A Prospective Observational Registry Study of Repository Corticotropin Injection for the Treatment of Multiple Sclerosis Relapse (4503)

Objective: The objective of this multicenter, prospective, observational registry study was to characterize the treatment patterns, recovery, and safety outcomes of patients receiving RCI for the treatment of acute MS relapse. Background: Effective relapse treatment is critical for minimizing disability in patients with multiple sclerosis (MS). Repository corticotropin injection (RCI) is approved by the US Food and Drug Administration for the treatment of exacerbations of MS. Design/Methods: Change from baseline in the MS Impact Scale (MSIS-29v1) physical subscale score, the Expanded Disability Status Scale (EDSS), Clinical Global Impression of Improvement (CGI-I) scale, and adverse events (AEs) were assessed. Results: After treatment with RCI (N=125), mean MSIS-29v1 physical subscale scores decreased from baseline (55.69) by 7.99 at 2 months (p=0.0002) and 9.64 at 6 months postbaseline (p 5 doses of RCI. Patients who received >5, compared with ≤5, daily doses of RCI showed larger improvements on the MSIS-29v1 physical subscale (2 months postbaseline: −6.48, p=0.0177 vs. −10.74, p=0.0180; 6 months postbaseline: −7.9, p=0.0011 vs. −14.62, p=0.0415) and on the EDSS (2 months postbaseline: −0.24, p=0.0059 vs. −0.50, p=0.0068; 6 months postbaseline: −0.36, p=0.0111 vs. −0.64, p=0.0430). A total of 83 AEs were reported by 35 (28.0%) patients; 16 serious AEs were reported by 11 (8.8%) patients. Conclusions: Clinically meaningful improvements in MSIS-29v1 physical subscale scores, the EDSS and CGI-I scales, and low incidence of serious AEs support the efficacy and safety of RCI as a treatment option for MS relapse. Disclosure: Dr. Kaplan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Amgen/Novartis, Allergan, Biogen, Teva, EMD Serono, and Lilly. Dr. Miller has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Speaking and/or consulting fees (Acorda, Allergan, Amgen, Biogen, Genentech, Mallinckrodt, Novartis, Reven, Sanofi, and Teva).. Dr. Miller has received research support from Research support (Adamas, Allergan, Biogen, Elan, EMD Serono, Genentech, Ipsen, Novartis, Ono, Sanofi, Sun Pharma, and Teva).. Dr. Baker has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Avanir, Biogen, Celgene, Genentech, Mallinckrodt Pharmaceuticals, Sanofi-Genzyme, and Teva.. Dr. Due has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mallinckrodt Pharmaceuticals. Dr. Zhao has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mallinckrodt Pharmaceuticals.