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So you've had one incident that makes docs suspect you may develop MS, called “clinically isolated syndrome” (CIS). Do you start treatment immediately or wait until you are officially diagnosed with MS? The answer is not clear cut according to a 10-year study.
In the study, MSers who had immediate treatment of clinically isolated disease with interferon had fewer relapses... but no improvement in disability outcomes.
Note that patients randomized to immediate treatment were more likely to have no relapses, whereas patients assigned to delayed treatment were more likely to have three or more relapses.
In the cases where treatment was delayed, the median time to start treatment was 30 months. That's 30 extra months of injecting no medication, paying no copays, and suffering no drug side effects.
The urge to start therapy can be overwhelming when you are waiting to get diagnosed, hanging out in limbo. You want to do something, anything, to slow this disease down. But according to this CHAMPS study, it appears chilling out isn't a bad option either, at least with interferon. - Dave
Mixed Results Seen for Immediate MS Treatment
By Charles Bankhead, Staff Writer, MedPage Today October 10, 2011
Multiple sclerosis patients had fewer relapses with immediate treatment of clinically isolated disease but no improvement in disability outcomes, data from a randomized trial showed.
Patients who received immediate treatment with interferon had a 36% lower 10-year odds for progression to clinically definite MS and lower relapse rates at five and 10 years.
However, disability scores, MRI-visible lesions, and the rate of progressive disease at 10 years all did not differ between patients randomized to immediate or delayed treatment.
The findings are consistent with the previously reported five-year results of the trial, investigators reported online in Archives of Neurology.
"Overall, annualized relapse rates were low in both groups, and there was no difference in standard MRI outcomes at either five or 10 years," wrote R. Philip Kinkel, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, and colleagues.
"These results suggest that immediate initiation of intramuscular interferon beta-1a in high-risk patients who had a clinically isolated syndrome delays the development of clinically definite MS but has only a modest effect on subsequent relapses and no significant effect on new MRI T2-weighted lesions compared with a randomized group that delayed the onset of therapy."
The CHAMPS (Controlled High-Risk Avonex Multiple Sclerosis Prevention Study) trial was the first to demonstrate the benefit of disease-modifying therapy in patients with clinically isolated MS (N Engl J Med. 2000; 343: 898-904).
The CHAMPIONS (CHAMPS In Ongoing Neurological Surveillance) trial continued follow-up in CHAMPS patients to see whether the benefits of early treatment persisted over time compared with patients randomized to delayed therapy.
The five-year follow-up data from CHAMPIONS showed a lower rate of clinically definitive MS in the immediate-therapy group, but few patients in either group developed significant disability.
Follow-up in CHAMPIONS continued for 10 years, providing the basis for the analysis and report by Kinkel and colleagues.
Upon completion of CHAMPS, study participants were informed of the results and offered the opportunity to participate in CHAMPIONS without knowledge of their treatment assignment during the CHAMPS trial.
All patients enrolled in CHAMPIONS were offered weekly treatment with interferon beta-1a, but were not required to accept treatment.
The 10-year analysis included 81 patients originally randomized to immediate therapy and 74 originally assigned to delayed treatment. The immediate-treatment group started interferon beta-1a within 30 days of enrollment, whereas the median time to the start of delayed treatment was 30 months.
The primary outcome of CHAMPS and CHAMPIONS was progression to clinically definite MS, as determined by an independent review committee. Secondary outcomes included number of relapses, disease classification over time, and neurologic disability as determined by two validated scales.
The 10-year cumulative probability of clinically definite MS was 58% in the immediate-treatment group and 69% with delayed treatment, a difference that represented a 36% reduction in the hazard (HR 0.64, P=0.001). Independent predictors of progression to MS were younger age at disease onset, nine or more T2-weighted lesions at baseline, and two or more gadolinium-enhancing lesions at baseline.
From year five to year 10, the annualized relapse rate was twice as high in the delayed-treatment group (0.31 versus 0.14, P=0.03). The difference was similar during the first five years (0.36 versus 0.18) and over the entire 10 years (0.33 versus 0.16). However, the differences did not reach the prespecified threshold of 0.01 for statistical significance.
Patients randomized to immediate treatment were more likely to have no relapses (59% versus 42%), whereas patients assigned to delayed treatment were more likely to have three or more relapses (25% versus 9%).
Overall, 92% of patients who completed 10 years of follow-up still had relapsing disease, 81% of patients had Expanded Disability Status Scale scores <3.0, and the Multiple Sclerosis Functional Composite scale showed no worsening of disease status between five and 10 years. The treatment groups did not differ significantly on any of these outcomes, the authors reported.
Analysis of MRI findings showed that 93% of patients with clinically definite MS had new or enlarging T2-weighted lesions, as did 84% of patients without clinically definite MS.
The study was funded by Biogen Idec.
Kinkel disclosed relationships with Acorda, Avanir, Biogen Idec, and Teva. Co-authors disclosed relatinships with Actelion, Biogen Idec, Celgene, sanofi-aventis, EMD Serono, Abbott, Teva, Bayer, BioMS Technology, Genentech, Lilly, Roche, Novartis, Genzyme, Protein Design Labs, Pfizer, Bristol-Myers Squibb, and Artielle Immunotherapeutics.
