Methods for the therapy of Inflammatory Bowel Disease using a type-1 interferon antagonist
View Patent ↗Compositions and methods for the therapy of Inflammatory Bowel Disease (IBD), including Celiac Disease, Crohn's Disease, and Ulcerative Colitis, are disclosed. Illustrative compositions comprise one or more anti-type 1 interferon antagonists, such as anti-type 1 interferon receptor antibody antagonists and fragments thereof, as well as polypeptides and small molecules that inhibit the interaction of type 1 interferon with its receptor (IFNAR).
1. A method for the treatment of a patient afflicted with ulcerative colitis comprising the step of administering to said patient a therapeutically effective amount of a humanized or fully human anti-type 1 interferon receptor monoclonal antibody, wherein the antibody inhibits the binding of IFN-α, IFN-β, and IFN-ω to the type 1 interferon receptor.
2. A method for the treatment of a patient afflicted with ulcerative colitis or Crohn's disease comprising the step of administering to said patient a therapeutically effective amount of a humanized or fully human anti-type 1 interferon receptor monoclonal antibody, wherein the antibody inhibits the binding of IFN-α, IFN-β and IFN-ω to the type 1 interferon receptor, and is not administered in combination with another antibody, and wherein administration of the anti-type 1 interferon receptor antibody results in decreased neutrophil infiltration as compared to a control, following administration of the anti-type 1 interferon receptor antibody.
3. A method for the treatment of a patient afflicted with ulcerative colitis or Crohn's disease comprising the step of administering to said patient a therapeutically effective amount of a humanized or fully human anti-type 1 interferon receptor monoclonal antibody, wherein the antibody inhibits the binding of IFN-α, IFN-β, and IFN-ω to the type 1 interferon receptor, and is not administered in combination with another antibody, and wherein administration of the anti-type 1 interferon receptor antibody results in improved colon morphology as compared to a control, following administration of the anti-type 1 interferon receptor antibody.
4. A method for the treatment of a patient afflicted with ulcerative colitis or Crohn's disease comprising the step of administering to said patient a therapeutically effective amount of a humanized or fully human anti-type 1 interferon receptor monoclonal antibody, wherein the antibody inhibits the binding of IFN-α, IFN-β, and IFN-ω to the type 1 interferon receptor, and is not administered in combination with another antibody, and wherein administration of the anti-type 1 interferon receptor antibody results in decreased mucosal tissue thickness as compared to a control, following administration of the anti-type 1 interferon receptor antibody.
5. A method increasing body weight in a patient afflicted with ulcerative colitis or Crohn's disease comprising the step of administering to said patient a therapeutically effective amount of a humanized or fully human anti-type 1 interferon receptor monoclonal antibody, wherein the antibody inhibits the binding of IFN-α, IFN-β, and IFN-ω the type 1 interferon receptor, and is not administered in combination with another antibody, and wherein administration of the anti-type 1 interferon receptor antibody results in measurable body weight increase as compared to a control, following administration of the anti-type 1 interferon receptor antibody.
6. A method for the treatment of a patient afflicted with ulcerative colitis or Crohn's disease comprising the step of administering to said patient a therapeutically effective amount of a humanized or fully human anti-type 1 interferon receptor monoclonal antibody, wherein the antibody inhibits the binding of IFN-α, IFN-β, and IFN-ω to the type 1 interferon receptor, and is not administered in combination with another antibody.
7. A method for the treatment of a patient afflicted with Crohn's disease comprising the step of administering to said patient a therapeutically effective amount of a humanized or fully human anti-type 1 interferon receptor monoclonal antibody, wherein the antibody inhibits the binding of IFN-α, IFN-β, and IFN-ω to the type 1 receptor, and is not administered in combination with another antibody.
8. The method of any one of claims 1 , 6 , and 7 , wherein said anti-type 1 interferon receptor antibody is administered by a route selected from the group consisting of intravenous bolus, intravenous slow bolus, and infusion.
9. The method of any one of claims 1 , 6 , and 7 , wherein said anti-type 1 interferon receptor antibody is administered by a route selected from the group consisting of subcutaneously, intramuscularly, transdermally, intradermally, and intravenously.
10. The method of any one of claims 1 , 6 , and 7 , wherein said anti-type 1 interferon receptor antibody is administered in a dosage range of between 0.1 mg/kg body weight and 50 mg/kg body weight, inclusive.
11. The method of claim 10 wherein said anti-type 1 interferon receptor antibody is administered in a dosage range of between 0.5 mg/kg body weight and 10 mg/kg body weight, inclusive.
12. The method of claim 11 wherein said anti-type 1 interferon receptor antibody is administered in a dosage range of between 2 mg/kg body weight and 5 mg/kg body weight, inclusive.
13. The method of any one of claims 1 , 6 , and 7 , wherein said anti-type 1 interferon receptor antibody is administered at a frequency between once per day and once per month, inclusive.
14. The method of claim 13 wherein said anti-type 1 interferon receptor antibody is administered at a frequency between twice per week and every two weeks, inclusive.
15. The method of claim 13 wherein said anti-type 1 interferon receptor antibody is administered at a frequency of approximately once per week.
16. The method of any one of claims 1 , 6 , and 7 , further comprising administration of a second therapeutic selected from the group consisting of an immunosuppressive, an anti-inflammatory, a steroid, an immunomodulatory agent, a cytokine, and a TNF antagonist.