Uses and compositions for treatment of ankylosing spondylitis

a technology of ankylosing spondylitis and compositions, applied in the direction of drug compositions, antibody medical ingredients, peptides, etc., can solve the problems of fatigue and pain associated with use, impairment of health-related quality of life, and eventual loss of spinal mobility, so as to improve the fatigue and pain associated, safe and effective treatment

Inactive Publication Date: 2010-01-28
WONG ROBERT L
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0005]Although TNFα inhibitors are effective at treating AS, there remains a need for a more effective treatment option for subjects suffering from AS, especially in improving the fatigue and pain associated with the disease and in treating subjects who have failed more conventional, i.e., DMARD or NSAIDs therapy. Thus, there also remains a need for improved methods and compositions that provide a safe and effective treatment of AS using TNFα inhibitors.

Problems solved by technology

AS is difficult to diagnose in its early stages and is often an overlooked cause of persistent back pain in young adults.
In severe cases, AS may result in complete spinal fusion, causing extreme physical limitation.
As the disease progresses, patients with AS experience pain, joint stiffness, and the eventual loss of spinal mobility.
These clinical symptoms and subsequent disease progression result in functional limitations and impairment in health-related quality of life (HRQOL) (Dagfinrud et al.

Method used

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  • Uses and compositions for treatment of ankylosing spondylitis
  • Uses and compositions for treatment of ankylosing spondylitis
  • Uses and compositions for treatment of ankylosing spondylitis

Examples

Experimental program
Comparison scheme
Effect test

example 1

Adalimumab in the Treatment of Active Ankylosing Spondylitis: Results of an Open-Label, 52-Week Trial

[0203]Tumor necrosis factor (TNF) antagonists infliximab and etanercept have shown efficacy in the treatment of ankylosing spondylitis (AS). Adalimumab (Abbott Laboratories) is a fully human, anti-TNF monoclonal antibody that reduces the signs and symptoms and progression of disease of rheumatoid arthritis and has been evaluated in AS over 20 weeks.

[0204]The objective of this study was to examine the potential therapeutic effects of adalimumab in NSAID-refractory AS patients who were treated for 52 weeks (Ann Rheum Dis 2005; 64(Suppl III):316). To further this objective, fifteen patients were enrolled (patient characteristics are detailed in Table 1). All patients suffered from spinal pain, and 4 patients also had peripheral arthritis. Adalimumab 40 mg was administered subcutaneously every other week (eow). Clinical outcome assessments included disease activity (BASDAI), function (BA...

example 2

Adalimumab Reduces Fatigue in Patients with Active Ankylosing Spondylitis (AS)

[0209]Fatigue, defined as enduring, subjective sensation of generalized tiredness or exhaustion, has been increasingly recognized as an important outcome measure in AS (Dagfinrud et al. Arth Rheum 2005; 53(1):5-11; Jones S D et al. J Rheumatol 1996; 23(3):487-90; Haywood H L et al. Rheumatol 2002; 41:1295-1302; Ward M M. Arth Care Res 1999; 12:247-55; Van Tubergen et al. Arth Rheum 2002; 27(1):8-16). It has been reported that 65% of people living with AS describe fatigue as a major symptom from time to time (Jones S D et al. J Rheumatol 1996; 23(3):487-90). The objective of this study was to evaluate the impact of adalimumab therapy (a TNF antagonist) on fatigue in active AS patients.

Overview

[0210]This phase III, double-blind, randomized, placebo-controlled trial was conducted at 11 sites in Canada (study design is shown in FIG. 3). The study enrolled active AS patients with an inadequate response to at le...

example 3

Major Clinical Response and Partial Remission in Ankylosing Spondylitis Subjects Treated with Adalimumab: Study H

[0221]Ankylosing Spondylitis (AS) is a common inflammatory rheumatic disease that produces progressive spinal stiffness and restriction of mobility. Tumor necrosis factor (TNF) is thought to play a major role in the pathogenesis of AS. No trial of a disease-modifying antirheumatic drug (DMARD) has yielded consistent positive results for the treatment of AS.

[0222]Adalimumab is a fully human monoclonal antibody targeting TNF, currently approved for the treatment of rheumatoid arthritis and psoriatic arthritis in the US and Europe, and currently pending approval from the FDA and EMEA for AS. The objective of the study described herein was to investigate the ability of adalimumab to effect a major clinical response and partial remission in subjects with ankylosing spondylitis. Partial remission is defined as a value of <20 on a 0-100 VAS scale in each of the 4 ASAS domains: P...

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Abstract

The invention provides methods, uses and compositions for the treatment of ankylosing spondylitis (AS). The invention describes methods and uses for treating ankylosing spondylitis, wherein a TNFα inhibitor, such as a human TNFα antibody, or antigen-binding portion thereof, is used to reduce signs and symptoms of ankylosing spondylitis in a subject. Also described are methods for determining the efficacy of a TNFα inhibitor for treatment of ankylosing spondylitis in a subject.

Description

RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Patent Application No. 60 / 812,312, filed on Jun. 8, 2006; U.S. Provisional Patent Application No. 60 / 857,352, filed on Nov. 6, 2006; and U.S. Provisional Patent Application No. 60 / 858,328, filed on Nov. 10, 2006.BACKGROUND OF THE INVENTION[0002]Ankylosing spondylitis (AS) is a chronic, progressive, inflammatory disease with considerable impact on patient functioning, well-being, and disability. The prevalence of AS has traditionally been estimated in the range of 0.1-1.9%, with more males affected than females (Sieper et al. Ann Rheum Dis 2001; 60:3-18; Silmani & Hochberg Rheum Dis Clin North Am 1996; 22:737-49; Gran & Husby, Semin Arthritis Rheum 1993; 22(5):319-34). Millions of people are affected by ankylosing spondylitis (AS). As a chronic disease of the axial skeleton and large peripheral joints, AS causes inflammatory back pain and stiffness and it is associated with other inflammatory diseases of t...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/395A61P25/00A61P29/00
CPCA61K2039/505C07K16/241A61P25/00A61P29/00
Inventor WONG, ROBERT L.
Owner WONG ROBERT L
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