Upper GI Tract

Key clinical point: Eosinophilic esophagitis (EoE) can be distinguished from eosinophilia caused by inflammatory bowel diseases (IBD) by measuring the expression levels of the major basic protein (MBP) biomarker.

Major finding: The median MBP staining levels were significantly higher in patients with EoE vs those with IBD-associated eosinophilia (52.8 vs 0.2; P < .001). Based on the MBP cutoff point of 3.49 units that distinguished EoE from non-EoE cases, 100% of patients with EoE were MBP positive compared with 3% of patients with IBD-associated eosinophilia (P < .05).

Study details: This retrospective study included 29 patients with EoE, 27 patients with both EoE and IBD, 29 patients with IBD-associated eosinophilia, 30 patients with IBD, and 30 control individuals without either EoE or IBD.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Butzke S, Nasiri-Blomgren S, Corao-Uribe D, He Z, Molle-Rios Z. Major basic protein is a useful marker to distinguish eosinophilic esophagitis from IBD-associated eosinophilia in children. J Pediatr Gastroenterol Nutr. 2024 (Feb 5). doi: 10.1002/jpn3.12143 Source

Key clinical point: Eosinophilic esophagitis (EoE) can be distinguished from eosinophilia caused by inflammatory bowel diseases (IBD) by measuring the expression levels of the major basic protein (MBP) biomarker.

Major finding: The median MBP staining levels were significantly higher in patients with EoE vs those with IBD-associated eosinophilia (52.8 vs 0.2; P < .001). Based on the MBP cutoff point of 3.49 units that distinguished EoE from non-EoE cases, 100% of patients with EoE were MBP positive compared with 3% of patients with IBD-associated eosinophilia (P < .05).

Study details: This retrospective study included 29 patients with EoE, 27 patients with both EoE and IBD, 29 patients with IBD-associated eosinophilia, 30 patients with IBD, and 30 control individuals without either EoE or IBD.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Butzke S, Nasiri-Blomgren S, Corao-Uribe D, He Z, Molle-Rios Z. Major basic protein is a useful marker to distinguish eosinophilic esophagitis from IBD-associated eosinophilia in children. J Pediatr Gastroenterol Nutr. 2024 (Feb 5). doi: 10.1002/jpn3.12143 Source

Key clinical point: Eosinophilic esophagitis (EoE) can be distinguished from eosinophilia caused by inflammatory bowel diseases (IBD) by measuring the expression levels of the major basic protein (MBP) biomarker.

Major finding: The median MBP staining levels were significantly higher in patients with EoE vs those with IBD-associated eosinophilia (52.8 vs 0.2; P < .001). Based on the MBP cutoff point of 3.49 units that distinguished EoE from non-EoE cases, 100% of patients with EoE were MBP positive compared with 3% of patients with IBD-associated eosinophilia (P < .05).

Study details: This retrospective study included 29 patients with EoE, 27 patients with both EoE and IBD, 29 patients with IBD-associated eosinophilia, 30 patients with IBD, and 30 control individuals without either EoE or IBD.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Butzke S, Nasiri-Blomgren S, Corao-Uribe D, He Z, Molle-Rios Z. Major basic protein is a useful marker to distinguish eosinophilic esophagitis from IBD-associated eosinophilia in children. J Pediatr Gastroenterol Nutr. 2024 (Feb 5). doi: 10.1002/jpn3.12143 Source

Key clinical point: Pediatric patients with a more recent diagnosis of eosinophilic esophagitis (EoE) are likely to have a greater psychosocial burden from their condition, with a higher symptom burden score correlating positively with somatic symptom scores and negatively with quality of life (QoL).

Major finding: Compared with patients with longer disease duration (>12 months), those with shorter disease duration (6-12 months) had higher symptom burden (P = .03), somatic symptom (P < .01), and trait anxiety (P < .01) scores. Furthermore, a higher symptom burden was significantly associated with increased somatic symptoms (adjusted β [aβ] 0.34; 95% CI 0.23-0.45) and decreased QoL (aβ −0.42; 95% CI −0.59 to −0.25).

Study details: Findings are from a cross-sectional study including 87 pediatric patients with EoE, of whom 71 patients had longer disease duration.

Disclosures: This study was supported by a grant from the University of California San Diego (USCD) Academic Senate and US National Institutes of Health K24 and partially supported by the UCSD Altman Clinical and Translational Research Institute (ACTRI). The authors declared no conflicts of interest.

Source: Jensen ET, Chaiboonma K, Ayala O, Proia A, Aceves SS. 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  Source

Key clinical point: Pediatric patients with a more recent diagnosis of eosinophilic esophagitis (EoE) are likely to have a greater psychosocial burden from their condition, with a higher symptom burden score correlating positively with somatic symptom scores and negatively with quality of life (QoL).

Major finding: Compared with patients with longer disease duration (>12 months), those with shorter disease duration (6-12 months) had higher symptom burden (P = .03), somatic symptom (P < .01), and trait anxiety (P < .01) scores. Furthermore, a higher symptom burden was significantly associated with increased somatic symptoms (adjusted β [aβ] 0.34; 95% CI 0.23-0.45) and decreased QoL (aβ −0.42; 95% CI −0.59 to −0.25).

Study details: Findings are from a cross-sectional study including 87 pediatric patients with EoE, of whom 71 patients had longer disease duration.

Disclosures: This study was supported by a grant from the University of California San Diego (USCD) Academic Senate and US National Institutes of Health K24 and partially supported by the UCSD Altman Clinical and Translational Research Institute (ACTRI). The authors declared no conflicts of interest.

Source: Jensen ET, Chaiboonma K, Ayala O, Proia A, Aceves SS. 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  Source

Key clinical point: Pediatric patients with a more recent diagnosis of eosinophilic esophagitis (EoE) are likely to have a greater psychosocial burden from their condition, with a higher symptom burden score correlating positively with somatic symptom scores and negatively with quality of life (QoL).

Major finding: Compared with patients with longer disease duration (>12 months), those with shorter disease duration (6-12 months) had higher symptom burden (P = .03), somatic symptom (P < .01), and trait anxiety (P < .01) scores. Furthermore, a higher symptom burden was significantly associated with increased somatic symptoms (adjusted β [aβ] 0.34; 95% CI 0.23-0.45) and decreased QoL (aβ −0.42; 95% CI −0.59 to −0.25).

Study details: Findings are from a cross-sectional study including 87 pediatric patients with EoE, of whom 71 patients had longer disease duration.

Disclosures: This study was supported by a grant from the University of California San Diego (USCD) Academic Senate and US National Institutes of Health K24 and partially supported by the UCSD Altman Clinical and Translational Research Institute (ACTRI). The authors declared no conflicts of interest.

Source: Jensen ET, Chaiboonma K, Ayala O, Proia A, Aceves SS. 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  Source

Key clinical point: Treatment with dupilumab led to histologic remission and clinical benefits in patients with eosinophilic esophagitis (EoE) as early as within 12 weeks.

