FIELD: medicine.
SUBSTANCE: group of inventions relates to therapy and immunology, and is intended for the treatment of a subject requiring treatment with acidic human α-glucosidase. A method of treating a subject comprises administering to the subject methotrexate and acidic human α-glucosidase; and detection of an erythropoiesis biomarker in a sample obtained from a subject over a period of time from at least one day to about 30 days after methotrexate administration. Further treatment with acid human α-glucosidase is continued with or without additional therapy to induce immune tolerance or immunosuppressive therapy based on the level of the erythropoiesis biomarker compared to that in the control. If the level of the erythropoiesis biomarker is approximately equal to or lower than the control level, the specified additional therapy is administered simultaneously with further treatment with acidic human α-glucosidase; or if the level of the biomarker of erythropoiesis is increased compared with the control, continue further treatment with acidic human α-glucosidase without the introduction of the said additional therapy. In other embodiments, a method for assessing the level of immune tolerance in a subject with Pompe disease and a method for assessing the level of immune tolerance to acidic human α-glucosidase is provided.
EFFECT: use of a group of inventions makes it possible to increase the effectiveness of treating a subject with acidic human α-glucosidase through a strategy to reduce an unwanted immune response.
16 cl, 1 tbl, 11 dwg, 3 ex
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