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Anesi SD, Chang PY, Maleki A, Manhapra A, Look-Why S, Asgari S, Walsh M, Drenen K, Foster S—Ocular Immunology and Inflammation, 2023
Disclosure statement: Funding to support these studies was provided by Mallinckrodt Pharmaceuticals. Some authors of this study have financial and/or employment relationships with Mallinckrodt Pharmaceuticals.
To evaluate the effects of Acthar Gel on regulatory T cell populations in noninfectious retinal vasculitis, with a secondary endpoint of response level
Key inclusion and exclusion criteria
PPP=per-protocol population; Treg=T regulatory.
*PPP-responsive patients were those with response level ≥50% at any study visit that was maintained until the end of the study.
PPP-nonresponsive patients were those who completed the study but did not meet the criteria for response level.
The primary endpoint of this study was not met.
Treg=T regulatory.
No clinically significant changes were seen in weight, systolic/diastolic blood pressure, or heart rate*
No clinically significant changes were seen in IOP between baseline, Week 12, and Week 24 in both groups
IOP=intraocular pressure.
*Between baseline, Week 12, and Week 24 in both groups.
†Four patients showed intolerable side effects to Acthar Gel. One patient discontinued after 1 follow-up visit due to insomnia and heart palpitations.
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