Inflammatory bowel disease and mucosal barrier disorders — evidence across compounds
Every compound the Institute assesses in inflammatory bowel disease and mucosal barrier disorders, with its certainty rating.
§2Evidence across compounds
Every compound the Institute assesses in this indication, with the effect as recorded, the certainty rating and the contributing trials. Effects are reported on the anchor outcome where the contributing trials measured it and on the outcome the trial actually reported where they did not.
Table 1. Compounds assessed in inflammatory bowel disease and mucosal barrier disorders, ordered by certainty.
| Compound | Effect as recorded | Interval as reported | Certainty | Trials |
|---|---|---|---|---|
| Larazotide acetateOctapeptide tight-junction regulator (zonulin antagonist) | A phase 2b trial met its primary endpoint on symptom scores at the 0.5 mg dose; the subsequent phase 3 trial was discontinued for futility at interim analysis | phase 2b positive; phase 3 futility | Moderate | 2 |
| TeduglutideGLP-2 receptor agonist | Response defined as ≥20 % reduction in parenteral support volume in 63 % versus 30 % with placebo at 24 weeks | difference 33 percentage points (95 % CI 16 to 49) | Moderate | 3 |
| BPC-157Synthetic pentadecapeptide derived from a gastric juice… | A phase 2 programme in ulcerative colitis was conducted and results were not published in a peer-reviewed journal in a form the Institute could verify | not reportable | Very low | 1 |
| KPVC-terminal tripeptide fragment of alpha-melanocyte-stimulati… | No randomised controlled human trial identified | — | Very low | 0 |
| Estimates in this table are not on a common scale and must not be subtracted from one another. Where a comparison between two compounds has been made directly, it appears in a synthesis and not here. | ||||
§2.1Syntheses bearing on this indication
- Human evidence for BPC-157 — Very low
- Teduglutide in inflammatory bowel disease and mucosal barrier disorders: effect on the anchor outcome — Moderate
- Larazotide acetate in inflammatory bowel disease and mucosal barrier disorders: effect on the anchor outcome — Moderate
- Teduglutide in inflammatory bowel disease and mucosal barrier disorders: tolerability and discontinuation — Moderate
- Larazotide acetate in inflammatory bowel disease and mucosal barrier disorders: tolerability and discontinuation — Moderate
- Teduglutide in inflammatory bowel disease and mucosal barrier disorders: durability of effect — Moderate
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.
- 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
- Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng HY, Corbett MS, Eldridge SM, Emberson JR, Hernán MA, Hopewell S, Hróbjartsson A, Junqueira DR, Jüni P, Kirkham JJ, Lasserson T, Li T, McAleenan A. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898. doi:10.1136/bmj.l4898 · PMID 31462531
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.