Nature of Anifrolumab Impact on Vaccine-Emergent Immunity in SLE

Summary

This study to examines the impact of anifrolumab on disease activity, immune phenotypes, and development of neutralizing antibodies to quadrivalent influenza vaccine in patients with Systemic Lupus Erythematosus (SLE). 10 patients with moderately to severely active SLE will be treated with anifrolumab in addition to standard of care lupus treatments and 10 will receive only standard of care medications. All will receive influenza vaccine.

Timeline

Start

2021-01-20

Primary completion

2023-12-31

Completion

2024-12-31

Publications

• Background Crowe SR, Merrill JT, Vista ES, Dedeke AB, Thompson DM, Stewart S, Guthridge JM, Niewold TB, Franek BS, Air GM, Thompson LF, James JA. Influenza vaccination responses in human systemic lupus erythematosus: impact of clinical and demographic features. Arthritis Rheum. 2011 Aug;63(8):2396-406. doi: 10.1002/art.30388.
• Background Battafarano DF, Battafarano NJ, Larsen L, Dyer PD, Older SA, Muehlbauer S, Hoyt A, Lima J, Goodman D, Lieberman M, Enzenauer RJ. Antigen-specific antibody responses in lupus patients following immunization. Arthritis Rheum. 1998 Oct;41(10):1828-34. doi: 10.1002/1529-0131(199810)41:103.0.CO;2-T.
• Background Abu-Shakra M, Press J, Buskila D, Sukenik S. Influenza vaccination of patients with systemic lupus erythematosus: safety and immunogenecity issues. Autoimmun Rev. 2007 Sep;6(8):543-6. doi: 10.1016/j.autrev.2006.12.004. Epub 2007 Jan 9.

Drugs

Indications