Infliximab Biosimilars As Effective as Remicade In Children With Inflammatory Bowel Disease

RM Maltz, J Adler. J Pediatr Gastroenterol Nutr. 2026; 83: 710-716. ImproveCareNow Pediatric IBD Learning Health System. Infliximab originator and biosimilars have similar efficacy in children with inflammatory bowel disease.

Background: “Biosimilars are nearly identical to the originator biologic with only minor differences, usually in the inactive components such as buffers or stabilizers, which have no effect on efficacy as shown in adult studies and limited pediatric studies13–22…The introduction of biosimilars has significantly contributed to competition, which has driven down the price of the infliximab originator along with infliximab biosimilars.23 The price of the infliximab originator dropped by more than 50% between 2018 and 2021.23“

Methods: This was a retrospective cohort study evaluating prospectively collected data from the ImproveCareNow (ICN) Network registry. 428 children were studied using propensity score matching.

Key findings:

  • Efficacy at 12 months was similar as assessed by steroid-free clinical remission (p = 0.25), height-z-score (p = 0.68), hematocrit (p = 0.37), albumin (p = 0.40), and erythrocyte sedimentation rate (p = 0.06). 
  • Time to infliximab discontinuation (p = 0.21), time to surgery (p = 0.79), and time to hospitalization (p = 0.66) were comparable between infliximab originator and biosimilar users
  • In subset of patients with available results (fewer than one in three patients had calprotectin results available), fecal calprotectin values were statistically higher (p = 0.032) at 12 months in patients in the biosimilar cohort. At baseline, fecal calprotectin values were >250 in 11 (60%) of biosimilar cohort compared to 22 (38%) of the originator cohort. At 12 months, 36 (54%) in the biosimilar cohort and 28 (49%) in the originator cohort had fecal calprotectin values >250.
Outcomes comparing the infliximab originator (blue dashed line) to infliximab biosimilar (red solid line). Time to discontinuation of originator or biosimilar infliximab with 95% confidence intervals
Outcomes comparing the infliximab originator (blue dashed line) to infliximab biosimilar (red solid line). Proportion needing intestinal surgery with 95% confidence intervals
Outcomes comparing the infliximab originator (blue dashed line) to infliximab biosimilar (red solid line). Proportion needing hospitalization with 95% confidence intervals

My take (borrowed in part from the authors): “This study adds to the growing literature that children with IBD, regardless of initiating infliximab originator or a biosimilar, have similar clinical outcomes at 1 year.16–19, 21” Despite this, many families still request/prefer Remicade.

Related blog posts:

NASPGHAN Paper: Dietary Management in Pediatric Aerodigestive and GI Dysmotility

K El-Chammas et al. J Pediatr Gastroenterol Nutr. 2026; 83: 748-760. Dietary management and feeding considerations of pediatric aerodigestive and upper gastrointestinal motility disorders.

Oropharyngeal dysphagia (OPD):

  • “Untreated OPD (either penetration and/or aspiration) is associated with persistent symptoms, recurrent respiratory infections, elevations in pulmonary inflammatory markers, and even bronchiectasis”
  • “Because >80% of pediatric aspiration is silent, the presence of symptoms at the time of an aspiration event should not be the determining factor when considering thickening”
  • “Most infants with OPD and aspiration experience improvements in swallow function over time, and thickeners/delivery vehicles can be weaned or changed as swallow function, palate, and caloric needs change. Antegrade aspiration is unlikely to be seen in neurodevelopmentally normal children older than 2 years of age exhibiting persistent lower respiratory tract infections”
  • Table 2 lists common thickeners and key differences. In infants, cereals and gelmix (if >37 weeks gestational age) are recommended. In older age groups, xanthan gum (SimplyThick®), Corn starch (Thick-It®), Tapioca starch, and Tara gum (PuraThick®) are options.
  • “Thickening gastrostomy tube feeds either with commercial thickeners or food improves GI and pulmonary outcomes and reduces the number of gastroesophageal reflux events without prolonging gastric emptying”
  • Table 3 provides specific recommendations including the following: ‘The recommended thickener for formula-fed infants younger than 1 year of age is cereal or purées. Commercial thickeners may be an option for some expressed breast milk- or formula-fed infants under the age of 1 year without comorbidities, depending on institutional practices.”

Esophageal Dysmotility

This section reviews several disorders including achalasia, gastroesophageal reflux, and esophageal atresia.

