Corticosteroid Alternative Demonstrates High Rate of MS Relapse Resolution

Results from a long-term, large-scale analyses of multiple sclerosis (MS) relapse treatments demonstrate superior relapse resolution with oral corticosteroids (OCS) and repository corticotropin injections (RCI) compared to other treatments.

The study included patients age 18 to 89 who experienced MS relapse from January 1, 2008 to June 30, 2015. Patients were treated with different earlier-line MS treatments, including OCS, intravenous corticosteroids [intravenous methylprednisolone (IVMP)], as well as alternatives including RCI, plasmapheresis (PMP), and intravenous immunoglobulin (IVIG).

If patients experienced zero relapses following their first episode, investigators deemed the treatment effective. Patients were allowed a 5-day OCS taper if they received IVMP, as well as an option to use both IVMP and OCS at the same time.

Patients were assessed on relapse frequency, treatment use, and relapse resolution. Investigators also observed relapse resolution in patients enrolled for 12 months before and after their first treatment with RCI or PMP/IVIG; treatment with PMP/IVIG within 7 days of each other was considered a single course of therapy.

Of the assessed, 9574 patients had at least 1 relapse, while 26% of patients had at least 2 relapses per year. The mean follow-up period was 2.7 years per patient for an annualized relapse rate (ARR) of 1.0, as well as a mean relapse episode per patient of 2.6. In 90.4% of relapses, corticosterioids were the first treatment used (51.8% OCS, 38.6% IVMP), followed by IVIG (6%), RCI (2.2%), and PMP (1.5%).

Investigators noted that 90.5% and 96.9% of patients achieved relapse resolution in the OCS (n=5710) and RCI (n=195) groups, respectively. These 2 treatment groups were among the highest to achieve relapse resolution compared to other treatments, with 47.8% of patients treated with IVMP+OCS (n=3425) achieving relapse resolution, 50.7% with PMP (n=73), and 43.9% with IVIG (n=171).

Among patients who were continuously enrolled who received a corticosteroid (CS) alternative, 222 of 232 patients (95.7) treated with RCI had resolved relapse, compared to 93 of 141 patients (66%) in the PMP/IVIG group.

Investigators did not report any safety analysis from the trial.

“The results of this study are an important start toward evaluating an appropriate patient type and supporting a relapse treatment algorithm, given treatment effectiveness results realized by patients receiving CS alternatives,” the study authors concluded.

This study was funded by Mallinckrodt Pharmaceuticals.

REFERENCE:

Nazareth T, Datar M, Yu TC. Treatment effectiveness for resolution of multiple sclerosis relapse in a US health plan population. Neurol Ther. 2019.;8(2): 383-395. doi:10.1007/s40120-019-00156-5.