Dosage regimen of an s1p receptor modulator

Abstract

S1P receptor modulators are administered following a dosage regimen providing a positive benefit-risk profile.

1 . A method for treating an inflammatory or autoimmune disease or disorder in a patient in need thereof, comprising administering to said patient a therapeutically effective amount of a S1P receptor modulator or agonist, in such as way that the adverse events possibly associated with administering said S1P receptor modulator or agonist are controlled, limited, reduced or abolished, wherein said method comprises the steps of
 i) monitoring the patient during a specific period of time after the first administration of said S1P receptor modulator or agonist,   wherein said patient monitoring comprises one or more steps of
 a) monitoring infections or infestations, e.g. viral infections, throughout administering said S1P receptor modulator or agonist, 
 b) performing an ophthalmologic examination, 
   ii) optionally interrupting the administration of said S1P receptor modulator or agonist and/or modifying the treatment regimen thereof.   
     
     
         2 . A method of controlling, reducing, or abolishing the possible adverse events associated with treating a patient suffering from an inflammatory or autoimmune disease or disorder with a S1P receptor modulator or agonist, comprising administering to said patient a therapeutically effective amount of said S1P receptor modulator or agonist, wherein said method comprises one or more steps of
 a) monitoring infections or infestations, e.g. viral infections, and   b) performing an ophthalmologic examination,   
       ii) optionally interrupting the administration of said S1P receptor modulator or agonist and/or modifying the treatment regimen thereof. 
     
     
         3 . Method according to  claim 1  wherein the patient monitoring further comprises a step of
 c) monitoring the heart rate of the patient at least during the first hours after the first administration of said S1P receptor modulator or agonist, e.g. the 1 to 10 hours after the first administration of said S1P receptor modulator or agonist. 
 
     
     
         4 . Method according to  claim 3  further comprises a step of
 d) observing the patient for the 1 to 10 hours after the first administration of said S1P receptor modulator or agonist to monitor the heart rate of the patient, e.g. during the first 6 hours. 
 
     
     
         5 . Method according to  claim 1  wherein the ophthalmologic examination is performed at least 3 to 4 months after starting administration. 
     
     
         6 . A method for treating an inflammatory or autoimmune disease or disorder in a patient in need thereof, comprising administering to said patient a therapeutically effective amount of S1P receptor modulator or agonist in such as way that the adverse events possibly associated with said S1P receptor modulator or agonist are controlled, limited, reduced or abolished, wherein said method comprises i) checking specific parameters of the patient before initiating and/or during administration of said S1P receptor modulator or agonist, wherein said parameters comprise one or more of
 a) signs of infections or infestations, e.g. viral infections,   b) visual acuity   c) liver enzymes   d) blood pressure   
       and ii) as necessary, interrupting the administration of said S1P receptor modulator or agonist and/or modifying the treatment regimen thereof. 
     
     
         7 . Method of  claim 7  wherein signs of infections or infestations are monitored throughout administering said S1P receptor modulator or agonist. 
     
     
         8 . Method of  claim 7  wherein visual acuity is monitored at initiating administration of said S1P receptor modulator or agonist or within the months preceding the first administration of said S1P receptor modulator or agonist, e.g. within the 6 months preceding the first administration of said S1P receptor modulator or agonist. 
     
     
         9 . Method of  claim 7  wherein visual acuity is monitored within the next months following the first administration of said S1P receptor modulator or agonist, e.g. within the 1 to 12 months following the first administration of said S1P receptor modulator or agonist. 
     
     
         10 . Method of  claim 7  further comprising checking the heart rate of the patient at initiating administration of said S1P receptor modulator or agonist and optionally within the 1 to 10 hours following the first administration of said S1P receptor modulator or agonist. 
     
     
         11 . Method according to  claim 1  wherein step ii) is performed in case the monitoring reveals infections or an eyes disease. 
     
     
         12 . Method according to  claim 1  wherein specific parameters of the patient are checked before initiating said S1P receptor modulator or agonist, said parameters being selected from blood analysis (e.g. complete blood count), liver enzymes, ophthalmologic examination, electrocardiogram (ECG), pulmonary functions tests, dermatological examination, and liver function tests. 
     
     
         13 . A method according to  claim 1  wherein the S1P receptor modulator or agonist is fingolimod (FTY720), a phosphate derivative thereof or a pharmaceutically acceptable salt thereof. 
     
     
         14 . A method according to claim  20  wherein the S1P receptor modulator or agonist is administered at a daily dosage not exceeding about 0.5 mg to the patient, e.g. of about 0.5 mg. 
     
     
         15 . A method of controlling, reducing, limiting or abolishing the possible adverse events associated with a treatment of a patient suffering from an inflammatory or autoimmune disease or disorder, wherein said treatment comprises administering a daily dosage of a drug selected from fingolimod (FTY720), a phosphate derivative thereof or a pharmaceutically acceptable salt thereof, not exceeding about 0.5 mg to the patient, such a method comprising monitoring the patient during a specific period of time after the first administration of said drug, and if necessary either interrupting the administration of said drug, either modifying the treatment regimen thereof and/or administering a second drug which mitigates said possible adverse events,
 wherein said monitoring comprises one or more steps of
 a) monitoring infections or infestations, e.g. viral infections, throughout drug administration, and 
 b) performing an ophthalmologic examination after starting administration. 
   
     
     
         16 . A method of claim  26 , wherein step (b) comprises one or more steps of
 i) monitoring infections or infestations, e.g. viral infections,   ii) performing an ophthalmologic examination, e.g. 3 to 4 months after starting drug administration.   
     
     
         17 . Method according to claim  23  wherein the adverse events are selected from bradycardia, atrioventricular conduction abnormalities, macular edema, skin cancer, altered liver functions, infections and hypertension. 
     
     
         18 . Method of according to  claim 1  wherein the patient is vaccinated before initiating administration of said S1P receptor modulator or agonist, e.g. vaccinated against viral infection.