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Methods and compositions for predicting responsiveness to treatment with TNF-a inhibitor

A technology for alpha inhibitors, responsiveness, in the field of predicting responsiveness and composition to TNF-alpha inhibitor therapy

Inactive Publication Date: 2013-03-06
ABBVIE BIOTECHNOLOGY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, known treatments can lead some patients to repeatedly experience ineffective treatments before effective therapies are identified

Method used

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  • Methods and compositions for predicting responsiveness to treatment with TNF-a inhibitor
  • Methods and compositions for predicting responsiveness to treatment with TNF-a inhibitor
  • Methods and compositions for predicting responsiveness to treatment with TNF-a inhibitor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0262] Example 1: Early Rheumatoid Arthritis Response to Treatment with Adalimumab Plus Methotrexate Versus Methotrexate Alone: ​​Prediction of Clinical Response by Genetic Marker Analysis

[0263] The following studies and Examples 2-4 examine the genetic contribution to the treatment of rheumatoid arthritis (RA) with a TNFα inhibitor, adalimumab plus methotrexate versus methotrexate alone.

[0264] The purpose of this study was to evaluate the results of the OPTIMA (multicenter randomized double-phase double-blind study for treatment initiation with methotrexate and adalimumab combination therapy in patients with early rheumatoid arthritis). 3 genetic risk factors for severe RA (HLA - Association of DRB1 common epitopes (SE), FcγRIIb and IL-4R) with clinical disease activity.

[0265] OPTIMA was an uninterrupted 78-week study with 26-week and 52-week periods. Eligible patients have RA 3.2, ≥6 swollen joints (TJC68≥6) and ≥8 tender joints (SSJC66≥6) 8). Patients have elev...

Embodiment 2

[0312] Example 2: Effect of Gene Interactions on Response to Adalimumab Plus Methotrexate Versus Methotrexate Alone: ​​Six-Month Results of the OPTIMA Trial

[0313] Identification of genetic factors that influence disease severity and response to treatment in rheumatoid arthritis (RA) may guide personalized treatment approaches. To explore the influence of candidate genetic factors on changes in disease activity, the following study examined the contribution of genetic factors to the treatment of rheumatoid arthritis (RA) with adalimumab plus methotrexate versus methotrexate alone.

[0314]OPTIMA was an uninterrupted 78-week study with 26-week and 52-week time periods. Details of the study design and patient eligibility / exclusion criteria are described in Example 1 above. Briefly, eligible patients had RA 3.2, SJC > 6, TJC > 8. ESR ≥ 28 mm / h or CRP ≥ 1.5 mg / dL, and ≥ 1 of the following parameters: > 1 for erosion, RF+, or anti-CCP+ (see above). MTX-naïve patients were ran...

Embodiment 3

[0323] Example 3: Effect of Genetic Interactions on Response to Adalimumab Plus Methotrexate Versus Methotrexate Alone: ​​Six-Month Results of the OPTIMA Trial

[0324] background

[0325] Identification of genetic factors that influence disease severity and response to treatment in rheumatoid arthritis (RA) may guide personalized treatment approaches. Although specific genetic factors have been implicated in the susceptibility to and severity of rheumatoid arthritis (RA), the effect of genomic components on response to biologic RA treatments has not been extensively studied.

[0326] Purpose

[0327] The aim of this study was to investigate the effect of candidate genetic factors on changes in disease activity following treatment with adalimumab (ADA) plus methotrexate (MTX) or MTX alone. In addition, the influence of candidate genetic factors on changes in disease activity in patients with early RA following treatment with adalimumab (ADA) plus methotrexate (MTX) or MTX al...

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Abstract

The invention provides methods of determining or predicting the responsiveness of a subject to treatment with a TNFa inhibitor, such as a TNFa antibody by determining genetic factors.

Description

[0001] References to related applications [0002] This application claims U.S. Provisional Application No. 61 / 300,807, filed February 2, 2010, U.S. Provisional Application No. 61 / 353,595, filed June 10, 2010, U.S. Provisional Application No. 61, filed June 28, 2010 / 359,009, U.S. Provisional Application No. 61 / 409,461, filed November 2, 2010, and U.S. Provisional Application No. 61 / 434,296, filed January 19, 2011, the entire contents of each application, including specification, Any figures, as well as the sequence listing, are hereby incorporated by reference. [0003] sequence listing [0004] This application contains a Sequence Listing submitted in ASCII format via EFS-Web, and is hereby incorporated by reference in its entirety. Said ASCII copy, created on February 1, 2011, is named 11781316.txt and is 28,619 bytes in size. Background of the invention [0005] Rheumatoid arthritis (RA) is considered a chronic inflammatory autoimmune disorder. RA is a disabling and pa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68
CPCC12Q2600/156C12Q2600/106C12Q1/6883A61P19/02A61P29/00
Inventor H·库佩尔H·舒尔策-科普斯A·斯卡彭克
Owner ABBVIE BIOTECHNOLOGY LTD
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