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US 2024/0254243 A1Published application
Systems and methods for improved targeted therapy
AssigneePrometheus Laboratories Inc.
InventorThierry DERVIEUX
Life of this patent
Estimating the term…
Abstract
Provided herein are systems and methods for optimizing a biological therapy regimen for a subject. The subject may be a patient diagnosed with an immune mediated inflammatory disease. In some embodiments, the systems and methods may involve inputting patient data into a model to forecast a drug concentration level in a patient and establish a dosing regimen for maintaining a pre-specified threshold drug concentration level in the patient. The pre-specified threshold may be a target concentration level for effective treatment of the immune mediated inflammatory disease in the patient.
Claims283
A method for treating an immune mediated inflammatory disease in a subject, the method comprising:
- (a) analyzing a biological sample obtained from a subject with an immune-mediated inflammatory disease, wherein the analyzing comprises:
- (i) obtaining or having obtained the biological sample from the subject;
- and
- (ii) quantifying or having quantified analytes in the biological sample, wherein the analytes comprise:
- (1) a level of a biologic drug, (2) a level of autoantibodies against the biologic drug, and (3) a level of albumin, wherein the subject has received a treatment for the immune-mediated inflammatory disease that comprises a current dose of the biologic drug administered to the subject at a current inter-dose interval;
- (b) determining a likelihood of achieving a pre-specified threshold concentration of the biologic drug in the subject based, at least in part, on (1) the level of the biologic drug, the level of the autoantibodies, and the level of albumin quantified in (a)(ii), and (2) the current dose of the biologic drug and the current inter-dose interval;
- and
- (c) if the likelihood of achieving the pre-specified threshold concentration of the biologic drug is above 50%, then:
- (1) administering the current dose of the biologic drug to the subject at the current inter-dose interval;
- or
- (2) administering a dose of the biologic drug that is (i) lower than the current dose to the subject at the current inter-dose interval, (ii) the same as the current dose to the subject at an inter-dose interval that is longer than the current inter-dose interval, or (iii) lower than the current dose to the subject at an inter-dose interval that is longer than the current inter-dose interval;
- (d) if the likelihood of achieving the pre-specified threshold concentration of the biologic drug is below 50%, then administering a dose of the biologic drug that is (i) higher than the current dose to the subject in the current inter-dose interval, (ii) the current dose at an inter-dose interval that is shorter than the current inter-dose interval, or (iii) higher than the current dose to the subject in the inter-dose interval that is shorter than the current inter-dose interval;
- or
- (e) if the dose of the biologic drug in (d) is above a maximum dose and the inter-dose interval in (d) is less than or equal to a minimum inter-dose interval, then discontinuing the treatment comprising the biologic drug.
11 more elements
A method for achieving a threshold biologic drug concentration value in a subject, the method comprising:
- (a) initializing a model of a biologic drug concentration profile for a biologic drug, wherein the model comprises data received from a reference population that were or currently are being treated with the biologic drug for treatment of an immune-mediated inflammatory disease;
- (b) generating subject specific parameters relating to pharmacokinetic performance of the biologic drug in the subject;
- (c) simulating the biologic drug concentration profile for the subject based on the subject specific parameters and the data from the reference population;
- (d) updating the model based on newly received data from the subject in (b) and newly received data from the reference population in (a);
- and
- (e) estimating a dose of the biologic drug at an inter-dose interval to achieve the threshold biologic drug concentration value in the subject with the model updated in (d), wherein the threshold biologic drug concentration is sufficient to treat the immune-mediated inflammatory disease in the subject.
