Claims for Patent: 10,434,172

Summary for Patent: 10,434,172

Title:	Methods of treating generalized pustular psoriasis (GPP) using IL-17 antagonists
Abstract:	The disclosure is directed to methods, treatment regimens, uses, kits and therapies for treating Generalized Pustular Psoriasis (GPP). These methods, treatment regimens, uses, kits and therapies utilize, inter alia, administration of an IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab. Additionally disclosed are improved methods for treating plaque-type psoriasis that utilize up-titration and down-titration of the IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab, as well as modification of dose frequency. Further disclosed are methods of treating palmoplantar pustular psoriasis using the disclosed IL-17 antagonists, e.g., IL-17 antibodies, such as secukinumab.
Inventor(s):	Papavassilis; Charis (Lorrach, DE), Sander; Oliver (Basel, CH), Shima; Tomohiro (Tokyo, JP), Kitamura; Susumu (Yokohama, JP)
Assignee:	Novartis AG (Basel, CH)
Application Number:	14/911,387
Patent Claims:	1. A method of treating Generalized Pustular Psoriasis (GPP), comprising administering an effective amount of secukinumab to a patient in need thereof. 2. The method according to claim 1, wherein secukinumab is administered to the patient by subcutaneous injection at a dose of about 150 mg-about 300 mg at weeks 0, 1, 2, 3, and 4, and then every four weeks thereafter. 3. The method according to claim 2, wherein the patient has von Zumbusch GPP, generalized form of acrodermatitis continua (Hallopeau), acute exanthematic, GPP of pregnancy (impetigo herpetiformis), infantile or juvenile GPP, or circinate or annular GPP. 4. The method according to claim 2, wherein the patient has GPP without psoriasis vulgaris. 5. The method according to claim 2, wherein the patient has GPP with psoriasis vulgaris. 6. The method according to claim 2, wherein the patient has GPP with palmoplantar pustular psoriasis (PPP). 7. The method according to claim 2, wherein the patient has a decreased level of Interleukin-36 Receptor Antagonist mRNA or protein in the skin relative to a subject not having GPP. 8. The method according to claim 2, wherein the patient is selected for treatment with secukinumab based on having been previously determined to have a decreased level of Interleukin-36 Receptor Antagonist mRNA or protein in the skin relative to a subject not having GPP. 9. The method according to claim 2, wherein, prior to treatment with secukinumab, the patient has failed to respond to, had a contraindication to, or was intolerant to phototherapy or systematic therapy. 10. The method according to claim 2, wherein the patient has erythema with pustules .gtoreq.10% prior to treatment with secukinumab. 11. The method according to claim 2, wherein the patient has a Body Surface area Affected (BSA) of at least 5% or greater prior to treatment with secukinumab. 12. The method according to claim 2, wherein the patient has a Body Surface area Affected (BSA) of .gtoreq.10% prior to treatment with secukinumab. 13. The method according to claim 2, wherein the patient is able to stop or reduce concomitant use of a psoriasis agent by at least about 50% in response to treatment with secukinumab. 14. The method according to claim 2, wherein all doses are about 150 mg or about 300 mg. 15. The method according to claim 2, wherein each dose is about 150 mg. 16. The method according to claim 15, wherein each dose is administered in a volume of 1 milliliter. 17. The method according to claim 2, wherein each dose is about 150 mg, wherein secukinumab is formulated in a pharmaceutical composition comprising a buffer and a stabilizer, wherein the pharmaceutical composition is disposed in an autoinjector, and wherein the pharmaceutical composition delivery volume is 1 milliliter. 18. The method according to claim 2, wherein each dose is about 150 mg, and wherein secukinumab is disposed in a pre-filled syringe, a vial, an injection pen, or an autoinjector. 19. The method according to claim 2, wherein each dose is about 300 mg. 20. The method according to claim 19, wherein each dose is administered in a volume of 2 milliliters. 21. The method according to claim 2, wherein each dose is about 300 mg, wherein secukinumab is formulated in a pharmaceutical composition comprising a buffer and a stabilizer, wherein the pharmaceutical composition is disposed in an autoinjector, and wherein the pharmaceutical composition delivery volume is 2 milliliters. 22. The method according to claim 2, wherein each dose is about 300 mg, and wherein secukinumab is disposed in pre-filled syringes, a vial, injection pens, or autoinjectors. 23. The method according to claim 2, wherein secukinumab is formulated in a pharmaceutical composition comprising a buffer and a stabilizer. 24. The method according to claim 2, further comprising administering the patient at least one additional psoriasis agent. 25. The method according to claim 24, wherein the at least one additional psoriasis agent is selected from the group consisting of ustekinumab, a TNF alpha antagonist, a systemic corticosteroid, cyclosporin, etretinate, and methotrexate. 26. A method of treating GPP, comprising a) subcutaneously administering secukinumab to a patient in need thereof at a dose of about 150 mg during weeks 0, 1, 2, 3, and 4; b) assigning the patient to a treatment assessment based on clinical components of a Clinical Global Impression (CGI) evaluation administered during week 8, wherein assigning a treatment assessment "very much improved" or "much improved" provides an indication that no up-titration is required, and wherein assigning a treatment assessment "worse", "no change" or "minimally improved" provides an indication that up-titration is required; and c) i) thereafter, subcutaneously administering secukinumab to the patient at a dose of about 150 mg monthly, beginning during week 8, if no up-titration is required; or ii) thereafter, subcutaneously administering secukinumab to the patient at a dose of about 300 mg during weeks 8, 9 and 12 and then monthly thereafter, beginning during week 16, if up-titration is required. 27. The method according to claim 26, wherein the clinical components of the CGI are area of erythema with pustules, area of erythema, area of edema and fever. 28. A method of treating GPP, comprising a) subcutaneously administering secukinumab to a patient in need thereof at a dose of about 150 mg during weeks 0, 1, 2, 3, and 4; and b) thereafter, subcutaneously administering secukinumab to the patient at a dose of about 300 mg during week 8, 9, and 12 and then monthly thereafter, beginning during week 16.

Details for Patent 10,434,172

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	09/25/2009		2033-08-15
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	12/30/2009		2033-08-15
Novartis Pharmaceuticals Corporation	COSENTYX	secukinumab	Injection	125504	01/21/2015		2033-08-15
Novartis Pharmaceuticals Corporation	COSENTYX	secukinumab	For Injection	125504	01/21/2015		2033-08-15
Novartis Pharmaceuticals Corporation	COSENTYX	secukinumab	Injection	125504	05/28/2021		2033-08-15
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	761044	09/23/2016		2033-08-15