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Methods of treating new-onset plaque type psoriasis using il-17 antagonists

A psoriasis, new technology, applied in the direction of antibody medical components, chemical instruments and methods, anti-animal/human immunoglobulin, etc.

Pending Publication Date: 2019-03-15
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, once treatment is stopped, psoriatic skin lesions usually recur in the same areas previously affected, but sometimes relapses also occur in new sites

Method used

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  • Methods of treating new-onset plaque type psoriasis using il-17 antagonists
  • Methods of treating new-onset plaque type psoriasis using il-17 antagonists
  • Methods of treating new-onset plaque type psoriasis using il-17 antagonists

Examples

Experimental program
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Effect test

example 1

[0143] Example 1: Imiquimod Skin and Ear Inflammation

[0144]Imiquimod is used topically in the treatment of genital and perineal warts caused by human papillomavirus. The clinical indications for this therapy have been further expanded to include the treatment of other viral-associated skin abnormalities as well as precancerous and cancerous skin lesions, such as actinic keratosis and superficial basal cell carcinoma. Clinically, imiquimod was found to exacerbate psoriasis in patients whose disease was previously well controlled during topical therapy for actinic keratosis and superficial basal cell carcinoma. Imiquimod-induced exacerbations of psoriasis occurred in the treated area and, interestingly, also in distant skin sites previously unaffected by the disease. Thus, treatment of mice with imiquimod cream, which produces psoriasis-like skin lesions, can be used to study putative antipsoriatic treatments early in the disease process (van der Fits et al. (2009) J . Immu...

example 2

[0154] Example 2: IL-23-induced ear swelling

[0155] IL-23, a cytokine that drives the development of Th17 cells producing IL-17 and IL-22, has been proposed to be functionally involved in the pathogenesis of psoriasis. (See, eg, van der Fits et al. (2009) J. Immunol 182:5836-5845). IL-23 expression is increased in psoriatic skin lesions, and there are increased numbers of Th17 cells. Intradermal injection of IL-23 into mouse skin resulted in erythema, mixed inflammatory infiltrate and epidermal hyperplasia, and swelling at the injection site after repeated injections. Since IL-23 and IL-17 have been found to be critical in the development of psoriasis, the IL-23 ear injection model in mice can also be used as a simple and rapid method to study the development of early psoriasis. Useful therapies in therapy.

[0156] On day 0, female Balb / c mice (approximately 20 g) were injected intradermally (i.d.) with 1 μg of IL-23 in 10 μl PBS in the pinnae of the right ear, and in th...

example 3

[0159] Example 3: Analysis of Duration of Disease Response to Secukinumab Treatment in Psoriasis Patients

[0160] Two Phase 3, double-blind, 52-week trials ERASURE (Efficacy of Response and Safety with Two Fixed Secukinumab Regimen in Psoriasis; CAIN457A2302) and FIXTURE (Secukinumab Using Two Dosing Details of the design and results of a year-round study of etanercept to determine efficacy in psoriasis; CAIN457A2303) are presented in Langley et al. (2014) N Engl J Med [New England Journal of Medicine] 371:326- 38 in. At week 12, a higher proportion of patients met PASI 75 criteria with each secukinumab dose compared with patients on placebo or etanercept: PASI 75 rates were 81.6%, 71.6% with 150 mg secukinumab, and 4.5% with placebo; in the FIXTURE study, these rates were 77.1% with 300 mg secukinumab, 150 mg secukinumab 67.0% with mAb, 44.0% with etanercept, and 4.9% with placebo (P<0.001 for each secukinumab dose vs comparator). At Week 12, the proportion of patients wi...

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Abstract

The present disclosure relates to methods for treating new-onset plaque-type psoriasis patients and inhibiting the progression of structural damage in these patients, using IL-17 antagonists, e.g., secukinumab. Also disclosed herein are uses of IL-17 antagonists, e.g., IL-17 antibodies, such as secukinumab, for treating new-onset plaque-type psoriasis patients, as well as medicaments, dosing regimens, pharmaceutical formulations, dosage forms, and kits for use in the disclosed uses and methods.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Patent Application No. 62 / 346,007, filed July 19, 2016, which is hereby incorporated by reference in its entirety. technical field [0003] The present disclosure relates to methods of treating patients with de novo plaque psoriasis and inhibiting psoriatic disease progression in these patients using an IL-17 antagonist (eg, secukinumab). Background technique [0004] Psoriasis is an immune-mediated inflammatory disease that can have a major impact on a patient's life, especially when the intensity is moderate or severe. Treatment of psoriasis during the first few years is usually conservative and often based on topical agents that make it difficult to completely clear the lesions. Treatment with systemic agents, including biologics, is usually initiated only when topical agents, phototherapy, and traditional systemic therapies prove insufficient, even in patients wit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K16/24A61P17/06
CPCA61K2039/505A61K2039/545C07K2317/21C07K2317/76C07K16/244A61P17/06A61K9/0019A61K47/20A61K47/22A61K47/26A61K2039/55
Inventor A·法斯特J·奥利弗
Owner NOVARTIS AG
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