Zymogenetics, Inc.

Ares Trading S.a.

Rafael A Ponce, Jr

Hans Otto Lennart Graffner

Kirk P Van Ness

Herve Broly

Wayne J Wallis

Alisa M Littau

Linda Zuckerman

Matthew S Holdren

Claudia Pena Rossi

Sergio Peano

The invention relates to novel combination therapies involving BLyS or BLyS/APRIL inhibition and anti-CD20 agents for the treatment of autoimmune diseases. One preferred method is where the BLyS antagonist is a Fc-fusion protein which can be a TACI-Fc-fusion protein comprising the extracellular domain of TACI or a functional fragment thereof, a BAFF&#x2014;R-Fc-fusion protein comprising the extracellular domain of BAFF&#x2014;R or a functional fragment thereof, or a BCMA-Fc-fusion protein comprising the extracellular domain of BCMA or a functional fragment thereof. In the methods of the present invention some of anti-CD20 agents contemplated include RITUXAN&#xae;, (rituximab),ocrelizumab, ofatumumab (HuMax-CD20&#xae;), TRU-015, and DXL625, although any agent that binds to CD 20 may be suitable. The methods of the present invention reduce the levels of B cells in patients in need of such reduction, such as those suffering from autoimmune diseases.

Combination of BLyS inhibition and anti-CD 20 agents for treatment of autoimmune disease

The invention relates to novel combination therapies involving BLyS or BLyS/APRIL inhibition and immunosuppressants for the treatment of autoimmune diseases. One preferred method is where the BLyS and/or APRIL antagonist is a Fc-fusion protein which can be a TACI-Fc-fusion protein comprising the extracellular domain of TACI or a functional fragment thereof, a BAFF-R-Fc-fusion protein comprising the extracellular domain of BAFF-R or a functional fragment thereof, or a BCMA-Fc-fusion protein comprising the extracellular domain of BCMA or a functional fragment thereof. In the methods of the present invention some of the immunosuppressive drugs contemplated include cyclophosphamide (CYC), azathioprine (AZA), cyclosporine A (CSA), or mycophenolate mofetil (MMF), although any drug that suppresses the immune system may be suitable. The methods of the present invention reduce the levels of various immunoglobulins in patients in need of such reduction, such as those suffering from autoimmune diseases.

Combination of BLyS and/or APRIL inhibition and immunosuppressants for treatment of autoimmune disease

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Seattle, WA, United States of America

Rafael A Ponce, Jr