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High-dose intravenous immunoglobulin

Intravenous immunoglobulin was developed for patients with primary and secondary immunodeficiencies as it provides antibodies against a wide variety of infectious organisms. High-dose intravenous immunoglobulin (hdIVIg) is also used as immunomodulatory therapy in graft vs host disease, immune-mediated thrombocytopenia, Kawasaki disease and Guillain Barré syndrome. Surprisingly, these approved indications only account for 40% of hdIVIg use. The remaining 60% is used in a broad range of un-approved indications, including certain severe inflammatory skin diseases.

It is made from large pools of human plasma obtained from blood donors. It is specially treated to reduce the risk of transmitting serious viral infection such as hepatitis or human immunodeficiency virus. Intravenous Immunoglobulin is a scarce and expensive resource which may further limit its use.

hdIVIg for skin diseases

Although hdIVIg has been used to treat a number of dermatological diseases it must be noted that its effectiveness has only been shown through the treatment of small and mostly uncontrolled study groups. The exception is the use of hdIVIg in treating dermatomyositis, where a number or clinical studies, including a randomised double-blind placebo-controlled trial, have been performed.

The following is a list of reported dermatological uses of hdIVIg therapy:

• Atopic dermatitis
• Bullous pemphigoid
• Chronic urticaria
• Dermatomyositis
• Epidermolysis bullosa acquisita
• Erythema multiforme
• Linear IgA dermatosis
• Pemphigoid gestationis
• Pemphigus vulgaris and foliaceus
• Pyoderma gangrenosum
• Toxic epidermal necrolysis

The use of hdIVIg in these and other skin conditions requires further assessment using randomised double-blind placebo-controlled trials.

hdIVIg in Dermatomyositis

The mainstay of dermatomyositis treatment usually involves oral corticosteroids alone or in combination with an immunosuppressive agent such as methotrexate, azathioprine, cyclophosphamide and ciclosporin. These medicines all have significant side effects and often a less than adequate response is achieved with this conventional therapy.

High dose IVIg is an effective additional therapy for patients with dermatomyositis who fail to respond to conventional therapy or who experience unacceptable side effects. A dose of 1-2 g/kg per month administered over 2 days or 5 days of each month is recommended (currently there is no clear difference in efficacy between the 2-day and 5-day regimen). A summary of clinical trials shows an overall response rate of 80% at about 2 months, with maximal response at 4 months. Most patients require ongoing hdIVIg therapy in conjunction with conventional treatments given at lower and better-tolerated dosages.

With the treatment of other skin conditions, hdIVIg should also be used as an additional therapy. A review of all reported cases of hdIVIg use in dermatological diseases showed efficacy to be much greater when hdIVIg is used as additional therapy, with a response rate of 88% compared with 46% if used alone.

Precautions

Patients with immunoglobulin A (IgA) deficiency are at risk of anaphylactic reactions if given hdIVIg. Deficiency of IgA occurs in about 1 in 700 of the population and should be screened for before hdIVIg therapy is instituted.

Side Effects

Side effects from hdIVIg therapy are generally mild and self-limiting. The most common side effects occur 30-60 minutes after onset of the infusion and include:

• Flushing
• Headache
• Chills
• Fever
• Nausea or vomiting
• Wheezing
• Lower back pain
• Tachycardia (rapid heart beat)
• Changes in blood pressure
• Myalgia (muscle pain)

These symptoms can be managed by stopping the infusion or a patient can be premedicated with antihistamines and intravenous hydrocortisone.

Intravenous immunoglobulin