DOSING REGIMENS USING ANTI-IL-6 ANTIBODIES FOR THE TREATMENT OF RHEUMATOID AND PSORIATIC ARTHRITIS

摘要

The present invention relates to therapeutic methods of using an antibody, or antigen-binding fragment thereof, which selectively binds IL-6 for the treatment or prevention of psoriatic arthritis or rheumatoid arthritis and for managing the side effects and symptoms of psoriatic or rheumatoid arthritis and therapeutic compositions for use therein comprising an antibody, or antigen-binding fragment thereof, which selectively binds IL-6 for the treatment or prevention of psoriatic or rheumatoid arthritis. The invention further relates to low dosing therapeutic regimens for treating inflammatory IL-6 associated diseases, i.e., characterized by elevated 11-6 levels such as psoriatic arthritis or rheumatoid arthritis that provided for reduced adverse side effects and improved safety. Also the invention further relates to compositions for use in low dosing therapeutic regimens for treating inflammatory IL-6 associated diseases, i.e., diseases characterized by elevated IL-6 levels such as psoriatic arthritis or rheumatoid arthritis, wherein such compositions may be administered by self-injection or by a caregiver using an autoinjector pen and a syringe containing the low dosage of anti-IL-6 antibody, e.g., 1, 5, 10, 15, 20 or 25 mg.

主权项

1. A method for treating or preventing rheumatoid arthritis, or managing one or more of the symptoms of rheumatoid arthritis comprising administration of a composition comprising an effective amount of an anti-IL-6 antibody or antibody fragment thereof to a subject in need thereof, wherein the anti-IL-6 antibody or antibody fragment thereof comprises a variable light (VL) chain polypeptide comprising a CDR1 sequence of SEQ ID NO:4, a CDR2 sequence of SEQ ID NO:5, and a CDR3 sequence of SEQ ID NO:6, and a variable heavy (VH) chain polypeptide comprising a CDR1 sequence of SEQ ID NO:7, a CDR2 sequence of SEQ ID NOs:8 or 120, and a CDR3 sequence of SEQ ID NO:9, and wherein said anti-IL-6 antibody or antibody fragment thereof is administered every 4 weeks or monthly at a dosage of at most 1, 5, 10, 15, 20 or 25 mg.