Methods and compositions for use in treatment of patients with autoantibody positive diseases

A technology for autoimmune diseases and patients, applied in the direction of antibodies, chemical instruments and methods, preparations for in vivo tests, etc.

Inactive Publication Date: 2009-08-19
HUMAN GENOME SCI INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Finally, no laboratory test can confirm the diagnosis of lupus

Method used

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  • Methods and compositions for use in treatment of patients with autoantibody positive diseases
  • Methods and compositions for use in treatment of patients with autoantibody positive diseases
  • Methods and compositions for use in treatment of patients with autoantibody positive diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0593] Example 1: Summary of Clinical Trial Results of Application of Neutrokine-α Protein Antibody (Belimumab (Belimumab)) in the Treatment of Systemic Lupus Erythematosus (SLE)

[0594] A prospective, randomized, double-blind, placebo-controlled trial is about the addition of Belimumab (neutrokine-α antibody) to the standard treatment of SLE in the treatment of SLE. A total of 449 patients who met ACR criteria (Tan et al., Arthritis Rheum. 25:1271-7, (1982); and Hochberg et al., Arthritis Rheum. 40:1725, (1997)), with measurable self Medical history of antibodies and SLE subjects with SELENA SLEDAI score ≥4 at screening.

[0595] Study drug (1, 4, 10 mg / kg Belimumab) or placebo was administered intravenously on Days 0, 14, 28 and then every 28 days for 52 weeks. Subjects who completed 52 weeks of treatment were given the option of continuing the 24-week extension study. Belimumab was formulated in 10 mM sodium citrate, 1.9% glycerol, 0.5% sucrose, 0.01% (w / v) polysorbate 8...

Embodiment 2

[0605] Example 2: SELENA SLEDAI proteinuria score

[0606] Renal insufficiency is often associated with systemic lupus erythematosus. Those skilled in the art know a variety of standard measures that can be used to assess renal function, such as time to progression to end-stage renal disease, serum creatinine doubling time, creatinine clearance, iothalamic acid clearance, protein concentration in a single urine sample, and Protein concentration in 24-hour urine samples.

[0607] Proteinuria change calculated from "24-hour urine sample" is one of the items scored by SELENA SLEDAI. Proteinuria measurements can be made by any method known in the art. In a specific embodiment, a single urine sample is collected and protein levels and / or creatinine clearance are determined, see for example Lemann, et al., Clin Chem., 33:297-9, 1987 and Schwab, et al. al., ArchIntern Med., May;147(5):943-4, 1987. In a specific embodiment, urine is collected for 24 hours, and the amount of protei...

Embodiment 3

[0611] Example 3: Summary of Clinical Trial Results for Rheumatoid Arthritis (SLE) Using Neutrokine-α Protein Antibody (Belimumab)

[0612] A phase 2, multicenter, randomized, double-blind, placebo-controlled study was conducted in subjects with RA. Subjects were randomized into 4 treatment groups (placebo, 1 mg / kg, 4 mg / kg and 10 mg / kg). Belimumab or placebo was administered at 1, 4, 10 mg / kg or placebo on days 0, 14, 28 and then every 28 days for 24 weeks. This is followed by an optional 24-week extension period. Belimumab was formulated in 10 mM sodium citrate, 1.9% glycerol, 0.5% sucrose, 0.01% (w / v) polysorbate 80 (pH 6.5±0.3). Subjects receiving placebo also received the formulation without Belimumab (10 mM sodium citrate, 1.9% glycerol, 0.5% sucrose, 0.01% (w / v) polysorbate 80 (pH 6.5±0.3)). A total of 283 subjects participated in the study. Belimumab was administered to 214 subjects at 1, 4, or 10 mg / kg during the 24-week study treatment period. Ninety-nine subjec...

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Abstract

The present invention relates to methods and compositions for use in treatment of patients with autoantibody positive disease. In a specific embodiment, the present invention relates to a method of treating a patient that has an ANA titer of 1:80 or greater and / or greater than or equal to 30 IU / ml of anti-dsDNA antibodies in his / her blood plasma or serum comprising administering a therapeutically effective amount of an immunomodulatory agent, such as an antagonist of Neutrokine-alpha. Additionally provided is a method of reducing the frequency and / or quantity of corticosteroid administration to patients. In preferred embodiments, the patient has systemic lupus erythematosus. Methods for determining if a lupus patient is responding to medical treatment are also provided.

Description

Background technique [0001] Neutrokine-α protein (SEQ ID NO: 2) is a member of TNF ligand family, and it and APRIL (28.7%, SEQ ID NO: 4), TNFα (16.2%), and lymphotoxin-α (LTα) (14.1 %) share amino acid sequence identity (Moore, et al., (1999) Science 285:260-263). Neutrokine-α is known by several names in the scientific and patent literature, including B Lymphocyte Stimulator (BLyS), B Cell Activating Factor (BAFF), TNF, and ApoL-Associated Leukocyte Expressed Ligand-1 (TALL-1) (Moore , et al., (1999) Science 285:260-263; Schneider et al., (1999) J.Exp.Med.189:1747-1756; and Khare et al., (2000) Proc.Natl.Acad. Sci. 97:3370-3375). The official name of Neutrokine-α is tumor necrosis factor (ligand) superfamily member 13B (TNFSF13b). The full-length Neutrokine-α gene encodes a polypeptide of 285 amino acids, with a transmembrane region between the 47th and 73rd amino acids, and a non-hydrophobic sequence characteristic of type II membrane-bound proteins in front of the transm...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12P21/06C07H21/04C07K16/00A61K39/395A61K49/00
Inventor M·谢弗瑞尔W·弗里穆特钟振劭D·奥登海姆尔M·D·珀金斯
Owner HUMAN GENOME SCI INC
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