Exacerbation rates and adherence to disease type in a prospectively followed-up population with multiple sclerosis. Implications for clinical trials
D. E. Goodkin, D. Hertsgaard and R. A. Rudick
Cleveland Clinic Foundation, Mellen Center for MS Patient Care and Research, Cleveland Clinic Foundation, OH 44106.
Two hundred fifty-four patients with definite multiple sclerosis were
followed up prospectively for 1 to 5 years (mean, 2.6 years). None of the
patients received immunosuppressive medication. Yearly exacerbation rates
and each patient's adherence to initial disease type were determined.
Disease type was defined at entry and prospectively each subsequent year as
stable, relapsing remitting stable, relapsing remitting progressive, or
chronic progressive. Exacerbation rates determined prospectively did not
decline significantly during 3 years of follow-up, even if patients were
stratified by disease duration. Adherence to the initially assigned disease
type was highly variable. When followed up for 2 years, 30% of patients
with chronic progressive disease had conditions become stable, 32% of
patients with stable disease had conditions become chronic progressive, 20%
of patients with relapsing remitting disease had conditions become stable,
and 20% of patients with relapsing remitting disease had conditions become
chronic progressive. Patients with stable or relapsing remitting stable
disease switched to one of the progressive categories as frequently (44%)
as patients with progressive disease stabilized (46%). Progression of
disease measured by changes in Kurtzke Expanded Disability Status Scores
did not differ between the different disease types. The results challenge
dogma regarding the natural history of exacerbation rates and the
assumption that we can reliably assign patients to a specific disease type.
The findings have important implications for understanding the natural
history of multiple sclerosis and designing clinical trials.
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