Major finding: The median composite symptom score reduced from 5.5 to 0 (P = .000488) and the median peak eosinophil counts decreased from 44.5 eosinophils/high‐power field (eos/hpf) to 2 eos/hpf (P = .000977) in patients who received dupilumab for 0-12 weeks. However, there were no significant differences in changes in median composite symptom score (P = .1350) and peak eosinophil count (P = .0746) among patients who received dupilumab between 0-12, 12-24, and >24 weeks.

Study details: This retrospective study included 79 patients with EoE who received dupilumab for a median period of 22.7 weeks, and of whom 12 patients received dupilumab for 0-12 weeks.

Disclosures: This study did not receive any specific funding. The corresponding author J Leung declared serving as a consultant for several sources.

Source: Sia T, Miller A, Bacchus L, et al. Dupilumab improves clinical and histologic features of eosinophilic esophagitis prior to 12 weeks of treatment. Clin Transl Allergy. 2024;14(1):e12333. Doi: 10.1002/clt2.12333 Source

Key clinical point: Treatment with dupilumab led to histologic remission and clinical benefits in patients with eosinophilic esophagitis (EoE) as early as within 12 weeks.

Major finding: The median composite symptom score reduced from 5.5 to 0 (P = .000488) and the median peak eosinophil counts decreased from 44.5 eosinophils/high‐power field (eos/hpf) to 2 eos/hpf (P = .000977) in patients who received dupilumab for 0-12 weeks. However, there were no significant differences in changes in median composite symptom score (P = .1350) and peak eosinophil count (P = .0746) among patients who received dupilumab between 0-12, 12-24, and >24 weeks.

Study details: This retrospective study included 79 patients with EoE who received dupilumab for a median period of 22.7 weeks, and of whom 12 patients received dupilumab for 0-12 weeks.

Disclosures: This study did not receive any specific funding. The corresponding author J Leung declared serving as a consultant for several sources.

Source: Sia T, Miller A, Bacchus L, et al. Dupilumab improves clinical and histologic features of eosinophilic esophagitis prior to 12 weeks of treatment. Clin Transl Allergy. 2024;14(1):e12333. Doi: 10.1002/clt2.12333 Source

Key clinical point: Treatment with dupilumab led to histologic remission and clinical benefits in patients with eosinophilic esophagitis (EoE) as early as within 12 weeks.

Major finding: The median composite symptom score reduced from 5.5 to 0 (P = .000488) and the median peak eosinophil counts decreased from 44.5 eosinophils/high‐power field (eos/hpf) to 2 eos/hpf (P = .000977) in patients who received dupilumab for 0-12 weeks. However, there were no significant differences in changes in median composite symptom score (P = .1350) and peak eosinophil count (P = .0746) among patients who received dupilumab between 0-12, 12-24, and >24 weeks.

Study details: This retrospective study included 79 patients with EoE who received dupilumab for a median period of 22.7 weeks, and of whom 12 patients received dupilumab for 0-12 weeks.

Disclosures: This study did not receive any specific funding. The corresponding author J Leung declared serving as a consultant for several sources.

Source: Sia T, Miller A, Bacchus L, et al. Dupilumab improves clinical and histologic features of eosinophilic esophagitis prior to 12 weeks of treatment. Clin Transl Allergy. 2024;14(1):e12333. Doi: 10.1002/clt2.12333 Source

Key clinical point: Patients diagnosed with both eosinophilic esophagitis (EoE) and inflammatory bowel diseases (IBD), like ulcerative colitis (UC) or Crohn’s disease (CD), are found to be more susceptible to immune-mediated comorbidities and IBD-related conditions but less susceptible to food bolus impaction.

Major finding: The risk for IBD-related complications (adjusted hazard ratio [aHR] > 1.1; P < .05) was higher, whereas the risk for food bolus impaction was lower (aHR 0.445; P  =  .0011), in patients with EoE and a concurrent diagnosis of IBD. The risk for immune-related comorbidities, such as celiac disease, IBD-related inflammatory conditions, eczema, and asthma, was also higher (P < .05) in patients with IBD who did vs did not have EoE.

Study details: Findings are from a retrospective population-based cohort study that included 174,755 patients with CD, 150,774 patients with UC, and 47,615 patients with EoE.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Malik A, Liu BD, Zhu L, Kaelber D, Song G. A comprehensive global population-based analysis on the coexistence of eosinophilic esophagitis and inflammatory bowel disease. Dig Dis Sci. 2024 (Jan 13). doi: 10.1007/s10620-024-08283-2 Source

Key clinical point: Patients diagnosed with both eosinophilic esophagitis (EoE) and inflammatory bowel diseases (IBD), like ulcerative colitis (UC) or Crohn’s disease (CD), are found to be more susceptible to immune-mediated comorbidities and IBD-related conditions but less susceptible to food bolus impaction.

Major finding: The risk for IBD-related complications (adjusted hazard ratio [aHR] > 1.1; P < .05) was higher, whereas the risk for food bolus impaction was lower (aHR 0.445; P  =  .0011), in patients with EoE and a concurrent diagnosis of IBD. The risk for immune-related comorbidities, such as celiac disease, IBD-related inflammatory conditions, eczema, and asthma, was also higher (P < .05) in patients with IBD who did vs did not have EoE.

Study details: Findings are from a retrospective population-based cohort study that included 174,755 patients with CD, 150,774 patients with UC, and 47,615 patients with EoE.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Malik A, Liu BD, Zhu L, Kaelber D, Song G. A comprehensive global population-based analysis on the coexistence of eosinophilic esophagitis and inflammatory bowel disease. Dig Dis Sci. 2024 (Jan 13). doi: 10.1007/s10620-024-08283-2 Source

Key clinical point: Patients diagnosed with both eosinophilic esophagitis (EoE) and inflammatory bowel diseases (IBD), like ulcerative colitis (UC) or Crohn’s disease (CD), are found to be more susceptible to immune-mediated comorbidities and IBD-related conditions but less susceptible to food bolus impaction.

Major finding: The risk for IBD-related complications (adjusted hazard ratio [aHR] > 1.1; P < .05) was higher, whereas the risk for food bolus impaction was lower (aHR 0.445; P  =  .0011), in patients with EoE and a concurrent diagnosis of IBD. The risk for immune-related comorbidities, such as celiac disease, IBD-related inflammatory conditions, eczema, and asthma, was also higher (P < .05) in patients with IBD who did vs did not have EoE.

Study details: Findings are from a retrospective population-based cohort study that included 174,755 patients with CD, 150,774 patients with UC, and 47,615 patients with EoE.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Malik A, Liu BD, Zhu L, Kaelber D, Song G. A comprehensive global population-based analysis on the coexistence of eosinophilic esophagitis and inflammatory bowel disease. Dig Dis Sci. 2024 (Jan 13). doi: 10.1007/s10620-024-08283-2 Source

Key clinical point: A twice-daily moderate proton pump inhibitor (PPI) dose (20 mg omeprazole twice daily) induced greater histologic response rates in patients with eosinophilic esophagitis (EoE) than a once-daily moderate PPI dose (40 mg once daily), regardless of the total daily dosage.