3 more elements
A computer-implemented method of training an algorithm that determines an biologic drug profile of a biologic drug for a subject having an immune-mediated inflammatory disease, the method comprising:
- (a) receiving data from a database, wherein the data is related to a pharmacokinetic performance of the biologic drug in individuals from a reference population having the immune-mediated inflammatory disease that have been treated with the biologic drug;
- (b) establishing a first set of parameter estimates from the data;
- (c) deriving a second set of parameter estimates for a model based at least in part on the first set of parameter estimates;
- (d) receiving subject specific data related to the pharmacokinetic performance of the biologic drug in the subject;
- (e) updating the model based at least in part on the subject specific data received in (d);
- and
- (f) determining a biologic drug profile for the subject with the model, wherein the biologic drug profile comprises a dose of the biologic drug at an inter-dose interval estimated to achieve a threshold biologic drug concentration value in the subject that is sufficient to treat the immune-mediated inflammatory disease in the subject.
4 more elements
A computer-implemented system for achieving a threshold biologic drug concentration value in a subject, the computer-implemented system comprising:
- a computing device comprising at least one processor;
- an operating system configured to perform executable instructions;
- a memory;
- and
- a computer program including instructions executable by the computing device to create an application comprising:
- a software module configured to initialize a model of a biologic drug concentration profile for a biologic drug, wherein the model comprises data related to a pharmacokinetic performance of the biologic drug in individuals from a reference population having the immune-mediated inflammatory disease that have been treated with the biologic drug;
- a software module configured to establish a first set of parameter estimates from the data;
- a software module configured to derive a second set of parameter estimates for a model based at least in part on the first set of parameter estimates;
- a software module configured to receive subject specific data related to the pharmacokinetic performance of the biologic drug in the subject;
- and
- a software module configured to update the model based at least in part on the subject specific data;
- and
- a software module configured to determine a biologic drug profile for the subject, wherein the biologic drug profile comprises a dose of the biologic drug at an inter-dose interval estimated to achieve a threshold biologic drug concentration value in the subject that is sufficient to treat the immune-mediated inflammatory disease in the subject.
10 more elements
Non-transitory computer-readable storage media encoded with a computer program including instructions executable by one or more processors for achieving a threshold biologic drug concentration value in a subject, wherein the instructions comprise:
- (a) initializing a model of a biologic drug concentration profile for a biologic drug, wherein the model comprises data received from a reference population that were or currently are being treated with the biologic drug for treatment of an immune-mediated inflammatory disease;
- (b) generating subject specific parameters relating to pharmacokinetic performance of the biologic drug in the subject;
- (c) simulating the biologic drug concentration profile for the subject based on the subject specific parameters and the data from the reference population;
- (d) updating the model based on newly received data from the subject in (b) and newly received data from the reference population in (a);
- and
- (e) estimating a dose of the biologic drug at an inter-dose interval to achieve the threshold biologic drug concentration value in the subject with the model updated in (d), wherein the threshold biologic drug concentration is sufficient to treat the immune-mediated inflammatory disease in the subject.
3 more elements
A method of treating an immune-mediated inflammatory disease of a subject, the method comprising:
- (a) performing or having performed an immunoassay on a biological sample obtained from the subject to determine a level of albumin and a level of a biologic drug that are predictive of clinical remission of the immune-mediated inflammatory disease of the subject, wherein the subject is currently receiving the biologic drug for treatment of the immune-mediated inflammatory disease;
- (b) estimating a clearance rate of the biologic drug for the subject based, at least in part, on the level of albumin determined in (a) and a weight of the subject;
- and
- (c) if the level of the biologic drug is above a cutoff level in milligrams/L (mg/L) and the clearance rate is estimated to be below a threshold level of liters (L)/day, then administering a lower dose of the biologic drug to the subject or discontinuing the treatment of the immune-mediated inflammatory disease with the biologic drug;
- or
- (d) if the level of the biologic drug is below the cutoff level and the clearance rate is estimated to be above the threshold level, then administering the biologic drug to the subject in the same or higher dose than a dose of the biologic drug the subject is currently receiving, or administering a different drug to the subject, wherein the threshold level and the cutoff level are derived from an optical Youden index.
3 more elements
Dependencies are inferred from the claim text.