportion of patients receiving dupilumab vs placebo with (>50% vs ≤5%; P < .0001) or without (>45% vs ≤25%; P < .05) prior exposure to STC achieved a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field, with the improvements being maintained till week 52. No new adverse events were reported.

Study details: This sub-group analysis of the phase 3 LIBERTY EoE TREET study included 321 patients with EoE who were randomly assigned to receive dupilumab or placebo for 24 weeks, after which 304 patients received dupilumab for 28 weeks additionally.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Seven authors declared being employees or stockholders of Regeneron Pharmaceuticals or Sanofi. The other authors declared ties with various sources, including Sanofi and Regeneron.

Source: Bredenoord AJ et al. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: A subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2023 (Nov 27). doi: 10.1136/gutjnl-2023-330220

Key clinical point: In adolescents and adults with eosinophilic esophagitis (EoE), 300 mg dupilumab per week was effective and well-tolerated regardless of prior exposure to swallowed topical corticosteroids (STC).

Major finding: At week 24, a significantly higher proportion of patients receiving dupilumab vs placebo with (>50% vs ≤5%; P < .0001) or without (>45% vs ≤25%; P < .05) prior exposure to STC achieved a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field, with the improvements being maintained till week 52. No new adverse events were reported.

Study details: This sub-group analysis of the phase 3 LIBERTY EoE TREET study included 321 patients with EoE who were randomly assigned to receive dupilumab or placebo for 24 weeks, after which 304 patients received dupilumab for 28 weeks additionally.

Disclosures: This study was funded by Sanofi and Regeneron Pharmaceuticals Inc. Seven authors declared being employees or stockholders of Regeneron Pharmaceuticals or Sanofi. The other authors declared ties with various sources, including Sanofi and Regeneron.

Source: Bredenoord AJ et al. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: A subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2023 (Nov 27). doi: 10.1136/gutjnl-2023-330220

Key clinical point: The use of antibiotics and acid-suppressants during the prenatal period and infancy increased the risk of developing eosinophilic esophagitis (EoE) later in life.

Major finding: The risk for EoE increased by 50% in offsprings who were administered antibiotics during the prenatal period (adjusted odds ratio [aOR] 1.5; 95% CI 1.2-1.9); moreover, the administration of antibiotics (aOR 1.4; 95% CI 1.1-1.7) and acid-suppressants (aOR 15.9; 95% CI 9.1-27.7) in infancy was significantly associated with an increased risk for EoE.

Study details: Findings are from a case-control study including 392 children with EoE and 3637 age- and sex-matched control individuals without EoE.

Disclosures: This study was supported by a grant from the US National Institutes of Allergy and Infectious Diseases. Some authors declared receiving grants, consulting fees, or funding from various sources.

Source: Jensen ET et al. Maternal and infant antibiotic and acid suppressant use and risk of eosinophilic esophagitis. JAMA Pediatr. 2023;177(12):1285-1293 (Oct 30). doi: 10.1001/jamapediatrics.2023.4609

Key clinical point: The use of antibiotics and acid-suppressants during the prenatal period and infancy increased the risk of developing eosinophilic esophagitis (EoE) later in life.

Major finding: The risk for EoE increased by 50% in offsprings who were administered antibiotics during the prenatal period (adjusted odds ratio [aOR] 1.5; 95% CI 1.2-1.9); moreover, the administration of antibiotics (aOR 1.4; 95% CI 1.1-1.7) and acid-suppressants (aOR 15.9; 95% CI 9.1-27.7) in infancy was significantly associated with an increased risk for EoE.

Study details: Findings are from a case-control study including 392 children with EoE and 3637 age- and sex-matched control individuals without EoE.

Disclosures: This study was supported by a grant from the US National Institutes of Allergy and Infectious Diseases. Some authors declared receiving grants, consulting fees, or funding from various sources.

Source: Jensen ET et al. Maternal and infant antibiotic and acid suppressant use and risk of eosinophilic esophagitis. JAMA Pediatr. 2023;177(12):1285-1293 (Oct 30). doi: 10.1001/jamapediatrics.2023.4609

Key clinical point: The use of antibiotics and acid-suppressants during the prenatal period and infancy increased the risk of developing eosinophilic esophagitis (EoE) later in life.

Major finding: The risk for EoE increased by 50% in offsprings who were administered antibiotics during the prenatal period (adjusted odds ratio [aOR] 1.5; 95% CI 1.2-1.9); moreover, the administration of antibiotics (aOR 1.4; 95% CI 1.1-1.7) and acid-suppressants (aOR 15.9; 95% CI 9.1-27.7) in infancy was significantly associated with an increased risk for EoE.

Study details: Findings are from a case-control study including 392 children with EoE and 3637 age- and sex-matched control individuals without EoE.

Disclosures: This study was supported by a grant from the US National Institutes of Allergy and Infectious Diseases. Some authors declared receiving grants, consulting fees, or funding from various sources.

Source: Jensen ET et al. Maternal and infant antibiotic and acid suppressant use and risk of eosinophilic esophagitis. JAMA Pediatr. 2023;177(12):1285-1293 (Oct 30). doi: 10.1001/jamapediatrics.2023.4609

Antireflux surgery may be no more effective than antireflux medication for reducing risk of esophageal adenocarcinoma (EAC) among patients with Barrett’s esophagus, according to a Nordic retrospective study.

Risk of EAC was higher among patients who underwent surgery, and risk appeared to increase over time, suggesting that postoperative patients should continue to participate in surveillance programs, reported lead author Jesper Lagergren, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues.

Karolinska Institutet

“Antireflux surgery with fundoplication increases the ability of the gastroesophageal anatomic and physiological barrier to prevent reflux, and can thus prevent any carcinogenic gastric content from reaching the esophagus, including both acid and bile,” the investigators wrote in Gastroenterology, noting that surgery reduces esophageal acid exposure to a greater degree than medication. “Antireflux surgery may thus prevent esophageal adenocarcinoma better than antireflux medication.”

Three meta-analyses to date, however, have failed to provide consistent support for this hypothesis.

“Most of the studies included in these meta-analyses came from single centers, were of small sample size, examined only one treatment arm, and had a short or incomplete follow-up, and ... were hampered by heterogeneity among the included studies,” they noted.

For the present study, Dr. Lagergren and colleagues analyzed national registry data from 33,939 patients with Barrett’s esophagus in Denmark, Finland, Norway, and Sweden. Out of this group, 542 patients (1.6%) had undergone antireflux surgery, while the remainder were managed with antireflux medication.

