Methods for diagnosing and treating inflammatory bowel disease

A gastroenteritis, reactive technique used in the field of diagnosis and treatment of inflammatory bowel disease

Active Publication Date: 2016-11-09
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This trial and error often involves considerable risk and discomfort for the patient in order to find the most effective therapy

Method used

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  • Methods for diagnosing and treating inflammatory bowel disease
  • Methods for diagnosing and treating inflammatory bowel disease
  • Methods for diagnosing and treating inflammatory bowel disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0334] Phase II, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension Study to Evaluate the Efficacy and Safety of rhuMAbβ7 (etrolizumab) in Patients with Moderate-to-Severe Ulcerative Colitis

[0335] Clinical Study Description

[0336] rhuMAbβ7 (etrolizumab) Description

[0337] rhuMAbβ7 (etrolizumab) is a humanized monoclonal antibody based on human IgG1 subclass III V H , κ subtype-IV L Consensus sequence, and specificity against the β7 subunit of integrin heterodimers. see Figure 1A and B. It has been shown to bind α4β7 with high affinity (K of about 116 pM d ) and αEβ7 (K about 1800pM d ).

[0338] This recombinant antibody has two heavy chains (446 residues) and two light chains (214 residues) covalently linked by interchain and intrachain disulfide bonds typical of IgGl antibodies. For the studies described here, it was produced in Chinese Hamster Ovary (CHO) cells. The molecular weight of the intact aglycosylated rhuMAbβ7 molecule is a...

Embodiment 2

[0367] Example 2 - Predictive Biomarker Research and Analysis

[0368] Experimental design selected for enrichment of predictive biomarkers of efficacy in etrolizumab-treated patients

[0369] To identify novel biomarkers predictive of response to etrolizumab treatment, we first used RNA-sequencing to establish baseline gene expression profiles of colonic biopsies from all etrolizumab-treated patients. Baseline biopsies from etrolizumab-treated TNF antagonist-naïve patients were used to identify differential gene expression profiles between etrolizumab-treated patients who experienced remission and etrolizumab-treated patients who did not. Differentially expressed genes were further selected based on signal strength, biological relevance, and expression in other IBD datasets, and then further evaluated using quantitative polymerase chain reaction in colon biopsies from etrolizumab-treated patients and placebo-treated patients for subgroup analysis. group analysis.

[0370] B...

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Abstract

Biomarkers predictive of responsiveness to integrin beta7 antagonists, including anti-beta7 integrin subunit antibodies, and methods of using such biomarkers are provided. In addition, methods of treating gastrointestinal inflammatory disorders such as inflammatory bowel diseases including ulcerative colitis and Crohn's disease are provided. Also provided are methods of using such predictive biomarkers for the treatment of inflammatory bowel diseases including ulcerative colitis and Crohn's disease.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Application No. 61 / 971,379, filed March 27, 2014, which is hereby incorporated by reference in its entirety. [0003] sequence listing [0004] This application contains a Sequence Listing, which has been submitted via EFS-Web, which is hereby incorporated by reference in its entirety. This ASCII copy, created on March 5, 2015, is named P5817R1-WO_SL.txt and is 20,156 bytes in size. technical field [0005] Biomarkers predictive of reactivity to integrin β7 antagonists, including anti-β7 integrin subunit antibodies, and methods of using such biomarkers are provided. Additionally, methods of treating gastrointestinal inflammatory disorders, such as inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are provided. Also provided are methods of using such predictive biomarkers for the treatment of inflammatory bowel disease, including ulcerative ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/00C12Q1/68C07K16/00C12P21/08A61K38/00
CPCC07K16/2842A61K2039/505C07K2317/24C12Q2600/106C12Q2600/158C12Q1/6883A61P1/04A61K39/395G01N33/573G01N33/53
Inventor J·A·哈克尼M·凯伊尔G·W·特乌
Owner F HOFFMANN LA ROCHE & CO AG
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