US 12,440,561 B2
Method of diagnosis and treatment of rheumatoid arthritis
Anita Boyapati, Chappaqua, NY (US); Jérôme Msihid, Antony (FR); and Moshe E. Zilberstein, North Caldwell, NJ (US)
Assigned to SANOFI BIOTECHNOLOGY, Gentilly (FR); and REGENERON PHARMACEUTICALS, INC., Tarrytown, NY (US)
Filed by Sanofi Biotechnology, Paris (FR); and Regeneron Pharmaceuticals, Inc., Tarrytown, NY (US)
Filed on Apr. 24, 2020, as Appl. No. 16/858,301.
Claims priority of provisional application 62/837,793, filed on Apr. 24, 2019.
Claims priority of application No. 20305193 (EP), filed on Feb. 27, 2020.
Prior Publication US 2020/0405851 A1, Dec. 31, 2020
Int. Cl. A61K 39/395 (2006.01); A61B 5/00 (2006.01); A61K 9/08 (2006.01); A61K 31/519 (2006.01); A61P 19/02 (2006.01); C07K 16/28 (2006.01)
CPC A61K 39/3955 (2013.01) [A61B 5/4848 (2013.01); A61K 9/08 (2013.01); A61K 31/519 (2013.01); A61P 19/02 (2018.01); C07K 16/2866 (2013.01); C07K 2317/51 (2013.01); C07K 2317/515 (2013.01)] 27 Claims
 
1. A method of treating rheumatoid arthritis in a subject comprising:
A) (a) identifying a subject with rheumatoid arthritis whose serum sample is determined to have a pre-dose (baseline) serum concentration of serum amyloid A (SAA) greater than 105.2 ng/ml and less than 256.0 ng/ml,
(b) identifying a subject with rheumatoid arthritis whose serum sample is determined to have a pre-dose (baseline) serum concentration of matrix metalloproteinase-3 (MMP-3) greater than 77.0 ng/ml and less than 154.3 ng/ml, or
(c) identifying a subject with rheumatoid arthritis whose serum sample is determined to have a pre-dose (baseline) serum concentration of chemokine C-X-C motif ligand 13 (CXCL13) less than 72.0 pg/mL and a pre-dose (baseline) serum concentration of soluble intracellular adhesion molecule-1 (sICAM-1) less than 212.1 ng/ml; and
B) administering to the subject identified in any of (a)-(c) about 150 mg to about 200 mg of an anti-interleukin 6 receptor (anti-IL-6R) antibody once every two weeks, wherein the antibody comprises a heavy chain variable region comprising the sequence of SEQ ID NO: 1 and a light chain variable region comprising the sequence of SEQ ID NO: 2, and wherein the antibody is administered subcutaneously.