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Last Updated: April 20, 2024

Claims for Patent: 9,539,263

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Summary for Patent: 9,539,263

Title:	Subcutaneously administered anti-IL-6 receptor antibody for treatment of systemic sclerosis
Abstract:	The present application discloses methods for treating an IL-6-mediated disorder such as rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), systemic JIA (sJIA), polyarticular course JIA (pcJIA), systemic sclerosis, or giant cell arteritis (GCA), with subcutaneously administered antibody that binds interleukin-6 receptor (anti-IL-6R antibody). In particular, it relates to identification of a fixed dose of anti-IL-6R antibody, e.g. tocilizumab, which is safe and effective for subcutaneous administration in patients with IL-6-mediated disorders. In addition, formulations and devices useful for subcutaneous administration of an anti-IL-6R antibody are disclosed.
Inventor(s):	Zhang; Xiaoping (Wayne, NJ), Terao; Kimio (Funabashi, JP), Jahreis; Angelika M. (Menlo Park, CA)
Assignee:	Genentech, Inc. (South San Francisco, CA) Hoffmann-La Roche, Inc. (Nutley, NJ) Chugai Seiyaku Kabushiki Kaisha (Tokyo, JP)
Application Number:	14/062,005
Patent Claims:	1. A method of treating systemic sclerosis in a patient comprising subcutaneously administering an anti-IL-6 receptor (IL-6R) antibody to the patient in an amount effective to treat the systemic sclerosis, wherein the anti-IL-6R antibody is administered as a fixed dose of 162 mg per dose every week, and wherein the anti-IL-6R antibody comprises the light chain and heavy chain amino acid sequences of SEQ ID NOs. 1 and 2, respectively. 2. The method of claim 1 wherein the effective amount improves cutaneous sclerosis, improves physical function, and/or slows progression of organ damage, relative to placebo. 3. The method of claim 2 wherein cutaneous sclerosis improvement is assessed by modified Rodnan skin score (mRSS). 4. The method of claim 2 wherein physical function improvement is assessed by Scleroderma Health Assessment Questionnaire-Disability Index (HAQ-DI). 5. A method of treating systemic sclerosis in a patient comprising subcutaneously administering tocilizumab to the patient, wherein the tocilizumab is administered as a fixed dose of 162 mg per dose every week.

Details for Patent 9,539,263

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125276	01/08/2010	⤷ Try a Trial	2030-11-08
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125472	10/21/2013	⤷ Try a Trial	2030-11-08
Genentech, Inc.	ACTEMRA	tocilizumab	Injection	125472	11/19/2018	⤷ Try a Trial	2030-11-08
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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