Methods of treating a subject afflicted with an autoimmune disease using predictive biomarkers of clinical response to glatiramer acetate therapy in multiple sclerosis

A method for treating a subject afflicted with relapsing-remitting multiple sclerosis, including subjects who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis with a pharmaceutical composition comprising glatiramer acetate and a pharmaceutically acceptable carrier, comprising the steps of:

• a) administering a therapeutic amount of the pharmaceutical composition to the subject;
• b) determining whether the subject is a glatiramer acetate responder by
• i) measuring the value of IL-10 concentration in the blood of the subject, and comparing the measured value to a reference value to identify the subject as a glatiramer acetate responder, wherein an increase in IL-10 concentration, relative to the reference value, is associated with a subject being a responder to glatiramer acetate treatment wherein the value of IL-10 concentration is measured about 3 months to about 24 months after the beginning of administration of the pharmaceutical composition, and
• ii) measuring the value of one or more biomarkers selected from the group consisting of IL-17 concentration, IL-18 concentration, TNF-α concentration, BDNF concentration, caspase-1 concentration, IL-10/IL-18 ratio and IL-10/IL-17 ratio in the blood of the subject, and comparing the measured value to a reference value to identify the subject as a glatiramer acetate responder, wherein an increase in BDNF concentration, IL-10/IL-18 ratio, or IL-10/IL-17 ratio is associated with a subject being a responder to glatiramer acetate treatment, and wherein a decrease in IL-17 concentration, IL-18 concentration or caspase-1 concentration is associated with a subject being a responder to glatiramer acetate treatment;
• and
• c) continuing the administration if the subject is identified as a glatiramer acetate responder, or modifying treatment of the subject if the subject is not identified as a glatiramer acetate responder, so as thereby to treat the subject.