Results from a multicenter, randomized, double-blind, placebo-controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids.
CNS Neurosci Ther
; 28(3): 364-371, 2022 03.
Article
in English
| MEDLINE | ID: covidwho-1685248
ABSTRACT
INTRODUCTION:
About 20%-35% of multiple sclerosis (MS) patients fail to respond to high-dose corticosteroids during a relapse. Repository corticotropin injection (RCI, Acthar® Gel) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and pituitary peptides that has anti-inflammatory and immunomodulatory effects.AIMS:
The study objective was to determine the efficacy and safety of RCI in patients with MS relapse that inadequately responded to corticosteroids. This was a multicenter, double-blind, placebo-controlled study. Nonresponders to high-dose corticosteroids were randomized to receive RCI (80 U) or placebo daily for 14 days. Assessments included improvements on the Expanded Disability Status Scale (EDSS), Multiple Sclerosis Impact Scale (MSIS-29), Clinical Global Impression of Improvement (CGI-I), and adverse events (AEs).RESULTS:
Eighteen patients received RCI, and 17 received placebo. A greater proportion of EDSS responders was observed in the RCI group at Day 7, 21, and 42 compared with the placebo group. Qualitative CGI-I showed that more patients receiving RCI were much improved or very much improved than with placebo. No meaningful differences were observed between treatment groups for MSIS-29. No serious AEs or deaths were reported.CONCLUSION:
RCI is safe and effective for MS relapse patients who do not respond to high-dose corticosteroids.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Multiple Sclerosis
Type of study:
Experimental Studies
/
Prognostic study
/
Qualitative research
/
Randomized controlled trials
Limits:
Humans
Language:
English
Journal:
CNS Neurosci Ther
Journal subject:
Neurology
/
Therapeutics
Year:
2022
Document Type:
Article
Affiliation country:
Cns.13789
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