Teduglutide in inflammatory bowel disease and mucosal barrier disorders — evidence extract
The Institute's graded assessment of Teduglutide for inflammatory bowel disease and mucosal barrier disorders, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Inflammatory bowel disease and mucosal barrier disorders
§1.1Question and anchor outcome
- Population
- Chronic immune-mediated inflammation of the intestinal tract, or disorders of intestinal permeability including coeliac disease.
- Intervention
- Teduglutide, subcutaneous once daily
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Clinical remission
Additional outcomes the Institute extracts for this indication: Endoscopic healing; Faecal calprotectin; Intestinal permeability by lactulose–mannitol ratio.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Teduglutide in inflammatory bowel disease and mucosal barrier disorders.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| STEPS | 3 | Randomised, double-blind, placebo-controlled | 86 | 24 weeks | 2012 |
| STEPS-2 | 3 | Single-arm open-label | 88 | 24 months | 2013 |
| TED-PAEDIATRIC | 3 | Single-arm open-label | 59 | 24 weeks | 2020 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | Serious | The event count falls below the optimal information size. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Drucker DJ. Mechanisms of action and therapeutic application of glucagon-like peptide-1. Cell Metabolism 2018;27(4):740–756. doi:10.1016/j.cmet.2018.03.001 · PMID 29617641
- Müller TD, Finan B, Bloom SR, D’Alessio D, Drucker DJ, Flatt PR, Fritsche A, Gribble F, Grill HJ, Habener JF, Holst JJ, Langhans W, Meier JJ, Nauck MA, Perez-Tilve D, Pocai A, Reimann F, Sandoval DA, Schwartz TW, Seeley RJ. Glucagon-like peptide 1 (GLP-1). Molecular Metabolism 2019;30:72–130. doi:10.1016/j.molmet.2019.09.010 · PMID 31767182
- D’Hondt M, Bracke N, Taevernier L, Gevaert B, Verbeke F, Wynendaele E, De Spiegeleer B. Related impurities in peptide medicines. Journal of Pharmaceutical and Biomedical Analysis 2014;101:2–30. doi:10.1016/j.jpba.2014.06.012 · PMID 25044089
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.