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Study · Randomized controlled trial · n = 86 · 2018

5 results

Identifying a subpopulation with higher likelihoods of early response to treatment in a heterogeneous rare disease: a post hoc study of response to teduglutide for short bowel syndrome.

Chen KS, Xie J, Tang W, Zhao J, Jeppesen PB, Signorovitch JE

Therapeutics and clinical risk management25 Jul 2018Cited by 17 (Europe PMC)

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In the overall SBS-IF population, the response-rate difference between teduglutide and placebo was 33%.

    In plain wordsIn the overall SBS-IF population, the response-rate difference favored teduglutide over placebo.

    Outcome
    IncreaseResponse rate in overall population
    Study

    n = 86

    Comparator
    Placebo
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Response rate difference, teduglutide vs placebo
    33%
    overall population

    Source sentences

    Summary
    The difference in response rate between teduglutide and placebo was 62% in the subpopulation, which was substantially higher than the difference of 33% in the overall population.
    2 context sentences
    Summary · context
    Data were from a 24-week, Phase III trial (Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent SBS Subjects; NCT00798967) that randomized SBS-IF patients with PS dependency to receive teduglutide (n=43) or placebo (n=43).
    Summary · context
    Two prediction models (1 for each arm) were developed for response, defined as 20% reduction in weekly PS at Weeks 20 and 24.
  2. 02HumanObservational studyEfficacy outcome

    In SBS-IF patients receiving teduglutide, response predictors were older age, volvulus, baseline PS volume >6 L/week, longer PS dependency, absent ileocecal valve, and less remaining colon.

    In plain wordsIn SBS-IF patients, baseline characteristics predicted response to teduglutide.

    Outcome
    Direction not reportedPredictors of teduglutide response
    Study

    n = 43

    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Baseline PS volume predictor threshold
    > 6 L/week
    Predictor of response to teduglutide

    Source sentences

    Summary
    Six predictors of response to teduglutide were selected: older age, volvulus as the cause of major intestinal resection, baseline PS volume >6 L per week, longer time since start of PS dependency, absence of ileocecal valve, and lower percentage of colon remaining.
    2 context sentences
    Summary · context
    Data were from a 24-week, Phase III trial (Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent SBS Subjects; NCT00798967) that randomized SBS-IF patients with PS dependency to receive teduglutide (n=43) or placebo (n=43).
    Summary · context
    Two prediction models (1 for each arm) were developed for response, defined as 20% reduction in weekly PS at Weeks 20 and 24.
  3. 03HumanObservational studyEfficacy outcome

    In a post hoc analysis of a randomized SBS-IF trial, the teduglutide-versus-placebo response-rate difference was 62% in the subpopulation with the top 60% effect scores and 33% in the overall population.

    In plain wordsIn people with SBS-IF, teduglutide's response-rate gap over placebo was 62% in a model-chosen subgroup and 33% overall.

    Outcome
    IncreaseResponse-rate difference versus placebo in model-identified subpopulation
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Response-rate difference, teduglutide versus placebo
    62%
    Subpopulation with top 60% effect scores
    Response-rate difference, teduglutide versus placebo
    33%
    Overall population

    Source sentences

    Summary
    The difference in response rate between teduglutide and placebo was 62% in the subpopulation, which was substantially higher than the difference of 33% in the overall population.
    3 context sentences
    Summary · context
    A subpopulation of patients more likely to respond to teduglutide was identified as those with the top 60% effect scores.
    Summary · context
    Data were from a 24-week, Phase III trial (Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent SBS Subjects; NCT00798967) that randomized SBS-IF patients with PS dependency to receive teduglutide (n=43) or placebo (n=43).
    Summary · context
    Two prediction models (1 for each arm) were developed for response, defined as 20% reduction in weekly PS at Weeks 20 and 24.
  4. 04HumanObservational studyEfficacy outcome

    In a post hoc SBS-IF subgroup selected by the top 60% effect scores, the response-rate difference between teduglutide and placebo was 62%.

    In plain wordsIn a post hoc subgroup of SBS-IF patients, the response-rate difference favored teduglutide over placebo.

    Outcome
    IncreaseResponse rate in enriched subgroup
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Response rate difference, teduglutide vs placebo
    62%
    post hoc subgroup with top 60% effect scores

    Source sentences

    Summary
    The difference in response rate between teduglutide and placebo was 62% in the subpopulation, which was substantially higher than the difference of 33% in the overall population.
    2 context sentences
    Summary · context
    Data were from a 24-week, Phase III trial (Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent SBS Subjects; NCT00798967) that randomized SBS-IF patients with PS dependency to receive teduglutide (n=43) or placebo (n=43).
    Summary · context
    Two prediction models (1 for each arm) were developed for response, defined as 20% reduction in weekly PS at Weeks 20 and 24.
  5. 05HumanObservational studyEfficacy outcome

    In a post hoc SBS-IF subgroup selected by the top 60% effect scores, teduglutide significantly reduced mean PS days more than placebo.

    In plain wordsIn a post hoc subgroup of SBS-IF patients, teduglutide reduced support days more than placebo.

    Outcome
    DecreasePS day reduction in enriched subgroup
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Mean PS day reduction was also significantly higher for teduglutide compared to placebo in the subpopulation.
    2 context sentences
    Summary · context
    Data were from a 24-week, Phase III trial (Study of Teduglutide Effectiveness in Parenteral Nutrition-Dependent SBS Subjects; NCT00798967) that randomized SBS-IF patients with PS dependency to receive teduglutide (n=43) or placebo (n=43).
    Summary · context
    Two prediction models (1 for each arm) were developed for response, defined as 20% reduction in weekly PS at Weeks 20 and 24.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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