Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Allergen or component thereof
Reexamination Certificate
2000-08-23
2002-12-03
Chan, Christina (Department: 1644)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Allergen or component thereof
C514S825000, C514S172000, C514S169000
Reexamination Certificate
active
06488937
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a treatment protocol for administering rapid immunotherapy, and, more particularly, to a method of treating a patient having an immediate hypersensitivity to an allergen using an accelerated rapid immunotherapy schedule, in combination with a method of pretreating such patient prior to receiving the accelerated immunotherapy.
2. Description of the Related Art
Conventional immunotherapy has been found generally effective in the treatment of allergic rhinitis, allergic asthma, chronic sinusitis, and associated headaches. However, disadvantages include poor compliance, delayed efficacy, and patient frustration. Various medical practices have therefore turned their attention towards the use of rush immunotherapy or rapid desensitization because it offers the potential of rapid response, improved compliance, and cost effectiveness.
However, the use in rush immunotherapy of higher antigen dosage levels at accelerated injection schedule intervals is a significant consideration in terms of its impact or responsibility in causing systemic reactions in the patient.
In typical desensitization treatment, it is typically necessary for the patient to have injections very frequently, e.g., initially every two or three days, gradually reducing to once every two or three weeks. This is not only a time-consuming and inconvenient procedure that poses an obstacle to full compliance, but is also very complex due to the need to carefully monitor and control the administered dose of allergen. The potential for allergic reactions such as hives, asthma, and, in some extreme cases, anaphylactic shock, makes desensitization difficult to successfully implement.
SUMMARY OF THE INVENTION
According to the present invention, there is provided a method of treating a patient having an immediate hypersensitivity to allergens of the type that may produce systemic responses such as anaphylactic shock reactions. In accordance with the treatment method, a therapeutically effective desensitizing amount of the allergen is administered to the patient according to a rush or rapid immunotherapy protocol having an accelerated schedule. In one form, the treatment protocol involves administering to the patient gradually increasing doses of the allergen at selected time intervals over a duration of less than about 120 minutes, resulting in a treatment method that when combined with a subsequent observation period lasts less than half a day.
In a preferred form, the allergen is administered at fifteen minute intervals according to a dosing schedule that involves a sequence of six injections effective in advancing the allergic patient to an immunizing or maintenance dose of allergen. For example, such dosing schedule may consist of 0.025 cc of a 1:100,000 allergen dilution, 0.25cc of a 1:100,000 dilution, 0.025 cc of a 1:10,000 dilution, 0.25 cc of a 1:10,000 dilution, 0.025 cc of a 1:1000 dilution, and 0.25 cc of a 1:1000 dilution.
In this application, the ratios and volumes may be altered as may come to be known in the art and still stay within the scope of the invention. Alterations of the ratio and volume dosage may be varied in view of patient needs, allergen sensitivity, and allergen manufacturing and availability.
According to another aspect of the present invention, there is provided a method for pretreating the patient prior to receiving the foregoing rapid immunotherapy treatment protocol. According to the method, a pretreatment protocol is performed which involves administering to the patient prednisone (or any other suitable corticosteroid) and at least one of an H
1
histamine antagonist and/or an H
2
histamine antagonist. The H
1
histamine antagonist may be selected from the group consisting of Claritin™, Seldane™, Zyrtec™, and Allegra™, or other similar medication while the H
2
histamine antagonist may be selected from the group consisting of Zantac™, Pepcid™, and Tagamet™, or other similar medication. Such similar medication may be generic forms of the groups or other similar physiological active compounds.
In a preferred form, this premedication regimen is combined with the administration of a therapeutically effective amount of at least one composition which is effective in reducing a sensitivity of the patient to an asthma associated allergenic reaction or simply an allergenic reaction. For example, to control the sensitivity of the patient to an asthma-related allergen, the patient may be administered an inhaled corticosteroid and/or the drug Singular™, which is a trade name of the generic drug leukotriene.
The invention, in one form thereof, is directed to a method of treating a patient sensitive to an allergen or allergens, comprising administering to the patient a therapeutically effective desensitizing amount of a composition comprising the allergen or allergens over a duration of less than about 120 minutes. The treatment method is preferably conducted according to a rapid immunotherapy protocol.
The method, in a preferred form, further includes a pretreatment protocol of administering to the patient prednisone and at least one of an H
1
histamine antagonist and/or an H
2
histamine antagonist. The H
1
histamine antagonist is preferably selected from the group consisting of Claritin™, Seldane™, Zyrtec™, and Allegra™, while the H
2
histamine antagonist is preferably selected from the group consisting of Zantac™, Pepcid™, and Tagamet™. Other equivalent physiological active substitutes may be substituted into the H
1
and H
2
groups.
The pretreatment protocol further includes administering to the patient a therapeutically effective amount of at least one composition effective in reducing a sensitivity of the patient to an asthma associated allergenic reaction. For example, the patient may be administered at least one of a corticosteroid (oral or inhaled) and a Leukotriene antagonist such as Singular™, Accolade™, or Zyflo™.
According to the rush immunotherapy, rapid desensitization, or rapid allergen vaccination protocol of the treatment method, the administration of the allergen amount further comprises administering to the patient at selected intervals gradually increasing doses of the allergen. In a preferred form, each selected interval is about fifteen minutes.
In a more preferred form, the intervaled administration of allergen occurs in accordance with a dosing schedule consisting essentially of: (i) about 0.025 cc of about a 1:100,000 allergen dilution, (ii) about 0.25 cc of about a 1:100,000 dilution, (iii) about 0.025 cc of about a 1:10,000 dilution, (iv) about 0.25 cc of about a 1:10,000 dilution, (v) about 0.025 cc of about a 1:1000 dilution, and (vi) about 0.25 cc of about a 1:1000 dilution.
The invention, in another form thereof, is directed to a method of treating a patient sensitive to an allergen, comprising a protocol of administering to the patient a series of gradually increasing doses of a composition comprising the allergen at selected intervals for a duration of less than about 120 minutes.
In a preferred form, each selected interval is about fifteen minutes. Additionally, the dilution level of allergen within each dosage is preferably within the range from between about 1:150,000 to about 1:50,000 to between about 1:1500 to about 1:500. The amount of the allergen composition administered to the patient is therapeutically effective in desensitizing the patient against the allergen.
The method, in a preferred form, further includes a pretreatment protocol of administering to the patient prednisone and at least one of an Hi histamine antagonist and/or an H
2
histamine antagonist. Additionally, the pretreatment protocol further includes administering to the patient a therapeutically effective amount of at least one composition effective in reducing a sensitivity of the patient to an asthma associated allergenic reaction. For example, the patient may be administered at least one of a corticosteroid and the drug Singular™.
The invention, in another form thereof, is directed to a method of treat
Chan Christina
Huynh Phuong N.
Knuth Randall J.
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