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AssigneeGenzyme Corporation
InventorsDarren Phillip BAKER, Emanuele DE RINALDIS, Richa HANAMSAGAR, Evis HAVARI, Virginia SAVOVA, Srinivas SHANKARA
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The invention provides methods of assessing the risk of secondary autoimmunity in a patient with a primary autoimmune disease (e.g., MS) following lymphocyte depleting therapy (e.g., anti-CD52 antibody therapy) based on the fraction of a novel cell type termed platelet lineage cells (PLCs) among total cells, and/or the Immature Platelet Fraction (IPF) value, in a biological sample from the patient.
A method for assessing the risk of developing secondary autoimmunity in a patient with a primary autoimmune disease following lymphocyte depleting therapy, comprising:
A method for treating a patient with a primary autoimmune disease, comprising:
The method of any one of the preceding claims, wherein the PLC fraction is reduced by >2 standard deviations compared to that of a control subject.
The method of any one of the preceding claims, wherein the IPF value is increased by >2 standard deviations compared to that of a control subject.
The method of any one of the preceding claims, wherein the PLCs are characterized by being CD41+CD61+SPARC+TREML1+.
The method of any one of the preceding claims, further comprising the step of determining the fraction of immature PLCs among the total PLC population in the biological sample from the patient, wherein an increased fraction of immature PLCs compared to a third reference is indicative of a heightened risk of developing secondary autoimmunity in the patient after treatment.
The method of any one of the preceding claims, wherein the secondary autoimmunity is selected from the group consisting of immune thrombocytopeniaurpura (ITP), Graves' disease, Hashimoto's disease, Goodpasture's disease, membranous glomerulonephritis, red cell aplasia, autoimmune thyroid disease, transient thyroiditis, autoimmune hemolytic anemia, diabetes mellitus type 1, alopecia areata/alopecia totalis, vitiligo, myalgia, sarcoidosis, autoimmune neutropenia, autoimmune hepatitis, and autoimmune lymphopenia.
The method of any one of the preceding claims, wherein the primary autoimmune disease is relapsing MS.
The method of any one of the preceding claims, wherein the primary autoimmune disease is relapsing-remitting multiple sclerosis (RR-MS).
The method of any one of the preceding claims, wherein the primary autoimmune disease is secondary progressive MS (SPMS).
A lymphocyte-depleting therapy for use in treating a primary autoimmune disease in a patient, wherein the patient has been selected as not being at a heightened risk of developing secondary autoimmunity after the lymphocyte depleting therapy, wherein the risk has been diagnosed by determining
Use of a lymphocyte-depleting therapy in the manufacture of a medicament for treating a primary autoimmune disease in a patient, wherein the patient has been selected as not being at a heightened risk of developing secondary autoimmunity after the lymphocyte depleting therapy, wherein the risk has been diagnosed by determining
Dependencies are inferred from the claim text.