Mallinckrodt presents data on real-world outcomes with Acthar Gel (repository corticotropin injection) at the International Congress on Systemic Lupus Erythematosus (LUPUS 2025)

Mallinckrodt plc,  announced a late-breaking poster abstract on Acthar Gel (repository corticotropin injection) in patients with systemic lupus erythematosus (SLE) at the International Congress on Systemic Lupus Erythematosus (LUPUS 2025), taking place in Toronto from May 21-24, 2025.

The poster abstract details a chart review from April 1, 2022, and November 2024 of 56 patients who had been treated with Acthar Gel for SLE within the prior 24 months. Data collected included demographics, comorbidities, symptoms, prior treatments, and health outcomes following Acthar Gel treatment. Details are as follows:

Abstract #799: Treatment  patterns and outcomes of Acthar Gel in systemic lupus erythematosus : A physician-reported chart review 

• Presenter: Dr. Johanna Purcell
• Presentation Date: Friday May 23-  Saturday May 24, 2025

Results reported from this chart review included:

• 84% (47/56) of patients were female and 50% (28/56) were black American
• Common comorbidities included chronic joint disease (34%, 19/56), hyperlipidemia (34%, 19/56), hypertension (34%, 19/56), and arthritis/osteoarthritis (30%, 17/56)
• Physicians reported 63% (35/56) of patients were in fair-to-poor health status prior to treatment with Acthar Gel
• The average duration of Acthar Gel treatment was 8 months, and 91% (51/56) of patients were dosed at 40-80 units twice per week
• Physicians reported that 89% (50/56) of patients experienced improved health status after Acthar Gel treatment
  • This included physician-reported improvements in overall symptoms (82%, 41/50), pain (54%, 27/50), fatigue (44%, 22/50), physical function (38%, 19/50), and strength (28%, 14/50). A reduction in corticosteroid use (44%, 22/50) was also reported.

The limitations of this physician-reported chart review include, but are not limited to, small sample sizes, variables in methodolog, and possible errors. Safety outcomes were not reported. Most patients were previously treated with other therapies and may have been using other therapies in tandem with Acthar Gel; clinical outcomes may not be solely attributable to Acthar Gel.

This study is an example of how real-world evidence can improve our understanding of the impact of treatment for individuals affected by lupus, particularly in populations with the greatest disease burden. The Lupus Foundation of America (LFA) is grateful for the research conducted by companies like Mallinckrodt, who remain committed to advancing treatments and improving outcomes for those impacted by this disease," said Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America.

May 2025-"Mallinckrodt is committed to evaluating real-world treatment outcomes among those living with SLE, particularly among patient subpopulations who are disproportionally affected" said Dr. George Wan, Vice President, Evidence Generation and Data Sciences, Mallinckrodt. "This chart review provides additional data to consider when treating appropriate patients with this often difficult-to-manage disease."