Treatment of steroid resistant acute graft versus host disease with an anti-CD26 monoclonal antibody—Begelomab: Bone Marrow Transplantation

A. Bacigalupo, E. Angelucci, A.M. Raiola, R. Varaldo, C. Di Grazia, F. Gualandi, E. Benedetti, A. Risitano, M. Musso, F. Zallio, F. Ciceri, P. Chiusolo, S. Sica, A. Rambaldi, F. Bonifazi, M. Parma, M. Martino, F. Onida, A.P. Iori, C. SelleriC. Borghero, A. Bertaina, L. Prezioso, M. Algeri, F. Locatelli

Research output: Contribution to journalArticlepeer-review

Abstract

We have treated 69 patients with steroid refractory acute graft versus host disease (SR-aGvHD), with an anti-CD26 monoclonal antibody (Begelomab): 28 patients in two prospective studies (EudraCT No. 2007-005809-21; EudraCT No. 2012-001353-19), and 41 patients on a compassionate use study. The median age of patients was 42 and 44 years; the severity of GvHD was as follows: grade II in 8 patients, grade III in 33, and grade IV in 28 patients. There were no adverse events directly attributable to the antibody. Day 28 response was 75% in the prospective studies and 61% in the compassionate use patients, with complete response rates of 11 and 12%. Response for grade III GvHD was 83 and 73% in the two groups; response in grade IV GvHD was 66 and 56% in the two groups. Non relapse mortality (NRM) at 6 months was 28 and 38%. Overall there were 64, 56, 68% responses for skin, liver, and gut stage 3–4 GvHD. The overall survival at 1 year was 50% for the prospective studies and 33% for the compassionate use patients. In conclusion, Begelomab induces over 60% responses in SR-aGvHD, including patients with severe gut and liver GvHD, having failed one or more lines of treatment.

Original languageEnglish
Pages (from-to)1580-1587
Number of pages8
JournalBone Marrow Transplant.
Volume55
Issue number8
DOIs
Publication statusPublished - Aug 1 2020

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