Monthly intravenous methylprednisolone in relapsing-remitting multiple sclerosis - reduction of enhancing lesions, T2 lesion volume and plasma prolactin concentrations

Background: Intravenous methylprednisolone (IV-MP) is an
established treatment for multiple sclerosis ( MS) relapses,
accompanied by rapid, though transient reduction of gadolinium
enhancing (Gd+) lesions on brain MRI. Intermittent IV-MP, alone or
with immunomodulators, has been suggested but insufficiently
studied as a strategy to prevent relapses. Methods: In an open,
single-cross-over study, nine patients with relapsing-remitting MS
(RR-MS) underwent cranial Gd-MRI once monthly for twelve months.
From month six on, they received a single i.v.-infusion of 500 mg
methylprednisolone ( and oral tapering for three days) after the
MRI. Primary outcome measure was the mean number of Gd+ lesions
during treatment vs. baseline periods; T2 lesion volume and monthly
plasma concentrations of cortisol, ACTH and prolactin were
secondary outcome measures. Safety was assessed clinically, by
routine laboratory and bone mineral density measurements. Soluble
immune parameters (sTNF-RI, sTNF-RII, IL1-ra and sVCAM-1) and
neuroendocrine tests ( ACTH test, combined dexamethasone/CRH test)
were additionally analyzed. Results: Comparing treatment to
baseline periods, the number of Gd+ lesions/scan was reduced in
eight of the nine patients, by a median of 43.8% ( p = 0.013,
Wilcoxon). In comparison, a pooled dataset of 83 untreated RR-MS
patients from several studies, selected by the same clinical and
MRI criteria, showed a non-significant decrease by a median of 14%
( p = 0.32). T2 lesion volume decreased by 21% during treatment ( p
= 0.001). Monthly plasma prolactin showed a parallel decline ( p =
0.027), with significant cross-correlation with the number of Gd+
lesions. Other hormones and immune system variables were unchanged,
as were ACTH test and dexamethasone-CRH test. Treatment was well
tolerated; routine laboratory and bone mineral density were
unchanged. Conclusion: Monthly IV-MP reduces inflammatory activity
and T2 lesion volume in RR-MS.