Comparison of prophylactic use of intravenous immunoglobulin versus Pentaglobin^® in pediatric patients after hematopoietic stem cell transplantation

Abstract

There are few studies evaluating the use of IgM-enriched IVIG (Pentaglobin(®) ) in HSCT recipients. This study aimed to compare the efficacy of prophylactic use of IVIG versus prophylactic use of Pentaglobin(®) within the first 100 days after allogeneic HSCT. We performed a prospective, randomized study of the use of prophylactic IVIG versus prophylactic use of Pentaglobin(®) in patients after allogeneic HSCT. The first dose of IVIG or Pentaglobin(®) was given before conditioning regimen and after transplant was given on day +1, +8, +15, and +22. And then, it was given if IgG level was below 400 mg/dL. Twenty-seven patients in IVIG group and 32 patients in Pentaglobin(®) group were included in the study. There were no significant differences in the duration of neutropenia, hospitalization, fever, and in the number of pyrexial episode, septicemia, bacteremia, local infection, CMV infection, acute GVHD, VOD, and adverse events between the IVIG group and Pentaglobin(®) group. Randomized placebo-controlled trials are needed to conclude that utilization of IVIG or Pentaglobin(®) has no beneficial effect in HSCT.

A New Clinicobiological Scoring System for the Prediction of Infection-Related Mortality and Survival after Allogeneic Hematopoietic Stem Cell Transplantation

“…More recently, a prospective, randomized study in pediatric allo-HSCT compared the use of prophylactic i.v. polyclonal Ig with IgM-and IgA-enriched preparations given before conditioning and until engraftment, and found no significant differences between the 2 approaches [36]. Based on those data and our present results, we speculate that the impact of IgM-and IgAenriched Ig prophylactic administration on infection control might be not relevant when given without considering endogenous IgM and IgA levels.…”

Effectiveness of immunoglobulin prophylaxis in reducing clinical complications of hematopoietic stem cell transplantation: a systematic review and meta‐analysis

“…Among the included RCTs, 22 studies enrolled patients undergoing allogeneic HSCT (n = 3329), 43‐64 four (n = 435) enrolled patients undergoing either allogeneic or autologous HSCT, and one (n = 170) strictly enrolled patients undergoing autologous HSCT . Twelve RCTs (n = 2066) compared polyvalent IVIG to no treatment, nine compared CMVIG to no treatment (n = 619), two (n = 950) compared two different doses of IVIG, two (n = 177) compared polyvalent IVIG to CMVIG, one (n = 63) compared immunoglobulin M–enriched IVIG to no treatment, and one (n = 59) compared immunoglobulin M–enriched IVIG to polyvalent IVIG . No study used SCIG.…”

“…Availability of outcomes varied notably across trials. Eighteen studies (n = 2,553) reported overall survival, five (n = 443) reported transplant‐related mortality, 12 (n = 1,070) reported CMV infections, nine (n = 991) reported CMV diseases, 14 (n = 1,897) reported acute GVHD, seven (n = 551) reported chronic GVHD, five (n = 855) reported VOD, 11 (n = 2309) reported relapse, and 10 (n = 1699) reported interstitial pneumonitis. There were 12 studies that reported non‐CMV infections.…”

Pentaglobin® Efficacy in Reducing the Incidence of Sepsis and Transplant-Related Mortality in Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation: A Retrospective Study

“…The only study previously reported for the pediatric cohort, which compared intravenous immunoglobulin prophylactic use to Pentaglobin ® , was administered to patients within 100 days after allogeneic HSCT. This study showed no differences between two groups concerning neutropenia, number of hospitalization days, total days of fever, number of consecutive detected infectious events, acute GVHD onset, VOD onset, and side effects [24].…”