Genzyme Corporation

Susan Richards

Jad Zoghbi

Ryan Grabert

Valerie Theobald

Yuanxin Xu

Alexandra Joseph

Johnson Tran

Melanie Ruzek

Richard Garman

Jad Zhoghbi

The present application provides methods of treating a disease, such as Pompe disease, in a subject, comprising detecting an erythropoiesis biomarker in a sample of the subject after administration of methotrexate and a therapeutic agent to the subject, and administering further treatment with or without concurrently administering additional immune tolerance induction or immunosuppression therapy based on the level of the erythropoiesis biomarker. Further provided by the present application are methods and kits for assessing the level of immune tolerance to a therapeutic agent in a subject based on detection of an erythropoiesis biomarker after administration of methotrexate and the therapeutic agent to the subject.

Biomarkers of methotrexate-induced immune tolerance

Methods and kits for detecting antibodies (e.g., anti-drug antibodies). Such methods and kits permit the detection of, for example, anti-drug antibodies in human body fluids, such as blood, plasma and serum.

Assays for detecting the presence or amount of an anti-drug antibody

The invention provides methods for reducing undesired immune responses, such as anti-drug antibody (ADA) responses and other T- and/or B-cell-mediated immune responses, in patients by using treatment with methotrexate.

Induction of immune tolerance by using methotrexate

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Bridgewater, NJ, United States of America

Susan Richards