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| |  IFN Beta-1a More Effective Over Long Term in Patients at High Risk of Developing MS: Presented at ECTRIMS By Chris Berrie DÜSSELDORF, Germany -- September 11, 2009 -- Immediate initiation of intramuscular interferon (IFN) beta-1a after a clinically isolated syndrome (CIS) in high-risk patients continues to reduce development of clinically defined multiple sclerosis (CDMS) treatment after 10 years, compared with delayed IFN beta-1a initiation, researchers stated here on September 10 at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The CHAMPIONS Study Group reported the results of an open-label extension study that examined patients from the original 3-year Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) at both 5 and 10 years. Pamela Foulds, MD, Biogen Idec, Inc., Cambridge, Massachusetts, noted that “the initial results showed that patients treated with [IFN beta-1a] within the first month after their first [CIS] event were significantly less likely to convert to clinically definite MS.” The objective of the open-label extension trial was to determine whether an intramuscular dose of IFN beta-1a 30 mcg once weekly initiated immediately after a CIS in high-risk patients (intent-to treat [ITT] group) would continue to delay CDMS development over the long term, as compared with delayed initiation of IFN beta-1a treatment (delayed treatment [DT] group). The relative effects of ITT versus DT were monitored as annualised relapse rates by epoch, Expanded Disability Status Scale (EDSS) scores (>=4.0 or >=6.0), number of new or emerging T2 lesions, changes in T2 lesion volume, and presence of gadolinium-enhancing (Gd+) lesions. In all, 155 of 183 CHAMPS patients (85%) entered the 10-year CHAMPIONS extension, with 127 patients completing to 10 years (82%). The original active-treatment CHAMPS patients represented the ITT group (n = 81), with the original placebo subjects representing the DT group (n = 74). The median time to initiation of disease-modifying treatment in the DT group was 30 months. Patient baseline characteristics in the extension trial were similar to those for the entire CHAMPS cohort: mean age 34 years; 73% female; 91% with an EDSS score <3; median T2 lesion number 13; and 71% with no Gd+ lesions. At a median follow-up of 10 years, 64% of the total patients developed CDMS according to clinical criteria. Those in the ITT group, however, showed significantly lower CDMS development than did those in the DT group (58% vs 69%, respectively; hazard ratio, 0.64; 95% confidence interval, 0.47-0.86; P = .003). Dr. Foulds noted: “Fifty-seven percent of patients were still on [IFN beta-1a] after all this time, at 10 years ... and 30% were on no therapy.” Although the significant difference in ITT versus DT mean annual relapse rates from 0 to 2 years (0.15 vs 0.23, respectively; P = .03) lost significance for 0 to 5 years (0.18 vs 0.32), significance returned over the 5-10 year period and the 0-10 year period, with mean annual relapse rates of 0.17 versus 0.35 (P = .008) and 0.17 versus 0.34 (P = .02), respectively. Importantly, 74% of all patients had no measurable physical impairment at their last study visit (ie, EDSS score, 0.0-2.0), and only 21% had an EDSS score of 3.0 or greater. In the magnetic resonance imaging analysis, there were no differences between study groups for the number of new or enlarging T2 lesions, or for change in T2 lesion volume from the CHAMPS baseline to 10 years. Median T2 lesion volume, however, did increase from 1,836 mm3 at CHAMPS baseline to 4,826 mm3 at 10 years, representing a median percentage increase of 120% in T2 lesion volume over 10 years (approximately 300 mm3/year). An analysis of baseline and on-study factors independently associated with greater development of CDMS revealed the following: delayed initiation of treatment (P < .001); younger age at onset (P < .001); more T2 lesions at onset (P = .02 to < .001); and at least 2 Gd+ lesions at onset (P = .002). Dr. Foulds stressed that “those patients who were in the original placebo arm never caught up to the patients who started on [IFN beta-1a] right within the first month of their episode.” Funding for this study was provided by Biogen Idec, Inc. [Presentation title: CHAMPIONS: 10-Year Follow-Up After a Clinically Isolated Syndrome in Patients at High Risk for Developing Multiple Sclerosis. Abstract P446]
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