The Rheumatologist
COVID-19 NewsACR Convergence
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Axial Spondyloarthritis Resource Center
    • Gout Resource Center
    • Psoriatic Arthritis Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
    • Interprofessional Perspective
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Gout Resource Center
      • Axial Spondyloarthritis Resource Center
      • Psoriatic Arthritis
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / FDA Approves Ixekizumab for Treating Active Ankylosing Spondylitis

FDA Approves Ixekizumab for Treating Active Ankylosing Spondylitis

September 23, 2019 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

In late August, U.S. Food and Drug Administration (FDA) approved the use of ixekizumab (Taltz) in an 80 mg/mL dose injection for treating adults with active radiographic axial spondyloarthritis, also known as ankylosing spondylitis (AS).1

You Might Also Like
  • Ixekizumab Improves Outcomes of Ankylosing Spondylitis
  • Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA
  • Ixekizumab Promising for Non-Radiographic Axial SpA; Plus FDA Approves Belimumab for Pediatric Lupus
Explore This Issue
November 2019
Also By This Author
  • Canada & E.U. Approve Upadacitinib for RA

This is the third FDA approval for ixekizumab. In March 2016, the FDA first approved the treatment for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In December 2017, the FDA approved ixekizumab for treating adults with active psoriatic arthritis.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

The Supporting Research
This new approval was based on the results of two randomized, double-blind, placebo-controlled, phase 3 studies. These studies evaluated the safety and efficacy of ixekizumab in patients (N=657) with active AS. Patients received an 80 mg/mL subcutaneous injection of ixekizumab once every four weeks.

The first study, called COAST-V, enrolled patients who were biologic disease-modifying anti-rheumatic drug (bDMARD) naive. The second study, called COAST-W, enrolled patients who had previously had an inadequate response to anti-tumor necrosis factor (TNF) agents or were intolerant to anti-TNF agents. The primary efficacy endpoint of the studies was the proportion of patients who achieved an Assessment of Spondyloarthritis International Society 40 (ASAS40) response compared with the proportion of placebo-treated patients who achieved ASAS40 at Week 16.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

At Week 16 of the COAST-V study, the ASAS40 responses for ixekizumab-treated and placebo-treated patients were 48% and 18%, respectively. This result for patients treated with ixekizumab was considered to be a clinically meaningful, statistically significant (P<0.0001) improvement. At Week 16 of the COAST-W study, the ASAS40 responses for ixekizumab-treated and placebo-treated patients were 25% and 13%, respectively. Again, the result for patients treated with ixekizumab demonstrated clinically meaningful improvement and was statistically significant (P<0.05).

In both studies, key secondary endpoints were met in ixekizumab-treated patients. The ASAS20 response in the COAST-V study at Week 16 was 64% in ixekizumab-treated patients and 40% in placebo-treated patients (P=0.0015). In the COAST-W study at Week 16, the ASAS20 was 48% ixekizumab-treated patients and 30% in placebo-treated patients (P<0.01).

No new safety risks were identified.

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

Reference

  1. Eli Lilly and Co. News release: Lilly receives U.S. FDA approval for Taltz (ixekizumab) for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis). 2019 Aug 26.

Filed Under: DMARDs & Immunosuppressives, Drug Updates, Spondyloarthritis Tagged With: Ankylosing Spondylitis, FDA, ixekizumab, U.S. Food and Drug Administration (FDA)Issue: November 2019

You Might Also Like:
  • Ixekizumab Improves Outcomes of Ankylosing Spondylitis
  • Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA
  • Ixekizumab Promising for Non-Radiographic Axial SpA; Plus FDA Approves Belimumab for Pediatric Lupus
  • FDA Receives Upadacitinib Application for Ankylosing Spondylitis & Approves Tramadol Hydrochloride Oral Solution

Simple Tasks

Learn more about the ACR’s public awareness campaign and how you can get involved. Help increase visibility of rheumatic diseases and decrease the number of people left untreated.

Visit the Simple Tasks site »

American College of Rheumatology

Visit the official website for the American College of Rheumatology.

Visit the ACR »

ACR Convergence

Don’t miss rheumatology’s premier scientific meeting for anyone involved in research or the delivery of rheumatologic care or services.

Visit the ACR Convergence site »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use / Cookie Preferences

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2023 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)