  • Reflux: In infants with reflux, “thickening of feeds can reduce overt symptoms such as vomiting but does not decrease reflux events.” Also, in this population, “a trial of maternal cows’ milk elimination, extensively hydrolyzed or amino-acid based formulas (in more severe cases with intractable symptoms) may be appropriate”
  • Achalasia: “There are no clear guidelines on the management of feedings in pediatric or adult patients with achalasia…Patients should be encouraged to eat in an upright position and to minimize eating for several hours before bedtime. A liquid or purée may be required with the guidance of a dietitian to ensure adequate nutritional intake while waiting for the diagnosis and definitive management of achalasia”
  • Esophageal atresia: “Only 28% of children with EA are consuming age‐appropriate food textures within the first 2 years of life, with that improving to 70% of children over 5 years of age…Many infants with EA require gastrostomy tube placement because they cannot safely tolerate oral feeding or meet caloric requirements”
  • Table 4 summarizes recommendations for esophageal dysmotility, including “children with esophageal dysmotility should avoid foods with a high risk for esophageal obstruction/irritation, eat in an upright position, and avoid eating several hours before bedtime”

Gastric Dysmotility

  • “Most pediatric cases are idiopathic or post-viral, with less common causes being drug-induced or post-surgical”
  • “While dietary modification is often considered first-line therapy in patients with mild gastroparesis, it often results in suboptimal improvement in symptoms in clinical practice. Small, frequent meals and maintaining a post-prandial upright position may be better tolerated.74, 75 Liquids typically empty from the stomach faster than solids76; therefore, increasing liquid calories and switching from solid to liquid calories later in the day may help patients with their symptoms.”
  • “Fatty, acidic, spicy, and high-fiber foods can exacerbate symptoms in patients with gastroparesis as they delay gastric emptying, exacerbate pain, and promote release of cholecystokinin”
  • “Small-particle diets, consisting of puréed, blended, or finely ground foods, facilitate gastric emptying by reducing mechanical workload on the stomach”
  • “Caution is advised when initiating enteral or parenteral nutrition in patients with gastroparesis given the significant overlap with functional dyspepsia and increased prevalence of feeding intolerance in adolescents with disorders of gut–brain interaction”
  • “In aerodigestive patients with upper gut dysmotility and feeding intolerance, gastrostomy and/or post-pyloric tube placement may provide access to decompress as well as provide nutrition when oral feeding is inadequate to sustain appropriate growth and symptom control”
  • “Blenderized tube feeds may be considered over commercial formulas to help with symptoms, decrease healthcare utilization, and improve quality of life…The American Society for Parenteral and Enteral Nutrition recently published detailed practice recommendations (L Epp et al. Nutr Clin Pract. 2023; 38(6): 1190-1219) providing guidance to medical providers and family pertaining to the use of BTFs regardless of their indication”

My take: This is a useful article regarding potential dietary interventions across a wide range of pediatric GI disorders. Just like medications, dietary interventions can result in complications. As such, the involvement of experienced dietitians and careful follow-up are needed.

Related blog posts:

Dysphagia:

Esophageal dysmotility:

Blenderized Diets:

Gastroparesis:

Outcomes in Pediatric “Potential” Celiac Disease Plus One

B Laxer et al. J Pediatr Gastroenterol Nutr. 2026; 83: 717-722. Open Access! Heterogeneous outcomes in pediatric potential celiac disease: a multicenter longitudinal study.

Background: Potential celiac disease (PCD) is defined by positive celiac serology without villous atrophy.

Methods: This was a multicenter retrospective study with 88 children with mean follow-up of 3.3 years (with a range up to 6 years). Indications for repeat endoscopic evaluation while on a GCD included—a rise in tTG titers to >10× ULN, persistent tTG elevation >10× ULN for over 24 months and the emergence of clinical symptoms necessitating reassessment. During follow-up, only 23 patients (26.1%) underwent a repeat upper endoscopy, as per the clinician’s decision, after a median period of 29 (IQR 11.5–36.5) months from the initial PCD diagnosis.

Key findings:

  • 17/88 (19.3%) patients progressed to Celiac Disease (CeD).
  • 33/88 (37.5%) had normalization of anti-tissue transglutaminase antibodies (tTG), while continuing a diet containing gluten
  • 38/88 (43.2%) continue to have PCD
  • Among 16 patients with high tTG levels (>×10 upper limit of normal) at PCD diagnosis, the results were similar: three (18.8%) progressed to CeD and six (37.5%) normalized tTG
  • Asymptomatic patients were significantly more likely to achieve serological normalization compared to their symptomatic counterparts (61.9% vs. 35.8%, p = 0.011)

Discussion Points:

“A recent meta-analysis9 of 1010 patients reported a progression rate of approximately 33% to CeD, while another third achieved serological normalization.”

