Journal article
Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis
Danish Multiple Sclerosis Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark rikke.ratzer@regionh.dk.1
Danish Research Center for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Hvidovre Hospital, University of Copenhagen, Denmark.2
Danish Multiple Sclerosis Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.3
Department of Clinical Neurophysiology, Rigshospitalet, University of Copenhagen, Denmark.4
Department of Endocrinology, Hvidovre Hospital, University of Copenhagen, Denmark.5
There is a large unmet need for treatments for patients with progressive multiple sclerosis (MS). Phase 2 studies with cerebrospinal fluid (CSF) biomarker outcomes may be well suited for the initial evaluation of efficacious treatments. To evaluate the effect of monthly oral methylprednisolone pulse treatment on intrathecal inflammation in progressive MS.
In this open-label phase 2A study, 15 primary progressive and 15 secondary progressive MS patients received oral methylprednisolone pulse treatment for 60 weeks. Primary outcome was changes in CSF concentrations of osteopontin. Secondary outcomes were other CSF biomarkers of inflammation, axonal damage and demyelination; clinical scores; magnetic resonance imaging measures of disease activity, magnetization transfer ratio (MTR) and diffusion tensor imaging (DTI); motor evoked potentials; and bone density scans.
We found no change in the CSF concentration of osteopontin, but we observed significant improvement in clinical scores, MTR, DTI and some secondary CSF outcome measures. Adverse events were well-known side effects to methylprednisolone. Monthly methylprednisolone pulse treatment was safe, but had no effect on the primary outcome.
However, improvements in secondary clinical and MRI outcome measures suggest that this treatment regimen may have a beneficial effect in progressive MS.
| Language: | English |
|---|---|
| Publisher: | SAGE Publications |
| Year: | 2016 |
| Pages: | 926-34 |
| ISSN: | 14770970 and 13524585 |
| Types: | Journal article |
| DOI: | 10.1177/1352458515605908 |
Administration, Oral Adolescent Adult Aged Biomarkers Bone Density Denmark Diffusion Tensor Imaging Disease Progression Evoked Potentials, Motor Female Glucocorticoids Humans Inflammation Mediators Magnetic Resonance Imaging Male Methylprednisolone Middle Aged Multiple Sclerosis, Chronic Progressive Neurologic Examination Osteopontin Predictive Value of Tests Progressive multiple sclerosis Pulse Therapy, Drug Recovery of Function Recurrence SPP1 protein, human Time Factors Treatment Outcome Young Adult cerebrospinal fluid clinical trial magnetization transfer ratio methylprednisolone osteopontin