In both groups, approximately two-thirds of the patients were men. The median age at enrollment was about a decade higher in the medication group (66 vs. 54 years), and this group also tended to have more comorbidities.

After a follow-up period as long as 32 years, the absolute rates of EAC were 1.3% and 2.6% in the medication and surgery groups, respectively. Multivariate analysis, with adjustments for sex, age, year, comorbidities, and age, revealed that postsurgical patients had a 90% increased risk of EAC (hazard ratio [HR], 1.9; 95% CI, 1.1-3.5), versus patients treated with antireflux medication alone.

The relatively higher risk of EAC appeared to increase over time, based on a nonsignificant hazard ratio of 1.8 during the 1- to 4-year follow-up period (HR, 1.8; 95% CI, 0.6-5.0), versus a significant, fourfold risk elevation during the 10- to 32-year follow-up period (HR, 4.4; 95% CI, 1.4-13.5).

“In this cohort of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma did not decrease after antireflux surgery compared with antireflux medication,” the investigators wrote. “Instead, the risk was increased throughout the follow-up among patients having undergone antireflux surgery.”

Dr. Lagergren and colleagues suggested that the reason for relatively higher cancer risk in the group that underwent surgery likely stems from early and prolonged acid exposure.

“[P]erforming antireflux surgery after years of GERD may be too late to enable a cancer-preventative effect, and most of the patients first diagnosed with Barrett’s esophagus reported a history of many years of GERD symptoms,” they wrote, suggesting that carcinogenic processes had already been set in motion by the time surgery was performed.

“[P]atients with Barrett’s esophagus who undergo antireflux surgery remain at an increased risk of esophageal adenocarcinoma and should continue taking part in surveillance programs,” the investigators concluded.

The study was funded by the Swedish Cancer Society, Swedish Research Council, and Stockholm County Council. The investigators disclosed no conflicts of interest.

Antireflux surgery may be no more effective than antireflux medication for reducing risk of esophageal adenocarcinoma (EAC) among patients with Barrett’s esophagus, according to a Nordic retrospective study.

Risk of EAC was higher among patients who underwent surgery, and risk appeared to increase over time, suggesting that postoperative patients should continue to participate in surveillance programs, reported lead author Jesper Lagergren, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues.

Karolinska Institutet

“Antireflux surgery with fundoplication increases the ability of the gastroesophageal anatomic and physiological barrier to prevent reflux, and can thus prevent any carcinogenic gastric content from reaching the esophagus, including both acid and bile,” the investigators wrote in Gastroenterology, noting that surgery reduces esophageal acid exposure to a greater degree than medication. “Antireflux surgery may thus prevent esophageal adenocarcinoma better than antireflux medication.”

Three meta-analyses to date, however, have failed to provide consistent support for this hypothesis.

“Most of the studies included in these meta-analyses came from single centers, were of small sample size, examined only one treatment arm, and had a short or incomplete follow-up, and ... were hampered by heterogeneity among the included studies,” they noted.

For the present study, Dr. Lagergren and colleagues analyzed national registry data from 33,939 patients with Barrett’s esophagus in Denmark, Finland, Norway, and Sweden. Out of this group, 542 patients (1.6%) had undergone antireflux surgery, while the remainder were managed with antireflux medication.

In both groups, approximately two-thirds of the patients were men. The median age at enrollment was about a decade higher in the medication group (66 vs. 54 years), and this group also tended to have more comorbidities.

After a follow-up period as long as 32 years, the absolute rates of EAC were 1.3% and 2.6% in the medication and surgery groups, respectively. Multivariate analysis, with adjustments for sex, age, year, comorbidities, and age, revealed that postsurgical patients had a 90% increased risk of EAC (hazard ratio [HR], 1.9; 95% CI, 1.1-3.5), versus patients treated with antireflux medication alone.

The relatively higher risk of EAC appeared to increase over time, based on a nonsignificant hazard ratio of 1.8 during the 1- to 4-year follow-up period (HR, 1.8; 95% CI, 0.6-5.0), versus a significant, fourfold risk elevation during the 10- to 32-year follow-up period (HR, 4.4; 95% CI, 1.4-13.5).

“In this cohort of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma did not decrease after antireflux surgery compared with antireflux medication,” the investigators wrote. “Instead, the risk was increased throughout the follow-up among patients having undergone antireflux surgery.”

Dr. Lagergren and colleagues suggested that the reason for relatively higher cancer risk in the group that underwent surgery likely stems from early and prolonged acid exposure.

“[P]erforming antireflux surgery after years of GERD may be too late to enable a cancer-preventative effect, and most of the patients first diagnosed with Barrett’s esophagus reported a history of many years of GERD symptoms,” they wrote, suggesting that carcinogenic processes had already been set in motion by the time surgery was performed.

“[P]atients with Barrett’s esophagus who undergo antireflux surgery remain at an increased risk of esophageal adenocarcinoma and should continue taking part in surveillance programs,” the investigators concluded.

The study was funded by the Swedish Cancer Society, Swedish Research Council, and Stockholm County Council. The investigators disclosed no conflicts of interest.

Antireflux surgery may be no more effective than antireflux medication for reducing risk of esophageal adenocarcinoma (EAC) among patients with Barrett’s esophagus, according to a Nordic retrospective study.

Risk of EAC was higher among patients who underwent surgery, and risk appeared to increase over time, suggesting that postoperative patients should continue to participate in surveillance programs, reported lead author Jesper Lagergren, MD, PhD, of the Karolinska Institutet, Stockholm, and colleagues.

Karolinska Institutet

“Antireflux surgery with fundoplication increases the ability of the gastroesophageal anatomic and physiological barrier to prevent reflux, and can thus prevent any carcinogenic gastric content from reaching the esophagus, including both acid and bile,” the investigators wrote in Gastroenterology, noting that surgery reduces esophageal acid exposure to a greater degree than medication. “Antireflux surgery may thus prevent esophageal adenocarcinoma better than antireflux medication.”

Three meta-analyses to date, however, have failed to provide consistent support for this hypothesis.

“Most of the studies included in these meta-analyses came from single centers, were of small sample size, examined only one treatment arm, and had a short or incomplete follow-up, and ... were hampered by heterogeneity among the included studies,” they noted.

For the present study, Dr. Lagergren and colleagues analyzed national registry data from 33,939 patients with Barrett’s esophagus in Denmark, Finland, Norway, and Sweden. Out of this group, 542 patients (1.6%) had undergone antireflux surgery, while the remainder were managed with antireflux medication.

