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Low-dose oral methotrexate in chronic progressive multiple sclerosis: analyses of serial MRIs
D E Goodkin1, R A Rudick, S VanderBrug Medendorp
1University of California, San Francisco/Mt. Zion Multiple Sclerosis Center 94115, USA.
Abstract:
We monitored 56 patients with chronic progressive multiple sclerosis (MS) who participated in a clinical trial of weekly, low-dose oral methotrexate with annual gadolinium-enhanced MRIs of the brain (Gd + MRI). Not of these patients had clinical exacerbations during the 8 months preceding study entry. We also monitored 35 of the patients with serial Gd + MRIs every 6 weeks for 6 months. We observed a treatment effect, measured by absolute change in T2-weighted total lesion area (T2W-TLA), in the cohort that completed 6-week scans. We found change in T2W-TLA in this cohort to be significantly related to sustained change in performance on the nine-hold peg test but not to sustained change on the Expanded Disability Status Scale. Gadolinium enhancement of lesions on 6-week and annual scans was uncommon. Prestudy exacerbation frequency appears to be an important consideration in designing future clinical trials in patients with secondary and primary progressive MS.
Insights
Low-dose oral methotrexate showed a treatment effect in chronic progressive multiple sclerosis (MS) patients, impacting T2 lesion area. Changes correlated with hand function but not overall disability status.
Area of Science:
- Neurology
- Radiology
- Clinical Trials
Background:
- Chronic progressive multiple sclerosis (MS) requires effective treatment strategies.
- Understanding treatment effects on MRI lesion load is crucial for MS management.
Purpose of the Study:
- To evaluate the treatment effect of weekly, low-dose oral methotrexate in chronic progressive MS patients.
- To assess the relationship between MRI changes and clinical outcomes.
Main Methods:
- 56 chronic progressive MS patients received weekly low-dose oral methotrexate.
- Brain MRIs with gadolinium enhancement (Gd + MRI) were performed annually.
- A subset of 35 patients underwent serial Gd + MRIs every 6 weeks for 6 months.
- T2-weighted total lesion area (T2W-TLA) and clinical assessments (nine-hole peg test, Expanded Disability Status Scale) were monitored.
Main Results:
- A treatment effect was observed in the cohort completing 6-week scans, measured by absolute change in T2W-TLA.
- Changes in T2W-TLA significantly correlated with sustained changes in nine-hole peg test performance.
- No significant correlation was found between T2W-TLA changes and the Expanded Disability Status Scale.
- Gadolinium enhancement on MRI scans was infrequent.
Conclusions:
- Weekly low-dose oral methotrexate may influence T2 lesion area in chronic progressive MS.
- Nine-hole peg test performance is a sensitive indicator of treatment response in this MS population.
- Prestudy exacerbation frequency is a key factor for future progressive MS clinical trial design.