Low frequency glatiramer acetate therapy

Abstract

A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient.

What is claimed is: 
     
         1 . A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient. 
     
     
         2 . The method of  claim 1 , wherein alleviating a symptom comprises reducing the frequency of relapses. 
     
     
         3 . The method of  claim 1  or  2 , wherein alleviating a symptom comprises reducing the mean cumulative number of Gd-enhancing lesions in the brain of the patient. 
     
     
         4 . The method of any one of  claims 1 - 3 , wherein alleviating a symptom comprises reducing the mean number of new T 2  lesions in the brain of the patient. 
     
     
         5 . The method of any one of  claims 1 - 4 , wherein alleviating a symptom comprises reducing the cumulative number of enhancing lesions on T 1 -weighted images. 
     
     
         6 . The method of any one of  claims 1 - 5 , wherein alleviating a symptom comprises reducing brain atrophy in the patient. 
     
     
         7 . The method of any one of  claims 1 - 6 , wherein alleviating a symptom comprises increasing the time to a confirmed relapse in the patient. 
     
     
         8 . The method of any one of  claims 1 - 7 , wherein alleviating a symptom comprises reducing the total number of confirmed relapses in the patient. 
     
     
         9 . The method of any one of  claims 1 - 8 , wherein alleviating a symptom comprises reducing the progression of MRI-monitored disease activity in the patient. 
     
     
         10 . The method of any one of  claims 1 - 9 , wherein alleviating a symptom comprises reducing total volume of T 2  lesions in the patient. 
     
     
         11 . The method of any one of  claims 1 - 10 , wherein alleviating a symptom comprises reducing the number of new hypointense lesions on enhanced T 1  scans in the patient. 
     
     
         12 . The method of any one of  claims 1 - 11 , wherein alleviating a symptom comprises reducing the total volume of hypointense lesions on enhanced T 1  scans. 
     
     
         13 . The method of any one of  claims 1 - 12 , wherein alleviating a symptom comprises reducing the level of disability as measured by EDSS Score in the patient. 
     
     
         14 . The method of any one of  claims 1 - 13 , wherein alleviating a symptom comprises reducing the change in EDSS Score in the patient. 
     
     
         15 . The method of any one of  claims 1 - 14 , wherein alleviating a symptom comprises reducing the change in Ambulation Index in the patient. 
     
     
         16 . The method of any one of  claims 1 - 15 , wherein alleviating a symptom comprises reducing the level of disability as measured by EuroQoL (EQ5D) questionnaire in the patient. 
     
     
         17 . The method of any one of  claims 1 - 16 , wherein alleviating a symptom comprises reducing the level of disability as measured by the work productivity and activities impairment-General Health (WPAI-GH) questionnaire in the patient. 
     
     
         18 . The method of any one of  claims 1 - 17 , wherein the pharmaceutical composition is in a prefilled syringe for self administration by the patient. 
     
     
         19 . The method of any one of  claims 1 - 17 , wherein the therapeutically effective dose of glatiramer acetate is 40 mg. 
     
     
         20 . The method of any one of  claims 1 - 19 , wherein the patient has not received glatiramer acetate therapy prior to initiation of the subcutaneous injections. 
     
     
         21 . The method of any one of  claims 1 - 20 , wherein the frequency of an immediate post injection reaction or the frequency of an injection site reaction is reduced relative to daily subcutaneous administration of 20 mg glatiramer acetate. 
     
     
         22 . A method of increasing the tolerability of GA treatment in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis which comprises reducing the frequency of subcutaneous injections of a pharmaceutical composition comprising a therapeutically effective dose of glatiramer acetate to three times over a period of seven days with at least one day between every injection. 
     
     
         23 . The method of  claim 22 , wherein increasing the tolerability of glatiramer acetate treatment in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the frequency of an immediate post injection reaction. 
     
     
         24 . The method of  claim 22  or  23 , wherein the immediate post injection reaction is palpitations, feeling hot, flushing, hot flushes, tachycardia, dyspnoea, chest discomfort, chest pain, non-cardiac chest, asthenia, back pain, bacterial infection, chills, cyst, face edema, fever, flu syndrome, infection, injection site erythema, injection site hemorrhage, injection site induration, injection site inflammation, injection site mass, injection site pain, injection site pruritus, injection site urticaria, injection site welt, neck pain, pain, migrane, syncope, tachycardia, vasodilatation, anorexia, diarrhea, gastroenteritis, gastrointestinal disorder, nausea, vomiting, ecchymosis, peripheral edema, arthralgia, agitation, anxiety, confusion, foot drop, hypertonia, nervousness, nystagmus, speech disorder, tremor, vertigo, bronchitis, dyspnea, laryngismus, rhinitis, erythema, herpes simplex, pruritus, rash, skin nodule, sweating, urticaria, ear pain, eye disorder, dysmenorrheal, urinary urgency, or vaginal moniliasis. 
     
     
         25 . The method of  claim 22 , wherein increasing the tolerability of glatiramer acetate treatment in the human patient suffering from a relapsing form of multiple sclerosis comprises reducing the frequency of an injection site reaction. 
     
     
         26 . The method of  claim 22  or  24 , wherein the injection site reaction is erythema, hemorrhage, induration, inflammation, mass, pain, pruritus, urticaria, or welt that occurs immediately around the site of injection. 
     
     
         27 . Use of glatiramer acetate in the preparation of a medicament for treating relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis wherein the administration pattern of the medicament is three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection. 
     
     
         28 . Use of glatiramer acetate in the preparation of a medicament for treating relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis wherein the medicament is prepared for an administration pattern of three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection. 
     
     
         29 . Use of glatiramer acetate in the preparation of a medicament for increasing the tolerability of GA treatment in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis wherein the administration pattern of the medicament is three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection. 
     
     
         30 . Use of glatiramer acetate in the preparation of a medicament for increasing the tolerability of GA treatment in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis wherein the medicament is prepared for an administration pattern of three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection. 
     
     
         31 . Glatiramer acetate for use in treating relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis by three subcutaneous injections over a period of seven days with at least one day between every subcutaneous injection. 
     
     
         32 . Glatiramer acetate for use in increasing the tolerability of GA treatment in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis by three subcutaneous injections over a period of seven days with at least one day between every subcutaneous injection.