Document Detail


Cross-sectional study assessing long-term safety of interferon-beta-1b for relapsing-remitting MS.
MedLine Citation:
PMID:  20530324     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The 16-Year Long-Term Follow-Up (LTF) to the pivotal interferon-beta-1b (IFNbeta-1b) trial explored clinical, MRI, cognitive, and patient-reported outcomes. Here, we report the safety assessments.
METHODS: In the pivotal study, 372 patients were randomized to placebo (n = 123), IFNbeta-1b 50 microg (n = 125), or IFNbeta-1b 250 microg (n = 124) subcutaneously every other day for up to 5 years. Sixteen years later, patients were asked to participate in this cross-sectional follow-up study. No particular therapy was stipulated during follow-up. Adverse events experienced since the pivotal trial were recorded. Neutralizing antibodies (NAbs) to IFNbeta-1b were measured using the myxovirus protein A induction assay. Statistical analyses were descriptive.
RESULTS: In total, 88.2% of patients (328/372) were identified. Some centers achieved 100% ascertainment, obviating selection bias. Treatment-related adverse events (e.g., leukopenia and liver and thyroid dysfunction) reported by LTF participants were in keeping with those previously established. Based on a follow-up period that includes 2,000 patient-years of IFNbeta-1b treatment, no new adverse events were observed that were associated with long-term IFNbeta-1b exposure. By LTF, NAbs to IFNbeta-1b disappeared in the majority (76%) of NAb-positive patients. NAb status during the pivotal study appeared to have no impact on long-term clinical and MRI outcomes. There were more deaths among patients assigned to placebo in the pivotal study (20/109 [18.3%]) compared with patients who received IFNbeta-1b 50 microg (9/108 [8.3%]) or IFNbeta-1b 250 microg (6/111 [5.4%]).
CONCLUSION: The results from the 16-Year Long-Term Follow-Up study support the long-term safety of interferon-beta-1b therapy in multiple sclerosis.
CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that patients with relapsing-remitting MS taking IFNbeta-1b 50 microg or 250 microg subcutaneously every other day for up to 5 years, with subsequent unspecified treatment, have fewer deaths after 16 years of follow-up than similar patients on placebo for up to 5 years, with subsequent unspecified treatment (risk difference 11.5%, 95% confidence interval 4-19).
Authors:
A T Reder; G C Ebers; A Traboulsee; D Li; D Langdon; D S Goodin; T Bogumil; K Beckmann; A Konieczny;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Neurology     Volume:  74     ISSN:  1526-632X     ISO Abbreviation:  Neurology     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-06-10     Completed Date:  2010-06-25     Revised Date:  2011-08-25    
Medline Journal Info:
Nlm Unique ID:  0401060     Medline TA:  Neurology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1877-85     Citation Subset:  AIM; IM    
Affiliation:
Department of Neurology, University of Chicago, Chicago, IL 60637, USA. areder@neurology.bsd.uchicago.edu
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MeSH Terms
Descriptor/Qualifier:
Adjuvants, Immunologic / therapeutic use*
Adult
Antibodies / blood
Cross-Sectional Studies
Disability Evaluation
Dose-Response Relationship, Drug
Female
Follow-Up Studies
Humans
Interferon-beta / immunology,  therapeutic use*
Longitudinal Studies
Magnetic Resonance Imaging
Male
Middle Aged
Multiple Sclerosis, Relapsing-Remitting / drug therapy*,  immunology,  mortality
Outcome Assessment (Health Care)
Survival Analysis
Time Factors
Chemical
Reg. No./Substance:
0/Adjuvants, Immunologic; 0/Antibodies; 145155-23-3/interferon beta-1b; 77238-31-4/Interferon-beta
Investigator
Investigator/Affiliation:
Barry G W Arnason / ; Anthony T Reder / ; Adil Javed / ; Avertano Noronha / ; Barbara Harding-Clay / ; Mildred O Valentine / ; Krystal Q Ivy / ; Joseph Fink / ; Todd Nader / ; Maureen Lacy / ; Douglas S Goodin / ; Elena Kornyeyeva / ; David Cox / ; Jeff Greenstein / ; I Gold / ; Kenneth Johnson / ; Christopher Bever / ; Horea Rus / ; Robert K Shin / ; Elenor Katz / ; Valerie Wells / ; Kerry Naunton / ; Maureen Rogerson / ; Thomas Leist / ; S Gallardo / ; J Davis / ; Anette Okai / ; William A Sibley / ; Jeanette K Wendt / ; David A Weidman / ; Richard D Wachter / ; Joan Laguna / ; Brian Peterson / ; Drennen Brown / ; Khurram Bashir / ; Beverly Layton / ; Jennifer Castillo / ; Sara Krzywanski / ; Pierre Duquette / ; R Dubois / ; J Poirier / ; Yves Lapierre / ; Stanley Hum / ; Joel Oger / ; Virginia Devonshire / ; John P Hooge / ; Anthony Traboulsee / ; Penelope S Smyth / ; Shiori Hashimoto / ; Lorne F Kastrukoff / ; Wendy Morrison / ; F Lum / ; B Kosaka / ; George P A Rice / ; Marcelo Kremenchutzky / ; Rains Deshpande / ; Jane Lesaux / ; Holly Armstrong / ; Jennifer Moussa / ; Tracey Bentall / ; George C Ebers / ; Antonio Scalfari / ; Dawn Langdon / ; Jennifer Gurd / ; David Li / ; Anthony Traboulsee / ; R Tam / ; Marco Medina / ; A Riddlebough /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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