Efficacy, safety, and pharmacokinetics of teduglutide in adult Japanese patients with short bowel syndrome and intestinal failure: two phase III studies with an extension.

Nakamura S, Wada M, Mizushima T, Sugita A, Tazuke Y, Ohge H, Udagawa E, Suzuki RK, Yoon M, Grimm A, Chen ST, Ikeuchi H

Surgery today6 Oct 2022Cited by 12 (Europe PMC)

PMID36201060PMCIDPMC9950205DOI10.1007/s00595-022-02587-4PepBankPUB-36201060

Summary

PurposeThe short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).MethodsPatients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307). Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.ResultsThe parenteral support (PS) volume decreased by ≥ 20% for 9/18 patients at 24 weeks and in all 11 patients by data cut-off in SHP633-307. The mean (standard deviation) PS volume decreased from baseline at 24 weeks in TED-C14-004 (-30.1 ± 25.9%) and SHP633-306 (-25.6 ± 25.5%), and at data cut-off in SHP633-307 (-57.08 ± 28.49%). Teduglutide was absorbed quickly. The adverse events were consistent with the underlying disease and known adverse drug reactions. Anti-teduglutide antibody titers declined with long-term treatment.ConclusionsIn Japanese adults with SBS-IF, teduglutide treatment was associated with clinically meaningful reductions in PS requirements, similar to findings in prior international studies. No new safety concerns specific to the Japanese SBS-IF patient population were identified with short- or long-term teduglutide treatment. Anti-teduglutide antibody titers disappeared in most Japanese adults with long-term treatment. These results constitute the longest evaluation of teduglutide treatment within clinical trials reported to date.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanNon-randomized trialEfficacy outcome
In Japanese adults with SBS-IF receiving teduglutide, 9/18 had at least a 20% PS volume reduction at 24 weeks.
In plain wordsAt 24 weeks, 9/18 Japanese adults receiving teduglutide reduced intravenous support volume by at least 20%.
Peptide
Teduglutide
Outcome
DecreasePS volume response at 24 weeks
Study
n = 18
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Measurements
Patients with PS volume decrease of at least 20%
9 patients
24 weeks; 9 of 18 patients
Source sentences
Summary
The parenteral support (PS) volume decreased by ≥ 20% for 9/18 patients at 24 weeks and in all 11 patients by data cut-off in SHP633-307.
3 context sentences(design, population, supporting numbers)
Summary · context
The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
Summary · context
Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307).
Summary · context
Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
Show in the study text Report a problemFND-3620106001
02HumanNon-randomized trialEfficacy outcome
All 11 Japanese adults in SHP633-307 had at least a 20% PS volume reduction by the data cutoff.
In plain wordsAll 11 Japanese adults receiving teduglutide in the extension reduced intravenous support volume by at least 20% by the cutoff.
Peptide
Teduglutide
Outcome
DecreasePS volume response at extension cutoff
Study
n = 11
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Measurements
Patients with PS volume decrease of at least 20%
11 patients
data cut-off in SHP633-307; all 11 patients
Source sentences
Summary
The parenteral support (PS) volume decreased by ≥ 20% for 9/18 patients at 24 weeks and in all 11 patients by data cut-off in SHP633-307.
3 context sentences(design, population, supporting numbers)
Summary · context
The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
Summary · context
Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307).
Summary · context
Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
Show in the study text Report a problemFND-3620106002
03HumanNon-randomized trialEfficacy outcome
In Japanese adults receiving teduglutide in SHP633-307, mean PS volume changed by -57.08 ± 28.49% at the data cutoff.
In plain wordsIn SHP633-307, Japanese adults receiving teduglutide had lower intravenous support volume at the data cutoff.
Peptide
Teduglutide
Outcome
DecreasePS volume change in SHP633-307
Study
n = 11
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Measurements
PS volume change
−57.08%
reported result
SD
28.49%
reported result
Source sentences
Summary
The mean (standard deviation) PS volume decreased from baseline at 24 weeks in TED-C14-004 (-30.1 ± 25.9%) and SHP633-306 (-25.6 ± 25.5%), and at data cut-off in SHP633-307 (-57.08 ± 28.49%).
3 context sentences(design, population, supporting numbers)
Summary · context
The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
Summary · context
Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307).
Summary · context
Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
Show in the study text Report a problemFND-3620106005
04HumanNon-randomized trialEfficacy outcome
