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

90 Plasma KCE Reports 120
The proportion of SCT cases receiving IG supplementation has not been found in the
scientific publications. In Belgium, it varies across centres, type of transplant and age
group. The increase in non-myeloablative SCT, mainly in adults, has likely decrease the
IG needs in this group. The principle is that IG treatment should be administered in
cases of severe antibody deficiency and thus tailored to the patient. Among children, the
consensus among paediatricians during the expert consultation was that most paediatric
cases require IG supplementation, as post-SCT humoral immunodeficiency is common.
Among adults, experts consider that the prophylactic and pre-emptive use of antibiotics,
antifungal and antiviral drugs has replaced the routine use of IVIG, and that only patients
having a (transient) symptomatic secondary immunodeficiency should receive IVIG, on
an individual basis.
Based on comparison between survey results and INAMI data sources on allogenous
BMT, we estimated that 33% of all allogenous SCT (children and adult confounded)
receive IG supplementation.
The dosage used in Belgium ranges 0.2-0.5g/kg, with the majority of centres using
0.4g/kg. In the Netherlands, treatment scheme was 0.5g/kg per week (before transplant)
then followed by 0.5g/kg per month as maintenance dose; in France, 0.4-0.6g/kg as
loading dose followed by 0.3g/kg. In most studies, IG prophylaxis was given for 3
months and the maximum period of administration was 1 year. Most guidelines
recommend continuing IG after transplant until reconstitution of B cell and antibody
production has been achieved. We estimated that IG treatments were administered in
average 12 times per year, based on the survey results (10.8 in children and 12 in
adults).
Guillain-Barré Syndrome (GBS)
Five epidemiological studies, conducted in the period 1992-2000 in the UK, Italy (2
studies), Spain and Sweden were selected for the estimation of incidence rate. 164,165,166,167,
168
A German study based on hospital records has been excluded as the methods did
not include validation of diagnosis; 169 indeed, such studies were shown to over-estimate
disease incidence. 167 Most studies reported similar values, suggesting that GBS occur
evenly, at least throughout the Western hemisphere: the incidence rate ranged 1.26-
1.63 per 100,000 in the five studies, and the weighted average is 1.42 per 100,000.
In four studies conducted in Italy, Spain and Sweden (two studies) in the period 1996-
1999 and involving a total of 343 cases, the proportion of GBS cases treated with IG
165, 166, 170, 171
ranged 65-82% with a weighted average at 75%.
The dosage was 2 g/kg per treatment in all studies and reviews. Only one Dutch
publication described the proportion of cases requiring a second treatment from two
studies, which amounted at 7% of the GBS cases initially treated. 172
Chronic inflammatory demyelinating polyneuropathy (CIDP)
Two EU studies (Italy and England) and an Australian study calculated the CIDP
prevalence, which ranged 1.9-3.6. 173,174,175 These differences are explained by a lack of
diagnostic gold standard or clear diagnostic criteria. The weighted averaged incidence
rate was calculated at 2.7 per 100,000.
The proportion of all CIDP cases that were treated with long term IG were estimated
in 3 studies from France (2 studies) and the UK, published in 2007-2008, and ranged 51-
63%. 175 , 176 , 177 The weighted average was 56%.
The dosage ranged 0.4-2g/kg in studies and national recommendations. In Belgium, the
maximum reimbursed dose ranges 0.25-2g/kg with a maximum of 9g/kg/6 months. The
practice for CIDP (and MMN) is to start at 2g/kg dose and rapidly decrease the dose
according to the clinical response, to reach a minimal maintenance dose; it has been
estimated at 1.5g/kg in average. The median interval for IVIG administration in studies
was 3 weeks (frequency of 17.3 per year).