Ultima Comunicazione - inviata da: Neuroitc - Martedì, 19 Febbraio 2008 09:19
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Azathioprine reduces new brain lesions in patients with multiple sclerosis (MS), according to the results of an open-label study reported in the December issue of the Archives of Neurology.
"Many clinical trials have demonstrated the efficacy of new medications, such as interferon (IFN) beta, in modifying the clinical course and new brain lesion accumulation of patients with MS, but in many patients these medications show no or little efficacy or are not well tolerated," write Luca Massacesi, MD, from the University of Florence in Italy, and colleagues. "Azathioprine is an immunosuppressive agent that reduces relapse rates in patients with MS, but its efficacy in suppressing new brain lesions has never been evaluated."
At a university hospital-based outpatient MS center, 14 patients with relapsing-remitting MS (RRMS) of short duration and at least 3 gadolinium-enhancing (Gd+) brain lesions observed within 6 months before treatment received azathioprine, up to 3 mg/kg daily, with dose adjustments based on blood lymphocyte number and the occurrence of adverse events. The primary endpoints were brain Gd+ lesions seen on monthly magnetic resonance imaging (MRI) for 6 months before and 6 months during treatment, and new T2 lesions during the same periods and after an additional 6 months.
After treatment, the median Gd+ lesion number and volume per MRI was zero (P < .001 for both), resulting in a Gd+ lesion number reduction of 50% or more in 12 (86%) of 14 patients (P < .01). There was an equivalent reduction in the new T2 lesion number (P < .02), which was maintained during the additional treatment period (P < .01).
The median azathioprine dose administered was 2.6 to 2.8 mg/kg daily, which reduced the mean blood lymphocyte count to 57% of baseline. Adverse events were transient or reversible with dosage adjustment.
"This study indicates for the first time that azathioprine, administered at lymphocyte-suppressing doses, is effective in reducing MS new brain inflammatory lesions and is well tolerated," the authors write. "The dimension of the new brain lesion suppression observed in the present study is similar to that observed with different IFNs using the same study design, indicating that the treatment effect of azathioprine on brain lesion accumulation is probably equivalent to that of these medications and suggesting that phase 3 clinical trials directly comparing the efficacy of azathioprine with that of IFNs are worth planning."
The Multiple Sclerosis Project of the Italian Istituto Superiore di Sanità and the Florence University Magnetic Resonance Imaging Centre supported this study.
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Azatriopina: riduzione nuove lesioni infiammatorie
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