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Methods related to treatment of inflammatory diseases and disorders

A disease, autoimmune disease technology with application in the related field of treatment of inflammatory diseases and disorders

Inactive Publication Date: 2014-12-10
NOVO NORDISK AS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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

Method used

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  • Methods related to treatment of inflammatory diseases and disorders
  • Methods related to treatment of inflammatory diseases and disorders
  • Methods related to treatment of inflammatory diseases and disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0254] 1. A method for predicting a subject's response to an anti-inflammatory drug comprising: obtaining in a biological sample from said subject figure 1 Information about the expression level of one or more genes, wherein the change in the expression level of one or more genes compared to the reference level of the gene predicts the subject's response to the anti-inflammatory drug .

[0255] 2. Methods for predicting patient response to anti-inflammatory drugs, including:

[0256] a. Detection in a biological sample from said patient figure 1 the expression level of one or more genes, and

[0257] b. Comparing said level to a reference level for said gene

[0258] wherein the altered expression of one or more of said genes compared to said reference level predicts said patient's response to said anti-inflammatory drug.

[0259] 3. A method for identifying a subject with an increased likelihood of responding to an anti-inflammatory drug, comprising: obtaining in a biolog...

Embodiment 1

[0439] Blood samples from Phase 1b and Phase 2a trials examining the safety, tolerability and efficacy of anti-IL-20 in patients with rheumatoid arthritis (RA) were collected from patients at time points (Clinical Trials Government Identification numbers: NCT01038674 and NCT01282255): pre-dose (Day 1) and post-dose days 8, 15, 29, 43, and 99 in the Phase 1b trial, and pre-dose (Day 1 ) and the 15th and 36th day after administration. The patients were dosed weekly for 6 weeks (total of 7 doses) and weekly for 11 weeks (total of 12 doses), respectively.

[0440] Total RNA was obtained as described above. After reduction of globin mRNA and confirmation of RNA integrity, RNA samples were analyzed by AffyMetrix GeneChip hybridization following the procedure described above.

[0441] To identify transcripts in whole blood PaxGene samples that correlate with changes in DAS28-CRP and other disease score measures such as ACR20, ACR50, and ACR70, we performed regression analysis on ex...

Embodiment 2

[0450] To test whether baseline (pre-dose) determination of CFD mRNA alone correlates with CFD mRNA levels from different time points assessed in the microarray analysis, qRT-PCR was performed on CFD mRNA on available pre-dose samples, and the These correlate with recorded CFD levels from the microarray. Quantitative RT-PCR analysis was performed as described above and data were obtained from duplicate analyzes of each cDNA sample. CFD mRNA levels from the qRT-PCR platform were normalized to 18S rRNA levels also detected by qRT-PCR. To correlate microarray levels with qRT-PCR levels, RNA-normalized microarray levels were transformed to a linear scale. like Figure 6 As shown, a high association was found between qRT-PCR assays at baseline and microarray assays from several visits (R 2 =0,86). This suggests that CFD-based stratification of RA-patients at baseline (before dosing) is feasible because figure 1 and figure 2 Other predictive transcripts described in e.g. CFD...

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Abstract

The present invention relates to gene markers associated with a method for predicting the clinical response in a patient suffering from an inflammatory diseases or disorders to an anti-inflammatory treatment.

Description

technical background [0001] The present invention relates to methods in the field of diagnosis, prognosis and treatment optimization of inflammatory diseases and disorders with the aim of improving treatment options and regimens for patients by providing methods for predicting responsiveness to therapeutic agents. background [0002] For a large number of patients, inflammatory diseases and disorders and especially autoimmune diseases seriously affect patient health and treatment options are unsatisfactory. [0003] Rheumatoid arthritis (RA) is a clinically important, chronic systemic autoimmune RA is an autoimmune disease of unknown etiology. Most RA patients have a chronic disease course that, even with currently available treatments, can lead to progressive joint destruction, deformation, disability and even premature death. The diagnosis of RA usually relies on clinical and laboratory evaluation of the patient's signs and symptoms. Typically, laboratory evaluation of p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68G01N33/53
CPCC12Q2600/156C12Q2600/158C12Q1/6809C07K16/244C12Q2600/106C12Q1/6883C12Q1/6844
Inventor K.S.弗雷德里克森
Owner NOVO NORDISK AS
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