Malki, Monzr M. Al and London, Kaitlyn and Baez, Janna and Akahoshi, Yu and Hogan, William J. and Etra, Aaron and Choe, Hannah and Hexner, Elizabeth and Langston, Amelia and Abhyankar, Sunil and Ponce, Doris M. and Defilipp, Zachariah and Kitko, Carrie L. and Adekola, Kehinde and Reshef, Ran and Ayuk, Francis and Capellini, Alexandra and Chanswangphuwana, Chantiya and Eder, Matthias and Eng, Gilbert and Gandhi, Isha and Grupp, Stephan and Gleich, Sigrun and Holler, Ernst and Javorniczky, Nora Rebeka and Kasikis, Stelios and Kowalyk, Steven and Morales, George and Oezbek, Umut and Roesler, Wolf and Spyrou, Nikolaos and Yanik, Gregory and Young, Rachel and Chen, Yi-Bin and Nakamura, Ryotaro and Ferrara, James L. M. and Levine, John E. (2023) Phase 2 study of natalizumab plus standard corticosteroid treatment for high-risk acute graft-versus-host disease. BLOOD ADVANCES, 7 (17). pp. 5189-5198. ISSN 2473-9529, 2473-9537
Full text not available from this repository. (Request a copy)Abstract
Graft-versus-host disease (GVHD) of the gastrointestinal (GI) tract is the main cause of nonrelapse mortality (NRM) after allogeneic hematopoietic cell transplantation. Ann Arbor (AA) scores derived from serum biomarkers at onset of GVHD quantify GI crypt damage; AA2/3 scores correlate with resistance to treatment and higher NRM. We conducted a multicenter, phase 2 study using natalizumab, a humanized monoclonal antibody that blocks T-cell trafficking to the GI tract through the alpha 4 subunit of alpha 4 beta 7 integrin, combined with corticosteroids as primary treatment for patients with new onset AA2/3 GVHD. Seventy-five patients who were evaluable were enrolled and treated; 81% received natalizumab within 2 days of starting corticosteroids. Therapy was well tolerated with no treatment emergent adverse events in >10% of patients. Outcomes for patients treated with natalizumab plus corticosteroids were compared with 150 well-matched controls from the MAGIC database whose primary treatment was corticosteroids alone. There were no significant differences in overall or complete response between patients treated with natalizumab plus corticosteroids and those treated with corticosteroids alone (60% vs 58%; P = .67% and 48% vs 48%; P = 1.0, respectively) including relevant subgroups. There were also no significant differences in NRM or overall survival at 12 months in patients treated with natalizumab plus corticosteroids compared with controls treated with corticosteroids alone (38% vs 39%; P = .80% and 46% vs 54%; P = .48, respectively). In this multicenter biomarker-based phase 2 study, natalizumab combined with corticosteroids failed to improve outcome of patients with newly diagnosed high-risk GVHD.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CELL TRANSPLANTATION; PREVENTION; VEDOLIZUMAB; BIOMARKER; CYCLOPHOSPHAMIDE; BLOCKADE; THERAPY; BLOOD; TRIAL; SCORE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 30 Jan 2024 07:24 |
| Last Modified: | 30 Jan 2024 07:24 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60953 |
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