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Crohns Colitis 360. 2019 Jul;1(2):otz009. doi: 10.1093/crocol/otz009. Epub 2019 Jun 7.

Immunologic Alterations Associated With Oral Delivery of Anti-CD3 (OKT3) Monoclonal Antibodies in Patients With Moderate-to-Severe Ulcerative Colitis.

Author information

1
Division of Gastroenterology, Virginia Mason Medical Center, Seattle, WA.
2
Benaroya Research Institute, Seattle, WA.
3
Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, MA.
4
Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA.
5
Department of Medicine, Harvard Medical School, Boston, MA.
6
Division of Pediatric Gastroenterology, MassGeneral Hospital for Children, Boston, MA.
7
Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA.
8
Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA.
9
Ann Romney Center for Neurologic Diseases, Brigham and Women's Hospital, Boston, MA.
10
Department of Pathology, Massachusetts General Hospital, Boston, MA.
11
Department of Pathology, Harvard Medical School, Boston, MA.

Abstract

Aim:

The aim of this study was to determine the immunologic effects and safety of oral anti-CD3 in patients with ulcerative colitis (UC).

Methods:

An open-label pilot study of orally delivered anti-CD3 was performed in patients with moderate-to-severe UC. The primary end points were changes in immunologic parameters and evaluation for safety.

Results:

Six subjects received oral OKT3. Biologic effects of oral anti-CD3 included significantly increased proliferation in response to anti-CD3 and anti-inflammatory gene expression profile in peripheral blood mononuclear cells. No serious treatment-related adverse events occurred.

Conclusion:

Orally delivered anti-CD3 resulted in immunologic changes in patients with UC.

KEYWORDS:

muromonab-CD3; regulatory T cells; ulcerative colitis

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