ProHealth fibromyalgia Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

The Future Fibromyalgia Drugs? Pharmaceutical Source Predicts Four Drug Approvals in Coming Years

Namenda (memantine): A Potential NEW Treatment for Fibromyalgia

My ME/CFS & Fibromyalgia Recovery Story

Minimizing Fibromyalgia Symptoms: Valuable Lessons from Childhood

Respiratory Sinus Arrhythmia and Its Association with Pain in Women with Fibromyalgia

An Update on Drugs Used for Treating Fibromyalgia

SURVEY: What Triggered Your Illness?

Comparing Genomic Profiles of Women With and Without Fibromyalgia.

An Evaluation of Selective Serotonin Reuptake Inhibitors for Fibromyalgia

Why I Became a Fibromyalgia Advocate

 
Print Page
Email Article

9.5-Year Follow-Up on Effects of Rituximab in RA Patients

  [ 6 votes ]   [ Discuss This Article ]
www.ProHealth.com • November 9, 2012


Article:
Long-term safety of rituximab in rheumatoid arthritis: 9.5-year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients
– Source: Annals of Rheumatic Diseases, Nov 7, 2012

By Ronald F van Vollenhoven, et al.

[Note: The full text of this article is available free here. Rheumatoid arthritis is associated with elevated risks of serious infections, lymphomas and fatal cardiovascular events. The drug rituximab is used in combination with methotrexate to control autoimmune damage to RA patients' joints by reducing levels of a specific immune B-cell that attacks them. The therapy initially elevates risk of infection and malignancy somewhat. This long-term tracking study reflected a concern about the possibility that repeated courses of rituximab might further increase these risks. The findings will be of interest to researchers conducting experimental trials of rituximab as a potential treatment for ME/CFS as well.]

Abstract:
Objectives: Evaluation of long-term safety of rituximab in rheumatoid arthritis (RA).

Methods:

Pooled observed case analysis of data from patients with moderate-to-severe, active RA treated with rituximab in a global clinical trial program.

Results:
As of September 2010, 3,194 patients had received up to 17 rituximab courses over 9.5 years (11,962 patient-years). Of these, 627 had more than 5 years' follow-up (4,418 patient-years).

A pooled placebo population (n=818) (placebo + methotrexate (MTX)) was also analyzed.

Serious adverse event and infection rates generally remained stable over time and multiple courses.

• The overall serious infection event (SIE) rate was 3.94 per 100 patient-years (3.26 per 100 patient-years in patients observed for more than 5 years) and was comparable with placebo+MTX (3.79 per 100 patient-years).

• Serious opportunistic infections were rare.

• Overall, 22.4% (n=717) of rituximab-treated patients developed low immunoglobulin (Ig)M and 3.5% (n=112) low IgG levels for 4 months or more after 1 or more courses.

• Serious infection event rates were similar before and during/after development of low Ig levels; however, in patients with low IgG, rates were higher than in patients who never developed low IgG.

• Rates of myocardial infarction and stroke were consistent with rates in the general RA population.

• No increased risk of malignancy over time was observed.

Conclusion:

This analysis demonstrates that rituximab remains generally well tolerated over time and multiple courses, with a safety profile consistent with published data and clinical trial experience.

Overall, the findings indicate that there was no evidence of an increased safety risk or increased reporting rates of any types of adverse events with prolonged exposure to rituximab during the 9.5 years of observation.

Source: Annals of the Rheumatic Diseases, Nov 7, 2012. PMID:23136242, by van Vollenhoven RF, Emery P, Bingham CO 3rd, Keystone EC, Fleischmann RM, Furst DE, Tyson N, Collinson N, Lehane PB. Unit for Clinical Therapy Research, Inflammatory Diseases, The Karolinska Institute, Stockholm, Sweden. [Email: ronald.van.vollenhoven@ki.se]




Please Discuss This Article:   Post a Comment 



[ Be the first to comment on this article ]




 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Save on Vitamins and Supplements

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Fibro Freedom™ Fibro Freedom™
Soothes, strengthens & revitalizes
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Guaifenesin FA™ Guaifenesin FA™
Natural Expectorant Relieves Chest Congestion

Natural Remedies

Breaking Through the Mental Fog Breaking Through the Mental Fog
Astaxanthin - A Little-Known but Power-Packed Nutrient Astaxanthin - A Little-Known but Power-Packed Nutrient
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12
Carry a Massage Therapist in Your Pocket Carry a Massage Therapist in Your Pocket
Magnesium: An Essential Supplement for ME/CFS Magnesium: An Essential Supplement for ME/CFS

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia Diagnosis
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS Diagnosis
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE  |  PRIVACY
CONTACT US
LIBRARY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing