Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Methods of treating non-radiographic axial spondyloarthritis using interleukin-17 (IL-17) antagonists

A spinal arthritis and radiology technology, applied in chemical instruments and methods, anti-inflammatory agents, antibody medical components, etc., can solve problems such as failure to prevent joint structure damage

Pending Publication Date: 2018-08-03
NOVARTIS AG
View PDF9 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although effective in treating inflammatory symptoms, TNF antagonists failed to prevent joint structural damage in axSpA, which was initially studied in AS (van der Heijde et al. 2008a, Arthritis Rheum; 58:3063-70; van derHeijde et al. 2008b, Arthritis Rheum;58:1324-31)

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Methods of treating non-radiographic axial spondyloarthritis using interleukin-17 (IL-17) antagonists
  • Methods of treating non-radiographic axial spondyloarthritis using interleukin-17 (IL-17) antagonists
  • Methods of treating non-radiographic axial spondyloarthritis using interleukin-17 (IL-17) antagonists

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0129] Example 1: Proof of Concept AS Trial CAIN457A2209

Embodiment 11

[0130] Example 1.1 - Study Design CAIN457A2209

[0131] This is the treatment of patients diagnosed with moderate to severe AS, previously treated or A two-part multicenter proof-of-concept study in patients undergoing TNF antagonist therapy. In Part 1, 30 patients received secukinumab 10 mg / kg or placebo 4:1. 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 included a 28-day screening period, a 3-week treatment period, and a 25-week follow-up period. Subjects who met the inclusion / exclusion criteria at screening were evaluated at baseline, including ASAS core set domain (1-6) (Zochling et al. (2006) Ann Rheum Dis 65:442-452), BASMI score, BASDAI score A full evaluation with a physician. The primary endpoint of this trial is the proportion of patients achieving an ASAS20 response at week 6.

[0132] Patients meeting the revised New York criteria for diagnosis of AS with moderate to severe AS and diseas...

Embodiment 12

[0165] Example 1.2 - Secukinumab Shows Good Safety and Efficacy in the Treatment of Active Ankylosing Spondylitis

[0166] Demographics and baseline characteristics were comparable between groups. The mean (SD) BASDAI at baseline was 7.1 (1.4) for secukinumab-treated patients and 7.2 (1.8) for placebo-treated patients. Three patients in the placebo group and two patients in the secukinumab group discontinued the study before the primary endpoint, mainly because of unsatisfactory treatment effects. Efficacy data were not available for 1 patient because of a protocol violation after randomization. At week 6, 14 / 23 secukinumab-treated patients entering the efficacy analysis achieved an ASAS20 response compared to 1 / 6 placebo-treated patients (61% vs. 17%, positive treatment difference probability of 99.8%, 95% confidence interval 11.5%, 56.3%) (Table 3).

[0167]

[0168] Table 3: Week 6 results of trial CAIN457A2209

[0169] Patients treated with secukinumab had ASAS40 an...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The present disclosure relates to methods for treating non-radiographic axial spondyloarthritis (nr-axSpA) 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 nr-axSpA patients and inhibiting the progression of structural damage in these patients, as well as medicaments, dosing regimens, pharmaceutical formulations, dosage forms, and kits for use in the disclosed uses and methods.

Description

[0001] related application [0002] This application claims priority to US Provisional Application No. 62 / 243381, filed October 19, 2015, the contents of which are incorporated herein by reference in their entirety. field of invention [0003] The present invention relates to methods of treating patients with radiologically negative axial spondyloarthritis (nr-axSpA) and inhibiting the progression of structural joint damage in these patients using IL-17 antagonists such as secukinumab. technical background [0004] Axial spondyloarthritis (axSpA) is a rheumatic disease characterized by spondylitis and inflammatory back pain. According to the Spondyloarthritis Assessment International (ASAS) classification criteria (Rudwaleit et al. 2009, Ann Rheum Dis; 68:770-76), for patients with chronic back pain (onset before the age of 45), if they meet the criteria of clinical Aspects (clinical arm) or imaging (imaging arm), it can be classified as axSpA. Patients with axSpA were fur...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395C07K16/24A61P19/00A61P37/06A61K39/00
CPCA61K39/3955C07K16/244A61K2039/505A61K2039/545C07K2317/21C07K2317/34C07K2317/76A61P19/00A61P19/02A61P29/00A61P37/06A61K39/395C07K2317/32C07K2317/92C07K2317/94
Inventor C·曼B·波特H·理查德斯
Owner NOVARTIS AG
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com