Genetic markers for predicting responsiveness to fgf-18 compound

Abstract

This application is directed to the use of biomarkers for predicting the sensitivity to treatment with an FGF-18 compound of a patient having a cartilage disorder, such as osteoarthritis, cartilage injury, fractures affecting joint cartilage or surgical procedures with impact on joint cartilage (e.g., microfracture), in order to reduce the risk of adverse events and increase the overall benefit after therapy.

We claim: 
     
         1 . A kit comprising means for performing the method according to claim  19  and instructions for use. 
     
     
         2 . The kit according to  claim 1 , comprising at least a couple of specific primers or probes for detecting the presence or absence of the alleles in rs9005 and rs315952. 
     
     
         3 . A method for treating a patient having a cartilage disorder, comprising the following steps:
 a) determining, from a nucleic acid sample, the genotype at both IL-1RN rs9005 and IL-1RN rs315952;   b) selecting the patient having any combination of the genotype(s) selected from the group consisting of:
 i) G/G at IL-1RN rs9005 and T/C or C/C at IL-1RN rs315952; or 
 ii) A/G or A/A at IL-1RN rs9005 and T/T, T/C or C/C at IL-1RN rs315952; and 
   c) administering intraarticularly an FGF-18 compound to said selected patient.   
     
     
         4 . The method according to  claim 3 , wherein the FGF-18 compound is to be administered in a treatment cycle of once weekly for 3 weeks. 
     
     
         5 . The method according to  claim 4 , wherein the treatment cycle can be repeated. 
     
     
         6 . The method according to  claim 4 , wherein the FGF-18 compound is sprifermin. 
     
     
         7 . The method according to  claim 3 , wherein the cartilage disorder is selected from the group consisting of osteoarthritis, cartilage injury, fractures affecting joint cartilage or surgical procedures with impact on joint cartilage, such as microfracture.