A controlled trial of mitoxantrone in Multiple Sclerosis: Serial MRI evaluation at one year
Chair of Neuroradiology, University of Rome La Sapienza, Italy.The Canadian journal of neurological sciences. Le journal canadien des sciences neurologiques (Impact Factor: 1.53). 09/1994; 21(3):266-70.
We present the results of a randomized double-blinded placebo controlled, multicenter trial, of low-dose mitoxantrone (MX), after one year, in 25 patients with relapsing-remitting multiple sclerosis, who had serial enhanced magnetic resonance imaging (MRI). Treatment groups were balanced for age, gender, duration of illness and neurological disability. Five of the 13 MX patients and 10 of the 12 placebo patients had exacerbations during treatment (p < 0.02). The mean change in the extended disability status scale was not significantly different between the MX and placebo treatment groups. Serial Gadolinium-DTPA enhanced MRI detected no significant difference between the MX treated and placebo groups in the mean total number of new, enlarging, or Gadolinium-DTPA enhancing lesions; there was a trend toward a reduction of new, enlarging and Gadolinium-DTPA enhancing lesions in MX patients. Despite this ameliorating effect, the results indicate that serial Gadolinium-DTPA enhanced MRI, performed over one year in a limited number of patients, could not provide conclusive evidence for a role of MX therapy in relapsing-remitting multiple sclerosis.
Article: Multiple sclerosis: Immunotherapy[Show abstract] [Hide abstract]
ABSTRACT: Given our current knowledge, there is a need for the early institution of immunomodulatory therapy, especially for patients with poor prognostic factors (motor and cerebellar symptoms, frequent disease exacerbations, and a high level of activity on magnetic resonance imaging [MRI]). Patients who progress despite immunomodulatory therapy should be reevaluated in terms of diagnosis, development of neutralizing antibodies, or compliance. If a patient has a partial response to immunomodulatory therapy but his or her disease, as assessed by clinical and MRI criteria, remains very active, every effort should be made to modify disease progression by searching for an immunosuppressive therapy regimen before irreversible and considerable disability has accumulated. For the majority of patients, multiple sclerosis (MS) is a chronic condition. Therefore, until a curative treatment has been developed, the available repertoire of immunosuppressive or immunomodulatory treatments should be assessed with respect to the possibility of long-term use. This is particularly important for new immunosuppressive drugs, such as cladribine or mitoxantrone, or for invasive procedures, such as total lymphoid irradiation or autologous bone marrow transplantation. For the latter treatments, experience with long-term administration is not available or the potential side effects (eg, cardiotoxicity with mitoxantrone) limit the cumulative dose. These considerations may limit long-term administration and thus the general usefulness of some drugs. Even with proven efficacy, we need to define the next step once treatment has to be discontinued. We should also address whether exacerbating disease by discontinuing an effective therapy is a potential hazard. What other therapeutic options remain once the current treatment is discontinued? Answers are not readily available at the moment, but the question should influence our decisions in the selection of traditional, well-studied or new, potentially promising therapies.
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ABSTRACT: Tore Broman lay down the desiderata for multiple sclerosis (MS) therapeutics in 1970 (Broman 1970): 1. Complete cure of the patient; 2. Success in preventing further relapses; 3. Success in preventing further progress; 4. An acceptable risk that the treatment will be less harmful than the disease.
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