CLDF Title
Home | Contact Us | Bookmark
HBV HE HCC HCV
About CLDF Centers of Educational Expertise  
CME Dinner Meetings Webcasts Slide Library Abstract Library Conference Highlights
 
Back  
 
Reuters Health Information (2004-03-05): Hepatic injury with the beta-interferons for MS more common than thought

Clinical

Hepatic injury with the beta-interferons for MS more common than thought

Last Updated: 2004-03-05 17:08:19 -0400 (Reuters Health)

NEW YORK (Reuters Health) - A greater proportion of patients receiving a beta-interferon for multiple sclerosis develop elevated aminotransferase levels than were reported in clinical trials leading up to approval of these agents.

That's according to a postmarketing study in which researchers took a look back at biochemical liver tests of 844 MS patients prescribed one of the three commercially available beta-interferons in British Columbia, Canada, between 1995 and 2001.

Overall, 36.9% of patients developed new elevations of alanine aminotransferase (ALT), Dr. Helen L. Tremlett from the University of British Columbia in Vancouver and colleagues report in the February 24th issue of Neurology.

All of the beta-interferons -- subcutaneous IFN-beta-1a and IFN-beta-1b (IM), and intramuscular IFN-beta-1a -- caused elevated aminotransferase levels compared with pretreatment levels (p<0.005) and, as mentioned, the incidence aminotransferase elevation was substantially "higher than reported in clinical trials," the team notes.

For example, 11% of patients had mild or moderate ALT elevations in a pivotal trial of IFN-beta-1b compared with 38.9% in the current study and 37.5% in another postmarketing study published recently.

Likewise, in a pre-approval IFN-beta-1a (SC) trial, 19.6% and 27% of patients treated with low and high doses, respectively, experienced ALT increases, compared with 33.6% and 38.0% in the current study.

"No evidence of liver enzyme elevations" was reported in a pivotal trial of IFN-beta-1a (IM), whereas in the current study 23.0% developed de novo ALT elevations, the team reports.

As Dr. Tremlett's team notes in their report, the postmarketing experience prompted a Food and Drug Administration MedWatch warning in March 2003 of "hepatic injury including elevated serum hepatic enzyme levels, some of which have been severe."

The team was unable to identify predictors of IFN-beta-induced liver injury. They suggest "regular monitoring of the liver tests, particularly during the first year of treatment," emphasizing, however, that a "balance should be found because frequent testing can cause anxiety, pain, inconvenience, and is not without cost."

Neurology 2004;62:628-631.

 
 
 
 
                 
 
HBV
Webcasts
Slide Library
Abstract Library
 
HE
CME Dinner Meeting
Webcasts
Slide Library
Abstract Library
 
HCC
Slide Library
Abstract Library
 
 
HCV
Webcasts
Slide Library
Abstract Library
 
CLDF Follow Us
   
 
About CLDF
Mission Statement
Board of Trustees
Board of Advisors
CLDF Supporters
 
Other Resources
Liver News Library
Journal Abstracts
Hep C Link to Care
 
Centers of
Educational Expertise
Regional Map
     
   
  The Chronic Liver Disease Foundation is a non-profit organization with content developed specifically for healthcare professionals.
© Copyright 2012-2014 Chronic Liver Disease Foundation. All rights reserved. This site is maintained as an educational resource for US healthcare providers only.
Use of this Web site is governed by the Chronic Liver Disease Foundation terms of use and privacy statement.