The report is available in English with a French summary - KCE

58 Plasma KCE Reports 120
A third RCT, conducted in 101 patients with end-stage renal disease and involving 27
kidney transplants, showed that IG was effective in reducing anti-HLA antibody levels,
improving kidney transplant rates in highly sensitized patients compared to placebo, and
decreased waiting time to graft. 51 There was however no significant decrease in graft
survival rates and patient survival in the IG group compared to placebo and allograft
rejection was significantly higher in the IG group. The authors concluded that IG pretreatment
should improve the transplant potential for highly sensitized patients with
end-stage renal disease awaiting kidney transplantation, especially those resistant to
other therapies.
• IG, used alone or with antivirals, for the prophylaxis of CMV disease in SOT
recipients did not decrease the risk of CMV disease and overall mortality
compared to placebo, or to antivirals alone, in a meta-analysis of 30 RCT. IG
reduced the risk of death from CMV disease compared to placebo. Antiviral
medications are effective.
• In highly sensitized patients, three RCT suggested some benefit of IG
treatment after transplant but failed to show a significant reduction of
transplant rejection.
Suspected or proven infection in neonates
As endogenous synthesis of immunoglobulins does not begin until about 24 weeks after
birth, neonates are at high risk for morbidity and mortality from infections acquired in
utero, as well as from exposure to infectious sources in neonatal intensive care units. 56
Sepsis is an important cause of neonatal death and brain damage. Though effective
antibiotic treatment is essential for sepsis, adjuvant therapies such as IG may offer an
additional strategy. The rationale for IG treatment for neonatal infections is based on
the evidence that it provides IgG that can bind to cell surface receptors, provide
opsonic activity, activate complement, promote antibody dependent cytotoxicity and
improve neutrophilic chemoluminescence.
A Cochrane review published in 2004 included 9 RCT involving 553 neonates with
suspected infection. 57 Six studies reported on mortality and results showed a reduction
in mortality following IG treatment in cases with suspected infection of borderline
statistical significance. Treatment with IG in cases of subsequently proven infection did
result in a statistically significant reduction in mortality (RR 0.55, 95% CI: 0.31-0.98).
However, the authors points that these findings are in contrast with a previous
Cochrane meta-analysis (from the same author) that showed the reverse relationship
(significant reduction in mortality in suspected infections and non significant reduction in
proven infections). 58 The review also mentions that four former meta-analyses showed
statistically significant reductions in mortality following IG treatment for neonatal sepsis,
up to a six-fold decrease (p=0.007) when IG is administered in addition to standard
therapies.
IG given to neonates with proven infections reduced overall mortality in five
meta-analyses. However, the effectiveness of IG to reduce mortality in
neonates with suspected infections was not always significant.
Preterm / low birth weight infants
As maternal transfer of IG to the foetus occurs mainly after 32 weeks of gestation and
endogenous synthesis does not begin until about 24 weeks after birth, the preterm
infant is especially vulnerable to infectious sources. 57 Indeed, nosocomial infections
continue to be a significant cause of morbidity and mortality among preterm and/or low
birth weight infants. Due to the mechanisms above described, IG was considered to
have the potential of preventing or altering the course of nosocomial infections. 59