Abstract Details

Title A Prospective Observational Registry Study of Repository Corticotropin Injection for the Treatment of Multiple Sclerosis Relapse

Topic Multiple Sclerosis

Presentation(s) P10 - Poster Session 10 (5:30 PM-6:30 PM)

Poster/Presentation
Number 9-022

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<0.0001). Mean EDSS scores decreased from baseline (3.92) by 0.37 at 2 months (p<0.0001) and by 0.45 at 6 months (p<0.0001). CGI-I scores improved in 63.4% of patients (p<0.0001) at 2 months and 61.4% of patients at 6 months (p<0.0001). Post hoc analyses showed that most patients (n=71) received ≤5 doses of RCI (80U), compared to only 23 patients who received >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.

Authors/Disclosures
Matthew J. Baker, MD (Collier Neurologic Specialists) PRESENTER	No disclosure on file
Jeffrey M. Kaplan, MD (Kansas City MS and Headache Center)	Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for biohaven. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Kaplan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Allergan. Dr. Kaplan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Kaplan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. Dr. Kaplan has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Amgen. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Viela. Dr. Kaplan has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Kaplan has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck.
Tamara Miller, MD (Advanced Neurology of Colorado LLC)	Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics Therapeutics, Abbvie, Genentech. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono, TG Therapeutics, Biogen, Abbvie, Genentech, Lundbeck. The institution of Dr. Miller has received research support from Abbvie, Ipsen, Alexion, Pfizer, BMS, Genentech, ThermoFisher Scientific.
Bryan R. Due, PhD (Ono Pharma USA)	No disclosure on file
Enxu Zhao	No disclosure on file

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Abstract Details