Mallinckrodt announces retrospective analysis on Acthar Gel published

Mallinckrodt announced data from a retrospective chart review that analyzed physician assessments of 91 U.S. patients diagnosed with uveitis who had been treated with Acthar Gel in the previous 12 months. All patients had completed or were still receiving treatment at the time of the review. In response to a survey question, physicians reported that 84% of patients who completed or were still in treatment with Acthar Gel had improvement in disease status overall, and 86% had improvements in vision. Uveitis is a cause of preventable blindness in adults. Results of the study were recently published online ahead of print in the Journal of Ocular Pharmacology and Therapeutics. Acthar Gel is FDA-approved for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis and anterior segment inflammation. The study was a retrospective medical record review of physicians’ assessments of 91 patients diagnosed with uveitis, most of whom had moderate to severe visual impairment, who were treated with Acthar Gel. Average time since diagnosis was four years. All patients had received treatment with Acthar Gel in the past 12 months and had either completed a course of Acthar Gel or were receiving Acthar Gel treatment at the time of data collection. There were 17 different initial dosing regimens documented in the study, however, most patients were prescribed an initial regimen of 40-80 units, administered subcutaneously once or twice weekly. According to the Acthar Gel prescribing information, usual dosing of Acthar Gel is 40-80 units via subcutaneous or intramuscular injection every 1-3 days. Based on notes in medical records, physicians reported that overall disease status had improved in 84% of patients after therapy with Acthar Gel. Overall 86% had improvements in vision, 27% had improvements in eye pain, 26% had improvements in vitreous haze, 24% had reduction of background medication use, 23% had improvements in vitreous flare and 18% had improvements in macular edema. The study was a retrospective collection of data from medical records, which may be incomplete.

https://thefly.com/landingPageNews.php?id=2890067