Methods of treating antibody-mediated rejection in organ transplant patients with C1-esterase inhibitor
A method and composition for treating or preventing antibody-mediated rejection (AMR) of a transplanted organ are provided.
1. A method of treating antibody-mediated rejection (AMR) of an organ allograft in a patient in need thereof,
the method comprising administration of a C1 esterase inhibitor (C1-INH) protein at a dose of about 20,000 units given in divided doses over a duration of about 1 to 30 days,
wherein the administration is initiated within 1 to 90 days of organ transplantation, treatment with plasmapheresis, treatment with intravenous immunoglobulin (IVIg), or diagnosis of AMR of the patient,
wherein the method results in a therapeutic effect lasting for at least 3 months after cessation of therapy.
2. The method of claim 1 , further comprising subjecting the patient to plasmapheresis.
3. The method of claim 1 , further comprising administering fresh frozen plasma.
4. The method of claim 1 further comprising administering intravenous immunoglobulin.
5. The method of claim 1 , further comprising administering an anti-lymphocyte preparation, rituximab, bortezomib, eculizumab, or a combination thereof.
6. The method of claim 1 wherein the organ is a solid organ.
7. The method of claim 6 , wherein the solid organ is selected from the group consisting of kidney, pancreas, intestine, heart, lung, and liver.
8. The method of claim 7 , wherein the solid organ is a kidney.
9. The method of claim 1 , wherein the C1-INH protein is plasma-derived or recombinant.
10. The method of claim 1 , wherein the duration is about 10-20 days.
11. The method of claim 1 , wherein the duration is 13 days.
12. The method of claim 1 , wherein the therapeutic effect comprises the prevention of AMR.
13. The method of claim 1 , wherein the administration is initiated within about 5 to 10 days of organ transplantation, treatment with plasmapheresis, treatment with IVIg, or diagnosis of AMR.
14. A method of treating antibody-mediated rejection (AMR) of a kidney allograft in a patient in need thereof,
the method comprising administration of a C1 esterase inhibitor (C1-INH) protein at a dose of about 20,000 units given in divided doses over a duration of about 1 to 30 days,
wherein the administration is initiated within 1 to 90 days of organ transplantation, treatment with plasmapheresis, treatment with intravenous immunoglobulin (IVIg), or diagnosis of AMR of the patient,
wherein the method results in a therapeutic effect lasting for at least 3 months after cessation of therapy.
15. The method of claim 14 , wherein the C1-INH protein is plasma-derived or recombinant.
16. The method of claim 14 , further comprising subjecting the patient to plasmapheresis.
17. The method of claim 14 , further comprising administering fresh frozen plasma.
18. The method of claim 14 , further comprising administering intravenous immunoglobulin.
19. The method of claim 14 , further comprising administering an anti-lymphocyte preparation, rituximab, bortezomib, eculizumab, or a combination thereof.
20. The method of claim 14 , wherein the therapeutic effect comprises improvement in renal function.
21. The method of claim 14 , wherein the therapeutic effect comprises the prevention of AMR.
22. The method of claim 14 , wherein the therapeutic effect comprises the treatment or prevention of chronic or transplant glomerulopathy.
23. The method of claim 14 , wherein the administration is initiated within 5 to 10 days of one of organ transplantation, treatment with plasmapheresis, treatment with IVIg, or diagnosis of AMR.
24. The method of claim 14 , wherein the duration is from about 10-20-days.
25. The method of claim 14 , wherein the duration is 13 days.
26. The method of claim 2 , further comprising administering IVIg.
27. The method of claim 16 , further comprising administering IVIg.