In both groups, approximately two-thirds of the patients were men. The median age at enrollment was about a decade higher in the medication group (66 vs. 54 years), and this group also tended to have more comorbidities.

After a follow-up period as long as 32 years, the absolute rates of EAC were 1.3% and 2.6% in the medication and surgery groups, respectively. Multivariate analysis, with adjustments for sex, age, year, comorbidities, and age, revealed that postsurgical patients had a 90% increased risk of EAC (hazard ratio [HR], 1.9; 95% CI, 1.1-3.5), versus patients treated with antireflux medication alone.

The relatively higher risk of EAC appeared to increase over time, based on a nonsignificant hazard ratio of 1.8 during the 1- to 4-year follow-up period (HR, 1.8; 95% CI, 0.6-5.0), versus a significant, fourfold risk elevation during the 10- to 32-year follow-up period (HR, 4.4; 95% CI, 1.4-13.5).

“In this cohort of patients with Barrett’s esophagus, the risk of esophageal adenocarcinoma did not decrease after antireflux surgery compared with antireflux medication,” the investigators wrote. “Instead, the risk was increased throughout the follow-up among patients having undergone antireflux surgery.”

Dr. Lagergren and colleagues suggested that the reason for relatively higher cancer risk in the group that underwent surgery likely stems from early and prolonged acid exposure.

“[P]erforming antireflux surgery after years of GERD may be too late to enable a cancer-preventative effect, and most of the patients first diagnosed with Barrett’s esophagus reported a history of many years of GERD symptoms,” they wrote, suggesting that carcinogenic processes had already been set in motion by the time surgery was performed.

“[P]atients with Barrett’s esophagus who undergo antireflux surgery remain at an increased risk of esophageal adenocarcinoma and should continue taking part in surveillance programs,” the investigators concluded.

The study was funded by the Swedish Cancer Society, Swedish Research Council, and Stockholm County Council. The investigators disclosed no conflicts of interest.

Use of fluticasone and budesonide for eosinophilic esophagitis during pregnancy had no significant adverse effect on maternal or fetal outcomes, according to new research presented at the annual meeting of the American College of Gastroenterology.

“Currently, there are no specific recommendations about the safe use of steroids in pregnant women with eosinophilic esophagitis (EoE), Julton Tomanguillo Chumbe, MD, said in an interview. “Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.”

West Virginia University

In the study, Dr. Chumbe, an internal medicine resident at Charleston Area Medical Center, West Virginia University, Charleston, and colleagues identified pregnant patients aged 18 years and older with a diagnosis of EoE between January 2011 and December 2022 through the TriNetx Global Collaborative Network, which includes 101 health care organizations in 14 countries. The study population consisted of 1,263 individuals.

The researchers used propensity score matching (PSM) to compare the rates of spontaneous abortion, placenta previa, preeclampsia, premature delivery, HELLP syndrome, eclampsia, hyperemesis gravidarum, and major congenital abnormalities between women with EoE who did and did not use steroids during pregnancy. The PSM cohorts included 268 women in each group.

Overall, pregnant women who used steroids were not significantly more likely than were those who did not use steroids to experience spontaneous abortion (3.73% vs. 4.85%, P = .52). Rates of placenta previa, preeclampsia, premature delivery, HELLP syndrome, and hyperemesis gravidarum were equal between the groups (3.73% vs. 3.73%, P = 1.00 for all). No cases of eclampsia occurred in the steroid group, compared with a 3.73% rate in women who did not use steroids.

Incidence of major congenital abnormalities including but not limited to malformations of the eye, ear, face, neck, skull and face bones, and of the circulatory, respiratory, and digestive systems, were similar between the steroid and no steroid groups (7.09% vs. 8.20%, P = .62)

Dr. Chumbe said he was not surprised by the findings, given the robust data about the safe use of steroids in pregnant women with asthma, in terms of pregnancy outcomes and fetal outcomes.

“The findings of this study provide reassurance that the use of steroids in pregnant patients with eosinophilic esophagitis is not significantly associated with an increased risk of worse maternal or fetal outcomes,” he said. “During pregnancy, some patients may discontinue treatment due to safety concerns. However, this study suggests that this may not be necessary.” Consequently, patients can maintain EoE management while reducing the risk of complications.

Looking ahead, “it will be important to have some data about the safe use of dupilumab during pregnancy in patients with eosinophilic esophagitis,” he said.
 

Pregnant patients can maintain EoE management

“This study is able to address an important concern that many patients have regarding the safety of steroid therapy for EoE, particularly during pregnancy,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and executive vice chair of internal medicine at the University of Cincinnati. “As EoE impacts over 40% of women, most who are in childbearing age, it is important to review the safety of treatment and management of EoE so a mother does not have to choose between EoE management and pregnancy.”

The results from this study were certainly reassuring, though not surprising, Dr. Afzali said. “Previously, the safety profile of steroids during pregnancy was mostly extrapolated from asthma, and other diseases such as inflammatory bowel disease. The results from this study confirm that there are no significant associations with adverse maternal or birth outcomes among women with EoE treated with steroids during pregnancy,” she said.

The study has some limitations, including the retrospective design and potential for selection bias, Dr. Afzali noted. “Further research is needed for the evaluation of newer therapies in the pipeline for treatment of EoE and its safety profile with pregnancy,” she said.

However, “sharing this information in clinical practice “will allow our patients to feel comfortable with continuation of appropriate steroid therapy for treatment and management of their EoE, without having to choose between family planning or pregnancy and EoE care management,” Dr. Afzali said.

The study received no outside funding. Dr. Chumbe an Dr. Afzali indicated having no relevant financial conflicts to disclose.

Use of fluticasone and budesonide for eosinophilic esophagitis during pregnancy had no significant adverse effect on maternal or fetal outcomes, according to new research presented at the annual meeting of the American College of Gastroenterology.

“Currently, there are no specific recommendations about the safe use of steroids in pregnant women with eosinophilic esophagitis (EoE), Julton Tomanguillo Chumbe, MD, said in an interview. “Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.”

West Virginia University

In the study, Dr. Chumbe, an internal medicine resident at Charleston Area Medical Center, West Virginia University, Charleston, and colleagues identified pregnant patients aged 18 years and older with a diagnosis of EoE between January 2011 and December 2022 through the TriNetx Global Collaborative Network, which includes 101 health care organizations in 14 countries. The study population consisted of 1,263 individuals.

The researchers used propensity score matching (PSM) to compare the rates of spontaneous abortion, placenta previa, preeclampsia, premature delivery, HELLP syndrome, eclampsia, hyperemesis gravidarum, and major congenital abnormalities between women with EoE who did and did not use steroids during pregnancy. The PSM cohorts included 268 women in each group.