Major finding: The rate of histologic remission significantly improved with twice-daily moderate vs once-daily moderate PPI dose (52.8% vs 10.0%; P < .0001). Compared with a standard PPI dose (20 mg omeprazole once daily), twice-daily moderate (adjusted odds ratio [aOR] 6.75; P = .0008) and high (40 mg omeprazole twice daily; aOR 12.8; P < .0001) PPI doses were associated with increased odds of histologic response.

Study details: This retrospective cohort study included 305 newly diagnosed patients with EoE who received standard, once-daily moderate, twice-daily moderate, or high PPI doses for more than 8 weeks.

Disclosures: This study did not disclose the source of any funding. Walter W. Chan declared serving on scientific advisory boards for various organizations, including Sanofi and Regeneron Pharmaceuticals.

Source: Muftah M, Goldin AH, Barshop K, et al. Twice daily PPI induces higher remission rate in eosinophilic esophagitis than once daily regimen regardless of total daily dose. Am J Gastroenterol. 2024 (Feb 5). doi: 10.14309/ajg.0000000000002712  Source

Key clinical point: A twice-daily moderate proton pump inhibitor (PPI) dose (20 mg omeprazole twice daily) induced greater histologic response rates in patients with eosinophilic esophagitis (EoE) than a once-daily moderate PPI dose (40 mg once daily), regardless of the total daily dosage.

Major finding: The rate of histologic remission significantly improved with twice-daily moderate vs once-daily moderate PPI dose (52.8% vs 10.0%; P < .0001). Compared with a standard PPI dose (20 mg omeprazole once daily), twice-daily moderate (adjusted odds ratio [aOR] 6.75; P = .0008) and high (40 mg omeprazole twice daily; aOR 12.8; P < .0001) PPI doses were associated with increased odds of histologic response.

Study details: This retrospective cohort study included 305 newly diagnosed patients with EoE who received standard, once-daily moderate, twice-daily moderate, or high PPI doses for more than 8 weeks.

Disclosures: This study did not disclose the source of any funding. Walter W. Chan declared serving on scientific advisory boards for various organizations, including Sanofi and Regeneron Pharmaceuticals.

Source: Muftah M, Goldin AH, Barshop K, et al. Twice daily PPI induces higher remission rate in eosinophilic esophagitis than once daily regimen regardless of total daily dose. Am J Gastroenterol. 2024 (Feb 5). doi: 10.14309/ajg.0000000000002712  Source

Key clinical point: A twice-daily moderate proton pump inhibitor (PPI) dose (20 mg omeprazole twice daily) induced greater histologic response rates in patients with eosinophilic esophagitis (EoE) than a once-daily moderate PPI dose (40 mg once daily), regardless of the total daily dosage.

Major finding: The rate of histologic remission significantly improved with twice-daily moderate vs once-daily moderate PPI dose (52.8% vs 10.0%; P < .0001). Compared with a standard PPI dose (20 mg omeprazole once daily), twice-daily moderate (adjusted odds ratio [aOR] 6.75; P = .0008) and high (40 mg omeprazole twice daily; aOR 12.8; P < .0001) PPI doses were associated with increased odds of histologic response.

Study details: This retrospective cohort study included 305 newly diagnosed patients with EoE who received standard, once-daily moderate, twice-daily moderate, or high PPI doses for more than 8 weeks.

Disclosures: This study did not disclose the source of any funding. Walter W. Chan declared serving on scientific advisory boards for various organizations, including Sanofi and Regeneron Pharmaceuticals.

Source: Muftah M, Goldin AH, Barshop K, et al. Twice daily PPI induces higher remission rate in eosinophilic esophagitis than once daily regimen regardless of total daily dose. Am J Gastroenterol. 2024 (Feb 5). doi: 10.14309/ajg.0000000000002712  Source

The US Food and Drug Administration (FDA) has approved budesonide oral suspension (Eohilia, Takeda), the first oral treatment for eosinophilic esophagitis (EoE). 

Budesonide oral suspension is a corticosteroid indicated for 12 weeks of treatment of EoE in adults and children as young as 11 years. 

It will be available in 2-mg/10-mL single-dose stick packs by the end of February. 

“Developed specifically for EoE, Eohilia’s novel formulation of budesonide confers thixotropic properties — flowing more freely when shaken and returning to a more viscous state when swallowed,” the company said in a news release. 

Northwestern University

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With Eohilia, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” Ikuo Hirano, MD, professor of medicine and director of the Esophageal Center at Northwestern University Feinberg School of Medicine, Chicago, said in the release. 
 

Supporting Data 

The FDA approved budesonide oral suspension for EoE based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies. 

In study 1, significantly more patients receiving active treatment achieved histologic remission (53.1% vs 1% with placebo). The same was true in study 2, with 38% of patients receiving active treatment achieving histologic remission compared with 2.4% of those receiving placebo. 

The absolute change from baseline in the patient-reported Dysphagia Symptom Questionnaire combined score was -10.2 with budesonide vs -6.5 with placebo in Study 1 and -14.5 vs -5.9 in Study 2. 

During the last 2 weeks of treatment, more patients receiving budesonide oral suspension experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared with those receiving placebo, the company said. 

The most common adverse reactions seen in the clinical trials of budesonide oral suspension for EoE included respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%). 

Complete prescribing information is available on the FDA website.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved budesonide oral suspension (Eohilia, Takeda), the first oral treatment for eosinophilic esophagitis (EoE). 

Budesonide oral suspension is a corticosteroid indicated for 12 weeks of treatment of EoE in adults and children as young as 11 years. 

It will be available in 2-mg/10-mL single-dose stick packs by the end of February. 

“Developed specifically for EoE, Eohilia’s novel formulation of budesonide confers thixotropic properties — flowing more freely when shaken and returning to a more viscous state when swallowed,” the company said in a news release. 

Northwestern University

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With Eohilia, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” Ikuo Hirano, MD, professor of medicine and director of the Esophageal Center at Northwestern University Feinberg School of Medicine, Chicago, said in the release. 
 

Supporting Data 

The FDA approved budesonide oral suspension for EoE based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies. 

In study 1, significantly more patients receiving active treatment achieved histologic remission (53.1% vs 1% with placebo). The same was true in study 2, with 38% of patients receiving active treatment achieving histologic remission compared with 2.4% of those receiving placebo. 

The absolute change from baseline in the patient-reported Dysphagia Symptom Questionnaire combined score was -10.2 with budesonide vs -6.5 with placebo in Study 1 and -14.5 vs -5.9 in Study 2. 

During the last 2 weeks of treatment, more patients receiving budesonide oral suspension experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared with those receiving placebo, the company said. 

The most common adverse reactions seen in the clinical trials of budesonide oral suspension for EoE included respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%). 

Complete prescribing information is available on the FDA website.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved budesonide oral suspension (Eohilia, Takeda), the first oral treatment for eosinophilic esophagitis (EoE). 

Budesonide oral suspension is a corticosteroid indicated for 12 weeks of treatment of EoE in adults and children as young as 11 years. 

It will be available in 2-mg/10-mL single-dose stick packs by the end of February. 

“Developed specifically for EoE, Eohilia’s novel formulation of budesonide confers thixotropic properties — flowing more freely when shaken and returning to a more viscous state when swallowed,” the company said in a news release. 

