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Methods, agents and compositions for treatment of inflammatory conditions

Inactive Publication Date: 2016-12-01
ASTELLAS PHARMA INC +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent text describes a method for treating or preventing age-related inflammation, chronic inflammation, and cardiovascular disease by using a GnRH antagonist. The treatment can help decrease the risk of cardiovascular events, such as heart attacks, and also decrease the risk for developing metabolic syndrome or type II diabetes. The method can include administering the GnRH antagonist alone or in combination with other drugs like oestrogen or testosterone.

Problems solved by technology

It can be a disabling and painful condition which can lead to substantial loss of functioning and mobility.
There is no cure for ageing, chronic inflammation or inflammatory diseases.
The efficacy of such drugs is still inadequate in a large proportion of patients.
Of these patients, a significant proportion will have to cease these treatments either due to loss of efficacy over time, or serious side effects.
Whilst these treatments can be effective, many require close supervision because of hazardous side-effects.
Response to treatment with these agents is variable and some patients will experience pain and joint degeneration.

Method used

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  • Methods, agents and compositions for treatment of inflammatory conditions
  • Methods, agents and compositions for treatment of inflammatory conditions
  • Methods, agents and compositions for treatment of inflammatory conditions

Examples

Experimental program
Comparison scheme
Effect test

example 1

Examples of Treating Patients with Rheumatoid Arthritis with a GnRH Antagonist

Baseline Demographics

[0164]

VariablePatient 1Patient 2Patient 3Patient 4Patient 5Patient 6Age (years)565845717871SexFemaleFemalePremenopausalMaleFemaleFemaleFemaleDisease102617163138Duration (years)Disease activity 16.27.57.68.6  6.47.2Number of6753   1 25biologicspreviously failedOnset?MenopausePostpartumPostpartumAcute onset atMenopausePostpartumthe time of earinfectionDuration / Effect4 infusions4 months. 1 infusion 1 infusion2 infusions2 months.of last biologicRituximabTNF-inhibitor TNF-inhibitor RituximabRituximabRoactemra(Mabthera)(Simponi / golilimumab)(Remsima)(Mabthera)(Mabthera) (Tocilizumab)(each 6 Increasing diseaseSide effects.Increasing6 months apart.Very low white months apart). activityIncreasing diseasedisease Malignantcell count. No effect.documented.activity activitymelanomaIncreaseddocumented.documented.diagnosis. disease activityUnknown effect documented.on disease activity.1 Measured by DA...

example 2

Examples of Patients with Continued RA Improvement Over Several Weeks Despite Stably Low Levels of LH

[0173]Patient 3

Baseline4 wks8 wks12 wksACR %—30%40%50%responseLH2ESR46413620

[0174]Patient 4

Baseline3½ wks9 wksACR %—20%50%responseLH8ESR786836

example 3

Example of Treating a Patient with Lupus with a GnRH Antagonist

Social History

[0175]A male, 63 years old, married with 3 grown up children has been on sick benefits since 2010 primarily due to lupus diagnosed in 1988.

History of Lupus

[0176]The patient has a medical history of a multimorbid patient. Systemic lupus erythematosus (SLE) was diagnosed in 1988 based on Raynauds, skin changes, arthralgia, high titre lupus anticoagulant, ANA, SSA, and SSB. Chilblain type changes in hands and feet (FIGS. 6-8). He has previously tried methotrexate, azathioprine, and mycophenolate mofetil, which were not effective in reducing the pain in his extremities, and gave intolerable side effects such as mouth ulcers. He has had a pacemaker since 1986, AV block II. The patient suffered cardiac arrest in 2012, coronary stenosis was observed. The patient had kidney failure since 2012, required dialysis, stabilized creatinine around 150, osteoporosis, COPD, and is a smoker.

[0177]The patient has had severe p...

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Abstract

The present invention relates to the screening, diagnosis, prognostic evaluation, and treatment or prevention of age associated inflammation, chronic inflammation, and inflammatory diseases. In particular, the present invention relates to treating or preventing inflammatory diseases (e.g. rheumatoid arthritis or spondyloarthritis) or patients with inflammatory peripheral GnRH with GnRH antagonists or drugs that lower the effects of GnRH.

Description

FIELD OF THE INVENTION[0001]The present invention relates to the screening, diagnosis, prognostic evaluation, and treatment or prevention of age-related inflammation, chronic inflammation, and inflammatory diseases. In particular, the present invention relates to methods, agents and compositions for treating inflammatory diseases (e.g. rheumatoid arthritis or spondyloarthritis) or patients with inflammatory peripheral gonadotropin-releasing hormone (GnRH) with GnRH antagonists, including drugs that lower the effects of GnRH or GnRH inhibitors. Most particularly, the present invention relates to methods for treating inflammatory diseases, such as rheumatoid arthritis, with the GnRH antagonist ASP1707.BACKGROUND OF THE INVENTION[0002]Ageing is among the largest known risk factors for human diseases. Roughly 100,000 people die each day of age-related causes. Between 2000 and 2050, the proportion of the number of people aged 60 years and over is expected to increase from 605 million to ...

Claims

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Application Information

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IPC IPC(8): A61K31/4184G01N33/74A61K31/4409A61K31/519A61K45/06A61K47/48
CPCA61K31/4184A61K45/06A61K47/48215A61K31/4409G01N2800/7095G01N33/74G01N2333/575G01N2800/7042A61K31/519A61K31/568A61K31/565A61K47/60A61K38/09A61K31/513A61K31/58A61P1/00A61P1/04A61P13/12A61P17/06A61P19/02A61P19/10A61P25/00A61P29/00A61P3/00A61P35/00A61P3/06A61P43/00A61P7/00A61P9/00A61P9/10A61P9/12A61K2300/00A61K9/0019A61K9/0053A61K39/3955A61K2039/505C07K16/2869C07K2317/76G01N33/564G01N2800/065G01N2800/10G01N2800/102G01N2800/205G01N2800/285
Inventor K SS, ANITA
Owner ASTELLAS PHARMA INC
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