Overall, pregnant women who used steroids were not significantly more likely than were those who did not use steroids to experience spontaneous abortion (3.73% vs. 4.85%, P = .52). Rates of placenta previa, preeclampsia, premature delivery, HELLP syndrome, and hyperemesis gravidarum were equal between the groups (3.73% vs. 3.73%, P = 1.00 for all). No cases of eclampsia occurred in the steroid group, compared with a 3.73% rate in women who did not use steroids.

Incidence of major congenital abnormalities including but not limited to malformations of the eye, ear, face, neck, skull and face bones, and of the circulatory, respiratory, and digestive systems, were similar between the steroid and no steroid groups (7.09% vs. 8.20%, P = .62)

Dr. Chumbe said he was not surprised by the findings, given the robust data about the safe use of steroids in pregnant women with asthma, in terms of pregnancy outcomes and fetal outcomes.

“The findings of this study provide reassurance that the use of steroids in pregnant patients with eosinophilic esophagitis is not significantly associated with an increased risk of worse maternal or fetal outcomes,” he said. “During pregnancy, some patients may discontinue treatment due to safety concerns. However, this study suggests that this may not be necessary.” Consequently, patients can maintain EoE management while reducing the risk of complications.

Looking ahead, “it will be important to have some data about the safe use of dupilumab during pregnancy in patients with eosinophilic esophagitis,” he said.
 

Pregnant patients can maintain EoE management

“This study is able to address an important concern that many patients have regarding the safety of steroid therapy for EoE, particularly during pregnancy,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and executive vice chair of internal medicine at the University of Cincinnati. “As EoE impacts over 40% of women, most who are in childbearing age, it is important to review the safety of treatment and management of EoE so a mother does not have to choose between EoE management and pregnancy.”

The results from this study were certainly reassuring, though not surprising, Dr. Afzali said. “Previously, the safety profile of steroids during pregnancy was mostly extrapolated from asthma, and other diseases such as inflammatory bowel disease. The results from this study confirm that there are no significant associations with adverse maternal or birth outcomes among women with EoE treated with steroids during pregnancy,” she said.

The study has some limitations, including the retrospective design and potential for selection bias, Dr. Afzali noted. “Further research is needed for the evaluation of newer therapies in the pipeline for treatment of EoE and its safety profile with pregnancy,” she said.

However, “sharing this information in clinical practice “will allow our patients to feel comfortable with continuation of appropriate steroid therapy for treatment and management of their EoE, without having to choose between family planning or pregnancy and EoE care management,” Dr. Afzali said.

The study received no outside funding. Dr. Chumbe an Dr. Afzali indicated having no relevant financial conflicts to disclose.

Use of fluticasone and budesonide for eosinophilic esophagitis during pregnancy had no significant adverse effect on maternal or fetal outcomes, according to new research presented at the annual meeting of the American College of Gastroenterology.

“Currently, there are no specific recommendations about the safe use of steroids in pregnant women with eosinophilic esophagitis (EoE), Julton Tomanguillo Chumbe, MD, said in an interview. “Our recommendations about the use of steroids among this population are based on the safety data extrapolated mainly from pregnant women with asthma.”

West Virginia University

In the study, Dr. Chumbe, an internal medicine resident at Charleston Area Medical Center, West Virginia University, Charleston, and colleagues identified pregnant patients aged 18 years and older with a diagnosis of EoE between January 2011 and December 2022 through the TriNetx Global Collaborative Network, which includes 101 health care organizations in 14 countries. The study population consisted of 1,263 individuals.

The researchers used propensity score matching (PSM) to compare the rates of spontaneous abortion, placenta previa, preeclampsia, premature delivery, HELLP syndrome, eclampsia, hyperemesis gravidarum, and major congenital abnormalities between women with EoE who did and did not use steroids during pregnancy. The PSM cohorts included 268 women in each group.

Overall, pregnant women who used steroids were not significantly more likely than were those who did not use steroids to experience spontaneous abortion (3.73% vs. 4.85%, P = .52). Rates of placenta previa, preeclampsia, premature delivery, HELLP syndrome, and hyperemesis gravidarum were equal between the groups (3.73% vs. 3.73%, P = 1.00 for all). No cases of eclampsia occurred in the steroid group, compared with a 3.73% rate in women who did not use steroids.

Incidence of major congenital abnormalities including but not limited to malformations of the eye, ear, face, neck, skull and face bones, and of the circulatory, respiratory, and digestive systems, were similar between the steroid and no steroid groups (7.09% vs. 8.20%, P = .62)

Dr. Chumbe said he was not surprised by the findings, given the robust data about the safe use of steroids in pregnant women with asthma, in terms of pregnancy outcomes and fetal outcomes.

“The findings of this study provide reassurance that the use of steroids in pregnant patients with eosinophilic esophagitis is not significantly associated with an increased risk of worse maternal or fetal outcomes,” he said. “During pregnancy, some patients may discontinue treatment due to safety concerns. However, this study suggests that this may not be necessary.” Consequently, patients can maintain EoE management while reducing the risk of complications.

Looking ahead, “it will be important to have some data about the safe use of dupilumab during pregnancy in patients with eosinophilic esophagitis,” he said.
 

Pregnant patients can maintain EoE management

“This study is able to address an important concern that many patients have regarding the safety of steroid therapy for EoE, particularly during pregnancy,” said Anita Afzali, MD, MPH, AGAF, a gastroenterologist specializing in inflammatory bowel disease and executive vice chair of internal medicine at the University of Cincinnati. “As EoE impacts over 40% of women, most who are in childbearing age, it is important to review the safety of treatment and management of EoE so a mother does not have to choose between EoE management and pregnancy.”

The results from this study were certainly reassuring, though not surprising, Dr. Afzali said. “Previously, the safety profile of steroids during pregnancy was mostly extrapolated from asthma, and other diseases such as inflammatory bowel disease. The results from this study confirm that there are no significant associations with adverse maternal or birth outcomes among women with EoE treated with steroids during pregnancy,” she said.

The study has some limitations, including the retrospective design and potential for selection bias, Dr. Afzali noted. “Further research is needed for the evaluation of newer therapies in the pipeline for treatment of EoE and its safety profile with pregnancy,” she said.

However, “sharing this information in clinical practice “will allow our patients to feel comfortable with continuation of appropriate steroid therapy for treatment and management of their EoE, without having to choose between family planning or pregnancy and EoE care management,” Dr. Afzali said.

