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Methods of treating ankylosing spondylitis using IL-17 antagonists

An antagonist and α-antagonist technology, applied in anti-inflammatory agents, chemical instruments and methods, biochemical equipment and methods, etc., can solve problems such as increased incidence of malignant tumors

Inactive Publication Date: 2014-12-24
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, there are general concerns about the short-term and long-term tolerability and safety of long-term TNF-α antagonism, most notably reactivation of serious infections (such as tuberculosis infection), hepatotoxicity due to TNF-α antagonism , increased cardiovascular disease, induced (or exacerbated) demyelinating conditions and increased incidence of malignancies (M.Khraishi (2009) J.Rheumatol Suppl 82:25-32; Salliot et al. (2009) Ann.Rheum.Dis .68:25-32)

Method used

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  • Methods of treating ankylosing spondylitis using IL-17 antagonists
  • Methods of treating ankylosing spondylitis using IL-17 antagonists
  • Methods of treating ankylosing spondylitis using IL-17 antagonists

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0206] Example 1: Proof of Concept AS Trial CAIN457A2209

Embodiment 11

[0207] Example 1.1 - Study Design CAIN457A2209

[0208] This is multiple 10 mg / kg, 1.0 mg / kg, and 0.1 mg / kg doses of secukinumab (2 infusions given 3 weeks apart) for a diagnosis of moderate to severe AS with or without prior TNF A two-part multicenter proof-of-concept study in antagonist-treated patients ( figure 1 ). In Part 1, 30 patients received secukinumab 10 mg / kg or placebo in a 4:1 ratio. In Part 2, an additional 30 patients received secukinumab 0.1 mg / kg, 1.0 mg / kg, or 10 mg / kg in a 2:2:1 ratio. The study consisted of a 28-day screening period, a 3-week treatment period, and a 25-week follow-up period. Individuals who met the inclusion / exclusion criteria were screened for baseline assessment, including the ASAS core set (1-6) (Zochling et al. (2006) Ann Rheum Dis 65:442-452), BASMI score, BASDAI score, and physician global assessment. The primary endpoint of the trial was the proportion of patients achieving an ASAS20 response at week 6.

[0209] Patients with m...

Embodiment 13

[0249] Example 1.3 - Secukinumab reduces vertebral inflammation in AS patients as early as week 6 as detected by magnetic resonance imaging

[0250] Magnetic resonance imaging (MRI) is considered the highest standard for assessing spinal inflammation in AS. It was therefore determined whether the clinical effects observed after 2 infusions (10 mg / kg i.v.) of secukinumab were consistent with the reduction in bone marrow edema seen on MRI. Sagittal MRI of the spine, including T1 and short tau inversion recovery (STIR) sequences, was performed at baseline (BL), week 6, and week 28. Images were analyzed by an independent reader blinded to treatment assignment and image timing using the "Berlin modification" of the AS spine MRI (ASspiMRI-a) scoring system. Changes between baseline and follow-up in each treatment group were assessed by the Wilcarson signed-rank test.

[0251] Twenty-seven patients (22 secukinumab; 5 placebo) had evaluable MRI images at baseline. A small number of...

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Abstract

The disclosure is directed to novel personalized therapies and methods for treating ankylosing spondylitis (AS). Specifically, this disclosure relates to methods of treating a patient having AS by selectively administering an IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab, to the AS patient on the basis of that patient being predisposed to have a favorable response to treatment with the IL-17 antagonist. Also disclosed herein are diagnostic methods and transmittable forms of information useful in predicting the likelihood that a patient having AS will respond to treatment with an IL-17 antagonist, e.g., an IL-17 antibody, such as secukinumab.

Description

[0001] This application claims priority to US Provisional Patent Application No. 61 / 636062, filed April 20, 2012, the disclosure of which is incorporated herein by reference in its entirety. technical field [0002] The present application is directed to novel personalized therapies, kits, communicable forms and methods for treating patients with ankylosing spondylitis (AS). Background technique [0003] Ankylosing spondylitis (AS) is a chronic inflammatory disease characterized primarily by involvement of axial joints and bilateral sacroiliitis. AS can also involve peripheral joints and extra-articular organs. Associated extra-articular expression includes cardiovascular and pulmonary abnormalities, neurologic sequelae, and clinical and subclinical gastrointestinal observations. Decreased bone mineral density (BMD) is a typical extra-articular symptom, and many AS patients have osteoporosis and consequent non-traumatic fractures despite their young age and male sex. Gener...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P37/00C07K16/24
CPCA61K2039/505A61P19/02A61P29/00A61P37/00C07K16/244C07K2317/21C07K2317/76C12Q1/6883C12Q2600/106C12Q2600/156
Inventor S·贝克A·布莱查特W·许布李亚莉汪盈R·叶连斯柯
Owner NOVARTIS AG
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