In Japanese adults receiving teduglutide in TED-C14-004, mean PS volume changed by -30.1 ± 25.9% at 24 weeks.
In plain wordsIn TED-C14-004, Japanese adults receiving teduglutide had lower intravenous support volume at 24 weeks.
Peptide
Teduglutide
Outcome
DecreasePS volume change in TED-C14-004
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Measurements
PS volume change
−30.1%
TED-C14-004
SD
25.9%
TED-C14-004
Source sentences
Summary
The mean (standard deviation) PS volume decreased from baseline at 24 weeks in TED-C14-004 (-30.1 ± 25.9%) and SHP633-306 (-25.6 ± 25.5%), and at data cut-off in SHP633-307 (-57.08 ± 28.49%).
3 context sentences(design, population, supporting numbers)
Summary · context
The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
Summary · context
Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307).
Summary · context
Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
Show in the study text Report a problemFND-3620106003
05HumanNon-randomized trialEfficacy outcome
In Japanese adults receiving teduglutide in SHP633-306, mean PS volume changed by -25.6 ± 25.5% at 24 weeks.
In plain wordsIn SHP633-306, Japanese adults receiving teduglutide had lower intravenous support volume at 24 weeks.
Peptide
Teduglutide
Outcome
DecreasePS volume change in SHP633-306
Study
n: not reported in source
Outcome group
Intensive care and hospital outcomes · Gastrointestinal
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Measurements
PS volume change
−25.6%
SHP633-306
SD
25.5%
SHP633-306
Source sentences
Summary
The mean (standard deviation) PS volume decreased from baseline at 24 weeks in TED-C14-004 (-30.1 ± 25.9%) and SHP633-306 (-25.6 ± 25.5%), and at data cut-off in SHP633-307 (-57.08 ± 28.49%).
3 context sentences(design, population, supporting numbers)
Summary · context
The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
Summary · context
Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307).
Summary · context
Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
Show in the study text Report a problemFND-3620106004
06HumanNon-randomized trialPharmacokinetics
In Japanese adults with SBS-IF, teduglutide was absorbed quickly.
In plain wordsTeduglutide was absorbed quickly in Japanese adults with SBS-IF.
Peptide
Teduglutide
Outcome
Not applicableAbsorption
Study
n: not reported in source
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Source sentences
Summary
Teduglutide was absorbed quickly.
3 context sentences(design, population, supporting numbers)
Summary · context
The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
Summary · context
Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307).
Summary · context
Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
Show in the study text Report a problemFND-3620106006
07HumanNon-randomized trialSafety outcome
In Japanese adults receiving teduglutide, adverse events matched the underlying disease and known adverse drug reactions.
In plain wordsIn Japanese adults receiving teduglutide, adverse events matched the underlying illness and known drug reactions.
Peptide
Teduglutide
Outcome
Not applicableAdverse event pattern
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Source sentences
Summary
The adverse events were consistent with the underlying disease and known adverse drug reactions.
3 context sentences(design, population, supporting numbers)
Summary · context
The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
Summary · context
Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307).
Summary · context
Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
Show in the study text Report a problemFND-3620106007
08HumanNon-randomized trialSafety outcome
In Japanese adults with SBS-IF, anti-teduglutide antibody titers declined with long-term treatment.
In plain wordsIn Japanese adults with SBS-IF, antibodies against teduglutide declined during long-term treatment.
Peptide
Teduglutide
Outcome
DecreaseAnti-teduglutide antibody titers
Study
n: not reported in source
Outcome group
Immune response · Immune and inflammation
Studied dose
0.05 mg/kg/dayAs given in this study (human).
Source sentences
Summary
Anti-teduglutide antibody titers declined with long-term treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
The short- and long-term efficacy, safety, and pharmacokinetics of teduglutide were analyzed in adult Japanese patients with short bowel syndrome and intestinal failure (SBS-IF).
Summary · context
Patients received teduglutide 0.05 mg/kg/day in clinical trials (TED-C14-004, SHP633-306, and extension SHP633-307).
Summary · context
Data were analyzed at 24 weeks and an interim data cut-off of 4.5 years.
Show in the study text Report a problemFND-3620106008

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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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