The study received no outside funding. Dr. Chumbe an Dr. Afzali indicated having no relevant financial conflicts to disclose.

The Food and Drug Administration has approved vonoprazan 10-mg and 20-mg tablets (Voquezna, Phathom Pharmaceuticals) for the healing and maintenance of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.

Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.

Olivier Le Moal/Getty Images

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.

The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.

Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.

In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.

In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).

Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.

The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.

“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.

Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.

Vonoprazan is expected to be available in the United States in December.

The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.

In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.

Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved vonoprazan 10-mg and 20-mg tablets (Voquezna, Phathom Pharmaceuticals) for the healing and maintenance of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.

Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.

Olivier Le Moal/Getty Images

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.

The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.

Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.

In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.

In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).

Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.

The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.

“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.

Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.

Vonoprazan is expected to be available in the United States in December.

The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.

In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.

Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved vonoprazan 10-mg and 20-mg tablets (Voquezna, Phathom Pharmaceuticals) for the healing and maintenance of all grades of erosive esophagitis, also known as erosive gastroesophageal reflux disease (GERD), as well as relief of associated heartburn, the company has announced.

Vonoprazan, an oral potassium-competitive acid blocker (PCAB), provides more potent inhibition of gastric acid than do proton pump inhibitors (PPIs) and is seen as a potential alternative.

Olivier Le Moal/Getty Images

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study.

The randomized, double-blind, multicenter study enrolled 1,024 patients with erosive GERD in the United States and Europe and compared vonoprazan with the PPI lansoprazole (Prevacid) in the healing and maintenance of healing of erosive GERD and associated heartburn symptom relief.

Vonoprazan 20 mg was noninferior to lansoprazole 30 mg for complete healing by week 8 in patients with all grades of erosive GERD, with healing rates of 93% vs. 85% for lansoprazole.

In addition, vonoprazan showed superior rates of healing in patients with moderate to severe disease (LA Grade C/D) at week 2 (70% vs. 53% with lansoprazole). Vonoprazan was also noninferior to lansoprazole in terms of heartburn-free days over the healing period.

In the maintenance phase of the trial, vonoprazan 10 mg was superior to lansoprazole 15 mg in maintaining healing at 6 months in all patients who were randomly assigned (79% vs. 72%) and in the subset of patients with moderate to severe erosive GERD (75% vs. 61%).

Adverse event (AE) rates for vonoprazan were comparable to lansoprazole. The most common AEs in the healing phase (≥ 2% with vonoprazan) were gastritis, diarrhea, abdominal distention, abdominal pain, and nausea.

The most common AEs in the maintenance phase (≥ 3% with vonoprazan) were gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection.

“For many GERD patients with erosive esophagitis, the response to current treatment is suboptimal, leaving them with incomplete healing and ongoing symptoms,” Colin W. Howden, MD, professor emeritus, University of Tennessee, Memphis, said in the news release.

Vonoprazan provides clinicians with a “new first-in-class therapeutic option that demonstrated faster healing in the more difficult-to-treat GERD patients with erosive esophagitis,” Dr. Howden added.

Vonoprazan is expected to be available in the United States in December.

The FDA also recently approved reformulated vonoprazan tablets for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin) for the treatment of Helicobacter pylori infection in adults, Phathom Pharmaceuticals announced.

In February, the FDA had put both the vonoprazan new drug application for erosive esophagitis and the postapproval supplement for H. pylori on hold until the company addressed concerns over the presence of nitrosamine impurities.

Dr. Howden is a former editor-in-chief of GI&Hepatology News. A version of this article appeared on Medscape.com.

COPENHAGEN – A real-time, blood-sensing capsule that detects upper gastrointestinal bleeding (UGIB) is safe and effective for patients before undergoing upper endoscopy, according to results from the first U.S.-based open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB. It is also the largest such trial.

The capsule (PillSense, EnteraSense) is rapidly deployed, safe to use, and easy to interpret, study researchers say. In under 7 minutes, it correctly detected the presence of blood in 26 of 28 patients and its absence in 87 of 96 patients, as confirmed afterward by esophagogastroduodenoscopy (EGD).

“The use of the PillSense system will positively impact patient outcomes by providing early diagnosis, triaging, and directing care for UGIB,” said Karl Akiki, MD, study lead, who is in the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn. He presented the results at the annual United European Gastroenterology Week.

“Due to its ability to rapidly diagnose UGIB, it helps us, as doctors, expedite accurate clinical decision-making while also optimizing services to ensure the maximum number of patients obtain the best outcome,” he told this news organization.

“There are some pre-endoscopic assessment scores, like the Rockell or the Glasgow-Blatchford score, but they have limited clinical utility in predicting and confirming bleeding in suspected patients,” explained Dr. Akiki. He highlighted the need for a novel device that is rapid, accurate, and safe to use. He also pointed out that despite being the gold standard for diagnosis, EGD remains challenging in terms of time, personnel, and resources.

“The results of our study show the PillSense is a good diagnostic tool that will aid triage,” he said. He noted that PillSense and EGD supplement each other in patient care.

It’s not a device to replace the EGD itself,” he explained, but given the results from the capsule, it will act “as a kind of a bridge that helps us to determine which patients should undergo EGD.”

Optical sensing technology

The researchers aimed to assess the safety and efficacy of the PillSense system for patients with suspected UGIB. They enrolled 131 patients (mean age, 62 years), 60% of whom were men. The most common presenting symptoms for UGIB were melena (52%), anemia (41%), and hematemesis (15%). Five participants withdrew consent before capsule ingestion, and for two patients, primary endpoint data were missing. This left an intent-to-treat population of 124 patients; 110 completed the study.

Patients were asked to swallow the capsule and to lay on their left side. The PillSense is based on optical sensing technology that uses an optical signature of blood in the gut. The device differentiates blood from any other liquids that may be present. After 5-7 minutes, the device gathers and transmits data wirelessly to an external, handheld receiver that processes binary data and indicates either “blood detected” or “no blood detected” in the upper GI tract, explained Dr. Akiki.

Following the capsule reading, patients underwent EGD within 4 hours. This enabled the researchers to compare data between the two modalities. Follow-up visits were conducted on days 7, 14, and 21 to ensure the capsule had passed from the body. Endoscopists were blinded to the capsule result when reading the EGD.

Primary endpoints were the sensitivity and specificity of the device; secondary endpoints were positive predictive value, negative predictive value, successful passage of the capsule, and safety.
 

Rapid and accurate

The researchers determined the efficiency of the capsule in correctly detecting a UGIB. The capsule’s positive and negative predictive values were 74.3% and 97.8%, respectively.