Northwestern University

“Various formulations of corticosteroids have been used in the past to manage EoE, but in an off-label capacity and using multiple delivery options. With Eohilia, it’s gratifying to now have an FDA-approved treatment specifically formulated for a consistent dose delivery with demonstrated ability to address esophageal inflammation and EoE dysphagia symptoms,” Ikuo Hirano, MD, professor of medicine and director of the Esophageal Center at Northwestern University Feinberg School of Medicine, Chicago, said in the release. 
 

Supporting Data 

The FDA approved budesonide oral suspension for EoE based on efficacy and safety data from two multicenter, randomized, double-blind, parallel-group, placebo-controlled 12-week studies. 

In study 1, significantly more patients receiving active treatment achieved histologic remission (53.1% vs 1% with placebo). The same was true in study 2, with 38% of patients receiving active treatment achieving histologic remission compared with 2.4% of those receiving placebo. 

The absolute change from baseline in the patient-reported Dysphagia Symptom Questionnaire combined score was -10.2 with budesonide vs -6.5 with placebo in Study 1 and -14.5 vs -5.9 in Study 2. 

During the last 2 weeks of treatment, more patients receiving budesonide oral suspension experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared with those receiving placebo, the company said. 

The most common adverse reactions seen in the clinical trials of budesonide oral suspension for EoE included respiratory tract infection (13%), gastrointestinal mucosal candidiasis (8%), headache (5%), gastroenteritis (3%), throat irritation (3%), adrenal suppression (2%), and erosive esophagitis (2%). 

Complete prescribing information is available on the FDA website.

A version of this article appeared on Medscape.com.

South Korea’s gastric cancer screening (GC) program has reduced disease-related mortality by 41%.

Japan’s? Not at all.

These findings suggest that the benefits of nationwide gastric cancer screening may vary widely between countries while offering insights into program best practices, reported lead author Dianqin Sun, a PhD candidate at the University Medical Center, Rotterdam, the Netherlands, and colleagues.

Mr. Sun

“Despite the lack of evidence from randomized controlled trials, South Korea and Japan, two countries with a high GC incidence, have been at the forefront of GC secondary prevention and have implemented nationwide organized GC screening programs for decades using endoscopy or upper gastrointestinal series,” the investigators wrote in Gastroenterology.

Although individual-level data from both programs supports their efficacy in reducing GC-related death, the investigators noted that these studies have been limited by volunteer bias, and population-level data remain scarce.

To address this knowledge gap, Mr. Sun and colleagues used the flexible synthetic control method to determine how screening programs affected GC mortality rate, as well as a composite mortality rate for esophageal cancer and peptic ulcer.

“The concept of the synthetic control method is to construct a synthetic control for the treated country by deriving a weighted average of multiple control countries without intervention,” the investigators wrote. “The weight of controls is determined in a data-driven way to minimize the differences in preintervention outcomes (i.e., GC mortality before the introduction of nationwide screening) and other covariates associated with GC mortality between the treated country and the synthetic control.”

This approach revealed starkly different benefits for South Korea and Japan.

Compared with the synthetic control, South Korea’s screening program was associated with a 17% reduction in GC mortality risk on average, with risk dropping as far as 41% after the 15th year of screening. The Korean program was also associated with a 28% reduction in mortality from esophageal cancer and peptic ulcer, with this rate decreasing as much as 53% after 15 years of screening.

In sharp contrast, Japan’s mortality rates for GC and the other GI diseases were not significantly different from the synthetic control after 34 years of screening.

The investigators suggested several possible factors behind the lack of benefit in Japan, including the absence of a recommendation for endoscopic screening until 2014. In 2015, just 19% of municipalities in Japan were using endoscopy for screening, compared with more than 72% in South Korea in 2011. Furthermore, guideline adherence and screening program adherence are lower in Japan, they noted.

“Therefore, the findings in our study may have been expected,” the investigators wrote. “However, it is important to note that certain covariates were unavailable for the analysis in Japan, which may have introduced potential biases, the directions of which are unclear. Further studies are needed to compare the screening impact in South Korea and Japan.”

Meanwhile, the present results could guide screening programs around the world, Mr. Sun and colleagues suggested.

“This [study] highlights the significance of a well-planned organizational structure and evidence-based decision making when organized screening is started,” they wrote. “With a quasi-experimental design, this study will facilitate triangulating current observational evidence and provide valuable insights while the GC screening randomized controlled trials are still underway. The data and experience from South Korea and Japan will inform GC screening policy in other countries.”

The investigators disclosed no conflicts of interest.

South Korea’s gastric cancer screening (GC) program has reduced disease-related mortality by 41%.

Japan’s? Not at all.

These findings suggest that the benefits of nationwide gastric cancer screening may vary widely between countries while offering insights into program best practices, reported lead author Dianqin Sun, a PhD candidate at the University Medical Center, Rotterdam, the Netherlands, and colleagues.

Mr. Sun

“Despite the lack of evidence from randomized controlled trials, South Korea and Japan, two countries with a high GC incidence, have been at the forefront of GC secondary prevention and have implemented nationwide organized GC screening programs for decades using endoscopy or upper gastrointestinal series,” the investigators wrote in Gastroenterology.

Although individual-level data from both programs supports their efficacy in reducing GC-related death, the investigators noted that these studies have been limited by volunteer bias, and population-level data remain scarce.

To address this knowledge gap, Mr. Sun and colleagues used the flexible synthetic control method to determine how screening programs affected GC mortality rate, as well as a composite mortality rate for esophageal cancer and peptic ulcer.

“The concept of the synthetic control method is to construct a synthetic control for the treated country by deriving a weighted average of multiple control countries without intervention,” the investigators wrote. “The weight of controls is determined in a data-driven way to minimize the differences in preintervention outcomes (i.e., GC mortality before the introduction of nationwide screening) and other covariates associated with GC mortality between the treated country and the synthetic control.”

This approach revealed starkly different benefits for South Korea and Japan.

Compared with the synthetic control, South Korea’s screening program was associated with a 17% reduction in GC mortality risk on average, with risk dropping as far as 41% after the 15th year of screening. The Korean program was also associated with a 28% reduction in mortality from esophageal cancer and peptic ulcer, with this rate decreasing as much as 53% after 15 years of screening.

In sharp contrast, Japan’s mortality rates for GC and the other GI diseases were not significantly different from the synthetic control after 34 years of screening.

The investigators suggested several possible factors behind the lack of benefit in Japan, including the absence of a recommendation for endoscopic screening until 2014. In 2015, just 19% of municipalities in Japan were using endoscopy for screening, compared with more than 72% in South Korea in 2011. Furthermore, guideline adherence and screening program adherence are lower in Japan, they noted.

“Therefore, the findings in our study may have been expected,” the investigators wrote. “However, it is important to note that certain covariates were unavailable for the analysis in Japan, which may have introduced potential biases, the directions of which are unclear. Further studies are needed to compare the screening impact in South Korea and Japan.”

Meanwhile, the present results could guide screening programs around the world, Mr. Sun and colleagues suggested.

