Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis. / Ratzer, Rikke; Iversen, Pernille; Börnsen, Lars; Dyrby, Tim B; Christensen, Jeppe Romme; Ammitzbøll, Cecilie; Madsen, Camilla Gøbel; Garde, Ellen; Lyksborg, Mark; Andersen, Birgit; Hyldstrup, Lars; Sørensen, Per Soelberg; Siebner, Hartwig R; Sellebjerg, Finn.
In: Multiple Sclerosis Journal, Vol. 22, No. 7, 2016, p. 926–934.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - Monthly oral methylprednisolone pulse treatment in progressive multiple sclerosis
AU - Ratzer, Rikke
AU - Iversen, Pernille
AU - Börnsen, Lars
AU - Dyrby, Tim B
AU - Christensen, Jeppe Romme
AU - Ammitzbøll, Cecilie
AU - Madsen, Camilla Gøbel
AU - Garde, Ellen
AU - Lyksborg, Mark
AU - Andersen, Birgit
AU - Hyldstrup, Lars
AU - Sørensen, Per Soelberg
AU - Siebner, Hartwig R
AU - Sellebjerg, Finn
N1 - © The Author(s), 2015.
PY - 2016
Y1 - 2016
N2 - BACKGROUND: 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.OBJECTIVE: To evaluate the effect of monthly oral methylprednisolone pulse treatment on intrathecal inflammation in progressive MS.METHODS: 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.RESULTS: 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.CONCLUSION: 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.
AB - BACKGROUND: 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.OBJECTIVE: To evaluate the effect of monthly oral methylprednisolone pulse treatment on intrathecal inflammation in progressive MS.METHODS: 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.RESULTS: 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.CONCLUSION: 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.
U2 - 10.1177/1352458515605908
DO - 10.1177/1352458515605908
M3 - Journal article
C2 - 26432857
VL - 22
SP - 926
EP - 934
JO - Multiple Sclerosis Journal
JF - Multiple Sclerosis Journal
SN - 1352-4585
IS - 7
ER -
ID: 161848991