“We achieved a sensitivity of around 93% (92.9%; P = 0.024) with the PillSense capsule and a specificity of 91% (90.6%; P < .001]), which were pretty good. We also detected a range from minimal bleeding – so, speckles of blood to large amounts of active bleeding covering the entire stomach,” reported Dr. Akiki.

There were no differences in terms of patient demographics, laboratory results, or concomitant use of medications. PillSense recording time was a mean of 6.71 minutes, the time from capsule ingestion to EGD was a mean of 55 minutes, and the time to capsule passage through the GI tract was 3.6 days. Most bleeds were found to be in the stomach (18/30; 60%), followed by the duodenum (5/30; 16.6%).

Various capsules for detecting UGIB are under development or are already available, but unlike some of the others, “[the PillSense] is not a video capsule,” said Dr. Akiki. “It does not take pictures at all but is more of a photo sensor capsule that measures the absorption of wavelengths.”

This explains why the PillSense was so rapid – results were available in around 7 minutes and did not require an interpretation by a physician, he explained. “Trained non-physician personnel can use it, and this is where it differs from other devices, such as video capsules that require someone highly trained to interpret the output. It’s an easy procedure and process to follow.”

The PillSense has value in improving workflow, Dr. Akiki said. “If we had someone come in during the night with a suspected upper GI bleed, we could give them the capsule, determine if they need an EGD or not, and potentially postpone it to a time – say, the morning, when more resources are available – freeing up the night for emergency cases. It helps me, as a physician, to determine which patients to send to EGD immediately or which to wait.”

He added that more studies are needed in the postmarketing phase to understand optimal use of the device and to define the exact clinical pathway for optimal implementation.

The device was approved by the U.S. Food and Drug Administration in February. Dr. Akiki noted that there were no adverse events or deaths related to the capsule.

Co-moderator, Philip Chiu, MD, a gastroenterologist from the Chinese University of Hong Kong, said, “It’s an interesting study, because sometimes we can’t differentiate by clinical symptoms as to whether this is a problem of continuous bleeding or something else. The capsule might help us in our decision-making in this respect and help determine whether we should scope the patients or just manage conservatively.”

Dr. Akiki and Dr. Chiu have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

COPENHAGEN – A real-time, blood-sensing capsule that detects upper gastrointestinal bleeding (UGIB) is safe and effective for patients before undergoing upper endoscopy, according to results from the first U.S.-based open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB. It is also the largest such trial.

The capsule (PillSense, EnteraSense) is rapidly deployed, safe to use, and easy to interpret, study researchers say. In under 7 minutes, it correctly detected the presence of blood in 26 of 28 patients and its absence in 87 of 96 patients, as confirmed afterward by esophagogastroduodenoscopy (EGD).

“The use of the PillSense system will positively impact patient outcomes by providing early diagnosis, triaging, and directing care for UGIB,” said Karl Akiki, MD, study lead, who is in the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn. He presented the results at the annual United European Gastroenterology Week.

“Due to its ability to rapidly diagnose UGIB, it helps us, as doctors, expedite accurate clinical decision-making while also optimizing services to ensure the maximum number of patients obtain the best outcome,” he told this news organization.

“There are some pre-endoscopic assessment scores, like the Rockell or the Glasgow-Blatchford score, but they have limited clinical utility in predicting and confirming bleeding in suspected patients,” explained Dr. Akiki. He highlighted the need for a novel device that is rapid, accurate, and safe to use. He also pointed out that despite being the gold standard for diagnosis, EGD remains challenging in terms of time, personnel, and resources.

“The results of our study show the PillSense is a good diagnostic tool that will aid triage,” he said. He noted that PillSense and EGD supplement each other in patient care.

It’s not a device to replace the EGD itself,” he explained, but given the results from the capsule, it will act “as a kind of a bridge that helps us to determine which patients should undergo EGD.”

Optical sensing technology

The researchers aimed to assess the safety and efficacy of the PillSense system for patients with suspected UGIB. They enrolled 131 patients (mean age, 62 years), 60% of whom were men. The most common presenting symptoms for UGIB were melena (52%), anemia (41%), and hematemesis (15%). Five participants withdrew consent before capsule ingestion, and for two patients, primary endpoint data were missing. This left an intent-to-treat population of 124 patients; 110 completed the study.

Patients were asked to swallow the capsule and to lay on their left side. The PillSense is based on optical sensing technology that uses an optical signature of blood in the gut. The device differentiates blood from any other liquids that may be present. After 5-7 minutes, the device gathers and transmits data wirelessly to an external, handheld receiver that processes binary data and indicates either “blood detected” or “no blood detected” in the upper GI tract, explained Dr. Akiki.

Following the capsule reading, patients underwent EGD within 4 hours. This enabled the researchers to compare data between the two modalities. Follow-up visits were conducted on days 7, 14, and 21 to ensure the capsule had passed from the body. Endoscopists were blinded to the capsule result when reading the EGD.

Primary endpoints were the sensitivity and specificity of the device; secondary endpoints were positive predictive value, negative predictive value, successful passage of the capsule, and safety.
 

Rapid and accurate

The researchers determined the efficiency of the capsule in correctly detecting a UGIB. The capsule’s positive and negative predictive values were 74.3% and 97.8%, respectively.

“We achieved a sensitivity of around 93% (92.9%; P = 0.024) with the PillSense capsule and a specificity of 91% (90.6%; P < .001]), which were pretty good. We also detected a range from minimal bleeding – so, speckles of blood to large amounts of active bleeding covering the entire stomach,” reported Dr. Akiki.

There were no differences in terms of patient demographics, laboratory results, or concomitant use of medications. PillSense recording time was a mean of 6.71 minutes, the time from capsule ingestion to EGD was a mean of 55 minutes, and the time to capsule passage through the GI tract was 3.6 days. Most bleeds were found to be in the stomach (18/30; 60%), followed by the duodenum (5/30; 16.6%).

Various capsules for detecting UGIB are under development or are already available, but unlike some of the others, “[the PillSense] is not a video capsule,” said Dr. Akiki. “It does not take pictures at all but is more of a photo sensor capsule that measures the absorption of wavelengths.”

This explains why the PillSense was so rapid – results were available in around 7 minutes and did not require an interpretation by a physician, he explained. “Trained non-physician personnel can use it, and this is where it differs from other devices, such as video capsules that require someone highly trained to interpret the output. It’s an easy procedure and process to follow.”

