THERAPEUTIC EFFECT OF MITOXANTRONE COMBINED WITH METHYLPREDNISOLONE IN MULTIPLE-SCLEROSIS - A RANDOMIZED MULTICENTER STUDY OF ACTIVE DISEASE USING MRI AND CLINICAL-CRITERIA

Objective-To evaluate the efficiency of mitoxantrone in multiple scler osis. Methods-Forty two patients with confirmed multiple sclerosis, se lected as having a very active disease on clinical and MRI criteria we re randomised to receive either mitoxantrone (20 mg intravenously (IV) monthly) and methylprednisolone (1 g iv monthly) or methylprednisolon e alone over six months. In the steroid alone group five patients drop ped out due to severe exacerbation. Results-Blinded analysis of MRI da ta showed significantly more patients with no new enhancing lesions in the mitoxantrone group compared with the steroid alone group, (90% v 31%, P < 0.001). In the mitoxantrone group there was a month by month decrease almost to zero in the number of new enhancing lesions, and in the total number of enhancing lesions, whereas both remained high in the steroid alone group. The differences were significant for both ind ices at all months from 1-6. Unblinded clinical assessments showed a s ignificant improvement in change in EDSS at months 2-6 in the mitoxant rone group, with a final mean improvement of more than one point (-1.1 v + 0.3; P < 0.001). There was a significant reduction in the number of relapses (7 v 31; P < 0.01), and an increase in the number of patie nts free of exacerbation (14 v 7; P < 0.05). Conclusion-In this select ed group of patients with multiple sclerosis with very active disease, mitoxantrone combined with methylprednisolone was effective in improv ing both clinical and MRT indices of disease activity over a period of six months whereas methylprednisolone alone was not. Further double b linded long term studies are needed to properly evaluate the effect of mitoxantrone on progression in disability.