Limitations:

  • Follow-up period of up to 6 years may not capture late-onset progression.
  • Only a small subset had a follow-up endoscopy; if all patients had had a repeat endoscopy, there would have been a higher rate of CeD diagnosis

My take: This study found about one-fifth of patients progressed from potential celiac disease to celiac disease during a mean follow-up of 3.3 years. However, 70% of patients did not undergo repeat endoscopy.

Related blog posts:

Also, in same issue:

MC Pacheco et al. J Pediatr Gastroenterol Nutr. 2026; 83: 723-727. Does diagnosis by biopsy versus serology-only affect follow-up in celiac disease? In this retrospective study wiht 54 children, there was no significant difference in frequency of clinical follow-up or decrease in TTG IgA levels between patients who were diagnosed with biopsy versus serology alone.

Bruarfoss (Iceland) is often called “Iceland’s Bluest Waterfall”

Micro-Computed Tomographic Imaging Shows the Blurry Line Between Potential Celiac Disease and Celiac Disease

A Reunamo et al. Gastroenterology, 2026; 171, 553-555. Open Access! Three-Dimensional Micro-Computed Tomographic Imaging Reveals Early Mucosal Remodeling in Individuals With Potential Celiac Disease

Background: “A subset of individuals, characterized as having potential CeD (PCeD), present with positive transglutaminase 2 or endomysial antibodies, or both, but lack histologic findings that meet the diagnostic criteria.1 Importantly, only a subgroup of individuals with PCeD progress to CeD during follow-up.1“

Methods: The authors “recently developed a 3-dimensional (3D) x-ray micro-computed tomographic (micro-CT) imaging and analysis procedure for duodenal biopsy specimens.6,7 The method enables the precise histomorphometric quantification, including measurements of villus height–to–crypt depth ratio (VH:CrD) and mucosal surface area, with excellent reproducibility.7” This study used micro-CT imaging to investigate the early-stage mucosal changes in individuals initially diagnosed with PCeD. This study enrolled 20 patients with PCeD who progressed to CeD, 5 patients who continued with PCeD, and 16 control individuals.

Key findings:

  • Micro-CT imaging revealed a significantly reduced VH:CrD at both the PCeD and CeD stages compared with the controls, but the difference between PCeD and CeD did not reach significance
  • Only 7/20 with PCeD had normal biopsy VH:CrD values >2.0 across all sites
A) VH:CrD (left) and relative mucosal surface area (right) across PCeD (orange), CeD (blue), and nonCeD control (non-CeD) groups. Box and whisker plot: The boxes indicate the 25th percentile (bottom border), median (center line), and 75th percentile (top border), the whiskers show the maximum and minimum ranges, and the circles indicate outliers

Discussion:

“Most of the PCeD cases were already below the commonly used VH:CrD cutoff when assessed using micro-CT cross-sections, implying that histologic thresholds may lack sufficient sensitivity to capture signs of early CeD.”

My take (borrowed in part from the authors): This study strengthens the “concept that enteropathy in CeD represents a progressive continuum.5 In fact, pinpointing the exact moment when the condition becomes “CeD” is difficult, especially because what is considered normal can vary individually and depending on the biopsy site.” This study may help explain why many symptomatic patients with PCeD respond to a gluten-free diet.

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Enteral Rifaximin May Reduce Central Line Infections in Children with Short Bowel Syndrome

Johnson E, Konicek C, Lamb N, Fishbein J, Jhaveri R, Cohran V. J Pediatr Gastroenterol Nutr. 2026; 83: 675-680. Effectiveness of rifaximin in reducing central line-associated bloodstream infections in pediatric intestinal failure

Methods: This was a retrospective cohort study of patients (n=33) with IF managed at a single pediatric center between January 2010 and December 2022. Patients in the cohort had at least 1 CLABSI prior to initiation of rifaximin. Rifaximin was prescribed one to two times a day for 2 weeks a month, every month; median dose was 22 mg/kg/day. Rifaximin was not administered concurrently with other antimicrobials.

