Tag Archives: biosimilars

How Bad is Reflux in Children with Esophageal Atresia?

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A recent retrospective study (FWT Vergouwe et al. JPGN 2019; 69: 515-22) with 57 children with esophageal atresia (EA) found most children have a normal reflux index.

This study, analyzing data between 2012-2017, reviewed all 24-hour pH-impedance (MII) studies in children at ≤18 months and 8 year olds with EA.  “All children with EA born in our hospital are offered a 24-hour pH-MII study at the age of 0.5 years and 8 years.”  In this institution, PPI treatment is given for at least 6 months after surgery. Of the 57 in the cohort, 20 had completed pH-MII at <18 months of age and 32 at age 8 years.

Key findings:

  • In children ≤18 months of age, median reflux index was 2.6% (abnormal in 2), median number of retrograde boluses was 61 (62% nonacid, 58% mixed)
  • In the older cohort (~8 years of age), median reflux index was 0.3% (abnormal in 4) and median number of retrograde boluses was 21 (64% nonacid, 75% mixed)
  • Overall, 10 of 57 children (17.5%) had GERD with reflux index >7% (n=6) or positive SI/SAP (n=4).  The authors note that much higher rates of GERD have been found in prior studies.  If they included children with fundoplication who were considered as having GERD (prior to fundoplication), then the GERD rate was 32%.

My take: This study showed that reflux in this cohort of children with EA was similar to the general population and likely indicates that a substantial portion of patients with EA do not need indefinite PPI therapy.  In children with more complex EA, PPI therapy is likely to be more beneficial.

Related blog posts:

Recent (November 4th) GI-Related Tweets:

CCFA: Updates in Inflammatory Bowel Disease 2017 (Part 4)

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Our local CCFA chapter provided a useful physician CME meeting.  The following are my notes. My notes may include some errors in transcription and errors of omission.

Ashish Patel  -Updates in Pediatric Inflammatory Bowel Disease Treatments

Key points:

  • Top-down or step-up models are outdated –use appropriate agent for each patient
  • Discussed therapeutic drug monitoring.  In pediatrics, checking infliximab (IFX) level after 14 weeks is recommended by ICN per Dr. Patel.
  • Veolizumab -no pediatric FDA indication yet..  Alpha4Beta7 integrin blocker –blocks recruitment of WBC
  • Stelara -off label in pediatrics.  Seems to be helpful for patients who have psoriasis on TNF agents.
  • Exclusive enteral nutrition (EEN) like medical therapies are therapies and not cures.  It has to be maintained to be effective.

Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) and changes in diet should be confirmed by prescribing physician.  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.

AGA Recommendations on Biosimilars

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The AGA has made several recommendations regarding biosimilars –#2 and #6 are particularly of interest to pediatric gastroenterologists. More on this topic will follow tomorrow.

Link: AGA Makes Six Recommendations to FDA on Interchangeable Biosimilars

Related blog posts:

Biosimilars -Position Statement

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Briefly noted:

“Use of Biosimilars in Paediatric Inflammatory Bowel Disease” Position Statement. JPGN 2015; 61: 503-08.  Conclusions:

  • “IBD Porto group advocates giving high priority to performing paediatric trials with long-term followup to support” the use of biosimilars (97% agreement)
  • “Treatment of a child with sustained remission on a specific medication should not be switched to a biosimilar until clinical trials in IBD are available to support the safety and efficacy of such a change” (94% agreement)
  • “Postmarketing surveillance…in children with IBD should be a mandatory requirement.” (100% agreement)

My take: Keep this reference handy.  The lower expected costs (>30% reduction) could create pressure to change treatment before the safety/efficacy is proven.

Atlanta Botanical Gardens

Atlanta Botanical Gardens