Claims for Patent: 8,828,946

Summary for Patent: 8,828,946

Title:	Composition comprising interleukin-1 receptor antagonist and corticosteroid
Abstract:	The present invention relates to pharmaceutical compositions for a combination therapy with a cytokine antagonist and a corticosteroid. By means of the combination therapy diseases such as osteoarthritis, tendon injuries and/or degenerative spinal diseases can be treated.
Inventor(s):	Wehling; Peter (Dusseldorf, DE), Reinecke; Julio (Cologne, DE)
Assignee:	Orthogen AG (Dusseldorf, DE)
Application Number:	13/142,577
Patent Claims:	1. A pharmaceutical composition comprising: a corticosteroid together with a cytokine antagonist and a further cytokine antagonist, wherein the cytokine antagonist is a recombinant interleukin antagonist IL-1Ra protein and the further cytokine antagonist is a naturally occurring interleukin antagonist IL-1Ra protein, wherein the recombinant interleukin antagonist IL-1Ra protein is anakinra and the naturally occurring interleukin antagonist IL-1Ra protein is obtained from human blood, and wherein the pharmaceutical composition is suitable for local administration. 2. The pharmaceutical composition of claim 1, further comprising a growth factor. 3. The pharmaceutical composition according to claim 2, wherein the pharmaceutical composition is prepared for simultaneous or sequential administration of the cytokine antagonists, the growth factor and the corticosteroid. 4. The composition according to claim 2, wherein the growth factor is selected from the group consisting of TGF-.beta., IGF, BMP, HGF and VEGF. 5. The pharmaceutical composition according to claim 1, wherein the cytokine antagonist is present in a concentration of 0.5 to 150 mg/dose. 6. The pharmaceutical composition according to claim 1, wherein the corticosteroid is one or more selected from the group of: (a) a glucocorticoid, or a salt, ester or prodrug thereof; (b) a mineral corticoid, or a salt, ester or prodrug thereof; and (c) an androgen, or a salt, ester or prodrug thereof. 7. The pharmaceutical composition of claim 6, wherein the glucocorticoid is one or more from the group consisting of, cortisone, hydrocortisone, prednisone, prednisolone, cloprednol, deflazacort, fluocortin, triamcinolone, dexamethasone, methylprednisolone, fluprednisolone, clocortolone, clobetasone, alclomethasone, flumethasone, fluoprednidene, fluorandrenolone, betamethasone, beclomethasone, fluocortolone, mometasone, fluticasone, halomethasone, fluocinolone, diflorasone, desoximethasone, fluocinonide, amcinonide, halcinonide, diflucortolone, clobetasol, paramethasone; wherein the mineral corticoid is selected from the group consisting of aldosterone, deoxycorticosterone, and fludrocortisone; and wherein the androgen is dehydroepiandrosterone (DHEA) or estrogens. 8. The pharmaceutical composition according to claim 1, wherein the corticosteroid is present in a concentration of 1 to 80 mg/dose. 9. The pharmaceutical composition according to claim 1, wherein the local administration is selected from the group consisting of injection into an affected body region, and topical administration. 10. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition further contains a carrier and/or an excipient. 11. A kit, comprising a pharmaceutical composition comprising a cytokine antagonist, a pharmaceutical composition comprising a corticosteroid, and a further cytokine antagonist, wherein the cytokine antagonist is a recombinant interleukin antagonist IL-1Ra protein, and the further cytokine antagonist is a naturally occurring interleukin antagonist IL-1Ra protein, wherein the recombinant interleukin antagonist IL1Ra protein is anakinra and the naturally occurring interleukin antagonist IL-1Ra protein is obtained from human blood, and wherein the pharmaceutical compositions are suitable for local administration. 12. The kit of claim 11, wherein the naturally occurring antagonist IL-1Ra protein is autologous serum in which IL-1Ra was enriched and is contained therein among other factors (Orthokine.RTM.) and the recombinant interleukin antagonist IL-1Ra protein is anakinra. 13. The kit of claim 11, the pharmaceutical composition comprising the cytokine antagonists, further comprising a growth factor. 