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 Secukinumab for Children with Enthesitis-Related Arthritis & PsA

FDA Approves Secukinumab for Children with Enthesitis-Related Arthritis & PsA

February 2, 2022 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

In late 2021, the U.S. Food and Drug Administration (FDA) approved secukinumab (Cosentyx) to treat two conditions in pediatric rheumatology patients: active enthesitis-related arthritis in patients aged four years and older and psoriatic arthritis (PsA) in patients aged 2 years and older.1 Secukinumab is a human IgG1κ monoclonal antibody that binds to interleukin-17A.

You Might Also Like
  • FDA Approves Secukinumab for Non-Radiographic Axial Spondyloarthritis
  • Secukinumab Inhibits Structural Joint Damage in Active PsA
  • FDA Approves Golimumab for Patients with pJIA & Psoriatic Arthritis
Explore This Issue
April 2022
Also By This Author
  • FDA to Review Abuse-Deterrent Oxycodone Capsule

Background: The International League of Associations for Rheumatology divides juvenile idiopathic arthritis (JIA) into seven categories based on presentation within the first six months of illness.2 One category is enthesitis-related arthritis, which is an HLA-B27-related JIA characterized by the involvement of the entheses, peripheral joints and axial skeleton. ERA represents 10–16% of all patients with JIA. Compared with other categories of JIA, children with ERA tend to have higher disease activity, greater pain intensity and worse health outcomes. Achieving and maintaining inactive disease is also more difficult for patients with ERA than those in other JIA categories.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

The Research

Results from the phase 3, double-blind, placebo-controlled JUNIPERA study were used for this FDA approval of secukinumab. In this two-year, three-part study, researchers enrolled 86 children and adolescents aged 2–17 years old with a confirmed diagnosis of ERA or juvenile PsA.3 At baseline, patients were randomized to receive 75 mg of subcutaneous secukinumab if they weighed less than 50 kg and 150 mg if they weighed at least 50 kg. Patients also received this dose at weeks 1, 2, 3, 4, 8 and 12.

Next, the patients who achieved at least a 30% improvement from baseline in at least three of the six core JIA criteria (i.e., a JIA ACR 30 response) were randomized into the double-blind, placebo-controlled part of the study.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Patients in part 2 received either secukinumab or placebo every four weeks until they experienced disease flare or reached week 100. The primary end point was the time to disease flare. Key secondary end points (e.g., JIA ACR 30, 50, 70, 90, 100, inactive disease, JADAS, enthesitis) were also evaluated, as well as drug safety.

The results: 97 patients were enrolled in the original open-label study, with a mean age of 13 years, with 33.7% of them being girls. Eighty-six of these patients entered into the randomized double-blind part of the study. Fifty-two of these patients had enthesitis-related arthritis, and 34 had juvenile PsA. At the end of part 1, 90% (75 of 83) of patients had achieved a JIA ACR 30 response, and 70% (58 of 83) had achieved a JIA ACR 70 response. (Note: The authors did not mention why the denominators for part 2 of the study were 83 vs. 86 patients.)

Pages: 1 2 | Single Page

Filed Under: DMARDs & Immunosuppressives, Drug Updates Tagged With: enthesitis-related arthritis (ERA), FDA, FDA approval, Pediatric, Pediatric Rheumatology, PsA, Psoriatic Arthritis, secukinumab, U.S. Food and Drug Administration (FDA)Issue: April 2022

You Might Also Like:
  • FDA Approves Secukinumab for Non-Radiographic Axial Spondyloarthritis
  • Secukinumab Inhibits Structural Joint Damage in Active PsA
  • FDA Approves Golimumab for Patients with pJIA & Psoriatic Arthritis
  • Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA

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 »

Meeting Abstracts

Browse and search abstracts from the ACR Convergence and ACR/ARP Annual Meetings going back to 2012.

Visit the Abstracts site »

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 »

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)