Methods and compositions to treat enteropathic arthritis
Inventors
Iversen, Jacqueline • Dahl, Thomas A.
Assignees
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Publication Number
US-10765630-B2
Publication Date
2020-09-08
Expiration Date
Abstract
The present invention is a method of treating enteropathic arthritis in a human subject in need thereof. The method comprises administering an effective amount of a pharmaceutical composition to the subject, wherein the pharmaceutical composition comprises: a) a non-steroidal anti-inflammatory drug (NSAID), and/or a salt thereof; and b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof.
Core Innovation
The disclosure provides a method of treating enteropathic arthritis in a human subject in need thereof by administering an effective amount of a pharmaceutical composition. The pharmaceutical composition consists of a non-steroidal anti-inflammatory drug (NSAID) and/or a salt thereof, together with a co-agent selected from fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof. The composition optionally further includes a pharmaceutical carrier, pharmaceutical excipient, and multiple formulation-related components.
The disclosure also provides defined pharmaceutical compositions for treating enteropathic arthritis, including specific quantitative compositions of naproxen sodium and fexofenadine. In these compositions, the NSAID and the selected co-agent are combined within a single pharmaceutical composition, optionally with conventional carriers and excipients.
The problem being addressed is enteropathic arthritis in human subjects, described as including spondyloarthritis with gastrointestinal disease such as inflammatory bowel disease (IBD), with the need to treat enteropathic arthritis while accounting for gastrointestinal comorbidity. The disclosure states that the combination provides a treatment effect and indicates a potential advantage relating to NSAID-related gastrointestinal adverse effects in patients with gastrointestinal comorbidity.
Claims Coverage
The document includes three independent claims. Across the independent claims, the inventive coverage centers on the co-administration or formulation of an NSAID (or its salt) with a specific antihistamine co-agent, optionally with defined formulation components, and in some instances defined quantitative ranges.
Treating enteropathic arthritis with an NSAID and selected antihistamine co-agent
Administering an effective amount of a pharmaceutical composition consisting of a non-steroidal anti-inflammatory drug (NSAID) and/or a salt thereof, and a co-agent selected from fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof, wherein enteropathic arthritis is treated.
Treating enteropathic arthritis using specified naproxen sodium and fexofenadine dosage ranges
Administering to the subject an effective amount of a pharmaceutical composition consisting of about 220 mg to about 880 mg of naproxen sodium, and about 60 mg to about 180 mg fexofenadine, wherein enteropathic arthritis is treated.
Pharmaceutical composition of an NSAID with selected antihistamine co-agent
Providing a pharmaceutical composition consisting of an NSAID and/or a salt thereof, and a co-agent selected from fexofenadine, ketotifen, desloratadine, cetirizine salts thereof and combinations thereof, optionally with a pharmaceutical carrier, pharmaceutical excipient, sweetening agent, flavoring agent, taste masking ingredient, diluent, alum, stabilizer, buffer, coloring agent, breath neutralizer, emulsifying agent, suspending agent, and combinations thereof.
Overall, the independent claims cover treating enteropathic arthritis by administering or formulating a pharmaceutical composition that combines an NSAID (or salt) with a specific antihistamine co-agent selected from fexofenadine, ketotifen, desloratadine, and cetirizine (including salts and combinations). Additional scope is provided by defining quantitative naproxen sodium and fexofenadine ranges in one independent method claim, and by optionally including conventional formulation components.
Stated Advantages
Potential advantage of reducing or avoiding NSAID-related gastrointestinal adverse effects in patients with gastrointestinal comorbidity.
Documented Applications
Treatment of enteropathic arthritis in a human subject, including spondyloarthritis with gastrointestinal disease such as inflammatory bowel disease (IBD) (including ulcerative colitis and Crohn’s disease).
Treatment context includes other gastrointestinal comorbidities described such as Whipple’s disease and celiac disease, and gastrointestinal disease related to jejunoileal bypass surgery.
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