Compositions comprising il6r antibodies for the treatment of uveitis and macular edema and methods of using same

Patent metadata

Field	Value
Publication number	US-2017166646-A1
Application number	US-201615342833-A
Country	US
Kind code	A1
Filing date	Nov 3, 2016
Priority date	Nov 3, 2015
Publication date	Jun 15, 2017
Grant date	—

Abstract

The present invention provides compositions and methods of treating and improving the symptoms of uveitis and/or macular edema using an antibody that specifically binds human interleukin-6 receptor (hIL-6R).

First claim

1 . A method for treating macular edema in a subject in need thereof comprising administering an effective amount of an antibody that specifically binds IL-6 receptor.

2 . The method of claim 1 , wherein the antibody that specifically binds to the IL-6 receptor comprises a heavy chain variable region comprising the sequence of SEQ ID NO:2 and a light chain variable region comprising the sequence of SEQ ID NO:3.

3 - 36 . (canceled)

37 . A method for treating uveitis in a subject in need thereof comprising administering an effective amount of an antibody that specifically binds IL-6 receptor, wherein the subject has a vitreous haze (VH) level greater than or equal to 2 on the Miami 9 step scale or wherein the subject has a central retinal thickness (CRT) greater than 300 μm.

38 - 75 . (canceled)

76 . A method of treating uveitis in a subject in need thereof comprising administering to the subject a therapeutically effective amount of an antibody, wherein the antibody comprises a heavy chain variable region comprising the sequence of SEQ ID NO:2 and a light chain variable region comprising the sequence of SEQ ID NO:3.

77 . The method of claim 76 , wherein the antibody is sarilumab.

78 . The method of claim 76 , wherein
the uveitis is selected from the group consisting of intermediate uveitis, posterior uveitis and pan-uveitis; or wherein the uveitis is non-infectious uveitis; or wherein the uveitis is systemic or idiopathic; or wherein the subject is suffering from macular edema; or wherein the subject has a CRT greater than 300 μm.

79 - 80 . (canceled)

81 . The method of claim 76 , wherein the subject has a VH level greater than or equal to 2 on the Miami 9 step scale.

82 - 83 . (canceled)

84 . The method of claim 76 , wherein the subject is suffering from macular edema.

85 - 86 . (canceled)

87 . The method of claim 76 , wherein the subject has other signs of intraocular inflammation selected from the group consisting of perivascular sheathing of retinal vessels and leakage of retinal vessels.

88 - 89 . (canceled)

90 . The method of claim 76 , wherein at least one symptom of uveitis in the subject is improved, wherein the symptom of uveitis is selected from the group consisting of elevated VH level, reduced BCVA, macular edema, signs of ocular inflammation, CRT and ocular inflammation in the anterior chamber.

91 . The method of claim 76 , wherein the subject has been treated for at least three months with a corticosteroid.

92 . The method of claim 91 , wherein the corticosteroid is prednisone.

93 . The method of claim 92 , wherein the prednisone was administered from 15 to 80 mg/day.

94 . The method of claim 76 , wherein the subject was also administered methotrexate.

95 . The method of claim 94 , wherein the methotrexate is administered from 6 to 25 mg/week.

96 . The method of claim 76 , wherein the subject is administered a corticosteroid.

97 . The method of claim 96 , wherein the corticosteroid is prednisone.

98 . The method of claim 97 , wherein the prednisone is administered from 15 to 80 mg/day.

99 . The method of claim 76 , wherein the subject is also administered methotrexate.

100 . The method of claim 99 , wherein the methotrexate is administered from 6 to 25 mg/week.

101 . The method of claim 91 ,
wherein the subject achieves after 16 weeks a reduction in the VH level on the Miami 9 point scale of at least 2 steps or a reduction of corticosteroid dose to less than 10 mg per day.

102 . The method of claim 96 , wherein the subject achieves after 16 weeks a reduction in VH level on the Miami 9 point scale of at least 2, or a reduction of corticosteroid dose to less than 10 mg per day.

103 . (canceled)

104 . The method of claim 76 , wherein the subject experiences
a greater than 20% reduction in CRT, greater than 10 letters of improvement in BCVA, shows a reduction in retinal vessel leakage, and/or an improvement in uveitis clinical assessment score.

105 - 108 . (canceled)

Assignees

• Sanofi Biotechnology
• Regeneron Pharma

Inventors

• Sridhara Sundaram Preethi Aavali
• Buggage Ronald
• Chu Karen W
• Corp Dit Genti Valérie
• Erickson Kristine A
• Mery-Mignard Dominique
• Varona Rafael
• Vitti Robert L

Classifications

• A61P9/10

  for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis · CPC title

• A61P3/10

  for hyperglycaemia, e.g. antidiabetics · CPC title

• A61K31/573

  substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone · CPC title

• A61K39/3955

  against proteinaceous materials, e.g. enzymes, hormones, lymphokines · CPC title

• C07K2317/56

  variable (Fv) region, i.e. VH and/or VL · CPC title