- Clinical Experience
- Rheumatology
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Wynn D, Goldstick L, Bauer W, Zhao E, Tarau E, Cohen JA, Robertson D, Miller A—CNS Neuroscience & Therapeutics, 2022
Disclosure statement: Funding to support this study was provided by Mallinckrodt Pharmaceuticals. Some authors of this study have financial and/or employment relationships with Mallinckrodt Pharmaceuticals.
To evaluate patients who required an alternative treatment for MS relapse due to inadequate response to high-dose corticosteroids
Patients who were receiving disease-modifying treatments must have been on a stable dose(s) for 30 days prior to baseline visit and planned to remain on that dose throughout the study. All patients included in the initial assessment had no prior use of Acthar Gel.
ACTH=adrenocorticotropic hormone; EDSS=Expanded Disability Status Scale; RRMS=relapsing-remitting multiple sclerosis.
The primary objective of this study was to determine the Expanded Disability Status Scale (EDSS) response rate with 90% confidence intervals (CIs) at Day 42 for each treatment group1
Additional efficacy assessments were1:
A total of 107 MS relapse patients were screened and EDSS/FSS measurements were taken prior to the initiation of any study drug. All patients had received prior high-dose IVMP/Prednisone/MP treatment.
FSS=Functional Systems Scores.
*One patient withdrew after 8 treatments but returned at final follow-up visit.
The study population was mostly composed of females, with an average age of 41.3 years
Most patients in the study were white, non-Hispanic/Latino women.
SD=standard deviation.
CI=confidence interval; EDSS=Expanded Disability Status Scale.
The findings in this clinical trial reinforce the results of a real-world registry study on the use of Acthar Gel for the treatment of MS relapse5
CGI-I=Clinical Global Impression of Improvement; MSIS-29=Multiple Sclerosis Impact Scale.
AE=adverse event; TEAE=treatment-emergent adverse event.
Start the referral process for your appropriate patients
Acthar Gel is indicated for:
Contraindications
Acthar is contraindicated:
Warnings and Precautions
Adverse Reactions
Pregnancy
Please see full Prescribing Information for additional Important Safety Information.
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