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

Author:

Boden Elisa K12ORCID,Canavan James B345,Moran Christopher J67,McCann Katelyn4,Dunn William A45,Farraye Francis A8,Ananthakrishnan Ashwin N57,Yajnik Vijay57,Gandhi Roopali59,Nguyen Deanna D57,Bhan Atul K1011,Weiner Howard L59,Korzenik Joshua R35,Snapper Scott B345

Affiliation:

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

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.

Funder

Mason Diamond Fund

National Institutes of Health

National Institute of Diabetes Digestive and Kidney Disease

Wolpow Family Chair in IBD Treatment and Research

Publisher

Oxford University Press (OUP)

Subject

Gastroenterology

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