Author Of 1 Presentation
P0895 - Outcomes from a prospective observational registry of repository corticotropin injection for the treatment of multiple sclerosis relapse (ID 414)
Abstract
Background
Effective treatment of relapse is critical for minimizing disability in patients with multiple sclerosis (MS). Repository corticotropin injection (RCI, Mallinckrodt Pharmaceuticals) is approved by the US Food and Drug Administration for treatment of MS exacerbations.
Objectives
This multicenter, prospective, observational, registry study aimed to characterize treatment patterns, recovery, and safety outcomes from patients receiving RCI for acute MS relapse.
Methods
Subjects were recruited before initiation of RCI for an MS exacerbation. Clinician assessments included the Expanded Disability Status Scale (EDSS), Functional System Score (FSS), and Clinical Global Impression of Improvement scale (CGI-I). Patient-reported outcome questionnaires included the MS Impact Scale (MSIS-29v1), Work Productivity and Activity Impairment: MS (WPAI:MS), and Health Resource Utilization (HRU). Safety was assessed by adverse events (AEs).
Results
In all, 125 subjects received ≥1 dose of RCI. Mean scores significantly decreased from baseline to month 6 for the EDSS (–0.45, n=56) and total (sum of all subsystem domain scores) FSS (–1.55; n=56) (p<0.0001 for both) with RCI treatment. The CGI-I also indicated statistically significant improvement at 6 months (p<0.0001). Mean MSIS-29v1 physical subscale scores decreased from baseline to month 2 (–7.99, p=0.0002, n=69, primary endpoint) and month 6 (–9.64, p<0.0001, n=48). For the WPAI:MS, mean changes from baseline to month 6 were statistically significant for percent work time missed due to MS (–27.75, p=0.0255, n=17) and percent activity impairment due to MS (–11.52, p=0.0003, n=46). Regarding HRU measures, the mean number of MS-related emergency department visits, hospitalizations, numbers of days in the hospital, and outpatient visits (other than healthcare professional visits at home) decreased from baseline at month 6. Thirty-five subjects (28.0%) reported 83 AEs, the most common being MS relapse, urinary tract infection (UTI), nasopharyngitis, and peripheral edema. Eleven subjects (8.8%) reported 16 serious AEs, the most common being MS relapse, UTI, and asthenia.
Conclusions
Clinically meaningful improvements on the EDSS, CGI-I, and MSIS-29v1 physical subscale, along with statistically significant improvements in additional clinician- and patient-reported outcomes and the low incidence of serious AEs, support the efficacy and safety of RCI for the treatment of MS relapse.