Abstract
BackgroundHigh-dose short-term methylprednisolone is the recommended treatment in the management of multiple sclerosis relapses, although it has been suggested that lower doses may be equally effective. Also, glucocorticoids are associated with multiple and often dose-dependent adverse effects. This quantitative benefit-risk assessment compares high- and low-dose methylprednisolone (at least 2000 mg and less than 1000 mg, respectively, during at most 31 days) and a no treatment alternative, with the aim of determining which regimen, if any, is preferable in multiple sclerosis relapses.MethodsAn overall framework of probabilistic decision analysis was applied, combining data from different sources. Effectiveness as well as risk of non-serious adverse effects were estimated from published clinical trials. However, as these trials recorded very few serious adverse effects, risk intervals for the latter were derived from individual case reports together with a range of plausible distributions. Probabilistic modelling driven by logically implied or clinically well motivated qualitative relations was used to derive utility distributions.ResultsLow-dose methylprednisolone was not a supported option in this assessment; there was, however, only limited data available for this treatment alternative. High-dose methylprednisolone and the no treatment alternative interchanged as most preferred, contingent on the risk distributions applied for serious adverse effects, the assumed level of risk aversiveness in the patient population, and the relapse severity.ConclusionsThe data presently available do not support a change of current treatment recommendations. There are strong incentives for further clinical research to reduce the uncertainty surrounding the effectiveness and the risks associated with methylprednisolone in multiple sclerosis relapses; this would enable better informed and more precise treatment recommendations in the future.Electronic supplementary materialThe online version of this article (doi:10.1186/s12883-015-0450-x) contains supplementary material, which is available to authorized users.
Highlights
High-dose short-term methylprednisolone is the recommended treatment in the management of multiple sclerosis relapses, it has been suggested that lower doses may be effective
Over the numerous sensitivity analysis scenarios considered in this quantitative benefit-risk assessment of methylprednisolone in multiple sclerosis (MS) relapses, the low-dose regimen of less than 1000 mg over at most 31 days was rarely the preferred alternative
It must be borne in mind that the risk of nonserious adverse effects was not evaluable from data for low-dose methylprednisolone, and its effectiveness was estimated based on only three trials comprising merely 62 patients in total
Summary
High-dose short-term methylprednisolone is the recommended treatment in the management of multiple sclerosis relapses, it has been suggested that lower doses may be effective. Glucocorticoids are associated with multiple and often dose-dependent adverse effects. This quantitative benefit-risk assessment compares high- and low-dose methylprednisolone (at least 2000 mg and less than 1000 mg, respectively, during at most 31 days) and a no treatment alternative, with the aim of determining which regimen, if any, is preferable in multiple sclerosis relapses. Glucocorticoids are the only pharmacological intervention with a demonstrated effect on multiple sclerosis (MS) relapses, with high-dose short-term methylprednisolone being the currently recommended first line treatment [1]. Experiences of adverse effects are typically presented separately, and to the best of our knowledge there exists no previous evaluation that considers the likelihood and desirability of relevant beneficial and adverse effects jointly
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