14. A method of preparing a pharmaceutical preparation comprising the following steps: providing a corticosteroid, a cytokine antagonist and a further cytokine antagonist, wherein the cytokine antagonist is a recombinant interleukin antagonist IL-1Ra protein and the further cytokine antagonist is a naturally occurring interleukin antagonist IL-1Ra protein, wherein the recombinant interleukin antagonist IL-1Ra protein is anakinra, the naturally occurring interleukin antagonist IL-1Ra protein is obtained from human blood, and admixing said corticosteroid, said cytokine antagonist and said further cytokine antagonist with a suitable carrier, wherein the pharmaceutical composition is suitable for local administration. 15. The method of claim 14, further comprising the step of adding a growth factor to the pharmaceutical composition. 16. A pharmaceutical composition comprising, a corticosteroid together with a cytokine antagonist and a further cytokine antagonist, wherein the cytokine antagonist is a recombinant interleukin antagonist IL-1Ra protein, and the further cytokine antagonist is a naturally occurring interleukin antagonist IL-1Ra protein wherein the recombinant interleukin antagonist IL-1Ra protein is obtained from E. coli and the naturally occurring IL-1Ra is obtained from human blood, and wherein the pharmaceutical composition is suitable for local administration. 17. A pharmaceutical composition comprising, a corticosteroid together with a cytokine antagonist and a further cytokine antagonist, wherein the cytokine antagonist is a recombinant interleukin antagonist IL-1Ra protein, and the further cytokine antagonist is a naturally occurring interleukin antagonist IL-1Ra protein, wherein the recombinant interleukin antagonist IL-1Ra protein is anakinra, and the naturally occurring interleukin antagonist IL-1Ra is Orthokine.RTM., and wherein the pharmaceutical composition is suitable for local administration. 18. A kit, comprising: a pharmaceutical composition comprising a cytokine antagonist, a pharmaceutical composition comprising a corticosteroid, and a further cytokine antagonist, wherein the cytokine antagonist is a recombinant interleukin antagonist IL-1Ra protein, and the further cytokine antagonist is a naturally occurring interleukin antagonist IL-1Ra protein, wherein the recombinant interleukin antagonist IL-1Ra protein is obtained from E. coli and the naturally occurring interleukin antagonist IL-1Ra protein is obtained from human blood, and wherein the pharmaceutical compositions are suitable for local administration. 19. A kit comprising: a pharmaceutical composition comprising a cytokine antagonist, a pharmaceutical composition comprising a corticosteroid, and a further cytokine antagonist, wherein the cytokine antagonist is a recombinant interleukin antagonist IL-1Ra protein, and the further cytokine antagonist is a naturally occurring interleukin antagonist IL-1Ra protein, wherein the recombinant interleukin antagonist IL-1Ra protein is anakinra and the naturally occurring interleukin antagonist IL-1Ra protein is Orthokine.RTM., and wherein the pharmaceutical compositions are suitable for local administration. 20. A method of preparing a pharmaceutical composition, comprising the following steps: providing a corticosteroid, a cytokine antagonist and a further cytokine antagonist, wherein the cytokine antagonist is a recombinant interleukin antagonist IL-1Ra protein and the further cytokine antagonist is a naturally occurring interleukin antagonist IL-1Ra protein, wherein the recombinant interleukin antagonist IL-1Ra protein is obtained from E. coli and the naturally occurring interleukin antagonist IL-1Ra protein is obtained from human blood, and admixing said corticosteroid, said cytokine antagonist and said further cytokine antagonist with a suitable carrier, wherein the pharmaceutical composition is suitable for local administration. 21. A method of preparing a pharmaceutical composition, comprising the following steps: providing a corticosteroid, a cytokine antagonist and a further cytokine antagonist, wherein the cytokine antagonist is a recombinant interleukin antagonist IL-1Ra protein and the further cytokine antagonist is a naturally occurring interleukin antagonist IL-1Ra protein, wherein the recombinant interleukin antagonist IL-1Ra protein is anakinra and the naturally occurring interleukin antagonist IL-1Ra protein is Orthokine.RTM., and admixing said corticosteroid, said cytokine antagonist and said further cytokine antagonist with a suitable carrier, wherein the pharmaceutical composition is suitable for local administration.

Details for Patent 8,828,946

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	11/14/2001		2029-12-10