Posted by: Thixia | October 17, 2008

Interferon Beta-1a 15-Year Long-Term Follow-up Study

Intramuscular Interferon Beta-1a Reduces Disability Progression and Improves Quality of Life in Relapsing Multiple Sclerosis: Presented at WCTRMS





Patients who have been taking intramuscular interferon beta-1a for as many as 15 years have significantly better quality-of-life scores and less long-term disability than patients on other disease-modifying therapies, according to a study presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).


The study was an open-label, multicentre, observational, retrospective, follow-up of patients who participated in the phase 3 Multiple Sclerosis Collaborative Research Group (MSCRG) study.


The goal of the current study was to evaluate the effect of intramuscular interferon beta-1a therapy on long-term disability and quality-of-life outcomes in patients who had completed 2 or more years of the MSCRG trial, said Robert Bermel, MD, Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic Foundation, Cleveland, Ohio.


­      The 172 patients in the original MSCRG study were identified, and

­      136 of them (79%) were enrolled in the present follow-up study. Of these,

­      122 were living and had a median age of 52 years and a median disease duration of 20.2 years.

They were assessed primarily through self-report questionnaires.


At follow-up, the most common disease-modifying therapies currently being used were

­      intramuscular interferon beta-1a therapy (46%, n = 56),

­      natalizumab (13%), and

­      glatiramer acetate (12%), while

­      15% were taking various other therapies, and

­      18% were taking no therapy.


Twenty-four percent of patients had used 3 or more disease-modifying therapies over the course of the treatment period.


For patients currently receiving intramuscular interferon beta-1a, 2% received the therapy for <5 years, 18% for 5 to <10 years, 55% for 10 to <15 years, and 25% for 15 years.


Patients receiving intramuscular interferon beta-1a demonstrated significantly lower mean Expanded Disability Status Scale (EDSS) scores than those not receiving the therapy (4.4 vs 5.7, respectively; P = .011), and significantly lower mean EDSS change from baseline (2.3 vs. 3.3, respectively; P = .011).


Patients receiving intramuscular interferon beta-1a also had a greater sense of general health (reported as “currently and over the past year”) with 89% reporting their health in general as excellent, very good, or good compared with 70% of patients not on the therapy (P = .0127). Patients on intramuscular interferon beta-1a also reported a significantly greater degree of living independently (89% vs 69%, P = .031).


At the 15-year follow-up, 26.8% of patients currently receiving intramuscular interferon beta-1a were progression-free since initiation of the MSCRG trial, while 35.7% progressed less than 2 points on the EDSS and 51.8% progressed less than 3 points.


“What we found is that patients who are currently on interferon beta-1a, and have been on it for the majority of the 15 years, have been doing markedly better than patients not on interferon beta-1a,” Dr. Bermel said.


He added that those patients might have unique characteristics that eventually might assist physicians in selecting treatment more intelligently, by identifying predictors of who may or may not do well on interferon beta-1a long-term.


“Long-term follow-up studies like this are essential [for] being able to say, ‘Do the benefits seen in the 2-year trials correlate in the patients doing well long-term?'” Dr. Bermel explained. “I think this study is one of the few that helps do that,” he concluded.


He said that the researchers were surprised to find 14 deceased patients out of the 136 enrolled in the study. “A 10% mortality rate over that period of time indicates [that] it’s important to identify and treat this disease early,” Dr. Bermel added.


Funding for this study was provided by Biogen Idec Inc.



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