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Claims for Patent: 7,208,516

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Claims for Patent: 7,208,516

Title:Methods of the treatment of psoriatic arthritis using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Abstract: Methods of treating, managing or preventing psoriatic arthritis are disclosed. Specific methods encompass the administration of (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione alone or in combination with a second active agent. Pharmaceutical compositions and single unit dosage forms are also disclosed.
Inventor(s): Muller; George W. (Bridgewater, NJ), Schafer; Peter H. (Sommerset, NJ), Rohane; Patricia E. W. (Florham Park, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Application Number:11/392,845
Patent Claims: 1. A method of treating psoriatic arthritis, which comprises administering to a patient in need of such treatment a therapeutically effective amount of (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, or a pharmaceutically acceptable salt or solvate thereof, substantially free of its (-) enantiomer.

2. The method of claim 1, wherein the patient is administered with (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione having the formula: ##STR00002##

3. The method of claim 1, wherein the (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione is administered as a pharmaceutically acceptable salt.

4. The method of claim 1, wherein the (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione is administered as a pharmaceutically acceptable solvate.

5. The method of claim 4, wherein the (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione is administered as a pharmaceutically acceptable hydrate.

6. The method of claim 1, further comprising administering to the patient a therapeutically effective amount of a second active agent, wherein the second active agent is an anti-inflammatory agent, an immunosuppressant, mycophenolate mofetil, a biologic agent, or a Cox-2 inhibitor.

7. The method of claim 6, wherein the second active agent is etanercept.

8. The method of claim 1, wherein the (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione or a pharmaceutically acceptable salt or solvate thereof is administered orally.

9. The method of claim 8, wherein the compound is administered in a dosage form of a tablet or a capsule.

10. The method of claim 1, wherein the (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione or a pharmaceutically acceptable salt or solvate thereof is administered topically.

11. The method of claim 10, wherein the compound is administered in a dosage form of a lotion or a liquid.

12. The method of claim 1, wherein the therapeutically effective amount is from about 1 mg to about 1,000 mg per day.

13. The method of claim 12, wherein the therapeutically effective amount is from about 5 mg to about 500 mg per day.

14. The method of claim 13, wherein the therapeutically effective amount is from about 10 mg to about 200 mg per day.

15. The method of claim 1, wherein the therapeutically effective amount is about 20 mg per day.

16. The method of claim 15, wherein the compound is administered once or twice per day.

17. The method of claim 1, wherein the therapeutically effective amount is from about 0.0 1 mg to about 100 mg per kg of a body weight of the patient per day.

18. The method of claim 17, wherein the therapeutically effective amount is about 1 mg, 5 mg or 25 mg per kg of a body weight of the patient per day.
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