Claims for Patent: 10,215,762

Summary for Patent: 10,215,762

Title:	Method to optimize the treatment of patients with biological drugs
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.
Inventor(s):	Ruiz Del Agua; Ainhoa (Derio, ES), Martinez Martinez; Antonio (Derio, ES), Nagore Casas; Daniel (Derio, ES), Simon Buela; Laureano (Derio, ES)
Assignee:	Progenika Biopharma, S.A. (Derio (Bizkaia), ES)
Application Number:	15/281,829
Patent Claims:	1. A method of treating a patient, comprising: providing a patient sample, wherein (a) the patient sample is blood, plasma, or serum obtained from a patient suffering from rheumatoid arthritis and receiving a treatment comprising the administration to the patient of a biological drug selected from infliximab and adalimumab; (b) the patient has received at least one dose of the biological drug; and (c) the sample was obtained at a time t1 between two successive administrations of the biological drug; determining the concentration of the biological drug in the patient sample; and determining the concentration of antibodies against the biological drug in the patient sample; comparing the concentration of the biological drug in the patient sample with a Reference Value 1 (RV1), wherein RV1 is a therapeutic efficiency cut-off value of the concentration of the circulating biological drug; determining that the concentration of the biological drug in the patient sample is greater than or equal to RV1; comparing the concentration of antibodies against the biological drug in the patient sample with a Reference Value 2 (RV2), wherein RV2 is a cut-off value of the concentration of the antibodies against the biological drug as determined in a group of treatment-naive individuals; determining that the concentration of antibodies against the biological drug in the patient sample is less than or equal to RV2; classifying the patient as a responder to the biological drug; and re-administering the biological drug to the patient because the patient is classified as a responder, wherein: the re-administering of the biological drug is the second of the two successive administrations of the biological drug; when the biological drug is infliximab, then RV1 is 1.5 .mu.g/ml and RV2 is 150 ng/ml; and when the biological drug is adalimumab, then RV1 is 0.8 .mu.g/ml and RV2 is 32 ng/ml. 2. The method according to claim 1, wherein said t1 is a time point within two weeks of the administration of the biological drug. 3. The method according to claim 1, wherein the concentration of the circulating biological drug or the antibodies against the biological drug is determined by an immunoassay. 4. The method according to claim 3, wherein the immunoassay is an ELISA. 5. The method according to claim 1, wherein said t1 is a time point within one week of the administration of the biological drug. 6. A method for treating a patient suffering from rheumatoid arthritis, comprising: administering to the patient a biological drug at a time, t1, wherein the biological drug is selected from infliximab and adalimumab; determining the concentration of the circulating biological drug in a sample from the patient at a time, t1, wherein t1 is a time point after t1; determining that the concentration of the circulating biological drug in the sample is greater than or equal to a Reference Value 1 (RV1); determining the concentration of antibodies against the biological drug in the sample from the patient at t1; determining that the concentration of the antibodies against the biological drug in the sample is less than or equal to a Reference Value 2 (RV2); classifying the patient as a responder to the biological drug because the concentration of the biological drug in the sample is greater than or equal to RV1 and because the concentration of antibodies against the biological drug in the sample is less than or equal to RV2; and re-administering to the effective amount of the biological drug, because the patient is classified as a responder to the biological drug, 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 a cut-off value of the concentration of the antibodies against the biological drug as determined in a group of treatment-naive individuals; when the biological drug is infliximab, then RV1 is 1.5 .mu.g/ml and RV2 is 150 nq/ml; and when the biological drug is adalimumab, then RV1 is 0.8 .mu.g/ml and RV2 is 32 ng/ml. 7. The method according to claim 6, wherein t1 is a time point within two weeks of ti. 8. The method according to 6, wherein t1 is a time point within one week of ti. 9. The method according to claim 6, wherein the concentration of the circulating biological drug or antibodies against the biological drug is determined by an immunoassay. 10. The method according to claim 9, wherein the immunoassay is an ELISA. 11. A method of treating a human patient suffering from rheumatoid arthritis, wherein the patient is receiving a biological drug selected from infliximab and adalimumab, comprising: detecting the concentration of the biological drug in a blood, plasma, or serum sample obtained from the subject, determining that the detected concentration of the biological drug in the sample is greater than or equal to a Reference Value 1 (RV1); detecting the concentration of antibodies against the biological drug in the sample; and determining that if the detected concentration of antibodies against the biological drug in the sample is less than or equal to a Reference Value 2 (RV2); and classifying the patient as a responder to the biological drug; and re-administering the biological drug to the patient, wherein: the patient would not have been classified as a responder and the biological drug would not have been re-administered to the patient if both the detected concentration of the biological drug in the patient sample were less than RV1 and the concentration of antibodies against the biological drug in the patient sample were greater than RV2; and when the biological drug is infliximab, then RV1 is 1.5 .mu.g/ml and RV2 is 150 ng/ml; or when the biological drug is adalimumab, then RV1 is 0.8 .mu.g/ml and RV2 is 32 ng/ml.

Details for Patent 10,215,762

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2030-12-22
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2030-12-22
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2030-12-22
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2030-12-22
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2030-12-22
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2030-12-22
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	03/09/2016		2030-12-22