Drug Information for Nonstandardized Allergenic Products (ALK-Abello, Inc.): CLINICAL PHARMACOLOGY

  • The treatment consists of the subcutaneous injection of gradually increasing doses of the allergens to which the patient is allergic. It has been demonstrated that this method of treatment induces an increased tolerance to the allergens responsible for the symptoms on subsequent exposure. The exact relationships between allergen, skin-sensitizing antibody (IgE) and the blocking antibody (IgG) have not been precisely established. Clinically confirmed immunological studies have adduced evidence of the efficacy of hyposensitization therapy.

    Numerous controlled studies have demonstrated the clinical efficacy of immunotherapy with cat, dust mites and some pollen extracts. Nevertheless, responses are variable, and in a few studies patients reported no appreciable benefit.

    Extracts containing Short Ragweed pollen bear a labeled potency declaration in terms of Antigen E content. Numerous studies have confirmed Antigen E (AgE) as the major antigen associated with Short Ragweed pollinosis.1 Therefore, it is essential that the physician be aware of AgE content of allergenic extract administered for hyposensitization therapy.

    Some studies have indicated that for most patients a cumulative Antigen E dosage of less than 0.1 units is not immunizing (sufficient to stimulate specific IgG antibodies.)2 This, however, does not suggest that 0.1 unit is a maximum tolerated dose. Most moderately sensitive patients may tolerate a dosage of ten to fifty times greater. If results with this product are unsatisfactory with exquisitely sensitive patients who cannot tolerate an immunizing dose, the physician should consider alternative therapy.

    One well-controlled study demonstrated that standard immunotherapy (gradually increasing doses of antigen given subcutaneously to a maximum tolerated peak dose), using crude ragweed extract of known Antigen E potency, was significantly superior to placebo and low dose immunotherapy ( 0.1 units AgE cumulative dose) in amelioration of symptoms associated with ragweed hay fever. These patients received a cumulative dose of 18-350 units Antigen E (median = 84.9 units). The maximum single dose ranged from 3.7 to 46.8 units (median = 11.1 units) prior to the ragweed hay fever season10.

    Patients for this study were sensitive to Ragweed Antigen E, as determined by intradermal skin testing at a dose 0.01 units AgE/mL. A series of 24 weekly injections were administered. Forty-seven percent of the patients experienced at least one systemic reaction with an average of 1.2 systemic reactions per patient. None of the patients were able to achieve the expected maximum dose (90 units of Antigen E) in the 24 weekly injection dosage schedule.

  • Drug Information Provided by National Library of Medicine (NLM).