PREDICTING OUTCOME OF TREATMENT WITH AN ANTI-alpha4beta7 INTEGRIN ANTIBODY
AssigneeMillennium Pharmaceuticals, Inc.
InventorsMaria Rosario, Timothy L. Wyant, Brihad Abhyankar
Life of this patent
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Abstract
The invention provides methods for treating patients with anti-α4β7 antibody comprising predicting outcome of the antibody therapy. The invention relates to the identification of patients who can respond to therapy comprising an anti-a4β7 antibody.
Claims30
A method of treating a patient suffering from Inflammatory Bowel Disease (IBD), the method comprising the steps of:
- a) measuring the concentration of vedolizumab in a patient wherein the patient was administered an induction phase dosing regimen of vedolizumab at least two weeks prior,
- b) selecting the patient whose measurement of vedolizumab in step a) indicates low clearance;
- and
- c) administering vedolizumab to the selected patient, thereby treating IBD.
A method of treating a patient suffering from Inflammatory Bowel Disease (IBD), the method comprising the steps of:
- a) administering two doses of vedolizumab to the patient suffering from IBD, wherein the second dose is administered about two weeks after the first dose is administered to the patient;
- b) selecting the patient wherein the patient has a serum concentration of at least 8 μg per ml as measured at least two weeks after the second dose;
- and
- c) administering vedolizumab to the selected patient, thereby treating the patient having IBD.
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22-35. (canceled)
A method for maintaining remission of inflammatory bowel disease in a patient, wherein the patient has received at least one dose of vedolizumab in the previous two months, the method comprising:
- a) obtaining a serum sample from the patient;
- b) measuring the concentration of vedolizumab in the sample;
- c) administering vedolizumab thereafter every eight weeks if the concentration is at least 8 μg per ml.
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A method for achieving corticosteroid-free remission of a patient having inflammatory bowel disease (IBD), wherein the patient was dependent on corticosteroids, the method comprising the steps of:
- a) selecting a human patient having IBD and having a low clearance of vedolizumab at a time point that is four weeks after a second dose of vedolizumab, wherein a first dose of vedolizumab was administered to the subject two weeks prior to the second dose of vedolizumab,
- b) administering vedolizumab to the human patient having IBD, and
- c) decreasing the amount of corticosteroid by a tapering regimen, until no corticosteroid is being administered;
- thereby achieving corticosteroid-free remission in the patient having IBD.
Dependencies are inferred from the claim text.