US 12,286,479 B2
Treatment with anti-α4β7 antibody
Irving H. Fox, Wellesley, MA (US); Catherine Scholz, Woburn, MA (US); Erica Helen Jenkins, Cambridgeshire (GB); and Maria Rosario, Mystic, CT (US)
Assigned to Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed by Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed on Apr. 23, 2021, as Appl. No. 17/239,512.
Application 17/239,512 is a division of application No. 16/787,521, filed on Feb. 11, 2020, granted, now 11,560,434, issued on Jan. 24, 2023.
Application 16/787,521 is a continuation of application No. 15/983,791, filed on May 18, 2018, abandoned.
Application 15/983,791 is a continuation of application No. 14/114,835, granted, now 10,040,855, issued on Aug. 7, 2018, previously published as PCT/US2012/036069, filed on May 2, 2012.
Claims priority of provisional application 61/544,054, filed on Oct. 6, 2011.
Claims priority of provisional application 61/481,522, filed on May 2, 2011.
Prior Publication US 2021/0340261 A1, Nov. 4, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 39/00 (2006.01); A61K 9/00 (2006.01); A61K 39/395 (2006.01); A61K 47/12 (2006.01); A61K 47/14 (2017.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); C07K 16/28 (2006.01)
CPC C07K 16/2839 (2013.01) [A61K 9/0019 (2013.01); A61K 39/39591 (2013.01); A61K 47/12 (2013.01); A61K 47/14 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); A61K 2039/505 (2013.01); A61K 2039/54 (2013.01); A61K 2039/545 (2013.01); C07K 2317/24 (2013.01)] 30 Claims
 
1. A method for treating inflammatory bowel disease (IBD) in a human patient in need thereof, the method comprising
intravenously administering an initial dose of 300 mg of a humanized antibody having binding specificity for human α4β7 integrin to the human patient,
intravenously administering a second dose of 300 mg of the humanized antibody to the human patient 2 weeks after the initial dose, and
subcutaneously administering a dose of 108 mg of the humanized antibody to the human patient via a prefilled syringe or an autoinjector every two weeks starting at 6 weeks after the initial dose,
wherein the IBD is ulcerative colitis or Crohn's disease,
wherein the treated human patient is in clinical remission, and
wherein the humanized antibody is an IgG1 isotype and comprises the following CDRs:
Light chain: CDR1 SEQ ID NO: 11
CDR2 SEQ ID NO: 12
CDR3 SEQ ID NO: 13
Heavy chain: CDR1 SEQ ID NO: 8
CDR2 SEQ ID NO: 9
CDR3 SEQ ID NO: 10.