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AssigneesAmgen Inc., MedImmune, LLC
InventorsRobert W. Georgantas, III, Chris Morehouse, Brandon Higgs, Koustubh Ranade, Katie Streicher, William Rees, Meina Liang, Raffaella Faggioni, Jing Li, Inna Vainshtein, Yen-Wah Lee, Jinging Chen, Robert A. Gasser, JR.
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The present invention relates to the use of the Chemokine (C—C motif) ligand 20 (CCL20) as a biomarker to stratify or identify populations of patients suffering from interleukin-23 (IL23)-mediated diseases (e.g., Crohn's disease) responsive to treatment with an, anti-IL23 antagonist (including, e.g., anti-IL23 antibodies). Levels of CCL20 above or below a predetermined threshold can be used, for example, (i) to determine whether a patient with an IL23-mediated disease or disorder such a Crohn's disease is eligible or non-eligible for treatment with a therapeutic agent, (ii) to determine whether treatment with a certain agent should be commenced, suspended, or modified, (iii) to diagnose whether the IL23-mediated disease is treatable or not treatable with a specific therapeutic agent, or (iv) to predict the outcome of treating the IL23-mediated disease with a specific therapeutic agent. CCL20 can be used in combination with other IL23 pathway biomarkers such as IL22 and/or lipocalin-2 (LCN2).
A method of treating an interleukin-23 (IL23)-mediated disease in a patient, comprising administering an IL23 antagonist to a patient if the patient is determined to have (i) a lower or decreased level of CCL20 in one or more samples taken from the patient compared to a predetermined CCL20 threshold level, or compared to a CCL20 level in one or more control samples.
A method of treating a patient having an IL23-mediated disease comprising suspending or not initiating the administration of an IL23 antagonist to a patient if the patient is determined to have a higher or increased level of CCL20 in one or more samples taken from the patient compared to a predetermined CCL20 threshold level, or compared to a CCL20 level in one or more control samples.
A method of treating an interleukin-23 (IL23)-mediated disease in a patient, wherein the patient failed, was non-responsive or intolerant to treatment with an anti-TNF agent comprising administering an IL23 antagonist to the patient if the patient is determined to have a lower or decreased level of CCL20 in one or more samples taken from the patient compared to a predetermined CCL20 threshold level, or compared to a CCL20 level in one or more control samples.
A method of determining whether to treat a patient having an IL23-mediated disease with an IL-23 antagonist, comprising determining to treat the patient if the patient is determined to have a lower or decreased level of CCL20 in one or more samples taken from the patient compared to a predetermined CCL20 threshold level, or compared to a CCL20 level in one or more control samples.
A method of selecting a patient diagnosed with an IL23-mediated disease as a candidate for treatment with an IL23 antagonist, comprising selecting the patient for treatment if the patient is determined to have lower or decreased level of CCL20 in one or more samples taken from the patient compared to a predetermined CCL20 threshold level, or compared to a CCL20 level in one or more control samples.
Dependencies are inferred from the claim text.