The PillSense has value in improving workflow, Dr. Akiki said. “If we had someone come in during the night with a suspected upper GI bleed, we could give them the capsule, determine if they need an EGD or not, and potentially postpone it to a time – say, the morning, when more resources are available – freeing up the night for emergency cases. It helps me, as a physician, to determine which patients to send to EGD immediately or which to wait.”

He added that more studies are needed in the postmarketing phase to understand optimal use of the device and to define the exact clinical pathway for optimal implementation.

The device was approved by the U.S. Food and Drug Administration in February. Dr. Akiki noted that there were no adverse events or deaths related to the capsule.

Co-moderator, Philip Chiu, MD, a gastroenterologist from the Chinese University of Hong Kong, said, “It’s an interesting study, because sometimes we can’t differentiate by clinical symptoms as to whether this is a problem of continuous bleeding or something else. The capsule might help us in our decision-making in this respect and help determine whether we should scope the patients or just manage conservatively.”

Dr. Akiki and Dr. Chiu have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

COPENHAGEN – A real-time, blood-sensing capsule that detects upper gastrointestinal bleeding (UGIB) is safe and effective for patients before undergoing upper endoscopy, according to results from the first U.S.-based open-label, single-arm comparative clinical trial of a novel bleeding sensor for patients with suspected UGIB. It is also the largest such trial.

The capsule (PillSense, EnteraSense) is rapidly deployed, safe to use, and easy to interpret, study researchers say. In under 7 minutes, it correctly detected the presence of blood in 26 of 28 patients and its absence in 87 of 96 patients, as confirmed afterward by esophagogastroduodenoscopy (EGD).

“The use of the PillSense system will positively impact patient outcomes by providing early diagnosis, triaging, and directing care for UGIB,” said Karl Akiki, MD, study lead, who is in the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn. He presented the results at the annual United European Gastroenterology Week.

“Due to its ability to rapidly diagnose UGIB, it helps us, as doctors, expedite accurate clinical decision-making while also optimizing services to ensure the maximum number of patients obtain the best outcome,” he told this news organization.

“There are some pre-endoscopic assessment scores, like the Rockell or the Glasgow-Blatchford score, but they have limited clinical utility in predicting and confirming bleeding in suspected patients,” explained Dr. Akiki. He highlighted the need for a novel device that is rapid, accurate, and safe to use. He also pointed out that despite being the gold standard for diagnosis, EGD remains challenging in terms of time, personnel, and resources.

“The results of our study show the PillSense is a good diagnostic tool that will aid triage,” he said. He noted that PillSense and EGD supplement each other in patient care.

It’s not a device to replace the EGD itself,” he explained, but given the results from the capsule, it will act “as a kind of a bridge that helps us to determine which patients should undergo EGD.”

Optical sensing technology

The researchers aimed to assess the safety and efficacy of the PillSense system for patients with suspected UGIB. They enrolled 131 patients (mean age, 62 years), 60% of whom were men. The most common presenting symptoms for UGIB were melena (52%), anemia (41%), and hematemesis (15%). Five participants withdrew consent before capsule ingestion, and for two patients, primary endpoint data were missing. This left an intent-to-treat population of 124 patients; 110 completed the study.

Patients were asked to swallow the capsule and to lay on their left side. The PillSense is based on optical sensing technology that uses an optical signature of blood in the gut. The device differentiates blood from any other liquids that may be present. After 5-7 minutes, the device gathers and transmits data wirelessly to an external, handheld receiver that processes binary data and indicates either “blood detected” or “no blood detected” in the upper GI tract, explained Dr. Akiki.

Following the capsule reading, patients underwent EGD within 4 hours. This enabled the researchers to compare data between the two modalities. Follow-up visits were conducted on days 7, 14, and 21 to ensure the capsule had passed from the body. Endoscopists were blinded to the capsule result when reading the EGD.

Primary endpoints were the sensitivity and specificity of the device; secondary endpoints were positive predictive value, negative predictive value, successful passage of the capsule, and safety.
 

Rapid and accurate

The researchers determined the efficiency of the capsule in correctly detecting a UGIB. The capsule’s positive and negative predictive values were 74.3% and 97.8%, respectively.

“We achieved a sensitivity of around 93% (92.9%; P = 0.024) with the PillSense capsule and a specificity of 91% (90.6%; P < .001]), which were pretty good. We also detected a range from minimal bleeding – so, speckles of blood to large amounts of active bleeding covering the entire stomach,” reported Dr. Akiki.

There were no differences in terms of patient demographics, laboratory results, or concomitant use of medications. PillSense recording time was a mean of 6.71 minutes, the time from capsule ingestion to EGD was a mean of 55 minutes, and the time to capsule passage through the GI tract was 3.6 days. Most bleeds were found to be in the stomach (18/30; 60%), followed by the duodenum (5/30; 16.6%).

Various capsules for detecting UGIB are under development or are already available, but unlike some of the others, “[the PillSense] is not a video capsule,” said Dr. Akiki. “It does not take pictures at all but is more of a photo sensor capsule that measures the absorption of wavelengths.”

This explains why the PillSense was so rapid – results were available in around 7 minutes and did not require an interpretation by a physician, he explained. “Trained non-physician personnel can use it, and this is where it differs from other devices, such as video capsules that require someone highly trained to interpret the output. It’s an easy procedure and process to follow.”

The PillSense has value in improving workflow, Dr. Akiki said. “If we had someone come in during the night with a suspected upper GI bleed, we could give them the capsule, determine if they need an EGD or not, and potentially postpone it to a time – say, the morning, when more resources are available – freeing up the night for emergency cases. It helps me, as a physician, to determine which patients to send to EGD immediately or which to wait.”

He added that more studies are needed in the postmarketing phase to understand optimal use of the device and to define the exact clinical pathway for optimal implementation.

The device was approved by the U.S. Food and Drug Administration in February. Dr. Akiki noted that there were no adverse events or deaths related to the capsule.

Co-moderator, Philip Chiu, MD, a gastroenterologist from the Chinese University of Hong Kong, said, “It’s an interesting study, because sometimes we can’t differentiate by clinical symptoms as to whether this is a problem of continuous bleeding or something else. The capsule might help us in our decision-making in this respect and help determine whether we should scope the patients or just manage conservatively.”

Dr. Akiki and Dr. Chiu have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Dupilumab provides histologic, endoscopic, and symptomatic improvement in patients with severe, treatment-refractory, fibrostenotic eosinophilic esophagitis (EoE), new research shows.

