Efficacy and safety of oral prednisolone tapering following intravenous methyl prednisolone in patients with multiple sclerosis relapses: A randomized, double-blind, placebo-controlled trial

Abstract Background : Relapse is one of the main features of multiple sclerosis (MS). Corticosteroids are the first line of management during MS relapse. Since tapering or non-tapering prednisolone after corticosteroid pulse has been a controversial issue, this clinical trial is designed to evaluate the efficacy and safety of the tapering regimen. Methods : Having been treated by intravenous methylprednisolone (IVMP) pulse, sixty-six patients with MS-relapse were randomly assigned to receive oral prednisolone tapering (OPT) or placebo. The regimen was administered in line with the study protocol and the dose was tapered over 20 days. Demographics and symptoms, impact on activities of daily living (ADL), and management procedures were recorded according to Assessing Relapse in Multiple Sclerosis (ARMS) Questionnaire. The incidence of adverse events was assessed using the same questionnaire. Patients’ disability improvement was assessed using the Extended Disability Scale (EDSS) during relapse, and over the first, third, sixth months following treatment. Results : As shown by the results of the questionnaire, 75% reported that their ADL was not or minimally affected by OPT and there was no significant difference in terms of ADL after treatment between the two groups (p=0.3). The effect of treatment on return to the previous state of health (RSH) showed that there were no differences between the two groups of the study (p=0.5). The improvement of disability in the two groups of oral prednisolone and placebo did not indicate a difference in terms of EDSS in the first and third and six months (p = 0.5, p = 0.9, p=0.3, respectively). Also, the occurrence of some side effects such as weight gain (p = 0.000) and increased appetite (p = 0.004) was higher in the OPT group. Conclusion : The findings of this study revealed that the efficacy of an OPT after a corticosteroid pulse is non-superior to IVMP plus only in case the safety and tolerability profile are comparable.