Methods for treating inflammatory bowel disease
AssigneeNogra Pharma Limited
InventorGiovanni Monteleone
Life of this patent
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Abstract
Methods of treating a subject with IBD with an anti-SMAD7 therapy, such as a SMAD7 antisense oligonucleotide, to reduce CRP levels are disclosed. Methods of treating and managing IBD in a subject using an anti-SMAD7 therapy, such as a SMAD7 antisense oligonucleotide, based on CRP levels are also disclosed. Also disclosed are methods of determining whether a subject with IBD is responsive or likely to be responsive to treatment an anti-SMAD7 therapy. Reduction of CRP levels may correlated with IBD remission or decreases in CDAI score. The present invention also relates to treatment of IBD using an anti-SMAD7 therapy (e.g., an antisense oligonucleotide) in combination with an additional agent. The invention also features related pharmaceutical compositions and kits.
Claims26
A method for treating or managing an inflammatory bowel disease (IBD) in a patient having the IBD, wherein the method comprises:
- (a) administering to the patient an initial dose of a SMAD7 antisense-oligonucleotide;
- (b) analyzing the level of C-reactive protein (CRP) in the patient;
- and
- (c) if the level of CRP is above a normal level of CRP, then administering to the patient a subsequent dose that is greater than or equal to the initial dose, or, if the level of CRP is below a normal level of CRP, then administering to the patient a subsequent dose that is equal to or smaller than the initial dose,
- wherein the normal level of CRP is about 0.01 mg/L, about 0.05 mg/L, about 0.1 mg/L, about 0.2 mg/L, about 0.3 mg/L, about 0.4 mg/L, about 0.5 mg/L, between 0.5 mg/L and 3 mg/L, between 1 mg/L and 3 mg/L, between 1.5 mg/L and 3 mg/L, between 2 mg/L and 3 mg/L, between 2.5 mg/L and 3 mg/L, or about 3.0 mg/L.
A method for treating or managing an inflammatory bowel disease (IBD) in a patient having the IBD, wherein the method comprises:
- (a) analyzing the level of CRP in the patient;
- and
- (b) if the level of CRP is above a threshold level of CRP, then administering to the patient an initial dose of a SMAD7 antisense-oligonucleotide,
- wherein the threshold level of CRP is about 0.5 mg/L, about 1.0 mg/L, about 1.5 mg/L, about 2.0 mg/L, about 2.5 mg/L, about 3.0 mg/L, about 3.5 mg/L, about 4.0 mg/L, about 4.5mg/L, about 5.0 mg/L, about 7.5 mg/L, or about 10.0 mg/L.
Dependencies are inferred from the claim text.