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Drobyski, William R; Szabo, Aniko; Zhu, Fenlu; Keever-Taylor, Carolyn; Hebert, Kyle M; Dunn, Renee; Yim, Sharon; Johnson, Bryon; D'Souza, Anita; Eapen, Mary; Fenske, Timothy S; Hari, Parameswaran; Hamadani, Mehdi; Horowitz, Mary M; Rizzo, J Douglas; Saber, Wael; Shah, Nirav; Shaw, Bronwen; Pasquini, Marcelo
Haematologica, 04/2018, Letnik: 103, Številka: 4Journal Article
We conducted a phase 2 study in which patients undergoing allogeneic hematopoietic stem cell transplantation received tocilizumab in addition to standard immune suppression with tacrolimus and methotrexate for graft- -host disease prophylaxis. Thirty-five patients were enrolled between January 2015 and June 2016. The median age of the cohort was 66 (range: 22-76). All patients received busulfan-based conditioning, and were transplanted with human leukocyte antigen-matched related or matched unrelated bone marrow or peripheral stem cell grafts. The cumulative incidences of grades II-IV and III-IV acute graft- -host disease were 14% (95% CI 5-30) and 3% (95% CI 0-11) at day 100, and 17% (95% CI 7-31) and 6% (95% CI 1-16) at day 180, respectively. Notably, there were no cases of graft- -host disease of the lower gastrointestinal tract within the first 100 days. A comparison to 130 matched controls who only received tacrolimus and methotrexate demonstrated a lower cumulative incidence of grades II-IV acute graft- -host disease (17% 45%, =0.003) and a significant increase in grades II-IV acute graft- -host disease-free survival at six months (69% 42%, =0.001) with tocilizumab, tacrolimus and methotrexate, which was the primary endpoint of the study. Immune reconstitution was preserved in patients treated with tocilizumab, tacrolimus and methotrexate, as T-cell and B-cell subsets recovered to near normal levels by 6-12 months post-transplantation. We conclude that tocilizumab has promising activity in preventing acute graft- -host disease, particularly in the lower gastrointestinal tract, and warrants examination in a randomized setting.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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