Methods and kits for evaluating clinical outcomes of autoimmune disease

A method of evaluating a clinical outcome of an autoimmune disease in a subject, the method comprising:

• isolating a T cell population comprising CD3+ CD4+ in a sample obtained from the subject;
• testing the T cell population for biomarkers (i) CD45RA and TNF-alpha, and optionally CXCR5, or (ii) CD45RA and CXCR5;
• determining the clinical outcome of the autoimmune disease in the subject, wherein the clinical outcome is indicated by comparing a level of the biomarker TNF-alpha and/or CXCR5 in the T cell population in relation to a predetermined level;
• wherein the predetermined level is expressed in terms of a percentage of the T cell population and is obtained from T cells isolated from a population of healthy subjects or subjects that have recovered from an immunological disease;
• wherein the level of the biomarker TNF-alpha and/or CXCR5 in the T cell population (a) above the predetermined level and in an absence of CD45RA indicates a flare state or an active state of the autoimmune disease;
• or (b) below the predetermined level and in an absence of CD45RA indicates an inactive state of the autoimmune disease;
• wherein the predetermined level of the biomarker TNF-alpha in the T cell population is at least 10% of the total CD3+CD4+ T cell population;
• and/or wherein the predetermined level of the biomarker CXCR5 in the T cell population is at least 4% of the total CD3+CD4+ T cell population;
• and
• (i)(a) selecting a subject determined to be in a flare state, or an active state, of the autoimmune disease, having the level of the biomarker TNF-alpha or CXCR5 in the T cell population above the predetermined level and an absence of CD45RA;
• and
• (i)(b) treating, or continuing to treat the subject determined to be in a flare state, or an active state, of the autoimmune disease with a biologic disease modifying anti-rheumatic drug;
• or
• (ii)(a) selecting a subject determined to be in the inactive state of the autoimmune disease, having the level of the biomarker TNF-alpha or CXCR5 in the T cell population below the predetermined level;
• and
• (ii)(b) withdrawing, or continuing to withhold from treatment with a biologic disease modifying anti-rheumatic drug, the subject determined to be in the inactive state of the autoimmune disease;
• and
• wherein the autoimmune disease is:
• (a) a rheumatic disease;
• (b) juvenile idiopathic arthritis (JIA);
• (c) rheumatoid arthritis;
• (d) psoriasis;
• (e) psoriatic arthritis;
• or (f) polyarticular JIA.