“This [study] highlights the significance of a well-planned organizational structure and evidence-based decision making when organized screening is started,” they wrote. “With a quasi-experimental design, this study will facilitate triangulating current observational evidence and provide valuable insights while the GC screening randomized controlled trials are still underway. The data and experience from South Korea and Japan will inform GC screening policy in other countries.”

The investigators disclosed no conflicts of interest.

South Korea’s gastric cancer screening (GC) program has reduced disease-related mortality by 41%.

Japan’s? Not at all.

These findings suggest that the benefits of nationwide gastric cancer screening may vary widely between countries while offering insights into program best practices, reported lead author Dianqin Sun, a PhD candidate at the University Medical Center, Rotterdam, the Netherlands, and colleagues.

Mr. Sun

“Despite the lack of evidence from randomized controlled trials, South Korea and Japan, two countries with a high GC incidence, have been at the forefront of GC secondary prevention and have implemented nationwide organized GC screening programs for decades using endoscopy or upper gastrointestinal series,” the investigators wrote in Gastroenterology.

Although individual-level data from both programs supports their efficacy in reducing GC-related death, the investigators noted that these studies have been limited by volunteer bias, and population-level data remain scarce.

To address this knowledge gap, Mr. Sun and colleagues used the flexible synthetic control method to determine how screening programs affected GC mortality rate, as well as a composite mortality rate for esophageal cancer and peptic ulcer.

“The concept of the synthetic control method is to construct a synthetic control for the treated country by deriving a weighted average of multiple control countries without intervention,” the investigators wrote. “The weight of controls is determined in a data-driven way to minimize the differences in preintervention outcomes (i.e., GC mortality before the introduction of nationwide screening) and other covariates associated with GC mortality between the treated country and the synthetic control.”

This approach revealed starkly different benefits for South Korea and Japan.

Compared with the synthetic control, South Korea’s screening program was associated with a 17% reduction in GC mortality risk on average, with risk dropping as far as 41% after the 15th year of screening. The Korean program was also associated with a 28% reduction in mortality from esophageal cancer and peptic ulcer, with this rate decreasing as much as 53% after 15 years of screening.

In sharp contrast, Japan’s mortality rates for GC and the other GI diseases were not significantly different from the synthetic control after 34 years of screening.

The investigators suggested several possible factors behind the lack of benefit in Japan, including the absence of a recommendation for endoscopic screening until 2014. In 2015, just 19% of municipalities in Japan were using endoscopy for screening, compared with more than 72% in South Korea in 2011. Furthermore, guideline adherence and screening program adherence are lower in Japan, they noted.

“Therefore, the findings in our study may have been expected,” the investigators wrote. “However, it is important to note that certain covariates were unavailable for the analysis in Japan, which may have introduced potential biases, the directions of which are unclear. Further studies are needed to compare the screening impact in South Korea and Japan.”

Meanwhile, the present results could guide screening programs around the world, Mr. Sun and colleagues suggested.

“This [study] highlights the significance of a well-planned organizational structure and evidence-based decision making when organized screening is started,” they wrote. “With a quasi-experimental design, this study will facilitate triangulating current observational evidence and provide valuable insights while the GC screening randomized controlled trials are still underway. The data and experience from South Korea and Japan will inform GC screening policy in other countries.”

The investigators disclosed no conflicts of interest.

A significant gap in our understanding of eosinophilic esophagitis (EoE) lies in how environmental factors, such as allergens or food, influence the response to proton pump inhibitor (PPI) therapy. While PPI achieve histologic remission in approximately 50% of patients, the response in the remaining 50% remains unclear. Addressing this, Muftah and colleagues conducted a study to evaluate the relationship between environmental and food allergies and PPI response in newly diagnosed EoE patients.

Between 2012 and 2016, adult patients newly diagnosed with EoE were tested for environmental and food allergies. Following diagnosis, patients participated in an 8-week trial of twice-daily PPI therapy. The treatment's effectiveness was assessed through repeated upper endoscopies with esophageal biopsies.

The study's primary outcome was the histologic remission of EoE, defined as a decrease in eosinophils to < 15 eosinophils/high-powered field (eos/hpf) in all esophageal biopsy samples during repeat endoscopy. Out of 61 patients, 21 achieved histologic remission, while 40 were classified as having PPI-nonresponding EoE. Among PPI-nonresponding EoE patients, positive food allergen testing was significantly more prevalent compared with PPI-responding EoE patients (82.5% vs 42.9%; P = .0003). Additionally, patients with >10 positive environmental allergen tests were significantly less likely to be PPI-responding EoE patients than those with <10 positive results (21% vs 53.9%; P = .03). A similar trend was observed in patients with >5 positive environmental allergens.

This study is not without limitations. It may exhibit a selection bias toward more severe cases and has a relatively small sample size, affecting its statistical power and generalizability.

This research supports the idea of more tailored management for EoE patients, focusing on their allergen profile, potentially leading to more effective treatment strategies and reducing unnecessary PPI trials. The statistically significant results pave the way for further research, providing an additional tool to predict PPI responsiveness and prevent delays in achieving remission.

Clinicians should consider patient characteristics, particularly positive food allergen tests, that might affect treatment response. More studies are needed, however, to understand the effect of environmental allergies on PPI response fully. A notable finding is that specific aeroallergens, such as oak, birch, Hormodendrum mold, dust mite (Dermatophagoides pteronyssinus), tree mix, and grass mix allergens, are associated with a lack of PPI response. This raises questions about whether exposure to these allergens during peak seasons could worsen PPI response in allergic EoE patients.

Key takeaways from this study include: (1) the importance of integrating allergen testing in EoE patients, especially those unresponsive to standard PPI therapy or suspected as having allergic phenotypes; (2) the need to monitor and adjust therapy based on clinical and histologic responses; and (3) the necessity of staying abreast of emerging research in this area.

EoE diagnosis presents unique challenges, particularly when patients exhibit exclusive distal esophageal eosinophilia or when discrepancies arise between endoscopic and histologic findings. Eosinophil-derived neurotoxin (EDN), a molecule previously studied for its role in monitoring allergy-mediated inflammatory diseases such as asthma and eczema, can shed light on these diagnostic difficulties.

Thomas and coworkers conducted a retrospective study in which they reviewed 231 pediatric patients, obtaining a minimum of four biopsies from at least two different levels of the esophagus. The study aimed to evaluate whether EDN concentrations, determined through esophageal epithelial brushing at the time of biopsy, could serve as an adjunctive diagnostic tool for EoE.

EDN levels proved sensitive (84.4%) and specific (94.6%) in evaluating active EoE when several measures of EoE were used in patients with active EoE compared with those with inactive EoE and the control group. Previous studies at the same institution had found EDN useful for differentiating EoE patients from non-EoE patients. Moreover, an EDN concentration > 10 μg/mL, when collected through esophageal epithelial brushing, was highly sensitive (97%) and specific (89%) for active EoE. This finding suggests the potential for using EDN as a biochemical marker, enhancing diagnostic accuracy and reducing the need for additional interventions in complex cases.

