Joshua Fitch

Dupilumab maintained histologic and endoscopic improvements across all pediatric age groups with EoE, according to Joshua Wechsler, MD.

Joshua Wechsler, MD, on dupilumab's sustained efficacy in pediatric patients with EoE

Pooled phase 3 data show durable EoE control with dupilumab in patients aged 1–17 years.

Histologic remission rates were highest in the youngest subgroup (1–<6 years).

Wechsler highlighted the critical role of maintenance therapy to prevent disease recurrence and fibrosis.

2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN)

 Annual Meeting in Chicago, new data highlighted continued benefits of dupilumab in children and adolescents with eosinophilic esophagitis (EoE). The abstract, titled 

“Dupilumab Improves Histologic and Endoscopic Features of Pediatric Onset Eosinophilic Esophagitis (EoE): Pooled Results From the EoE KIDS and LIBERTY EoE TREET Studies,”

 demonstrated that dupilumab produced significant and sustained histologic and endoscopic improvements across all pediatric age groups.

The pooled phase 3 analysis included patients aged 1 to <18 years treated with weight-tiered or fixed-dose dupilumab in the EoE KIDS and LIBERTY EoE TREET trials. Compared with placebo, dupilumab achieved markedly higher rates of histologic remission—defined as ≤6 eosinophils per high-power field—across all ages, with the youngest cohort (1 – <6 years) showing the highest response rates. These improvements were sustained or further enhanced through week 52, underscoring the therapy’s durable impact on disease control.

Specifically, at the end of the double-blind treatment period, dupilumab resulted in significantly greater proportions of patients achieving ≤6 and <15 eos/hpf vs placebo in all age groups, respectively (all 

Ages ≥1–<6 years: 85.7% vs 0.0% and 100.0% vs 0.0%

Ages ≥6–<12 years: 56.5% vs 3.8% and 73.9% vs 3.8%

Ages ≥12–<18 years: 51.4% vs 5.7% and 67.6% vs 5.7%

 at NASPGHAN, Joshua Wechsler, MD, MSCI, Medical Director, Eosinophilic Gastrointestinal Diseases Program; Attending Physician, Gastroenterology, Hepatology and Nutrition, Ann & Robert H. Lurie Children’s Hospital of Chicago, emphasized that the findings “really speak to the durability of treatment.” He explained, “This really tells us that, over time, the endpoints that we look at for therapy — things like eosinophil count and endoscopic measures — remain improved and potentially may even get better over time.”

“This is really important, because that term maintenance phase, when it comes to treatment of EoE, is so incredibly important,” Wechsler continued. “We don’t really just want to get our patients into remission and then pause therapy and wait for them to get sick again. We really want to keep that inflammation at bay.”

Going forward, Wechsler noted that dose optimization remains an active area of investigation, and hopes future research can explore ideal dosing. 

“One of the key questions for dupilumab, in my mind, is what’s ultimately the key dose that’s necessary to achieve remission?” he said. “At least what we know from studies in adolescents is that the symptoms are more impacted with the higher doses.”

As far as early treatment initiation, “There’s certainly a potential that the earlier we treat the disease — even potentially with dupilumab or other therapy — there’s a significant long-term potential to really impact outcomes,” Wechsler said.

Zevit N. Wechsler J. Markowitz J, et al. DUPILUMAB IMPROVES HISTOLOGIC AND ENDOSCOPIC FEATURES OF PEDIATRIC ONSET EOSINOPHILIC ESOPHAGITIS (EOE): POOLED RESULTS FROM THE EOE KIDS AND LIBERTY EOE TREET STUDIES. Abstract. Presented at: 2025 NASPGHAN Annual Meeting. November 5-9, 2025. Chicago, Illinois.

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Dale Lee, MD, told HCPLive that regular monitoring and potential psychosocial support are important to help children with celiac disease maintain a gluten-free diet.

NASPGHAN: Best Practices for Celiac Disease Follow-up with Dale Lee, MD

Early and structured follow-up after celiac diagnosis improves dietary adherence and symptom management.

Close collaboration between gastroenterologists and primary care providers enhances care continuity.

Psychosocial screening and support are crucial to address the burden of maintaining a gluten-free diet in children and adolescents.

