Skip to main content

Main menu

  • Home
  • Content
    • First Release
    • Current
    • Archives
    • Collections
    • Audiovisual Rheum
    • 50th Volume Reprints
  • Resources
    • Guide for Authors
    • Submit Manuscript
    • Payment
    • Reviewers
    • Advertisers
    • Classified Ads
    • Reprints and Translations
    • Permissions
    • Meetings
    • FAQ
    • Policies
  • Subscribers
    • Subscription Information
    • Purchase Subscription
    • Your Account
    • Terms and Conditions
  • About Us
    • About Us
    • Editorial Board
    • Letter from the Editor
    • Duncan A. Gordon Award
    • Privacy/GDPR Policy
    • Accessibility
  • Contact Us
  • JRheum Supplements
  • Services

User menu

  • My Cart
  • Log In

Search

  • Advanced search
The Journal of Rheumatology
  • JRheum Supplements
  • Services
  • My Cart
  • Log In
The Journal of Rheumatology

Advanced Search

  • Home
  • Content
    • First Release
    • Current
    • Archives
    • Collections
    • Audiovisual Rheum
    • 50th Volume Reprints
  • Resources
    • Guide for Authors
    • Submit Manuscript
    • Payment
    • Reviewers
    • Advertisers
    • Classified Ads
    • Reprints and Translations
    • Permissions
    • Meetings
    • FAQ
    • Policies
  • Subscribers
    • Subscription Information
    • Purchase Subscription
    • Your Account
    • Terms and Conditions
  • About Us
    • About Us
    • Editorial Board
    • Letter from the Editor
    • Duncan A. Gordon Award
    • Privacy/GDPR Policy
    • Accessibility
  • Contact Us
  • Follow Jrheum on BlueSky
  • Follow jrheum on Twitter
  • Visit jrheum on Facebook
  • Follow jrheum on LinkedIn
  • Follow jrheum on YouTube
  • Follow jrheum on Instagram
  • Follow jrheum on RSS
Research ArticleArticle
Open Access

Longterm Safety of Patients Receiving Rituximab in Rheumatoid Arthritis Clinical Trials

Ronald F. van Vollenhoven, Paul Emery, Clifton O Bingham III, Edward C. Keystone, Roy Fleischmann, Daniel E. Furst, Katherine Macey, Marianne Sweetser, Ariella Kelman and Ravi Rao
The Journal of Rheumatology January 2010, jrheum.090856; DOI: https://doi.org/10.3899/jrheum.090856
Ronald F. van Vollenhoven
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Paul Emery
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Clifton O Bingham III
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Edward C. Keystone
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Roy Fleischmann
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Daniel E. Furst
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Katherine Macey
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Marianne Sweetser
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ariella Kelman
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Ravi Rao
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Info & Metrics
  • References
  • PDF
Next
Loading

Abstract

Objective To evaluate the longterm safety of rituximab in clinical trials in patients with rheumatoid arthritis (RA).

Methods Pooled analysis of safety data, including adverse events (AE) and infections, from patients treated with rituximab in combination with methotrexate in a global clinical trial program.

Results A total of 2578 patients with RA received at least 1 course of rituximab. Safety analyses were based on 5013 patient-years of rituximab exposure. The most frequent AE was infusion-related reactions (25% of patients during the first infusion of Course 1). Less than 1% of infusion-related reactions were considered serious. Rates of AE and serious AE (SAE; 17.85 events/100 patient-yrs, 95% CI 16.72, 19.06) were stable following each course. The overall serious infection rate was 4.31/100 patient-years (95% CI 3.77, 4.92). Infections and serious infections over time remained stable across 5 courses at 4-6 events/100 patient-years. Compared with other patients with RA and with the general US population, there was no increased risk of malignancy.

Conclusion In this longterm safety update in RA clinical trial patients, rituximab remained well tolerated over multiple courses. SAE and infections remained stable over time and by treatment course.

Next
Back to top

In this issue

The Journal of Rheumatology
Vol. 52, Issue 6
1 Jun 2025
  • Table of Contents
  • Table of Contents (PDF)
  • Index by Author
  • Editorial Board (PDF)
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word about The Journal of Rheumatology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Longterm Safety of Patients Receiving Rituximab in Rheumatoid Arthritis Clinical Trials
(Your Name) has forwarded a page to you from The Journal of Rheumatology
(Your Name) thought you would like to see this page from the The Journal of Rheumatology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Citation Tools
Longterm Safety of Patients Receiving Rituximab in Rheumatoid Arthritis Clinical Trials
Ronald F. van Vollenhoven, Paul Emery, Clifton O Bingham, Edward C. Keystone, Roy Fleischmann, Daniel E. Furst, Katherine Macey, Marianne Sweetser, Ariella Kelman, Ravi Rao
The Journal of Rheumatology Jan 2010, jrheum.090856; DOI: 10.3899/jrheum.090856

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

 Request Permissions

Share
Longterm Safety of Patients Receiving Rituximab in Rheumatoid Arthritis Clinical Trials
Ronald F. van Vollenhoven, Paul Emery, Clifton O Bingham, Edward C. Keystone, Roy Fleischmann, Daniel E. Furst, Katherine Macey, Marianne Sweetser, Ariella Kelman, Ravi Rao
The Journal of Rheumatology Jan 2010, jrheum.090856; DOI: 10.3899/jrheum.090856
del.icio.us logo Twitter logo Facebook logo  logo Mendeley logo
  • Tweet Widget
  •  logo
Bookmark this article

Jump to section

  • Article
  • Info & Metrics
  • References
  • PDF

Related Articles

Cited By...

More in this TOC Section

  • Understanding the Psoriasis Phenotype Associated With Psoriatic Arthritis Using the PURE-4 Questionnaire: Insights From Spanish Real-World Settings
  • HLA-B27 Testing in Clinical Practice: A Retrospective Analysis of Testing Indications and Rheumatology Referral Patterns
  • Analysis of Gut-Homing Receptors in Circulating Mucosal-Associated Invariant T Cells and Their Presence in Synovial Tissue From Patients With Axial Spondyloarthritis
Show more Articles

Similar Articles

Content

  • First Release
  • Current
  • Archives
  • Collections
  • Audiovisual Rheum
  • COVID-19 and Rheumatology

Resources

  • Guide for Authors
  • Submit Manuscript
  • Author Payment
  • Reviewers
  • Advertisers
  • Classified Ads
  • Reprints and Translations
  • Permissions
  • Meetings
  • FAQ
  • Policies

Subscribers

  • Subscription Information
  • Purchase Subscription
  • Your Account
  • Terms and Conditions

More

  • About Us
  • Contact Us
  • My Alerts
  • My Folders
  • Privacy/GDPR Policy
  • RSS Feeds
The Journal of Rheumatology
The content of this site is intended for health care professionals.
Copyright © 2025 by The Journal of Rheumatology Publishing Co. Ltd.
Print ISSN: 0315-162X; Online ISSN: 1499-2752
Powered by HighWire