A Prospective Observational Registry of Repository Corticotropin Injection for the Treatment of Multiple Sclerosis Relapse: Baseline Characteristics and Interim Results

Background: Despite recent advances in multiple sclerosis (MS) treatments, patients continue to experience relapses. Effective treatment of MS relapses is highly important to minimize acute disability and potential residual deficits.

Objectives: To characterize the population receiving repository corticotropin injection (RCI) for treatment of acute MS relapse; describe treatment patterns, MS relapse recovery, and safety outcomes.

Methods: Patients whose MS relapse was treated with subcutaneous RCI were clinically evaluated and assessed with the MS Impact Scale (MSIS-29), Expanded Disability Status Scale (EDSS), and Clinical Global Impression of Improvement scale. Health outcome assessments were also administered. 

Results: As of August 30, 2017, 80 patients entered the study from multiple sites; presented results are from 62 patients in the intent-to-treat population. On average, patients were 48.3 years old; 90.3% were female; 85.5% were Caucasian; baseline MSIS-29 physical subscale score (scaled to 100) was 55.8; baseline EDSS score was 4.2; the average time since diagnosis of MS was 11.7 years, and 64.5% of patients experienced a prior relapse within the last 2 years. At least 59.7% had a history of insufficient treatment response, intolerance, or intravenous access problems associated with high‑dose corticosteroids. Disease‑modifying therapies (DMTs) were used in 72.6% of patients presenting with a relapse; those most often used concomitantly with RCI were dimethyl fumarate (24.2%), natalizumab (21.0%), glatiramer acetate (11.3%), teriflunomide (11.3%), fingolimod (9.7%), ocrelizumab (6.5%), and interferon beta-1a (3.2%). The median dose of RCI was 80 U daily for 5 days, with most patients dosed on consecutive days. Mean MSIS-29 physical subscale scores improved from baseline by 7.5 at month 2 and by 10.3 at month 6. Eight serious adverse events were reported; 2 were related to RCI treatment, with 1 patient discontinuing RCI due to atrial fibrillation.

Conclusions: The study is ongoing and will assess current practices relating to RCI and the impact on clinical outcome assessments after acute MS relapse. Baseline data suggest that patients receiving RCI tend to be older, have longer MS duration, and use more contemporary DMTs than patients in prior studies of relapse recovery. Despite this, interim results suggest clinically meaningful improvements in MSIS-29 scores and support the efficacy and tolerability of RCI as a treatment for MS relapse.