METHODOLOGY:

• The researchers conducted a retrospective cohort study of 46 patients with severe, treatment-refractory fibrostenotic EoE who were prescribed dupilumab 300 mg subcutaneously every other week or weekly.
• Histologic response, endoscopic severity, and symptom improvement were assessed using the results of esophagogastroduodenoscopy (EGD) conducted before and after dupilumab therapy.

TAKEAWAY:

• Most patients demonstrated endoscopic, histologic, and symptomatic improvement on dupilumab, compared with predupilumab EGD results.
• The average peak eosinophil count improved from 70 eosinophils/high-power field to 9 eosinophils/HPF while on dupilumab, and 80% of patients achieved histologic remission (< 15 eosinophils/HPF), compared with 11% before dupilumab.
• Endoscopic features also improved on dupilumab, with a significant reduction in exudates, rings, edema, and furrows. The total EoE Endoscopic Reference Score decreased from 4.62 to 1.89 (P < .001).
• With dupilumab, a significant increase in predilation esophageal diameter (from 13.9 to 16 mm; P < .001) was observed, with no change in the proportion of strictures.
• Global symptom improvement was reported in 91% of patients while on dupilumab versus 2% before dupilumab.

IN PRACTICE:

“These results echo the results from the prior phase 3 study, but in a population where most subjects would likely have been excluded due to stricture severity and need for dilation,” the authors wrote. “Dupilumab has real-world efficacy for a patient population with severe fibrostenotic EoE. Further studies are needed to determine not only long-term efficacy of dupilumab for this group of EoE patients, but whether dupilumab could be moved earlier in the treatment algorithm for this severe subgroup.”

SOURCE:

The study, by Christopher Lee, MD, and Evan Dellon, MD, MPH, with the Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The study involved a single tertiary care center, which could limit the generalizability of the findings. The patients were primarily adults, so the results may not be able to be extended to younger children.

DISCLOSURES:

The study had no specific funding. Dr. Dellon has received research funding and consulting fees from multiple pharmaceutical companies. Dr. Lee has no relevant disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

Dupilumab provides histologic, endoscopic, and symptomatic improvement in patients with severe, treatment-refractory, fibrostenotic eosinophilic esophagitis (EoE), new research shows.

METHODOLOGY:

• The researchers conducted a retrospective cohort study of 46 patients with severe, treatment-refractory fibrostenotic EoE who were prescribed dupilumab 300 mg subcutaneously every other week or weekly.
• Histologic response, endoscopic severity, and symptom improvement were assessed using the results of esophagogastroduodenoscopy (EGD) conducted before and after dupilumab therapy.

TAKEAWAY:

• Most patients demonstrated endoscopic, histologic, and symptomatic improvement on dupilumab, compared with predupilumab EGD results.
• The average peak eosinophil count improved from 70 eosinophils/high-power field to 9 eosinophils/HPF while on dupilumab, and 80% of patients achieved histologic remission (< 15 eosinophils/HPF), compared with 11% before dupilumab.
• Endoscopic features also improved on dupilumab, with a significant reduction in exudates, rings, edema, and furrows. The total EoE Endoscopic Reference Score decreased from 4.62 to 1.89 (P < .001).
• With dupilumab, a significant increase in predilation esophageal diameter (from 13.9 to 16 mm; P < .001) was observed, with no change in the proportion of strictures.
• Global symptom improvement was reported in 91% of patients while on dupilumab versus 2% before dupilumab.

IN PRACTICE:

“These results echo the results from the prior phase 3 study, but in a population where most subjects would likely have been excluded due to stricture severity and need for dilation,” the authors wrote. “Dupilumab has real-world efficacy for a patient population with severe fibrostenotic EoE. Further studies are needed to determine not only long-term efficacy of dupilumab for this group of EoE patients, but whether dupilumab could be moved earlier in the treatment algorithm for this severe subgroup.”

SOURCE:

The study, by Christopher Lee, MD, and Evan Dellon, MD, MPH, with the Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The study involved a single tertiary care center, which could limit the generalizability of the findings. The patients were primarily adults, so the results may not be able to be extended to younger children.

DISCLOSURES:

The study had no specific funding. Dr. Dellon has received research funding and consulting fees from multiple pharmaceutical companies. Dr. Lee has no relevant disclosures.

A version of this article first appeared on Medscape.com.

TOPLINE:

Dupilumab provides histologic, endoscopic, and symptomatic improvement in patients with severe, treatment-refractory, fibrostenotic eosinophilic esophagitis (EoE), new research shows.

METHODOLOGY:

• The researchers conducted a retrospective cohort study of 46 patients with severe, treatment-refractory fibrostenotic EoE who were prescribed dupilumab 300 mg subcutaneously every other week or weekly.
• Histologic response, endoscopic severity, and symptom improvement were assessed using the results of esophagogastroduodenoscopy (EGD) conducted before and after dupilumab therapy.

TAKEAWAY:

• Most patients demonstrated endoscopic, histologic, and symptomatic improvement on dupilumab, compared with predupilumab EGD results.
• The average peak eosinophil count improved from 70 eosinophils/high-power field to 9 eosinophils/HPF while on dupilumab, and 80% of patients achieved histologic remission (< 15 eosinophils/HPF), compared with 11% before dupilumab.
• Endoscopic features also improved on dupilumab, with a significant reduction in exudates, rings, edema, and furrows. The total EoE Endoscopic Reference Score decreased from 4.62 to 1.89 (P < .001).
• With dupilumab, a significant increase in predilation esophageal diameter (from 13.9 to 16 mm; P < .001) was observed, with no change in the proportion of strictures.
• Global symptom improvement was reported in 91% of patients while on dupilumab versus 2% before dupilumab.

IN PRACTICE:

“These results echo the results from the prior phase 3 study, but in a population where most subjects would likely have been excluded due to stricture severity and need for dilation,” the authors wrote. “Dupilumab has real-world efficacy for a patient population with severe fibrostenotic EoE. Further studies are needed to determine not only long-term efficacy of dupilumab for this group of EoE patients, but whether dupilumab could be moved earlier in the treatment algorithm for this severe subgroup.”

SOURCE:

The study, by Christopher Lee, MD, and Evan Dellon, MD, MPH, with the Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill, was published online in Clinical Gastroenterology and Hepatology.

LIMITATIONS:

The study involved a single tertiary care center, which could limit the generalizability of the findings. The patients were primarily adults, so the results may not be able to be extended to younger children.

DISCLOSURES:

The study had no specific funding. Dr. Dellon has received research funding and consulting fees from multiple pharmaceutical companies. Dr. Lee has no relevant disclosures.

A version of this article first appeared on Medscape.com.