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Published on: December 9, 2015
Mitoxantrone treatment in patients with early relapsing-remitting multiple sclerosis
1Centro Sclerosi Multipla, Dipartimento di. Scienze Cardiovascolari e Neurologiche, University of Cagliari, Italy.
Abstract:
We investigated the clinical and MRI effects of mitoxantrone (MITOX) administered to 45 patients during the first five years of highly active relapsing-remitting multiple sclerosis. Differences occurring between the end of treatment and follow-up (clinical mean: 3.6 years; brain MR: 1.8 years) with respect to baseline variables (EDSS, annualized relapse rate, active T2 lesions, new T1 lesions and number of Gd-enhancing lesions) were analysed using parametric and non-parametric tests. One patient developed leukemia four months after the end of the treatment; no other serious adverse events occurred during treatment and the follow-up period. A clinically relevant reduction in the annualized relapse rate ( P < 0.0001 at end of treatment and P < 0.0001 at follow-up) and improvement in the EDSS (P < 0.0001 at end of treatment and P = 0.0005 at follow-up) was found. At the end of treatment, 53% of patients experienced no increase in active T2 lesions, while 73% showed no increase in the number of new T1 lesions. At follow-up, 41 out of 45 (91%) patients showed a stable MRI pattern and were active-scan free. Despite potential serious adverse events, MITOX may be considered an option in selected patients with very active early MS.
Insights
Mitoxantrone (MITOX) significantly reduced relapse rates and improved disability scores in patients with highly active relapsing-remitting multiple sclerosis. Most patients maintained stable MRI scans post-treatment, suggesting MITOX is a viable option for active early MS.
Area of Science:
- Neurology
- Immunology
- Radiology
Background:
- Highly active relapsing-remitting multiple sclerosis (MS) requires effective early intervention.
- Mitoxantrone (MITOX) is an immunomodulatory agent with potential in MS treatment.
- Assessing long-term clinical and MRI outcomes of MITOX in early MS is crucial.
Purpose of the Study:
- To evaluate the clinical and MRI effects of mitoxantrone in patients with highly active early relapsing-remitting MS.
- To analyze changes in Expanded Disability Status Scale (EDSS) and annualized relapse rate (ARR).
- To assess the impact of MITOX on MRI lesion activity (T2, T1, and Gd-enhancing lesions).
Main Methods:
- A cohort of 45 patients with highly active early MS received mitoxantrone.
- Clinical data (EDSS, ARR) and brain MRI (T2, T1, Gd-enhancing lesions) were collected at baseline, end of treatment, and during follow-up (mean 3.6 years clinical, 1.8 years MRI).
- Parametric and non-parametric statistical tests were used for analysis.
Main Results:
- Significant reductions in ARR (P < 0.0001) and improvements in EDSS (P < 0.0001) were observed.
- At treatment end, 53% had no increase in T2 lesions and 73% had no new T1 lesions.
- At follow-up, 91% of patients showed stable MRI and were active-scan free.
Conclusions:
- Mitoxantrone demonstrated significant clinical benefits, including reduced relapse rates and improved disability.
- The majority of patients achieved stable MRI outcomes, indicating sustained disease control.
- Despite potential risks like leukemia in one patient, MITOX can be considered for selected early, highly active MS cases.
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