Data was presented at the 2025 NASPGHAN Annual Meeting, held in Chicago, Illinois, from November 5-9, 2025. During a session titled 

"A Precision Follow-Up: Best Practices for Follow-Up and Surveillance in Celiac Disease,"

 Dale Lee, MD, physician, Director, Celiac Program, Seattle Children's Hospital, emphasized the critical importance of structured follow-up care for children diagnosed with celiac disease.

“There's not enough emphasis on follow-up,” Lee said, noting that while clinicians often focus on making the correct diagnosis, ensuring patients understand the value of ongoing monitoring is equally important. He stressed that one of the challenges is the lack of clear, standardized guidelines: “One of the difficulties for physicians is that there are not great, clear-cut guidelines on how to do follow-ups.”

Lee outlined his recommendations for follow-up intervals, beginning shortly after diagnosis and initiation of a gluten-free diet. 

“I think it's important to have a follow-up at the 3-month mark, have a dialogue directly with the family and the patients about how well gluten-free diets are going. Also, repeating labs with the TTG IGA at that point in time really provides a little bit of feedback to the family about how their hard work with the gluten-free diets is doing.” Thereafter, Lee suggested follow-ups every six months to monitor laboratory values and symptom resolution, with annual visits once the patient is stable.

Working together for better celiac outcomes

He also emphasized the necessity of collaboration between gastroenterologists and primary care providers. “I think it's so important for the GI doctor to be in close collaboration with the general pediatrician and primary care doctors. So when I see patients, I'm writing a note that goes directly to the primary care provider. We're discussing what is going well for this individual, the individual's family, and the child. And we're also talking about which challenges there are.”

Lee highlighted that adherence to a gluten-free diet carries a substantial treatment burden, including psychosocial challenges. 

“The burden is usually not just symptoms, but it's how to survive and to be able to maintain an integrated gluten-free diet in everyday life. And I think that's where the psychological piece is really important.” He recommended screening for psychological well-being and incorporating psychologists or social workers whenever possible.

Citing the variable phases of childhood and adolescence, Lee underscored the importance of individualized, proactive care.

“As children, they're going to be entering different phases in life, high school, middle school, and college. So these are all areas where we want to be able to intervene, and there are higher risk times for the patient, so we as the medical team want to be able to support them.”

By focusing on structured follow-up, interdisciplinary collaboration, and attention to the psychosocial impact of the diet, Lee emphasized that clinicians can significantly improve quality of life and long-term outcomes for pediatric patients with celiac disease.

Lee D. A Precision Follow-Up: Best Practices for Follow-Up and Surveillance in Celiac Disease. Single-topic symposium. Presented at: 2025 NASPGHAN Annual Meeting. November 5-9, 2025. Chicago, Illinois.

 Annual Meeting, held November 5–8 at the Sheraton Grand Chicago in Chicago, Illinois, clinicians, researchers, and allied health professionals gathered to share the latest data, clinical updates, and expert perspectives in pediatric gastroenterology, hepatology, and nutrition. 

provided on-site reporting throughout the meeting, highlighting key findings across oral abstracts, posters, single- topic symposium sessions, and expert-led video interviews. 

 research, new pharmacologic therapies for irritable bowel syndrome with constipation (IBS-C), and long-term outcomes for patients with progressive cholestatic liver diseases. HCPLive will continue to provide coverage and updates from the meeting in the coming days, even as the conference concludes today.

Below, we recap our coverage of NASPGHAN 2025. 

Silvana Bonilla, MD, Explores Geographic Patterns of H. pylori in Pediatric Digestive Disease

New multicenter data presented by Silvana Bonilla, MD, attending physician, Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Boston Children’s Hospital, examined the prevalence of 

 infection (HPI) in children with eosinophilic esophagitis (EoE), celiac disease (CeD), or inflammatory bowel disease (IBD) across the Americas. Among 365 pediatric patients, overall HPI prevalence was 9.3%, with significant geographic variation—51.6% of positive cases were from Colombia, compared with 29% in the United States and 6.5% in Chile. HPI was more common in children with EoE and less frequent in those with CeD, highlighting the complex immunologic role of H. pylori in pediatric digestive diseases.

Click here to watch our discussion with Silvana Bonilla, MD.

