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Table 5 Difference between immunoglobulins (ScIg, IVIg) and typical drugs

From: Passive blood anaphylaxis: subcutaneous immunoglobulins are a cause of ongoing passive anaphylactic reaction

Feature

Drug/medicine

Immunoglobulin

Source

Chemical (for example catalytic, enzymatic) reaction “IN VITRO”

Plasma obtained from blood donorsa “IN VIVO”

Chemical composition, dose

Known

(standardization following pharmacopeia)

Dose [g] describe active compound content

Not precisely defined

Protein (in reality proteins complex)

Dose [g] describe total protein content

Clinical pharmacology

Mechanism of action

Defined (by strict receptors)

Multifactorial (depends on antigenic specificity)

Elimination and half-life (T½)

Renal intestinal etc. after easy diffusion from tissue compartment

Strictly defined T½

Not known

Serum T½ does not reflect immunoglobulin elimination, but FcR opsonizationb

Unpredictable adrs

Immunogenicity

Usually low (in general haptenic formula)

Pathological anti—IgAc

Immunoreactivity (immune reaction to pharmaceutical product)

Rare, but ever probable (e.g. benzylpenicillin allergy)

Physiological tolerance or antiidiotypic immune responsed

  1. Immunoglobulins are a pharmaceutical product with unique technology, contrary to bio-synthetic drugs
  2. aImmunoglobulin preparation is plasma fractionation: plasma is obtained in accordance with WHO guidelines from at least 1000 donors
  3. bAfter immunoglobulin distribution to tissue compartment FcR opsonization occurs (see Figs. 2a, 3). It blocks inverse diffusion to serum
  4. cIn clinical practice immunoglobulins are used as replacement therapy in patients with primary and secondary immunodeficiencies. Lack of active immune response after antigenic stimulation (e.g. vaccination) in such patients is one crucial mechanism of low immunogenicity. Contrary to CVID, patients with selective IgA deficiency may produce IgG that reacts with IgA in immunoglobulins (product characteristic of many immunoglobulins as well as Subcuvia® does not contain essential contraindication—selective IgA deficiency)
  5. dWhen immunoglobulin is used in immunomodulatory therapy (autoimmune disease) the immune response to immunoglobulins and hyperreactivity may be observed. For example Rheumatoid factor from patients with autoimmune disease and IgG from pharmaceutical product