Methods for diagnosing and treating inflammatory bowel disease

A method of identifying a human patient suffering from a gastrointestinal inflammatory disorder as likely to respond to a therapy comprising an integrin beta7 antagonist, the method comprising:

• (a) measuring the level of mRNA expression of at least one gene in a biological sample from the patient, wherein the at least one gene is selected from integrin beta7, integrin alphaE, and CD3epsilon;
• (b) comparing the level of mRNA expression measured in (a) to a reference level;
• and
• (c) identifying the patient as more likely to respond to the therapy comprising an integrin beta7 antagonist when the level of mRNA expression measured in (a) is above the reference level.

A method of treating a human patient having a gastrointestinal inflammatory disorder, the method comprising:

• (a) measuring the level of mRNA expression of at least one gene in a biological sample from the patient, wherein the at least one gene is selected from integrin beta7, integrin alphaE, and CD3epsilon;
• (b) comparing the level of mRNA expression measured in (a) to a reference level;
• (c) identifying the patient as more likely to respond a therapy comprising an integrin beta7 antagonist when the level of mRNA expression measured in (a) is above the reference level;
• and
• (d) administering the therapy when the level of mRNA expression measured in (a) is above the reference level, thereby treating the gastrointestinal inflammatory disorder.

A method of predicting the response of a patient suffering from a gastrointestinal inflammatory disorder to a therapy comprising an integrin beta7 antagonist, the method comprising:

• obtaining a biological sample from the patient,
• measuring the number of cells expressing at least one protein selected from integrin beta7, integrin alphaE, and CD3epsilon,
• comparing the number of expressing cells measured in the sample to a reference level, and
• predicting that the patient will respond to the therapy when the number of protein-expressing cells has been measured as elevated compared to the reference level and predicting that the patient will not respond to the therapy when the number of protein-expressing cells has been measured as low compared to the reference level.

A method of identifying a patient suffering from a gastrointestinal inflammatory disorder as likely to respond to a therapy comprising an integrin beta7 antagonist, the method comprising:

• (a) measuring the number of cells expressing at least one protein in a biological sample from the patient, wherein the at least one protein is selected from integrin beta7, integrin alphaE, and CD3epsilon;
• (b) comparing the number of cells measured in (a) to a reference level;
• and
• (c) identifying the patient as more likely to respond to the therapy comprising an integrin beta7 antagonist when the number of cells measured in (a) is above the reference level.

A method of treating a patient having a gastrointestinal inflammatory disorder, the method comprising:

• (a) measuring the number of cells expressing at least one protein in a biological sample from the patient, wherein the at least one protein is selected from integrin beta7, integrin alphaE, and CD3epsilon;
• (b) comparing the number of expressing cells measured in (a) to a reference level;
• (c) identifying the patient as more likely to respond a therapy comprising an integrin beta7 antagonist when the number of protein-expressing cells measured in (a) is above the reference level;
• and
• (d) administering the therapy when the number of protein-expressing cells measured in (a) is above the reference level, thereby treating the gastrointestinal inflammatory disorder.