# US 8,784,812 B2 · Methods for treating autoimmune diseases using a TACI-Ig fusion molecule > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,784,812 B2 - Document ID: US8784812B2 - Status: Granted - Kind: B2 - Application number: 11/748,978 - Filed: 2007-05-15 - Published: 2007-11-29 - Granted: 2014-07-22 - Earliest claimed: 2006-05-15 - Assignees: ZymoGenetics, Inc.; Ares Trading S.A. - Applicants: Herve Broly; Jennifer Visich; Ivan Nestorov; Sharon Busby; Jane Gross - Inventors: Herve Broly; Jennifer Visich; Ivan Nestorov; Sharon Busby; Jane Gross - Web page: https://patentgrep.com/patent/US8784812B2 ## CPC - A61K 33/242: Gold; Compounds thereof - A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00) - A61K 31/42: Oxazoles - A61K 31/4706: 4-Aminoquinolines; 8-Aminoquinolines, e.g. chloroquine, primaquine - A61K 31/519: ortho- or peri-condensed with heterocyclic rings - A61K 31/52: Purines, e.g. adenine - A61K 31/65: Tetracyclines - A61K 38/177: {Receptors; Cell surface antigens; Cell surface determinants} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 19/02: for joint disorders, e.g. arthritis, arthrosis - A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] - A61P 37/00: Drugs for immunological or allergic disorders - A61P 37/06: Immunosuppressants, e.g. drugs for graft rejection - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C07K 2319/30: Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) ## Abstract In various embodiments, the present invention provides methods and compositions for treatment of autoimmune diseases, including rheumatoid arthritis, for example comprising administering to a patient in need of such treatment a TACI-Ig fusion molecule. In one embodiment, the TACI-Ig fusion molecule is administered in amount sufficient to slow, suppress or inhibit proliferation-inducing functions of BlyS and APRIL. ## Claims ### Claim 1 A method for treatment of rheumatoid arthritis in a human patient comprising administering to the patient a composition comprising a fusion molecule selected from the group consisting of: (a) a fusion molecule comprising (i) TACI extracellular domain wherein said TACI extracellular domain is at least 95% identical to SEQ ID NO:1 and binds BlyS; and (ii) a human immunoglobulin-constant domain; (b) a fusion molecule comprising amino acids 30-110 of SEQ ID NO: 1 and a human immunoglobulin-constant domain; (c) a fusion molecule consisting of amino acids 30-110 of SEQ ID NO: 1 and a human immunoglobulin-constant domain; (d) a fusion molecule consisting of SEQ ID NO: 2; and (e) a fusion molecule consisting of amino acids 30-110 of SEQ ID NO:1 and the human immunoglobulin-constant domain of SEQ ID NO: 2; wherein said composition is administered in an amount from 1.0 mg per 1 kg of patient's body weight to 9.0 mg per 1 kg of patient's body weight and wherein said composition is administered in said amount 7 times during a twelve-week interval, 3 times during a four-week interval or every other week for 2 to 30 weeks. ### Claim 2 (depends on 1) The method of claim 1, wherein said composition is administered in said amount 7 times during a twelve-week interval. ### Claim 3 (depends on 2) The method of claim 2, wherein said composition is administered in said amount 7 times during a twelve-week interval, followed by additional administrations of said composition at said amount. ### Claim 4 (depends on 1) The method of claim 1, said composition is administered in said amount 3 times during a four-week interval. ### Claim 5 (depends on 4) The method of claim 4, wherein said composition is administered in said amount 3 times during a four-week interval, followed by additional administrations of said composition at said amount. ### Claim 6 (depends on 1) The method of claim 1, wherein said composition is administered in said amount every other week for 2 to 30 weeks. ### Claim 7 (depends on 1) The method of claim 1, wherein said method further comprises co-administering to the patient a second medicament. ### Claim 8 (depends on 7) The method of claim 7, wherein said second medicament is selected from the group consisting of: hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, rituximab, infliximab, azathioprine, D-penicillamine, Gold (oral or intramuscular), minocycline, cyclosporine, a corticosteroid, a non-steroidal anti-inflammatory drug (NSAIDS), a cytokine, an anti-cytokine and an interferon. ### Claim 9 (depends on 1) The method of claim 1, wherein said composition is administered subcutaneously, orally or intravenously. ### Claim 10 (depends on 1) The method of claim 1, wherein said human immunoglobulin-constant domain is a human immunoglobulin-constant domain of IgG. ### Claim 11 (depends on 10) The method of claim 10, wherein said human immunoglobulin-constant domain comprises Fc5. ### Claim 12 A method for treatment of rheumatoid arthritis in a human patient comprising administering to the patient a composition comprising a fusion molecule selected from the group consisting of: (a) a fusion molecule comprising amino acids 30-110 of SEQ ID NO: 1 and a human immunoglobulin-constant domain; (b) a fusion molecule consisting of amino acids 30-110 of SEQ ID NO: 1 and a human immunoglobulin-constant domain; and (c) a fusion molecule consisting of SEQ ID NO: 2; wherein said composition is administered in an amount from 1.0 mg per 1 kg of patient's body weight to 9.0 mg per 1 kg of patient's body weight and wherein said composition is administered in said amount 7 times during a twelve-week interval, 3 times during a four-week interval or every other week for 2 to 30 weeks. ### Claim 13 (depends on 12) The method of claim 12, said method further comprising co-administering to the patient a second medicament. ### Claim 14 (depends on 13) The method of claim 13, wherein said second medicament is selected from the group consisting of: hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, rituximab, infliximab, azathioprine, D-penicillamine, Gold (oral or intramuscular), minocycline, cyclosporine, a corticosteroid, a non-steroidal anti-inflammatory drug (NSAIDS), a cytokine, an anti-cytokine and an interferon. ### Claim 15 (depends on 12) The method of claim 12, wherein said composition is administered subcutaneously, orally or intravenously. ### Claim 16 (depends on 12) The method of claim 12, wherein said human immunoglobulin-constant domain is a human immunoglobulin-constant domain of IgG. ### Claim 17 (depends on 15) The method of claim 15, wherein said human immunoglobulin-constant domain comprises Fc5.