EDN as a biomarker could be invaluable for distinguishing difficult cases, such as those involving distal eosinophilia, active vs nonactive EoE, or non-EoE conditions, such as gastroesophageal reflux disease. Of note, lower EDN levels were observed in pediatric EoE patients who responded to PPI, suggesting EDN's potential utility in predicting PPI responsiveness. Incorporating the measurement of eosinophilic activity could add a new dimension to existing criteria, equipping clinicians with more precise diagnostic tools and reducing the reliance on multiple procedures. This approach would strengthen the correlation between symptomatic, endoscopic, and histologic data.

The study by Jensen and colleagues sheds light on a crucial aspect of EoE management: the psychosocial burden. A recent EoE diagnosis can be associated with increased symptom burden, somatization, and anxiety in patients and families, underscoring the need for a multidisciplinary approach to patient care that considers both physical and mental health. To date, numerous studies have focused on understanding the disease, its follow-up, and treatment. However, there has been limited exploration of the psychosocial burden and patient-associated factors in EoE.

In this context, this team aimed to enhance our understanding of the burden of EoE by evaluating psychosocial comorbidities, such as disordered sleep, anxiety, and somatization, in a pediatric population with EoE. The study included 87 patients of age 8-18 years who completed validated assessments during routine clinic visits, encompassing EoE symptoms (Pediatric Eosinophilic Esophagitis Symptom Scores, PEESSv2.0), quality of life (PedsQL-EoE), anxiety state and trait (State-Trait Anxiety Inventory for Children, STAI-C), somatization (Children's Somatic Symptoms Inventory-24, CSSI-24), and sleep-disordered breathing (University of Michigan Pediatric Sleep Questionnaire, PSQ).

The mean age of the participants was 12.8 years, highlighting the importance of addressing psychosocial distress in this age group, which undergoes crucial developmental stages. Most patients (82%, 71) had been diagnosed with EoE at least 12 months prior, and 60% (52) were treated with multiple approaches. Additionally, 34% (29) had undergone seven or more esophagogastroduodenoscopies, and nearly one third (33%, 27) had experienced a gastrointestinal-related emergency department visit. These factors potentially increase patient stress due to the continuous need for repeat procedures and hospital visits. An intriguing finding was that patients with shorter disease durations (6-12 months since diagnosis) experienced higher symptom burdens (P = .03). Patients with public insurance had less favorable scores for sleep-disordered breathing (P = .01).

Significantly, patients with neurodevelopmental comorbidities had higher scores for somatic symptoms, trait anxiety, and sleep-disordered breathing, and lower quality-of-life scores, compared with those without such comorbidities (P < .01 for all), suggesting that patients with neurodevelopmental issues might particularly benefit from tailored treatments addressing these aspects of the disease. Furthermore, patients with shorter disease durations since diagnosis exhibited higher somatic symptoms and trait anxiety (both P < .01). The study also revealed that patients with fewer esophagogastroduodenoscopies (1-3) had higher somatic symptom scores (P < .01), state anxiety (P = .02), and trait anxiety (P = .03). EoE-associated symptom burden was significantly correlated with increased somatic symptoms (0.34; 95% CI 0.23-0.45) and decreased quality of life (-0.42; 95% CI -0.59 to -0.25). Concerns about eating food and EoE-associated symptoms were both linked to the EoE-associated symptom burden.

This study has several limitations, including a relatively small sample size, which decreases the power and limits inferences for smaller groups within the sample. There was also an imbalance in gender distribution, with only 26% of patients being female, potentially limiting the generalizability of the findings. Moreover, the study included only EoE patients, lacking a control group for comparison to the general pediatric population.

Highlighting a significant aspect of pediatric EoE treatment, this study illuminates an area that might affect patients' long-term quality of life. It underscores the need for multidisciplinary care for EoE patients, where mental health professionals, such as psychologists or psychiatrists, can play a vital role in improving mental health through early identification and intervention for anxiety and somatization disorders. They can also provide education for patients and families on coping strategies. Peer support groups for children and adolescents could be another beneficial tool, allowing them to share experiences and reduce feelings of isolation.

Physicians who treat chronic diseases such as EoE should consider psychosocial factors, as they can affect both physical and mental quality of life. Using screening tools (such as PEESSv2.0, PedsQL-EoE, STAI-C, CSSI-24, or PSQ) during clinic visits can facilitate a more comprehensive evaluation.

A significant gap in our understanding of eosinophilic esophagitis (EoE) lies in how environmental factors, such as allergens or food, influence the response to proton pump inhibitor (PPI) therapy. While PPI achieve histologic remission in approximately 50% of patients, the response in the remaining 50% remains unclear. Addressing this, Muftah and colleagues conducted a study to evaluate the relationship between environmental and food allergies and PPI response in newly diagnosed EoE patients.

Between 2012 and 2016, adult patients newly diagnosed with EoE were tested for environmental and food allergies. Following diagnosis, patients participated in an 8-week trial of twice-daily PPI therapy. The treatment's effectiveness was assessed through repeated upper endoscopies with esophageal biopsies.

The study's primary outcome was the histologic remission of EoE, defined as a decrease in eosinophils to < 15 eosinophils/high-powered field (eos/hpf) in all esophageal biopsy samples during repeat endoscopy. Out of 61 patients, 21 achieved histologic remission, while 40 were classified as having PPI-nonresponding EoE. Among PPI-nonresponding EoE patients, positive food allergen testing was significantly more prevalent compared with PPI-responding EoE patients (82.5% vs 42.9%; P = .0003). Additionally, patients with >10 positive environmental allergen tests were significantly less likely to be PPI-responding EoE patients than those with <10 positive results (21% vs 53.9%; P = .03). A similar trend was observed in patients with >5 positive environmental allergens.

This study is not without limitations. It may exhibit a selection bias toward more severe cases and has a relatively small sample size, affecting its statistical power and generalizability.

This research supports the idea of more tailored management for EoE patients, focusing on their allergen profile, potentially leading to more effective treatment strategies and reducing unnecessary PPI trials. The statistically significant results pave the way for further research, providing an additional tool to predict PPI responsiveness and prevent delays in achieving remission.

Clinicians should consider patient characteristics, particularly positive food allergen tests, that might affect treatment response. More studies are needed, however, to understand the effect of environmental allergies on PPI response fully. A notable finding is that specific aeroallergens, such as oak, birch, Hormodendrum mold, dust mite (Dermatophagoides pteronyssinus), tree mix, and grass mix allergens, are associated with a lack of PPI response. This raises questions about whether exposure to these allergens during peak seasons could worsen PPI response in allergic EoE patients.

Key takeaways from this study include: (1) the importance of integrating allergen testing in EoE patients, especially those unresponsive to standard PPI therapy or suspected as having allergic phenotypes; (2) the need to monitor and adjust therapy based on clinical and histologic responses; and (3) the necessity of staying abreast of emerging research in this area.

EoE diagnosis presents unique challenges, particularly when patients exhibit exclusive distal esophageal eosinophilia or when discrepancies arise between endoscopic and histologic findings. Eosinophil-derived neurotoxin (EDN), a molecule previously studied for its role in monitoring allergy-mediated inflammatory diseases such as asthma and eczema, can shed light on these diagnostic difficulties.

