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Methods of identifying subjects responsive to treatment for an autoimmune disease and compositions for treating the same
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An autoimmune, subject technology, applied in allergic diseases, metabolic diseases, drug combinations, etc., which can solve problems such as not producing beneficial results
Pending Publication Date: 2020-06-05
THE GENERAL HOSPITAL CORP
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[0009] Although various investigational therapies for autoimmune diseases have demonstrated some palliative or even curative properties, these therapies may not produce consistent beneficial results in all subjects with autoimmune diseases such as type 1 diabetes
Method used
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Embodiment 1
[0103] Example 1. Identification of subjects with type 1 diabetes as likely to respond to treatment with TNFR2 activators
[0104] Prior to treatment with a pharmaceutical composition of the invention (eg, a TNFR2 activator), a subject (eg, a human) can be tested to determine whether the subject is likely to respond to the treatment. The test can be performed using a sample (eg, blood, blood components, or urine) collected from the subject. For example, to prepare a serum sample, blood can be collected by venipuncture, allowed to clot, and the serum can be separated by centrifugation. To prepare a plasma sample, blood can be collected by venipuncture into tubes containing heparin or EDTA as an anticoagulant; the plasma fraction can then be separated from the sample. For urine sample preparation, a 24-hour urine sample (without preservatives) can be collected. Cellular debris can be removed from the sample by filtration or centrifugation prior to testing.
[0105] The prepar...
Embodiment 2
[0107] Example 2. Use of the pharmaceutical composition of the present invention to treat type 1 diabetes in humans
[0108] Prior to treatment with a TNFR2 activator (eg, BCG), a sample (eg, blood) can be drawn from a subject identified in Example 1 as likely to respond to treatment. The HbA1c level of this sample can be analyzed to determine the baseline HbA1c level for the study.
[0109] Can contain 1.0-2.3×10 6 A dose of CFU / administration (volume = 0.1 cc / administration) was administered to subjects as two intradermal injections four weeks apart with a pharmaceutical composition containing BCG reconstituted in saline. Following treatment, it can be determined by using functional assays (autoreactive CD8 + T cell assay and regulatory CD4 + T cell assays) testing samples obtained from the subject to monitor the subject over time, these assays are described further below.
[0110] After treatment, 1 year (eg, 2 years, 3 years, 4 years, 5 years, or 6 years) after adminis...
Embodiment 3
[0120] Example 3. Analysis of CD8 in samples from subjects with EBV infection + T cell detection
[0121] Materials and Methods
[0122] subjects
[0123] Patients with type 1 diabetes were recruited at the Massachusetts General Hospital. Diabetic patients are routinely screened to characterize the disease course and to exclude subjects with potentially interfering medical conditions. During the screening process, three patients with long-standing type 1 diabetes and recent-onset EBV were identified. In this study, diabetic patients (N=66) without EBV infection were used as reference population. Draw all patient blood and control blood into a BD Vacutainer containing EDTA TM tube (BD, Franklin Lakes, NJ).
[0124] ethics statement
[0125] The study was approved by the Massachusetts General Hospital Institutional Review Board (IRB protocol number 2001P-001379). Written consent was obtained from all blood donors.
[0126] epitope-specific CD8 + T cell detection
[01...
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Abstract
The invention discloses methods of identifying subjects responsive to treatment for an autoimmune disease and compositions for treating the same. Methods of identifying a subject having an autoimmunedisease, such as Type 1 diabetes, as likely to respond to treatment with a tumor necrosis factor-[alpha] (TNF-[alpha]) receptor II activator, involving measuring CD8 protein density on the surface ofautoreactive CD8+ T cells and identifying the subject as likely to respond to the treatment if the CD8 protein density is reduced relative to a reference CD8+ T cell. For Type 1 diabetes, the method may involve measuring C-peptide levels in an in vitro biological sample from the subject, identifying the subject as likely to respond to the treatment if the C-peptide levels are detectable, and identifying the subject as unlikely to respond to the treatment if the C-peptide levels are substantially undetectable. The invention also features pharmaceutical compositions of one or more TNFR2 activators for therapeutic use.
Description
[0001] This application is a divisional application of Chinese patent application 201480068827.4 "Method for Identifying Subjects Responsive to Treatment for Autoimmune Diseases and Compositions for Treating the Diseases" filed on October 16, 2014. technical field [0002] In general, the present invention relates to methods of identifying subjects with autoimmune diseases who are likely to respond to treatment with a TNF-alpha receptor II activator and methods of treating subjects identified as likely to respond to such treatment . The invention also provides methods for treating a subject determined to be less likely to respond to treatment with a TNF-alpha receptor II activator alone. Background technique [0003] Autoimmune diseases are believed to involve an immune response to the body's own components that are not observed under normal conditions, resulting in a pathological state that causes distinct tissue and / or functional disorders. Autoimmune diseases are broadly...
Claims
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