Methods for treating chronic obstructive pulmonary disease

a technology for obstructive pulmonary disease and treatment methods, applied in the direction of antibody medical ingredients, drug compositions, peptides, etc., can solve the problems of shortened survival time, major healthcare costs of obstructive pulmonary disease, and loss of working capacity

Inactive Publication Date: 2015-08-27
RISK CLIFFORD G
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is about using anti-IgE therapy to treat COPD, a type of lung disease. This therapy has been found to be effective even in patients who smoke or have asthma. The invention also includes using anti-IgE therapy on patients with elevated levels of IgE serum regardless of their skin test results or in vitro reactivity to a perennial aeroallergen. The invention provides methods of treating mammals with COPD with a therapeutically effective amount of an anti-IgE moiety. The humanized antibodies that selectively bind to human immunoglobulin E, such as Omalizumab, are particularly useful.

Problems solved by technology

COPD is associated with major healthcare costs, largely due to expensive treatments such as long-term oxygen therapy and hospital admissions, as well as indirect costs including loss of working capacity.
Airflow obstruction in COPD is usually progressive in patients who continue to smoke eventually leading to disability and shortened survival time.
In emphysema instead, the elastin in the terminal bronchioles is destroyed leading to the collapse of the airway walls and inability to exhale.
In advanced cases of COPD, lung reduction surgery is sometimes performed, but it is not clear that it helps.
There is very little currently available to arrest its progression and otherwise prevent its exacerbations, preserve lung function, and otherwise improve the quality of life of COPD patients.
Oral steroids are only recommended for acute exacerbations with long term use contributing to excess mortality and morbidity.
Treatment of asthmatic and COPD patients with the bronchodilators ipratropium bromide or fenoterol was not superior to treatment on an as-needed basis, therefore indicating that they are not suitable for maintenance treatment.
This latter list of medications help alleviate symptoms associated with COPD but do not treat COPD.
Thus, there is very little currently available to alleviate symptoms of COPD, prevent exacerbations, preserve optimal lung function, and improve daily living activities and quality of life.

Method used

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  • Methods for treating chronic obstructive pulmonary disease
  • Methods for treating chronic obstructive pulmonary disease
  • Methods for treating chronic obstructive pulmonary disease

Examples

Experimental program
Comparison scheme
Effect test

example i

Selection Criteria for Inclusion in the Evaluation Study

[0051]Testing of the usefulness of anti-IgE for the treatment of COPD was carried on 143 patients with symptoms requiring ongoing management. For each patient, age, sex, smoking history, and family history (1st degree relatives) of allergic or obstructive disease were recorded. Serum IgE was measured in International Units (IU). Serum eosinophil levels were measured in most cases. Atopy was evaluated with skin test reactivity to a panel of 24 relevant inhalant antigens according to guidelines of the American Academy of Allergy, and was scored on a severity scale of 0 to 3 (3=prick test reactivity with wheal>2 mm; 2=prick test reactivity with wheal<2 mm; 1=negative prick test reactivity with intradermal reactivity only; 0=no reactivity). The individual skin test scores were added to obtain a total skin test score. Pulmonary function tests (PFT) were performed on a Collins G.S. Spirometer according to American Thoracic Society gu...

example ii

Evaluation Study

Patients Demographics

[0055]The demographics of the 143 patients evaluated are presented in Table 1.

TABLE 1Patients with symptoms requiring ongoing management (Group 1-4)from which 17 patients were selected to receive Omalizumab.1234IgE >30 IUIgE Patient GroupsNon-Non-N = 143SmokersmokerSmokerSmokerNumber68203916Age range30-80 (65)  17-85 (53) 35-83 (65)39-84 (73)(median)Female21122713Family history 4517255of obstructive diseaseIgE (IU)32-1618 (110)31-858 (140)0-22 (7) 0-25 (6)(median)Positive skin41 / 4918 / 20*6 / 124 / 10testsEosinophilia 27 / 6212 / 19 7 / 344 / 15(>300)Reversibility 11540(>15%)Baseline >80161257FEV1 (%)50-80396169predicted) 132180*One additional patient in this group who was not skin tested had positive RAST panel.

[0056]There were 110 patients (72%) with a primary cigarette history (Groups 1+3), indicating a large proportion of patients with a cigarette history in this practice.

[0057]There were 88 patients (62%) with an IgE>30 IU (Groups 1+2), indicating a large...

example iii

Evaluation Study

Omalizumab Treatment Group

[0058]Of the 88 patients in with an IgE>30 IU, 17 were entered into the study (Table 2) on the basis of disease severity in the one year baseline period prior to treatment—16 patients had experienced a total of 60 acute exacerbations that resulted in 20 hospitalizations and 40 outpatient emergency room / doctor visits, while 1 patient was O2 and steroid dependant with 3 prior intubations (four patients, overall, were O2 dependant). They had severe obstructive disease—8 patients had an FEV1 of less than 50% predicted. There was minimal reversibility—5 patients of the 16 had reversibility>15%. The COPD severity score ranged from 11 to 28. Eight patients had positive skin tests to both indoor and outdoor allergens, 6 patients were positive to indoor allergens alone, and 2 patients were negative to skin testing as well as to RAST testing (Table 3).

TABLE 3Skin test reactivity to inhaled allergensNUMBER OF PATIENTSAVERAGEINHALEDTESTINGREACTIVITYALLE...

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Abstract

The present invention provides methods of treating a mammal having chronic obstructive pulmonary disease (COPD), independent of both smoking status and asthma status, with a therapeutically effective amount of an anti-IgE moiety. In accordance with the invention, COPD patients with an elevated serum IgE level may benefit from the treatment methods disclosed. In certain instances, the methods of the disclosure have been found to be useful for the treatment of COPD patients regardless of their skin test results and / or in vitro reactivity to a perennial aeroallergen. Anti-IgE moieties, in accordance with the invention, include but are not limited to any IgG antibody that selectively binds to a given mammal immunoglobulin E (e.g., human immunoglobulin E) such as humanized anti-IgE, humanized murine monoclonal antibody, and / or Omalizumab.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of co-pending U.S. application Ser. No. 13 / 305,222 filed on Nov. 28, 2011, which is a continuation of U.S. application Ser. No. 11 / 917,572 filed on Jul. 18, 2008, now U.S. Pat. No. 8,080,249, which is a national stage entry of PCT Application No. PCT / US2006 / 025654, filed Jun. 30, 2006, which claims priority to U.S. Provisional Patent Application Ser. No. 60 / 695,675, filed on Jun. 30, 2005, entitled “Novel Uses for IgE Antibodies.” The content of each of the above applications is incorporated herein by reference in its entirety as though fully set forth.FIELD OF THE INVENTION[0002]The present invention relates to methods for the treatment of chronic obstructive pulmonary disease in patients with a comorbid component mediated by IgE antibody. More specifically, the present invention encompasses therapeutic modalities, and more particularly, relates to methods using known active entities for a novel indicat...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C07K16/42
CPCC07K2317/76C07K16/4291A61K2039/505A61P11/00Y10S424/805Y10S424/81Y10S530/862Y10S530/868A61K39/39566
Inventor RISK, CLIFFORD G.
Owner RISK CLIFFORD G
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