Thomas and coworkers conducted a retrospective study in which they reviewed 231 pediatric patients, obtaining a minimum of four biopsies from at least two different levels of the esophagus. The study aimed to evaluate whether EDN concentrations, determined through esophageal epithelial brushing at the time of biopsy, could serve as an adjunctive diagnostic tool for EoE.

EDN levels proved sensitive (84.4%) and specific (94.6%) in evaluating active EoE when several measures of EoE were used in patients with active EoE compared with those with inactive EoE and the control group. Previous studies at the same institution had found EDN useful for differentiating EoE patients from non-EoE patients. Moreover, an EDN concentration > 10 μg/mL, when collected through esophageal epithelial brushing, was highly sensitive (97%) and specific (89%) for active EoE. This finding suggests the potential for using EDN as a biochemical marker, enhancing diagnostic accuracy and reducing the need for additional interventions in complex cases.

EDN as a biomarker could be invaluable for distinguishing difficult cases, such as those involving distal eosinophilia, active vs nonactive EoE, or non-EoE conditions, such as gastroesophageal reflux disease. Of note, lower EDN levels were observed in pediatric EoE patients who responded to PPI, suggesting EDN's potential utility in predicting PPI responsiveness. Incorporating the measurement of eosinophilic activity could add a new dimension to existing criteria, equipping clinicians with more precise diagnostic tools and reducing the reliance on multiple procedures. This approach would strengthen the correlation between symptomatic, endoscopic, and histologic data.

The study by Jensen and colleagues sheds light on a crucial aspect of EoE management: the psychosocial burden. A recent EoE diagnosis can be associated with increased symptom burden, somatization, and anxiety in patients and families, underscoring the need for a multidisciplinary approach to patient care that considers both physical and mental health. To date, numerous studies have focused on understanding the disease, its follow-up, and treatment. However, there has been limited exploration of the psychosocial burden and patient-associated factors in EoE.

In this context, this team aimed to enhance our understanding of the burden of EoE by evaluating psychosocial comorbidities, such as disordered sleep, anxiety, and somatization, in a pediatric population with EoE. The study included 87 patients of age 8-18 years who completed validated assessments during routine clinic visits, encompassing EoE symptoms (Pediatric Eosinophilic Esophagitis Symptom Scores, PEESSv2.0), quality of life (PedsQL-EoE), anxiety state and trait (State-Trait Anxiety Inventory for Children, STAI-C), somatization (Children's Somatic Symptoms Inventory-24, CSSI-24), and sleep-disordered breathing (University of Michigan Pediatric Sleep Questionnaire, PSQ).

The mean age of the participants was 12.8 years, highlighting the importance of addressing psychosocial distress in this age group, which undergoes crucial developmental stages. Most patients (82%, 71) had been diagnosed with EoE at least 12 months prior, and 60% (52) were treated with multiple approaches. Additionally, 34% (29) had undergone seven or more esophagogastroduodenoscopies, and nearly one third (33%, 27) had experienced a gastrointestinal-related emergency department visit. These factors potentially increase patient stress due to the continuous need for repeat procedures and hospital visits. An intriguing finding was that patients with shorter disease durations (6-12 months since diagnosis) experienced higher symptom burdens (P = .03). Patients with public insurance had less favorable scores for sleep-disordered breathing (P = .01).

Significantly, patients with neurodevelopmental comorbidities had higher scores for somatic symptoms, trait anxiety, and sleep-disordered breathing, and lower quality-of-life scores, compared with those without such comorbidities (P < .01 for all), suggesting that patients with neurodevelopmental issues might particularly benefit from tailored treatments addressing these aspects of the disease. Furthermore, patients with shorter disease durations since diagnosis exhibited higher somatic symptoms and trait anxiety (both P < .01). The study also revealed that patients with fewer esophagogastroduodenoscopies (1-3) had higher somatic symptom scores (P < .01), state anxiety (P = .02), and trait anxiety (P = .03). EoE-associated symptom burden was significantly correlated with increased somatic symptoms (0.34; 95% CI 0.23-0.45) and decreased quality of life (-0.42; 95% CI -0.59 to -0.25). Concerns about eating food and EoE-associated symptoms were both linked to the EoE-associated symptom burden.

This study has several limitations, including a relatively small sample size, which decreases the power and limits inferences for smaller groups within the sample. There was also an imbalance in gender distribution, with only 26% of patients being female, potentially limiting the generalizability of the findings. Moreover, the study included only EoE patients, lacking a control group for comparison to the general pediatric population.

Highlighting a significant aspect of pediatric EoE treatment, this study illuminates an area that might affect patients' long-term quality of life. It underscores the need for multidisciplinary care for EoE patients, where mental health professionals, such as psychologists or psychiatrists, can play a vital role in improving mental health through early identification and intervention for anxiety and somatization disorders. They can also provide education for patients and families on coping strategies. Peer support groups for children and adolescents could be another beneficial tool, allowing them to share experiences and reduce feelings of isolation.

Physicians who treat chronic diseases such as EoE should consider psychosocial factors, as they can affect both physical and mental quality of life. Using screening tools (such as PEESSv2.0, PedsQL-EoE, STAI-C, CSSI-24, or PSQ) during clinic visits can facilitate a more comprehensive evaluation.

A significant gap in our understanding of eosinophilic esophagitis (EoE) lies in how environmental factors, such as allergens or food, influence the response to proton pump inhibitor (PPI) therapy. While PPI achieve histologic remission in approximately 50% of patients, the response in the remaining 50% remains unclear. Addressing this, Muftah and colleagues conducted a study to evaluate the relationship between environmental and food allergies and PPI response in newly diagnosed EoE patients.

Between 2012 and 2016, adult patients newly diagnosed with EoE were tested for environmental and food allergies. Following diagnosis, patients participated in an 8-week trial of twice-daily PPI therapy. The treatment's effectiveness was assessed through repeated upper endoscopies with esophageal biopsies.

The study's primary outcome was the histologic remission of EoE, defined as a decrease in eosinophils to < 15 eosinophils/high-powered field (eos/hpf) in all esophageal biopsy samples during repeat endoscopy. Out of 61 patients, 21 achieved histologic remission, while 40 were classified as having PPI-nonresponding EoE. Among PPI-nonresponding EoE patients, positive food allergen testing was significantly more prevalent compared with PPI-responding EoE patients (82.5% vs 42.9%; P = .0003). Additionally, patients with >10 positive environmental allergen tests were significantly less likely to be PPI-responding EoE patients than those with <10 positive results (21% vs 53.9%; P = .03). A similar trend was observed in patients with >5 positive environmental allergens.

This study is not without limitations. It may exhibit a selection bias toward more severe cases and has a relatively small sample size, affecting its statistical power and generalizability.

This research supports the idea of more tailored management for EoE patients, focusing on their allergen profile, potentially leading to more effective treatment strategies and reducing unnecessary PPI trials. The statistically significant results pave the way for further research, providing an additional tool to predict PPI responsiveness and prevent delays in achieving remission.

