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Effects of IV methylprednisolone on brain atrophy in relapsing-remitting MS
R Zivadinov1, R A Rudick, R De Masi
1Department of Clinical Medicine and Neurology, University of Trieste, Italy. zivadinov@hotmail.com
Background:
IV methylprednisolone (IVMP) has been used to treat relapses in patients with relapsing-remitting (RR) MS, but its effect on disease progression is not known. Furthermore, there are no data on the impact of IVMP on T1 black holes or whole-brain atrophy.
Objective:
To determine the effect of IVMP on MRI measures of the destructive pathology in patients with RR-MS and secondarily to determine the effect of IVMP on disability progression in patients with RR-MS.
Methods:
The authors conducted a randomized, controlled, single-blind, phase II clinical trial of IVMP in patients with RR-MS. Eighty-eight patients with RR-MS with baseline Expanded Disability Status Scale (EDSS) scores of < or =5.5 were randomly assigned to regular pulses of IVMP (1 g/day for 5 days with an oral prednisone taper) or IVMP at the same dose schedule only for relapses (IVMP for relapses) and followed without other disease-modifying drug therapy for 5 years. Pulsed IVMP was given every 4 months for 3 years and then every 6 months for the subsequent 2 years. Patients had quantitative cranial MRI scans at study entry and after 5 years and standardized clinical assessments every 4 to 6 months.
Results:
Eighty-one of 88 patients completed the trial as planned, and treatment was well tolerated. Baseline demographic, clinical, and MRI measures were well matched in the two study arms. Patients on the pulsed IVMP arm received more MP than patients on the control arm of the study (p < 0.0001). Mean change in T1 black hole volume favored pulsed IVMP therapy (+1.3 vs +5.2 mL; p < 0.0001), as did mean change in brain parenchymal volume (+2.6 vs -74.5 mL; p = 0.003). There was no significant difference between treatment arms in the change in T2 volume or annual relapse rate during the study. However, there was significantly more EDSS score worsening in the control group, receiving IVMP only for relapses. There was a 32.2% reduction (p
Conclusions:
In patients with RR-MS, treatment with pulses of IVMP slows development of T1 black holes, prevents or delays whole-brain atrophy, and prevents or delays disability progression. A phase III study of IVMP pulses is warranted.
Insights
Regular pulses of intravenous methylprednisolone (IVMP) significantly slowed disease progression in relapsing-remitting multiple sclerosis (RR-MS) by reducing T1 black holes and whole-brain atrophy.
Area of Science:
- Neurology
- Immunology
- Radiology
Background:
- Intravenous methylprednisolone (IVMP) is used for relapsing-remitting multiple sclerosis (RR-MS) relapses.
- Its impact on disease progression, T1 black holes, and whole-brain atrophy remains unclear.
Purpose of the Study:
- To assess IVMP's effect on MRI-measured destructive pathology in RR-MS.
- To evaluate IVMP's secondary impact on disability progression in RR-MS patients.
Main Methods:
- A 5-year, randomized, controlled, single-blind phase II trial involving 88 RR-MS patients.
- Patients received either regular pulsed IVMP or IVMP only for relapses.
- Quantitative MRI scans and clinical assessments were performed at baseline and study end.
Main Results:
- Pulsed IVMP significantly reduced T1 black hole volume and whole-brain atrophy compared to relapse-only treatment.
- No significant differences in T2 volume or annual relapse rate were observed.
- The pulsed IVMP group showed a 32.2% reduction in sustained EDSS worsening and better overall EDSS scores.
Conclusions:
- Pulsed IVMP treatment in RR-MS patients slows T1 black hole development and prevents/delays whole-brain atrophy.
- Pulsed IVMP also prevents or delays disability progression in RR-MS.
- A phase III study for pulsed IVMP is recommended.