Primary source: Archives of Neurology
In the study, MSers who had immediate treatment of clinically isolated disease with interferon had fewer relapses... but no improvement in disability outcomes.
Note that patients randomized to immediate treatment were more likely to have no relapses, whereas patients assigned to delayed treatment were more likely to have three or more relapses.
In the cases where treatment was delayed, the median time to start treatment was 30 months. That's 30 extra months of injecting no medication, paying no copays, and suffering no drug side effects.
The urge to start therapy can be overwhelming when you are waiting to get diagnosed, hanging out in limbo. You want to do something, anything, to slow this disease down. But according to this CHAMPS study, it appears chilling out isn't a bad option either, at least with interferon. - Dave
Mixed Results Seen for Immediate MS Treatment
By Charles Bankhead, Staff Writer, MedPage Today October 10, 2011
Multiple sclerosis patients had fewer relapses with immediate treatment of clinically isolated disease but no improvement in disability outcomes, data from a randomized trial showed.
Patients who received immediate treatment with interferon had a 36% lower 10-year odds for progression to clinically definite MS and lower relapse rates at five and 10 years.
However, disability scores, MRI-visible lesions, and the rate of progressive disease at 10 years all did not differ between patients randomized to immediate or delayed treatment.
The findings are consistent with the previously reported five-year results of the trial, investigators reported online in Archives of Neurology.
"Overall, annualized relapse rates were low in both groups, and there was no difference in standard MRI outcomes at either five or 10 years," wrote R. Philip Kinkel, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, and colleagues.
"These results suggest that immediate initiation of intramuscular interferon beta-1a in high-risk patients who had a clinically isolated syndrome delays the development of clinically definite MS but has only a modest effect on subsequent relapses and no significant effect on new MRI T2-weighted lesions compared with a randomized group that delayed the onset of therapy."
The CHAMPS (Controlled High-Risk Avonex Multiple Sclerosis Prevention Study) trial was the first to demonstrate the benefit of disease-modifying therapy in patients with clinically isolated MS (N Engl J Med. 2000; 343: 898-904).
The CHAMPIONS (CHAMPS In Ongoing Neurological Surveillance) trial continued follow-up in CHAMPS patients to see whether the benefits of early treatment persisted over time compared with patients randomized to delayed therapy.
The five-year follow-up data from CHAMPIONS showed a lower rate of clinically definitive MS in the immediate-therapy group, but few patients in either group developed significant disability.
Follow-up in CHAMPIONS continued for 10 years, providing the basis for the analysis and report by Kinkel and colleagues.
Upon completion of CHAMPS, study participants were informed of the results and offered the opportunity to participate in CHAMPIONS without knowledge of their treatment assignment during the CHAMPS trial.
All patients enrolled in CHAMPIONS were offered weekly treatment with interferon beta-1a, but were not required to accept treatment.
The 10-year analysis included 81 patients originally randomized to immediate therapy and 74 originally assigned to delayed treatment. The immediate-treatment group started interferon beta-1a within 30 days of enrollment, whereas the median time to the start of delayed treatment was 30 months.
The primary outcome of CHAMPS and CHAMPIONS was progression to clinically definite MS, as determined by an independent review committee. Secondary outcomes included number of relapses, disease classification over time, and neurologic disability as determined by two validated scales.
The 10-year cumulative probability of clinically definite MS was 58% in the immediate-treatment group and 69% with delayed treatment, a difference that represented a 36% reduction in the hazard (HR 0.64, P=0.001). Independent predictors of progression to MS were younger age at disease onset, nine or more T2-weighted lesions at baseline, and two or more gadolinium-enhancing lesions at baseline.
From year five to year 10, the annualized relapse rate was twice as high in the delayed-treatment group (0.31 versus 0.14, P=0.03). The difference was similar during the first five years (0.36 versus 0.18) and over the entire 10 years (0.33 versus 0.16). However, the differences did not reach the prespecified threshold of 0.01 for statistical significance.
Patients randomized to immediate treatment were more likely to have no relapses (59% versus 42%), whereas patients assigned to delayed treatment were more likely to have three or more relapses (25% versus 9%).
Overall, 92% of patients who completed 10 years of follow-up still had relapsing disease, 81% of patients had Expanded Disability Status Scale scores <3.0, and the Multiple Sclerosis Functional Composite scale showed no worsening of disease status between five and 10 years. The treatment groups did not differ significantly on any of these outcomes, the authors reported.
Analysis of MRI findings showed that 93% of patients with clinically definite MS had new or enlarging T2-weighted lesions, as did 84% of patients without clinically definite MS.
The study was funded by Biogen Idec.
Kinkel disclosed relationships with Acorda, Avanir, Biogen Idec, and Teva. Co-authors disclosed relatinships with Actelion, Biogen Idec, Celgene, sanofi-aventis, EMD Serono, Abbott, Teva, Bayer, BioMS Technology, Genentech, Lilly, Roche, Novartis, Genzyme, Protein Design Labs, Pfizer, Bristol-Myers Squibb, and Artielle Immunotherapeutics.
Primary source: Archives of Neurology