Transfusion Medicine and Hemotherapy
Daratumumab for Pure Red Cell Aplasia After ABO-Incompatible Allogeneic Hematopoietic Stem Cell Transplantation: A Systematic Review of Efficacy and Safety
By Abdulrahman Fadhl Al-Mashdali, Mujahid O Abdelraof, Mohamed Elfatih M Yousif and 4 others.
Abstract
Background
Pure red cell aplasia (PRCA) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an uncommon complication, most often associated with major or bidirectional ABO incompatibility. Daratumumab has emerged as a plasma cell–targeted therapy, but the supporting evidence remains limited.
Methods
We systematically searched PubMed/MEDLINE, Scopus, and Web of Science from inception to 25 January 2026 for English-language reports of daratumumab-treated PRCA after allo-HSCT. Patient-level data were synthesized descriptively, and aggregate study-level reports were summarized separately.
Results
Twenty patient-level reports comprising 53 patients were included, along with two aggregate study-level reports. The patient-level evidence consisted of 15 case reports, 2 case series, and 3 retrospective cohort studies. The median age was 52 years among 50 patients with available data, and 32 of 50 were male. Major ABO mismatch was present in 47 of 50 patients and bidirectional mismatch in 3. Daratumumab was used for refractory PRCA in 43 patients and as first-line therapy in 10. Prior PRCA-directed therapy was reported in 37 patients, most commonly rituximab. Daratumumab was administered intravenously in 29 of 52 patients and subcutaneously in 23 of 52. Hematologic response was achieved in 50 of 53 patients (94.3%), including complete response in 10, partial response in 1, and resolution without formal classification in 39 patients; 3 patients had no response. The median time to first response was 21 days, to best response 60 days, and to transfusion independence 29 days. No relapse was reported among 51 patients with available follow-up, although follow-up duration was variable. At last follow-up, 50 of 53 patients were alive. Infusion or injection reactions occurred in 11 patients and were predominantly mild to moderate. Infections were reported in 9 patients, hypogammaglobulinemia in 10 of 41 evaluable patients, and new or worsening graft-versus-host disease in 2 patients.