Key findings:

  • The observed incidence of CLABSI for all patient, before and after rifaximin initiation, was 10.2 (8.2, 12.7) and 7.3 (5.8, 9.2) per 1000 central line days, respectively, p = 0.03. 
  • Subgroup analysis showed patients who received rifaximin without ethanol lock therapy had significant reduction in CLABSIs, 8.3 versus 3.0 (p < 0.001).
  • There were no statistically significant differences in the proportion of gram-positive or gram-negative bacteria or yeast isolated before and after rifaximin.

Discussion:

  • “Cole et al. showed a correlation between SIBO, intestinal permeability, bacterial translocation,and an increase in bloodstream infections. Patients with IF and SIBO had seven-fold higher odds of having a bloodstream infection than those with IF without SIBO.” However, this was a very small study with only 10 patients with SBS; 5 of the 10 were determined to have SIBO. In addition, there may have been a selection bias as there was a high rate of CLABSI in this study (80%). Ref: Cole CR, et al. The rate of bloodstream infection is high in infants with short bowel syndrome: relationship with small bowel bacterial overgrowth, enteral feeding, and inflammatory and immune responses. J Pediatr. 2010;156(6):941‐947.e1.
  • An important limitation of this retrospective study was the lack of correlation with the presence of SIBO. While studies have shown correlation of CLABSI with SIBO, presumably related to intestinal translocation, the exact mechanisms for how CLABSI occur in children with intestinal failure remain speculative. Intestinal translocation has been shown in animals but not proven to cause CLABSI in humans.

My take: The degree of CLABSI reduction seen in this rifaximin study indicates it is a reasonable option when central locks are unavailable. However, it may be difficult to get covered. In addition, a liquid preparation requires compounding of crushed pills. For most patients, meticulous line care is likely more important than SIBO treatment in preventing CLABSI.

Related blog posts:

Faxafoss in Iceland

Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician. Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure. This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.

Real-World Outcomes of Risankizumab in Children With Crohn’s Disease

Briefly noted:

EA Spencer et al. Journal of Crohn’s and Colitis. 2026; 20: jjag134. https://doi.org/10.1093/ecco-jcc/jjag134 Real-world effectiveness and safety of risankizumab induction and maintenance therapy in pediatric patients with Crohn’s disease: a multicenter retrospective analysis.

Methods: This was a retrospective, global multicenter cohort of patients <18 years initiating risankizumab monotherapy (2022-2025). Among the 96 study participants, 38% had prior ustekinumab exposure.

Key findings:

  • Post-induction corticosteroid-free clinical remission (CFR) was achieved in 28/68 (41%), clinical response in 37/68 (54%), and combined CFR + CRP remission in 22/68 (32%).
  • Week 30 and 54 CFR were attained in 34/68 (50%) and 34/68 (50%), respectively.
  • No serious safety events occurred.

My take: This study bolsters previous studies showing that risankizumab is an effective treatment for Crohn’s disease in the pediatric age group.

Related blog posts:

Rule of Two’s No Longer Valid For Diagnosis of Meckel’s Diverticulum

Polachek A, Mehta MS, Shalaby A, Vadsariya A, Zong W, Troendle DM.J Pediatr Gastroenterol Nutr. 2026; 83: 658-664. Reevaluating the rule of two’s: age and epidemiological variations in Meckel’s diverticulum.

Background: “Meckel’s diverticulum (MD) is traditionally considered a disease of early childhood and is commonly summarized by the “Rule of Twos”; presenting before the age of 2 years, found 2 ft. from the ileocecal valve, approximately 2 in. in length, and present in roughly 2% of the population.” (I was taught an additional rule that it takes 2 physcians to diagnose)

Methods: A total of 1004 patients with a primary diagnosis of MD were identified from the Kids’ Inpatient Database (KID) for 2016 and 2019 in this retrospective review. In addition, 147 patients identified in the single-center cohort.

Key findings:

  • More than half were diagnosed after 5 years of age (n = 648, 64.8%) in the KID group and 63% in the single-center cohort
  • In the single-center cohort, patients ≤5 years more commonly presented with painless rectal bleeding (38.9%, p = 0.017) and underwent Meckel’s scintigraphy more frequently (48.1%, p < 0.005). In contrast, patients >5 years more often presented with abdominal pain (61.3%) or vomiting (54.8%) and were more likely to undergo abdominal computed tomography (68.9%, p < 0.0001).

My take: This study shows the “Rule of Two’s” for the diagnosis of Meckel’s is not helpful; nearly two-thirds of patients present after 5 years of age. The authors note that “overreliance on age-based assumptions and presenting symptoms associated with this paradigm may lead to missed or delayed diagnoses, especially in patients who present with atypical features.”

