Methods for the treatment of diseases ameliorated by pde4 inhibition using dosage titration of apremilast
AssigneeAmgen Inc.
InventorRobert Day
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Abstract
Methods of treating, managing or preventing diseases ameliorated by inhibiting PDE4 such as psoriasis, ankylosing spondylitis, Behcet's disease, rheumatoid arthritis, atopic dermatitis, Crohn's disease, and ulcerative colitis are disclosed. Specific methods encompass the administration of apremilast in specific dosage titration schedule, alone or in combination with a second active agent.
Claims20
A method for treating a patient having psoriasis, severe plaque psoriasis, ankylosing spondylitis, Behcet's disease, rheumatoid arthritis, atopic dermatitis, Crohn's disease, or ulcerative colitis, wherein the patient has severe renal impairment, the method comprising administering to the patient 30 mg once daily of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
A method for treating a patient having psoriasis, wherein the patient has severe renal impairment, the method comprising administering to the patient 30 mg once daily of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
A method for treating a patient having severe plaque psoriasis, wherein the patient has severe renal impairment, the method comprising administering to the patient 30 mg once daily of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
A method for treating a patient having ankylosing spondylitis, wherein the patient has severe renal impairment, the method comprising administering to the patient 30 mg once daily of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
A method for treating a patient having Behcet's disease, wherein the patient has severe renal impairment, the method comprising administering to the patient 30 mg once daily of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
A method for treating a patient having rheumatoid arthritis, wherein the patient has severe renal impairment, the method comprising administering to the patient 30 mg once daily of stereomerically pure (±)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
A method for treating a patient having atopic dermatitis, wherein the patient has severe renal impairment, the method comprising administering to the patient 30 mg once daily of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
A method for treating a patient having Crohn's disease, wherein the patient has severe renal impairment, the method comprising administering to the patient 30 mg once daily of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
A method for treating a patient having ulcerative colitis, wherein the patient has severe renal impairment, the method comprising administering to the patient 30 mg once daily of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
A method for treating a patient having psoriasis, severe plaque psoriasis, ankylosing spondylitis, Behcet's disease, rheumatoid arthritis, atopic dermatitis, Crohn's disease, or ulcerative colitis, wherein the patient has severe renal impairment, the method consisting of:
- (a) administering to the patient stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione in an initial titration dosing schedule consisting of
- (i) 10 mg in the morning on the first day of administration;
- (ii) 10 mg in the morning on the second day of administration;
- (iii) 10 mg in the morning on the third day of administration;
- (iv) 20 mg in the morning on the fourth day of administration;
- (v) 20 mg in the morning on the fifth day of administration;
- and
- (b) on the sixth and every subsequent day, administering to the patient 30 mg once daily of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
Dependencies are inferred from the claim text.