Efficacy and safety of porcine ALG compared to rabbit ATG as first‐line treatment for children with acquired aplastic anemia

Abstract

Objective To assess the outcomes of children with acquired aplastic anemia (AA) treated in China with first‐line porcine anti‐lymphocyte immunoglobulin (p‐ALG)/rabbit anti‐thymocyte immunoglobulin (r‐ATG) combined with cyclosporine A (CSA). Methods We performed a single‐center, non‐randomized, retrospective cohort study to assess the outcomes of 189 children with AA treated in China with first‐line p‐ALG/r‐ATG combined with CSA between 2014 and 2018. Results No significant differences were observed in the overall response rates at 3, 6, 12, or 24 months (3 months: 61.9% vs 67.4%, P = .5; 6 months: 70.9% vs 73.9%, P = .69; 12 months: 77.3% vs 73.3%, P = .58; 24 months: 81.6% vs 78.6%, P = .59) after either p‐ALG‐ or r‐ATG‐based immunosuppressive therapy. No significant differences were observed in overall survival or failure‐free survival between the p‐ALG group and the r‐ATG group. Conclusion Our results reveal that the therapeutic efficacy and safety of p‐ALG combined with CSA did not differ significantly from those of r‐ATG combined with CSA as first‐line therapy for pediatric patients with AA. Moreover, p‐ALG has the advantage of significantly lower cost compared with r‐ATG.

Clinical Outcome of Acquired Post-Immunosuppressive-Therapy Aplastic Anemia in Pediatric Patients: A 13-Year Experience in Two Southern China Tertiary Care Centers

“…After 6 months of IST, CsA was continually administered, and the patients were closely followed up with; each family gave full consent, or there were no other options available. With this CsA administration management, the results of the present study were partially consistent with Zhu’s; 33 however, there were no data with porcine anti-LY immunoglobulin included in the present study. Together, the stronger and longer immunosuppressive rATG effect, lower trough level, and prolonged use of CsA within the follow-up period might have contributed to a higher response rate, especially in patients with SAA and VSAA who did not have MSDs.…”

Comparison of porcine ALG and rabbit ATG on outcomes of HLA-haploidentical hematopoietic stem cell transplantation for patients with acquired aplastic anemia

“…Interestingly, in our study, the incidence of CMV viremia and EBV viremia was significantly lower in the P-ALG group than the R-ATG group (46.4% vs 71.4%, P = 0.022 and 3.6% vs 25.4%, P = 0.014). Previous studies of ATG/ALG in IST indicated more clearance of peripheral blood lymphocytes by R-ATG than by P-ALG [ 9 , 10 , 25 ]. Patients in R-ATG group had a significantly lower minimum number of lymphocytes than the P-ALG group and remained significantly lower after 1, 3 and 6 months of treatment initiation and recovered to equivalent levels after 12 months [ 10 ].…”

“…However, horse ATG is not available in China, while a new porcine anti-lymphocyte globulin (P-ALG) is available. Several studies have compared the efficacy and safety of R-ATG and P-ALG in IST and suggested that P-ALG was similar to or even better than R-ATG [ 9 – 11 ]. In addition, P-ALG containing conditioning regime before HSCT in the setting of MSD-HSCT and MUD-HSCT have also demonstrated good efficacy and tolerance [ 12 , 13 ].…”

Porcine anti-human lymphocyte immunoglobulin depletes the lymphocyte population to promote successful kidney transplantation

“…The optimal balance between treatment benefits (immunological and kidney protective) and risks (infections) of the typical lymphocyte-depleting antibody rATG still remains to be properly elucidated. pALG has been already used in the hematology and transplantation fields ( 20 , 23 ), and offers an appropriate option to build an individualized induction therapy based on relevant immunological characteristics.…”

“…Unlike rATG which is made in rabbits, pALG origins are from a genetically closer species to humans and therefore improved antigenic similarity, which may result in weaker cytolytic capacity on human lymphocytes than rATG ( 19 ). pALG has been successfully used as first-line treatment in acquired severe aplastic anemia ( 20 – 22 ). It has also been employed for other hematological indications such as graft versus host disease prophylaxis ( 23 ).…”