Effects of Monthly Pulse Methylprednisolone Therapy on Sustained Disease Progression in Secondary Progressive Multiple Sclerosis

Background: Most patients with multiple sclerosis (MS) initially experience a relapsing-remitting clinical course. Over years, patients who initially experience exacerbations may experience gradual progression of disability that occurs between or in the absence of exacerbations. This is known as the secondary-progressive phase of MS (SPMS). Although there is agreement that corticosteroids often shorten the duration of acute exacerbations, a convincing therapeutic effect on sustained progression of disability has never been demonstrated in SPMS.

Objectives: In the present study, we aimed to evaluate the efficacy of monthly pulse methylprednisolone treatment, especially on sustained progression of disability in SPMS patients.

Methods: SPMS patients receiving no ongoing treatment or any treatment such as immunosuppressant (e.g. azathiopirin), interferons or glatiramer acetate (GA) were eligible if they had Expanded Disability Status Scale (EDSS) scores of 3.0 or high, and if they had at least 0.5 point sustained EDSS progression within the previous year. Or, patients with at least one relapse and new T2 or gadolinium- enhanced lesion within the previous year were also included in the study. Patients received 1 g pulse IVMP once a month at least one year.  Outcomes included sustained EDSS progression (primary), relapse rate, and Multiple Sclerosis International Quality of Life (MUSIQoL) scores.

Results: A total of 94 SPMS patients were included in the study. 91 patients (62 female) finished the one year study period. Mean age was 46,06. Mean disease duration was 15,7. 60 patients were receiving azathiopirin, 3 patients were treating with interferon beta 1a (three times weekly), 2 patients with interferon beta 1b, 2 patients with GA. 24 patients had no treatment at the beginning of the study. Mean EDSS score was decreased significantly from 5,75±1,02 (3.0-8.0) to 5,41±1,12 (3.0-7.5) (p=0.000). 70 out of 91 (76.9%) patients had the same EDSS at the end of the study. 15 (16.5%) patients were less disabled. Only 6 patients has sustained EDSS (disease) progression at the end the study year. Relapse rate was decreased from 0.5/ year to 0.2/year (p=0.011). As the part of inclusion criteria, there was no relapse free plus progression free patients before study. But at the end of the study 83 (91.2%) patients became relapse and progression free. There was no gender difference based on both disability and relapse. There was no significant difference between patients with ongoing treatment or with no ongoing treatment. Health related quality of life (HRQoL) measured by MUSIQoL was significantly improved in the study population (p=0.007).

Conclusions: Our data suggested that methylprednisolone given in pulses every 4 weeks in SPMS leads to a significant reduction in disease progression and relapse rate. Significant improvement in HRQoL was also found in the study group. However, these findings need to be corroborated in larger cohorts and longer duration.