Prophylactic i.v. Igs in patients with a high risk for CMV after allo-SCT

Abstract

We developed a novel algorithm to define the need for high-dose prophylactic i.v. Igs (IVIG) in periods of high risk for CMV to patients after allo-SCT. IVIG were administered only if at least one of the following, monthlyassessed, criteria was fulfilled: (1) IgG concentration o4 g/l, (2) NK (natural killer) cell count o100/ll, (3) CD4 þ cell count o100/ll, (4) acute or chronic GVHD. The primary endpoint was to determine the cumulative incidence of CMV infection in patients who received prophylactic IVIG according to the algorithm (intervention group) and compare it with that of a sequentially assessed control group, to which prophylactic IVIG were not administered. The study included 79 patients (44 in the intervention and 35 in the control group). The estimated cumulative incidence of CMV infection in the intervention and control group did not differ significantly (44 and 36%; P ¼ 0.31). Additionally, prophylactic IVIG did not reduce the frequency of CMV infection episodes. CMV disease was rare in both cohorts (5 and 9%; P ¼ 0.65). We conclude that prophylactic IVIG should not be administered after allo-SCT, even if administered selectively in a high dose to patients with delayed immune reconstitution or GVHD.

Retrospective analysis of weekly intravenous immunoglobulin prophylaxis versus intravenous immunoglobulin by IgG level monitoring in hematopoietic stem cell transplant recipients

“…The incidence of CMV reactivation was similar between the two groups as the majority of patients in both groups received allo HCT from matched unrelated donors. These results were similar to a clinical trial where prophylactic IVIG did not reduce the cumulative incidence of CMV infection or disease, even when administered at a higher dose in patients with delayed immune reconstitution or GVHD [5]. Unlike the meta‐analysis by Raanani et al that included patients treated in the 1980s and 1990s, our study reflects the current allo HCT trends, including a growing population of matched unrelated, haploidentical, and cord blood transplants.…”

“…Patients undergoing allogeneic hematopoietic stem cell transplantation (allo HCT) have a higher incidence of infections, possibly related to secondary hypogammaglobulinemia [1–3]. Historically, one approach to overcome this risk is the prophylactic use of intravenous immunoglobulins (IVIG) [4, 5]. A meta‐analysis was performed by Raanani and colleagues [6] to compare the benefits of routine prophylaxis with IVIG with periodic monitoring of IgG levels and replacement only for profound hypogammaglobulinemia.…”

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

“…In addition to controversial results about the prophylactic Ig use in HSCT, leading to current recommendations of Ig administration only in HSCT recipients with severe hypogammaglobulinemia, high cost of large doses of IVIG and Pentaglobin Ò , and limited healthcare resources especially in the healthcare systems of developing countries are another limitations for prophylactic use of IVIG or Pentaglobin Ò in patients undergoing HSCT. Moreover, potential factors that may limit the use of IVIG prophylaxis in HSCT recipients are that IVIG is not always well tolerated and may lead to delay in immune recovery, increased risk of developing VOD, and higher incidence of fatal VOD, especially at higher doses (6,27,31,37,38). In the current study, IVIG or Pentaglobin Ò use was generally well tolerated and totally five patients (8.4%) experienced side effects that were considered to be related to Ig use, which were mild and did not lead to stop Pentaglobin Ò or IVIG administration.…”

Infectious diseases in allogeneic haematopoietic stem cell transplantation: prevention and prophylaxis strategy guidelines 2016

“…However, higher doses of immune globulin were again associated with deleterious SOS [ 227 ]. Therefore, the routine prophylactic substitution of immune globulin is not recommended if the IgG level is >4 g/L (DI) [ 227 , 228 ].…”