H. pylori Geographical Prevalence and NASPGHAN/ESPGHAN Guidelines, With Silvana Bonilla, MD

In a video interview, Bonilla discussed how these findings align with the 2023 joint NASPGHAN/ESPGHAN guidelines, which conditionally recommend against routine H. pylori biopsies in children evaluated for IBD, CeD, or EoE. She emphasized that biopsies should be guided by clinical suspicion rather than performed routinely, and noted ongoing plans to follow patients longitudinally to assess potential protective effects of H. pylori and the influence of environmental shifts on immune-mediated digestive diseases.

Newly-Approved Linaclotide's Long-Term Safety Data

Long-term safety data for linaclotide (Linzess; Ironwood Pharmaceuticals) in pediatric patients aged 7–17 years with IBS-C demonstrated a low incidence of diarrhea and favorable tolerability through 52 weeks of treatment. FDA approval for this population was granted on November 5, 2025, supported by extrapolated adult efficacy data and a 12-week pediatric trial. In an ongoing phase 3 study, 98 patients received once-daily linaclotide at 145 μg or 290 μg, with safety findings consistent with adult studies and no discontinuations due to adverse events.

Julie Khlevner, MD, AGAF, Reacts to the FDA Approval of Linaclotide for Pediatric IBS-C

Julie Khlevner, MD, AGAF, Associate Professor of Pediatrics at Columbia University Medical Center and Chair, NASPGHAN Neurogastroenterology and Motility Committee, discussed the FDA approval of linaclotide for children ≥7 years with IBS-C. She highlighted improvements in bowel movement frequency and abdominal pain, confirming the therapy’s tolerability and potential use by both pediatric gastroenterologists and general pediatricians. Khlevner also underscored the ongoing need for new pediatric therapeutics to address individual symptomatology.

Click here to watch Julie Khlevner offer thoughts on the linaclotide's FDA approval.

Discussing Safety, Tolerability of Tenapanor in Pediatric IBS-C Patients, with Thomas Wallach, MD

Interim data from the phase 3 R-ALLY trial and its open-label extension showed that tenapanor, a sodium/hydrogen exchanger isoform 3 (NHE3) inhibitor, was safe and well-tolerated in adolescents with IBS-C. Wallach highlighted that no serious treatment-related adverse events occurred and that the safety profile was consistent with adult data. He noted the potential utility of tenapanor in managing pediatric constipation while emphasizing that efficacy data are still under investigation.

Click here to watch our full interview with Thomas Wallach, MD.

NASPGHAN 2025: Odevixibat Shows Sustained Pruritus and Bile Acid Improvements in FIC1 Deficiency

Post hoc analyses of PEDFIC 1 and PEDFIC 2 demonstrated that odevixibat provided sustained reductions in serum bile acids and improvements in pruritus in patients with FIC1 deficiency (PFIC1). Among 35 patients, long-term treatment up to 96 weeks maintained clinically meaningful improvements, supporting odevixibat’s durable benefit in managing both biochemical and symptomatic burdens of PFIC1.

Click here for more on odevixibat for FIC1 deficiency.

Odevixibat Improves Long-Term Quality of Life, Sleep in Patients with Alagille Syndrome

In patients with Alagille syndrome, odevixibat treatment led to long-term improvements in sleep and caregiver-reported quality of life (QoL). Data from the ASSERT and ASSERT-EXT studies showed sustained improvements across multiple sleep parameters and Pediatric Quality of Life Inventory scores over 96 weeks of therapy. These findings reinforce odevixibat’s impact on both symptomatic relief and overall patient well-being, complementing previous data on pruritus reduction in cholestatic liver disease.

Click here for more on odevixibat's long-term QoL and sleep improvement data.

Articles

The 2025 NASPGHAN Annual Meeting showcased significant advancements in pediatric gastroenterology, hepatology, and nutrition. Key topics included the geographic prevalence of Helicobacter pylori in children with digestive diseases, the FDA approval of linaclotide for pediatric IBS-C, and the safety of tenapanor in adolescents. Odevixibat demonstrated sustained benefits in managing FIC1 deficiency and Alagille syndrome, improving pruritus, bile acid levels, sleep, and quality of life. These findings highlight the ongoing progress in understanding and treating pediatric digestive disorders, emphasizing the importance of tailored therapeutic approaches.

HCPLive highlights key pediatric gastroenterology updates from NASPGHAN 2025, with continuing coverage to follow.

