The Rheumatologist
COVID-19 News
  • 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
      • Systemic Lupus Erythematosus Resource Center
      • Rheumatoid Arthritis Resource Center
      • Gout Resource Center
      • 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 / Tocilizumab Promising for sJIA

Tocilizumab Promising for sJIA

September 7, 2016 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

GENERIC_Drugs_500x270In a recent clinical trial, researchers in Japan evaluated the effectiveness and safety of tocilizumab in pediatric patients with systemic juvenile idiopathic arthritis (sJIA).1 Four hundred seventeen patients were enrolled in, and observed during, this 52-week study, the results of which were published in the Annals of Rheumatic Disease.

You Might Also Like
  • FDA Approves Subcutaneous Tocilizumab for Ages 2–17
  • E6011 & Tocilizumab Monotherapy Studies Show Promising Results for RA Patients
  • Rheumatology Drug Updates: Abaloparatide Promising for Osteoporosis, Plus Secukinumab for Ankylosing Spondylitis
Also By This Author
  • Revised Application Expected for IV Meloxicam; Plus EU Approves Tildrakizumab

All new tocilizumab pediatric patients were enrolled and observed from April 2008–February 2012, and additional patients were drawn from participants who were involved in tocilizumab clinical trials. Patients had a median age of 11 years and a median disease duration of four to six years. Also, 48% of participants were female.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

Concomitant conditions included respiratory disease, cardiac functional disorders, liver disorders, renal dysfunction, gastrointestinal tract disturbances and diabetes mellitus. Tocilizumab exposure was 407.0 patient-years. Patients received 8 mg/kg tocilizumab once every two weeks.

Researchers collected data on patient characteristics, adverse events and effectiveness parameters. Serious adverse events were higher than reported in previous studies (54.5/100 patient years), rates of serious infections were 18.2/100 patient-years and total adverse events were 224.3/100 patient-years. The most common infection was bacterial pneumonia (10 patients, 2.9/100 patient-years), while eight patients developed gastroenteritis. The second most common adverse events were respiratory, thoracic and mediastinal events with a rate of 34.9/100 patient-years. The systemic features most reported at baseline were fever and rash, occurring in about a third of patients. At baseline, 61% of patients had no systemic sJIA symptoms. Twenty-six macrophage activation syndrome events were reported in 24 patients (6.4/100 patient-years), three of whom had a history of macrophage activation syndrome. There were 14 infusion reactions.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

The mean systemic feature score was based on the number of systemic manifestations present of eight sJIA parameters: rash; fever; cervical, axial or inguinal lymphadenopathy; hepatomegaly; splenomegaly; and serositis. The mean systemic feature score decreased from 1.6 at baseline to 0.2 at Week 52 (P<0.0001). At Weeks 4, 8 and 52, 91%, 96% and 99% of patients achieved normal C-reactive protein levels (<0.3 mg/dL), respectively.

The authors conclude that, in these real-world patients, tocilizumab was well tolerated, effective and safe. The higher serious adverse events and serious infection incidences may be due to concomitant disorders and corticosteroid use.


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

ad goes here:advert-3
ADVERTISEMENT
SCROLL TO CONTINUE

Reference

  1. Yokota S, Itoh Y, Morio T, et al. Tocilizumab in systemic juvenile idiopathic arthritis in a real-world clinical setting: results from 1 year of post-marketing surveillance follow-up of 417 patients in Japan. Ann Rheum Dis. 2016 Sep;75(9):1654–1660. doi: 10.1136/annrheumdis-2015-207818. Epub 2015 Dec 7.

Pages: 1 2 | Single Page

Filed Under: DMARDs & Immunosuppressives, Drug Updates Tagged With: clinical trial, Pediatric, sJIA, systemic juvenile idiopathic arthritis, tocilizumab

You Might Also Like:
  • FDA Approves Subcutaneous Tocilizumab for Ages 2–17
  • E6011 & Tocilizumab Monotherapy Studies Show Promising Results for RA Patients
  • Rheumatology Drug Updates: Abaloparatide Promising for Osteoporosis, Plus Secukinumab for Ankylosing Spondylitis
  • Upadacitinib Monotherapy Proves Promising; Plus FDA Approves Tocilizumab Autoinjector

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 »

Rheumatology Research Foundation

The Foundation is the largest private funding source for rheumatology research and training in the U.S.

Learn more »

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

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

Copyright © 2006–2022 American College of Rheumatology. All rights reserved.

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

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.