Method to optimize the treatment of patients with biological drugs
AssigneeProteomika, S.L.
InventorsAinhoa Ruiz Del Agua, Antonio Martinez Martinez, Daniel Nagore Casas, Laureano Simon Buela
Life of this patent
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Abstract
The invention relates to the field of personalized therapy and, in particular, to a method for classifying a patient suffering from rheumatoid arthritis as a responder or as a non-responder patient to a treatment based on a biological drug.
Claims17
A method for classifying a patient suffering from rheumatoid arthritis as a responder or as a non-responder patient to a treatment, said treatment comprising the administration to said patient of a biological drug selected from the group consisting of infliximab and adalimumab that is periodically administered by repetitive administrations, and wherein said patient has received at least one dose from said biological drug, said method comprising the steps of:
- a) determining the concentration of the circulating biological drug in a sample from said patient at a time t1 wherein said t1 corresponds to a time point within the period of time between two successive administrations of said biological drug;
- b) determining the concentration of antibodies against said biological drug in a sample from said patient at a time t1;
- and
- c) comparing the concentration of the circulating biological drug at said t1 with a Reference Value 1 (RV1) and the concentration of antibodies against said biological drug at said time t1 with a Reference Value 2 (RV2),
- wherein
- the sample is selected from a sample of blood, a sample of plasma and a sample of serum;
- RV1 is a therapeutic efficiency cut-off value of the concentration of the circulating biological drug;
- and
- RV2 is the cut-off value of the concentration of said antibody against the biological drug as determined in a group of treatment-naïve individuals by the same assay as that used for determining the concentration of the antibody against the biological drug in step b), and
- wherein if the concentration of the circulating biological drug is lower than RV1 and the concentration of antibodies against said biological drug is higher than RV2, then said patient is classified as a non-responder patient to said treatment, and
- wherein if the concentration of the circulating biological drug is equal to, or higher than RV1 and the concentration of antibodies against said biological drug is equal to, or lower than, RV2, then said patient is classified as a responder patient to said treatment, and
- wherein if the biological drug is infliximab, then RV1 is 1.5 μg/ml;
- and
- wherein if the biological drug is adalimumab, then RV1 is 0.8 μg/ml.
A method for treating a patient suffering from rheumatoid arthritis, comprising:
- a) administering to said patient a biological drug at a time, ti, wherein the biological drug is selected from the group consisting of infliximab and adalimumab;
- b) determining the concentration of the circulating biological drug in a sample from said patient at a time, ti, wherein t1 is a time point after ti;
- c) determining the concentration of antibodies against said biological drug in a sample from said patient at t1;
- and
- d) comparing the concentration of the circulating biological drug at ti with a Reference Value 1 (RV1) and the concentration of antibodies against said biological drug at t1 with a Reference Value 2 (RV2),
- wherein:
- the sample is selected from a sample of blood, a sample of plasma and a sample of serum;
- RV1 is a therapeutic efficiency cut-off value of the concentration of the circulating biological drug;
- RV2 is the cut-off value of the concentration of said antibody against the biological drug as determined in a group of treatment-naïve individuals by the same assay as that used for determining the concentration of the antibody against the biological drug in step c);
- wherein if the concentration of the circulating biological drug is equal to, or higher than RV1 and the concentration of antibodies against said biological drug is equal to, or lower than, RV2, then classifying the patient as a responder and repeating step a);
- and
- wherein if the concentration of the circulating biological drug is equal to, or higher than RV1 and the concentration of antibodies against said biological drug is equal to, or lower than, RV2, then classifying the patient as a non-responder and revising treatment.
Dependencies are inferred from the claim text.