Clinicians should consider patient characteristics, particularly positive food allergen tests, that might affect treatment response. More studies are needed, however, to understand the effect of environmental allergies on PPI response fully. A notable finding is that specific aeroallergens, such as oak, birch, Hormodendrum mold, dust mite (Dermatophagoides pteronyssinus), tree mix, and grass mix allergens, are associated with a lack of PPI response. This raises questions about whether exposure to these allergens during peak seasons could worsen PPI response in allergic EoE patients.

Key takeaways from this study include: (1) the importance of integrating allergen testing in EoE patients, especially those unresponsive to standard PPI therapy or suspected as having allergic phenotypes; (2) the need to monitor and adjust therapy based on clinical and histologic responses; and (3) the necessity of staying abreast of emerging research in this area.

EoE diagnosis presents unique challenges, particularly when patients exhibit exclusive distal esophageal eosinophilia or when discrepancies arise between endoscopic and histologic findings. Eosinophil-derived neurotoxin (EDN), a molecule previously studied for its role in monitoring allergy-mediated inflammatory diseases such as asthma and eczema, can shed light on these diagnostic difficulties.

Thomas and coworkers conducted a retrospective study in which they reviewed 231 pediatric patients, obtaining a minimum of four biopsies from at least two different levels of the esophagus. The study aimed to evaluate whether EDN concentrations, determined through esophageal epithelial brushing at the time of biopsy, could serve as an adjunctive diagnostic tool for EoE.

EDN levels proved sensitive (84.4%) and specific (94.6%) in evaluating active EoE when several measures of EoE were used in patients with active EoE compared with those with inactive EoE and the control group. Previous studies at the same institution had found EDN useful for differentiating EoE patients from non-EoE patients. Moreover, an EDN concentration > 10 μg/mL, when collected through esophageal epithelial brushing, was highly sensitive (97%) and specific (89%) for active EoE. This finding suggests the potential for using EDN as a biochemical marker, enhancing diagnostic accuracy and reducing the need for additional interventions in complex cases.

EDN as a biomarker could be invaluable for distinguishing difficult cases, such as those involving distal eosinophilia, active vs nonactive EoE, or non-EoE conditions, such as gastroesophageal reflux disease. Of note, lower EDN levels were observed in pediatric EoE patients who responded to PPI, suggesting EDN's potential utility in predicting PPI responsiveness. Incorporating the measurement of eosinophilic activity could add a new dimension to existing criteria, equipping clinicians with more precise diagnostic tools and reducing the reliance on multiple procedures. This approach would strengthen the correlation between symptomatic, endoscopic, and histologic data.

The study by Jensen and colleagues sheds light on a crucial aspect of EoE management: the psychosocial burden. A recent EoE diagnosis can be associated with increased symptom burden, somatization, and anxiety in patients and families, underscoring the need for a multidisciplinary approach to patient care that considers both physical and mental health. To date, numerous studies have focused on understanding the disease, its follow-up, and treatment. However, there has been limited exploration of the psychosocial burden and patient-associated factors in EoE.

In this context, this team aimed to enhance our understanding of the burden of EoE by evaluating psychosocial comorbidities, such as disordered sleep, anxiety, and somatization, in a pediatric population with EoE. The study included 87 patients of age 8-18 years who completed validated assessments during routine clinic visits, encompassing EoE symptoms (Pediatric Eosinophilic Esophagitis Symptom Scores, PEESSv2.0), quality of life (PedsQL-EoE), anxiety state and trait (State-Trait Anxiety Inventory for Children, STAI-C), somatization (Children's Somatic Symptoms Inventory-24, CSSI-24), and sleep-disordered breathing (University of Michigan Pediatric Sleep Questionnaire, PSQ).

The mean age of the participants was 12.8 years, highlighting the importance of addressing psychosocial distress in this age group, which undergoes crucial developmental stages. Most patients (82%, 71) had been diagnosed with EoE at least 12 months prior, and 60% (52) were treated with multiple approaches. Additionally, 34% (29) had undergone seven or more esophagogastroduodenoscopies, and nearly one third (33%, 27) had experienced a gastrointestinal-related emergency department visit. These factors potentially increase patient stress due to the continuous need for repeat procedures and hospital visits. An intriguing finding was that patients with shorter disease durations (6-12 months since diagnosis) experienced higher symptom burdens (P = .03). Patients with public insurance had less favorable scores for sleep-disordered breathing (P = .01).

Significantly, patients with neurodevelopmental comorbidities had higher scores for somatic symptoms, trait anxiety, and sleep-disordered breathing, and lower quality-of-life scores, compared with those without such comorbidities (P < .01 for all), suggesting that patients with neurodevelopmental issues might particularly benefit from tailored treatments addressing these aspects of the disease. Furthermore, patients with shorter disease durations since diagnosis exhibited higher somatic symptoms and trait anxiety (both P < .01). The study also revealed that patients with fewer esophagogastroduodenoscopies (1-3) had higher somatic symptom scores (P < .01), state anxiety (P = .02), and trait anxiety (P = .03). EoE-associated symptom burden was significantly correlated with increased somatic symptoms (0.34; 95% CI 0.23-0.45) and decreased quality of life (-0.42; 95% CI -0.59 to -0.25). Concerns about eating food and EoE-associated symptoms were both linked to the EoE-associated symptom burden.

This study has several limitations, including a relatively small sample size, which decreases the power and limits inferences for smaller groups within the sample. There was also an imbalance in gender distribution, with only 26% of patients being female, potentially limiting the generalizability of the findings. Moreover, the study included only EoE patients, lacking a control group for comparison to the general pediatric population.

Highlighting a significant aspect of pediatric EoE treatment, this study illuminates an area that might affect patients' long-term quality of life. It underscores the need for multidisciplinary care for EoE patients, where mental health professionals, such as psychologists or psychiatrists, can play a vital role in improving mental health through early identification and intervention for anxiety and somatization disorders. They can also provide education for patients and families on coping strategies. Peer support groups for children and adolescents could be another beneficial tool, allowing them to share experiences and reduce feelings of isolation.

Physicians who treat chronic diseases such as EoE should consider psychosocial factors, as they can affect both physical and mental quality of life. Using screening tools (such as PEESSv2.0, PedsQL-EoE, STAI-C, CSSI-24, or PSQ) during clinic visits can facilitate a more comprehensive evaluation.

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.

The FDA previously approved the drug for EoE in persons aged 12 years or older and weighing ≥ 40 kg in May 2022, 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.

The FDA previously approved the drug for EoE in persons aged 12 years or older and weighing ≥ 40 kg in May 2022, 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.

The FDA previously approved the drug for EoE in persons aged 12 years or older and weighing ≥ 40 kg in May 2022, 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 ulcerative colitis drug etrasimod (Velsipity, Pfizer) appears to be efficacious in eosinophilic esophagitis (EoE), with notable reductions seen in eosinophils.

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.

The ulcerative colitis drug etrasimod (Velsipity, Pfizer) appears to be efficacious in eosinophilic esophagitis (EoE), with notable reductions seen in eosinophils.

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.

The ulcerative colitis drug etrasimod (Velsipity, Pfizer) appears to be efficacious in eosinophilic esophagitis (EoE), with notable reductions seen in eosinophils.

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.