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Combination therapy for treatment of autoimmune diseases using B cell depleting/immunoregulatory anti-body combination

A technology for autoimmune diseases and immune regulation, which is applied in the field of combination therapy using B cell depletion/immunomodulatory antibody combinations to treat autoimmune diseases, and can solve the problems of not disclosing the combined use of CD40L antibodies and unreported uses

Inactive Publication Date: 2005-03-09
BIOGEN INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the use of these antibodies in combination with antibodies specific for CD40L is not disclosed, nor is the use of this antibody in conjunction with B cell depleting antibodies reported

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0194] Patients with a clinical diagnosis of rheumatoid arthritis (RA) were initially treated with the rituximab (RITUXAN(R)) antibody. This patient may or may not also have B cell depleting antibodies, ie malignancy. In addition, the patient is optionally further treated with any one or more of the agents used to treat RA, such as salicylates; non-steroidal anti-inflammatory drugs such as indomethacin, phenylbutazone, phenyl Acetic acid derivatives (such as ibuprofen and fenoprofen), naphthylacetic acids (naproxen), pyrrolidinic acids (tometin), indoleacetic acids (sulindac), halogenated anthranilic acids (formazan chlorfenamic acid sodium), piroxicam, zomeac, and diflunisal; antimalarials such as chloroquine; gold salts; penicillamine; or immunosuppressants such as methotrexate or corticosteroids at doses of Known dose or reduced dose. However it is preferred to treat the patient with RITUXAN(R) only.

[0195] Administer RITUXAN® intravenously (IV) to RA patients accordin...

Embodiment 2

[0204] Patients diagnosed with autoimmune hemolytic anemia (AIHA) such as cryoglobulinemia or Coombs test positive anemia are treated with RITUXAN(R) antibody. AIHA is an acquired hemolytic anemia caused by autoantibodies that react with the patient's red blood cells. The patient being treated may optionally also have a B-cell malignancy. The patient is first treated with a composition containing a humanized anti-human CD40L antibody at a dose of 500 mg / m 2 IV, this dose is given twice a week for 4 weeks.

[0205] Thereafter administer RITUXAN® intravenously (IV) to the patient according to any of the following dosing regimens:

[0206] (A) 50mg / m 2 IV Day 1

[0207] 150mg / m 2 IV Days 8, 15 and 22

[0208] (B) 150mg / m 2 IV Day 1

[0209] 375mg / m 2 IV Days 8, 15 and 22

[0210] (C)375mg / m 2 IV Days 1, 8, 15 and 22

[0211] Other adjuvant therapies (eg, glucocorticoids, prednisone, azathioprine, cyclophosphamide, vinca-laden platelets, or danazol) can be combin...

Embodiment 3

[0215] Adult immune thrombocytopenic purpura (ITP) is a relatively rare hematologic disorder that constitutes the most common immune-mediated cytopenia. The disease is typically characterized by severe thrombocytopenia, possibly with acute bleeding, with normal or increased megakaryocytes in the bone marrow. Most ITP patients have IgG antibodies directed against target antigens on the outer surface of the platelet membrane, leading to platelet sequestration in the spleen and accelerated platelet destruction by the reticuloendothelial system (Bussell, J.B. Hematol. Oncol. Clin. North Am. (4): 179( 1990)). Various therapeutic interventions have been shown to be effective in the treatment of ITP. Steroids are generally considered first-line therapy, after which intravenous immune globulin (IVIG), splenectomy, or other medical therapy including vincristine or immunosuppressive / cytotoxic agents can be considered in most patients. Up to 80% of patients with ITP initially respond t...

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PUM

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Abstract

The present invention relates to the treatment of autoimmune diseases with a combination of an immunomodulatory antibody (such as an anti-B7.1 or anti-B7.2 or anti-CD40L antibody) and at least one B-cell antibody (such as CD19, CD20, CD22, CD23 or CD37), wherein These antibodies may be administered alone or in combination and in either order for extended periods of time.

Description

[0001] Cross References to Related Applications [0002] This application is related to a U.S. Provisional Application entitled "Combination Therapy for the Treatment of Autoimmune Diseases Comprising a CD40L Antagonist and Antibodies against B7, CD19, CD20, CD22, or CD23," filed September 18, 2000, in the name of Nabil Hanna No. 60 / 233,607 and U.S. Provisional Application No. 60 / 257,147, filed December 22, 2000, in the name of Nabil Hanna, entitled "Combination Therapies Using B-Cell Depleting / Immunomodulatory Antibody Combinations for the Treatment of Autoimmune Diseases" concerned and claim its priority. field of invention [0003] The present invention provides a new combined therapy for treating autoimmune diseases. Specifically, the present invention relates to the combined use of immunomodulatory antibodies (preferably antibodies that regulate T and / or B cell differentiation, proliferation and / or function) and B cell depleting antibodies (B cell depleting antibody) for...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/00A61K38/00A61K39/395A61P1/04A61P3/10A61P5/14A61P7/06A61P9/00A61P9/10A61P11/00A61P11/06A61P13/00A61P13/12A61P17/00A61P17/02A61P17/06A61P19/02A61P21/00A61P21/04A61P25/00A61P29/00A61P35/00A61P37/00A61P37/02A61P37/08A61P43/00C07K16/28
CPCC07K16/28A61K2039/507A61K39/39541A61K2039/505C07K16/2827C07K16/2887C07K2317/24C07K16/2875A61P1/04A61P11/00A61P11/06A61P13/00A61P13/12A61P17/00A61P17/02A61P17/06A61P19/02A61P21/00A61P21/04A61P25/00A61P29/00A61P35/00A61P37/00A61P37/02A61P37/08A61P43/00A61P5/14A61P7/06A61P9/00A61P9/10A61P3/10A61K2300/00A61K39/395
Inventor N·翰纳
Owner BIOGEN INC
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