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.

Treatment of steroid resistant acute graft versus host disease with an anti-CD26 monoclonal antibody—Begelomab / Bacigalupo, A.; Angelucci, E.; Raiola, A. M.; Varaldo, R.; Di Grazia, C.; Gualandi, F.; Benedetti, E.; Risitano, A.; Musso, M.; Zallio, F.; Ciceri, F.; Chiusolo, P.; Sica, S.; Rambaldi, A.; Bonifazi, F.; Parma, M.; Martino, M.; Onida, F.; Iori, A. P.; Selleri, C.; Borghero, C.; Bertaina, A.; Prezioso, L.; Algeri, M.; Locatelli, F.. - In: BONE MARROW TRANSPLANTATION. - ISSN 0268-3369. - (2020). [10.1038/s41409-020-0855-z]

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

Risitano A.;Selleri C.;
2020

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.
2020
Treatment of steroid resistant acute graft versus host disease with an anti-CD26 monoclonal antibody—Begelomab / Bacigalupo, A.; Angelucci, E.; Raiola, A. M.; Varaldo, R.; Di Grazia, C.; Gualandi, F.; Benedetti, E.; Risitano, A.; Musso, M.; Zallio, F.; Ciceri, F.; Chiusolo, P.; Sica, S.; Rambaldi, A.; Bonifazi, F.; Parma, M.; Martino, M.; Onida, F.; Iori, A. P.; Selleri, C.; Borghero, C.; Bertaina, A.; Prezioso, L.; Algeri, M.; Locatelli, F.. - In: BONE MARROW TRANSPLANTATION. - ISSN 0268-3369. - (2020). [10.1038/s41409-020-0855-z]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/812189
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