Procedure to optimize the treatment of patients with biological drugs

摘要

Procedure for classifying a patient suffering from rheumatoid arthritis as a patient who responds or does not respond to a treatment, said treatment comprising the administration to said patient of a biological drug selected from the group comprising infliximab and adalimumab that is administered periodically by administrations repetitive, and in which said patient has received at least one dose of said biological drug, said procedure comprising the steps of: a) determining the concentration of the circulating biological drug in a sample of said patient at a time t1 in which 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 of said patient at a time t1; and c) comparing the concentration of the circulating biological drug in said t1 with a reference value 1 (VR1) and the concentration of antibodies against said biological drug in said time t1 with a reference value 2 (VR2), in which the sample is selects between a blood sample, a plasma sample and a serum sample; VR1 is a limit value of therapeutic efficacy of the concentration of the circulating biological drug; and VR2 is the limit value of the concentration of said antibody against the biological drug, as determined in a group of individuals who have never been treated by the same assay as that used to determine the concentration of the antibody against the biological drug in the stage. b), and in which if the concentration of the circulating biological drug is less than VR1 and the concentration of antibodies against said biological drug is greater than VR2, then said patient is classified as a patient who does not respond to said treatment, and in the that if the concentration of the circulating biological drug is equal to, or greater than VR1 and the concentration of antibodies against said biological drug is equal to, or less than, VR2, then said patient is classified as a patient responding to said treatment, and in which if the biological drug is infliximab, then VR1 is 1.5 mg / ml and VR2 is 150 ng / ml; and in which if the biological drug is adalimumab, then VR1 is 0.8 mg / ml and VR2 is 32 ng / ml