US 12,392,784 B2
Method of assessing risk of PML
Gary Lewis Bloomgren, Concord, MA (US); Carmen Bozic, Newton, MA (US); Sophia Lee, Waltham, MA (US); Amy Pace, Brookline, MA (US); Tatiana Plavina, North Reading, MA (US); and Meena Subramanyam, Stoneham, MA (US)
Assigned to Biogen MA Inc., Cambridge, MA (US)
Filed by BIOGEN MA INC., Cambridge, MA (US)
Filed on May 31, 2024, as Appl. No. 18/731,059.
Application 18/731,059 is a continuation of application No. 17/700,250, filed on Mar. 21, 2022, granted, now 12,031,990.
Application 17/700,250 is a continuation of application No. 16/896,074, filed on Jun. 8, 2020, granted, now 11,280,794, issued on Mar. 22, 2022.
Application 16/896,074 is a continuation of application No. 16/115,350, filed on Aug. 28, 2018, granted, now 10,677,803, issued on Jun. 9, 2020.
Application 16/115,350 is a continuation of application No. 14/893,989, granted, now 10,119,976, issued on Nov. 6, 2018, previously published as PCT/US2014/039525, filed on May 27, 2014.
Claims priority of provisional application 61/828,021, filed on May 28, 2013.
Prior Publication US 2025/0003983 A1, Jan. 2, 2025
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/569 (2006.01); C07K 16/08 (2006.01); C07K 16/28 (2006.01); C12N 7/00 (2006.01); G01N 33/53 (2006.01); G01N 33/68 (2006.01); C12Q 1/70 (2006.01)
CPC G01N 33/6854 (2013.01) [C07K 16/2842 (2013.01); C12N 7/00 (2013.01); G01N 33/56983 (2013.01); C07K 2317/24 (2013.01); C12N 2710/22011 (2013.01); C12Q 1/70 (2013.01); G01N 2333/025 (2013.01); G01N 2469/20 (2013.01); G01N 2800/24 (2013.01); G01N 2800/28 (2013.01); G01N 2800/50 (2013.01)] 26 Claims
 
1. A method of treating a subject in need thereof with an anti-VLA-4 therapy, the method comprising:
a) determining an anti-JC virus (JCV) antibody titer in two or more biological samples obtained from the subject over a period of time, wherein the titer is determined to be at or above a pre-determined level in a first biological sample of the two or more biological samples and below the pre-determined level in a second subsequent biological sample of the two or more biological samples; and
b) administering the anti-VLA-4 therapy to the subject, thereby treating the subject with the anti-VLA-4 therapy, wherein the subject suffers from multiple sclerosis, a relapsing form of multiple sclerosis or inflammatory bowel disease.