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How much gammaglobulin ?. INGID VII th Meeting Budapest, October 7, 2006 Rolf Gustafson. 1880sImmunotherapy von Behring, Kitasato 1950sSubstitution therapy Bruton 1980sImmunomodulation Imbach, Barandun. Immunotherapy - a short history. - PowerPoint PPT Presentation
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How much gammaglobulin ?
INGID VIIth Meeting
Budapest, October 7, 2006
Rolf Gustafson
Ökad infektionsbenägenhet
1880s Immunotherapy von Behring, Kitasato
1950s Substitution therapyBruton
1980s Immunomodulation Imbach, Barandun
Immunotherapy - a short history
Ökad infektionsbenägenhet
Serum from immunized animals (mainly horses)
1895 Diphtheria antiserum
1908 Meningococcal antiserum
1925 Streptococcal antitoxin
Immunotherapy
Ökad infektionsbenägenhet
1933 Placental extracts Diphteria
Scarlet fever
Polio
Measles
1935 Convalescent human serum Rheumatic fever
Impetigo
Measles
Chicken pox
Scarlet fever
Immunotherapy
Ökad infektionsbenägenhet
1940
The US National Research Council asked Dr.
Edwin Cohn to identify a stable blood derivate
or substitute.
1941
The American Red Cross began collecting blood.
A grant of 10,000 USD for large scale
production of human albumin was given.
Substitution therapy
Ökad infektionsbenägenhet
By help of manipulating the:
ethanol concentration
temperature
pH
Separation of plasma proteins
Rolf Gustafson/Baxter Medical
Rolf Gustafson/Baxter Medical
Rolf Gustafson/Baxter Medical
Ökad infektionsbenägenhet
WHO
International Red Cross
International Society of Transfusion (ISBT)
Council of Europe
European Union
European Agency for the Evaluation of
Medicinal Products (EMEA)
FDA
Statements, Directives & Resolutions
IgG Trace amounts of IgM & IgA
Soluble CD4 & CD8
Soluble HLA
What is gammaglobulin ?
Rolf Gustafson/Baxter Medical
Half - life of IgG
0
10
20
30
40
50
60
70
80
90
100
0 3 6 9 12 15 18 21
IgG
%
Weeks
Ökad infektionsbenägenhet
Gammaglobulin became available in the mid
– 1940s and was used for preventing viral
diseases like:
Measles
Hepatitis A
Gammaglobulin
Bruton´s boy
Ökad infektionsbenägenhet
…………. started as subcutaneous
injections at monthly intervals
Substitution therapy
Ökad infektionsbenägenhet
1950s - 1960s
Medical Research Council in England
Data from 176 patients
25 mg / kg / week 50 mg / kg / week
fewer deaths
less cases of pneumonia
IgG 1.2 – 2.6 g/L IgG 2.9 – 3.8 g/L
Substitution therapy
Ökad infektionsbenägenhet
Late 1980s
consencus of giving 300 - 400 mg / kg / month
IgG 4 – 5 g/L
1987
Roifman et al. reported that 600 mg / kg / month
was better than 200 mg / kg / month
IgG > 5 g / L
Substitution therapy
Ökad infektionsbenägenhet
2006
Approved and recommended dose:
400 - 800 mg / kg / month
Substitution therapy
Ökad infektionsbenägenhet
Evaluation
Clinical outcome
Increasing IgG level
Substitution therapy
Ökad infektionsbenägenhet
Intravenous infusions
Substitution therapy
Rolf Gustafson/Baxter Medical
IVIG - IgG levels
0
2
4
6
8
10
12
14
16
18
20
1 2 3 4 5 6 7 8 9 10 11 12 13 14
IgG
g/L
Day
Ökad infektionsbenägenhet
Subcutaneous infusions
Substitution therapy
Rolf Gustafson/Baxter Medical
SCIG - IgG levels
0
2
4
6
8
10
1 2 3 4 5 6 7 8 9 10 11 12 13 14
IgG
g/L
Days
Ökad infektionsbenägenhet
Indications
X-linked agammaglobulinemia (XLA)
Common variable immunodeficiency (CVID)
Severe combined immunodeficiency (SCID)
Wiskott Aldrich syndrome (WAS)
Substitution therapy
What about IgG subclass deficiences ?
In selected patients with:
IgG1 deficiency
IgG2 deficiency
IgG3 deficiency
Substitution therapy
Rolf Gustafson/Baxter Medical
Half - life of IgG3
0
10
20
30
40
50
60
70
80
90
100
0 7 14 21 28 35 42 49
IgG3
%
Days
Ökad infektionsbenägenhet
What about selective IgA deficiency ?
In selected adult patients with:
at least 4 treatments with antibiotics / year
Substitution therapy
Gammaglobulinbehandling
Gustafson R, Gardulf A, Granert C, Hansen S, Hammarström L
Prophylactic therapy for selective IgA deficiency. Lancet 1997;350:865
SCIG therapy in IgA deficiency
IgG therapy: 100 mg/kg/week
Infections per year Before IgG therapy During IgG therapy
0 – 1 0 5
2 – 3 0 5
≥ 4 10 0
Ökad infektionsbenägenhet
What is the goal with patient education ?
The goal is …
that the patient becomes an active and encouraged part in
the decision-making process and have the knowledge about
self-care activities and behaviors that foster health and
health-related quality of life instead of being a passive
receiver of information.
A. Gardulf, 2002
Patient training & education
Training & education should include knowledge &
understanding of:
primary antibody deficiencies
aim and importance of IgG therapy
infections & antibiotic treament
systemic adverse reactions
self-care and prevention
behaviour changes
self-infusion technique
Home-therapy training program – the key to success