HCPLive Coverage Recap: NASPGHAN 2025 Annual Meeting

Nadia Ovchinsky, MD | Image credit: NYU Langone Health

Pooled long-term data from the phase 3 ASSERT (NCT04674761) and ASSERT-EXT (NCT05035030) studies showed that treatment with odevixibat led to sustained improvements in sleep and caregiver-reported quality of life (QoL) in patients with Alagille syndrome (ALGS). The results were presented at the 

 and authored by Nadia Ovchinsky, MD, Pediatric Gastroenterology and Hepatology, Hassenfeld Children's Hospital, NYU Langone, New York, NY, and colleagues.

Odevixibat on Long-Term Improvements in Sleep and Quality of Life

Patients with Alagille syndrome frequently experience severe pruritus, disrupted sleep, and reduced quality of life. Odevixibat, a selective ileal bile acid transport inhibitor, has shown efficacy in reducing cholestatic pruritus in this population. In this pooled analysis, long-term outcomes from up to 96 weeks of treatment were evaluated for sleep parameters and caregiver-assessed QoL measures.

In the ASSERT trial, patients received 24 weeks of placebo or odevixibat 120 µg/kg/day; study completers were eligible for ASSERT-EXT, during which patients received odevixibat for an additional 72 weeks. Endpoints included observer-reported sleep parameters and caregiver-assessed Pediatric Quality of Life Inventory (PedsQL) scores. 

A total of 52 patients with a median age of 5.7 years (1.0-15.5) received odevixibat across both studies. 

“Patients had significant improvements in 6 of 7 Observer-Reported Outcome (ObsRO) sleep parameters from baseline (BL) up to weeks 93−96 and a numerical reduction in days taking medication to induce sleep," the study authors wrote. Caregiver-reported PedsQL scores “also showed numerical improvements from BL up to week 96 with odevixibat.”

Odevixibat Shows Sustained Pruritus and Bile Acid Improvements in FIC1 Deficiency

According to the authors, “Long-term odevixibat given for up to 96 weeks improved multiple sleep parameters and caregiver-reported QoL in patients with ALGS; data support long-term improvements in pruritus seen with odevixibat.”

Specifically, the following improvements in Mean ObsRo sleep parameters were demonstrated from baseline (n = 50) to week 93-96 (n = 31).

Days seeing blood due to scratching: 35.2% at baseline vs 4.7% at week 93-96

Days needing help falling asleep: 56.5% at baseline vs 8.8% at week 93-96

Days with soothing: 64.4% at baseline vs 14.5% at week 93-96

Days sleeping with caregiver: 43.2% vs 4.6%

Number of awakenings: 3.5 at baseline vs 0.6 at week 93-96

Days taking medication to sleep: 29.7% vs 18.1% 

Daytime tiredness (score): 2.1 at baseline vs 0.9 at week 93-966

Odevixibat received FDA approval to treat cholestatic pruritus in patients aged 12 months and older on June 13, 2023. Approval was based on the ASSERT data through 24 weeks, where more than 90% of patients were responders to pruritus. Additionally, no patients discontinued the study, and 96% of patients were rolled into the open-label extension.

Ovchinsky N, Aumar M, Baker A, et al. LONG-TERM QUALITY OF LIFE OUTCOMES FOR PATIENTS WITH ALAGILLE SYNDROME TREATED WITH ODEVIXIBAT: POOLED RESULTS FROM PHASE III, RANDOMIZED, DOUBLE-BLIND ASSERT AND OPEN-LABEL ASSERT-EXT STUDIES. Abstract. Presented at: 2025 NASPGHAN Annual Meeting. November 5-9, 2025. Chicago, Illinois.

Pooled data from the ASSERT and ASSERT-EXT studies indicate that odevixibat significantly improves sleep and caregiver-reported quality of life in Alagille syndrome patients over 96 weeks. Odevixibat, a selective ileal bile acid transport inhibitor, effectively reduces cholestatic pruritus, leading to enhanced sleep parameters and quality of life. The study involved 52 patients, with notable improvements in sleep disturbances and reduced need for sleep-inducing medication. Odevixibat received FDA approval in 2023 for treating cholestatic pruritus in patients aged 12 months and older, based on these findings.

Data presented at NASPGHAN 2025 revealed odevixibat demonstrated sustained improvements in sleep and caregiver-reported QOL in patients with Alagille syndrome through 96 weeks.