TY - JOUR
T1 - Treatment of steroid resistant acute graft versus host disease with an anti-CD26 monoclonal antibody—Begelomab
AU - Bacigalupo, Andrea
AU - Angelucci, Emanuele
AU - Raiola, Anna Maria
AU - Varaldo, Riccardo
AU - Di Grazia, Carmen
AU - Gualandi, Francesca
AU - Benedetti, Edoardo
AU - Risitano, Antonio
AU - Musso, Maurizio
AU - Zallio, Francesco
AU - Ciceri, Fabio
AU - Chiusolo, Patrizia
AU - Sica, Simona
AU - Rambaldi, Alessandro
AU - Bonifazi, Francesca
AU - Parma, Matteo
AU - Martino, Massimo
AU - Onida, Francesco
AU - Iori, Anna Paola
AU - Selleri, Carmine
AU - Borghero, Carlo
AU - Bertaina, Alice
AU - Prezioso, Lucia
AU - Algeri, Mattia
AU - Locatelli, Franco
PY - 2020/1/1
Y1 - 2020/1/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85082193477&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85082193477&partnerID=8YFLogxK
U2 - 10.1038/s41409-020-0855-z
DO - 10.1038/s41409-020-0855-z
M3 - Article
AN - SCOPUS:85082193477
JO - Bone Marrow Transplantation
JF - Bone Marrow Transplantation
SN - 0268-3369
ER -