Related blog posts:

Glymur Waterfall. This is the second tallest waterfall in Iceland
with a 198-meter (650-foot) drop into a narrow basalt canyon.

Evaluating Anti-TNF Withdrawal Success in UC Remission (BIOSTOP Study)

IP Berset et al. Journal of Crohn’s and Colitis, 2026; 20: jjag110. Anti-TNF withdrawal or long-term treatment in ulcerative colitis (BIOSTOP): a multicentre open label, randomized controlled trial 

Methods: “In this prospective, multicentre, randomized, controlled, open-label non-inferiority study, patients in deep clinical, biochemical and endoscopic remission were randomized 1:1 to anti-TNF withdrawal or maintenance treatment. Primary endpoint was endoscopically confirmed remission (Mayo Endoscopic Score 0 or 1) after two years, including UC flares treated with anti-TNF, or non-biologic agents.” This study analyzed 163 adult UC patients (2017-2021, median age 45 years). 29% of patients in the withdrawal group were receiving azathioprine.

Inclusioin criteria:

  • Clinical remission defined as six-point Mayo score≤1
  • Endoscopic remission defined as Mayo endoscopic score (MES) 0 or 1
  • Biochemical remission defined as two consecutive fecal (f-) calprotectin tests<200µg/g
  • Minimum one year of first-line anti-TNF treatment (94% of withdrawal group had rec’d anti-TNF therapy for at least two years)

Key findings:

  • Eighty percent (66/82) of anti-TNF withdrawal group and 96% (78/81) of maintenance patients were in endoscopic remission after 2 years
  • UC flares occurred in 52% (45/86) of withdrawal and 12% (10/86) of maintenance patients
  • Anti-TNF retreatment was successful in 74% (20/27) in the intervention group
  • 48% of anti-TNF withdrawal patients remained in steroid-free remission
  • There were no significant predictors for successful anti-TNF withdrawal
  • Serious adverse events:
    • In the withdrawal group: colectomy (n=1), and hospitalizaiton for flare-up (n=2)
    • In the control group: hospitalization for infection (n=2), and cancer (n=1) which was successfully treated and included anti-TNF discontinuation

The authors conclude that “withdrawal of anti-TNF treatment should be restricted to selected, well-informed and highly motivated patients.”

My take: This two-year randomized study showed that among patients in deep remission, almost half who stopped anti-TNF treatment continued with a steroid-free clinical remission after two years; however, there were no factors which identified those who were able to successfully withdraw from anti-TNF therapy. The results may overestimate the success rate of anti-TNF withdrawal as ~30% of patients were receiving azathioprine. In pediatrics, expert advice has favored continuation of advance therapies when patients are in remission.

Related blog posts:

Declining Child Health in the U.S.

CB Forrest, N Halfon. N Engl J Med 2026;395:1147-1149. Declining Child Health in the United States — Addressing the Developmental Ecosystem

This commentary paints a broad picture of declining health for U.S. children and what is needed to change the trajectory. Here are some excerpts:

Child health has been deteriorating in important and alarming ways in the United States…over the past two decades.1 Infants, children, and adolescents in the United States are 80% more likely to die than their peers in other high-income countries…77% of Americans 17 to 24 years of age would be ineligible to enlist in the U.S. military without a waiver, for reasons including obesity, mental health problems, and other medical conditions.2…

Researchers, policymakers, and the media have tended to attribute these trends to independent challenges — an obesity crisis, a mental health crisis, loneliness, gun violence — with distinct programmatic responses and potential remedies supported by separate advocacy groups and funding streams. But many of them have common origins and drivers…Interventions that target a single risk factor may relieve immediate suffering but will generally be insufficient to change developmental ecosystems in ways that can reverse generational declines in health…

At the base of the iceberg are a developmental ecosystem’s foundational values, which are often expressed in shared narratives about childhood: that raising children is chiefly a private responsibility, that markets are the fairest arbiters of who can be healthy…and that public support should be provided for children’s health programs only in exceptional circumstances…

The influence of these beliefs can be observed in the choices that society has made, including spending less than peer countries on early-childhood programs, opting not to regulate digital platforms that profit from the commodification of children’s attention, and organizing health care systems around the treatment of illness, rather than the promotion of healthy development.

The Elephant Rock is a natural rock formation located on the island of Heimaey in the Westman Islands

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