Mallinckrodt plc, a distinguished global specialty pharmaceutical company, has recently unveiled a late-breaking poster abstract regarding its product, Acthar® Gel (repository corticotropin injection), at the notable International Congress on Systemic Lupus Erythematosus (LUPUS 2025). The conference is set to take place in Toronto, Canada from May 21-24, 2025. The focus is on presenting physician-reported data that highlights treatment patterns and characteristics among patients suffering from systemic lupus erythematosus (SLE) who have undergone treatment with Acthar Gel.
Acthar Gel is a complex mixture derived from natural adrenocorticotropic hormone (ACTH) analogs and various pituitary peptides. This medication has gained FDA approval for treating a variety of autoimmune diseases and conditions characterized by inflammation, notably for cases involving SLE, either during flare-ups or as part of maintenance therapy.
The essence of the newly presented data revolves around a thorough chart review conducted between April 1, 2022, and November 2024, which focused on 56 patients who had received Acthar Gel treatment for SLE within the preceding 24 months. The researchers collected a wealth of data encompassing patient demographics, existing health conditions, observed symptoms, previous treatments, and health results following the application of Acthar Gel.
Among the key findings disclosed from the chart reviews, it was observed that:
- - Patient Demographics: Of the total 56 patients, a striking 84% (47/56) were women, and nearly half (50%, 28/56) identified as African American.
- - Common Comorbidities: The data revealed that prevalent comorbid conditions included chronic joint disease (34%), hyperlipidemia (34%), hypertension (34%), and arthritis/osteoarthritis (30%).
- - Health Status Prior to Treatment: Physicians reported that 63% (35/56) of the cohort were in either fair or poor health prior to commencing Acthar Gel treatment.
- - Treatment Duration and Dosage: The average treatment period lasted approximately 8 months, with 91% (51/56) of patients receiving doses between 40-80 units two times each week.
- - Health Improvements: Remarkably, 89% (50/56) of patients experienced improvement in their health status following the treatment. Reports indicated physician-assessed enhancements in various symptoms such as overall health (82%), pain reduction (54%), fatigue amelioration (44%), improvements in physical functionality (38%), and enhanced strength (28%). Furthermore, a notable reduction in corticosteroid usage was reported in 44% (22/50) of the patients.
Dr. George Wan, the Vice President of Evidence Generation and Data Sciences at Mallinckrodt, emphasized the company's commitment to evaluating treatment outcomes among SLE patients, particularly within marginalized populations like African Americans and women. He stated that this chart review contributes valuable data for practitioners managing a disease that is typically challenging to treat effectively.
The Lupus Foundation of America (LFA) expressed acknowledgment of the significance of such studies in enriching the understanding of lupus treatment impacts, particularly for demographics that face a greater disease burden. Louise Vetter, LFA's President and CEO, recognized Mallinckrodt’s ongoing commitment to advancing treatment methodologies and improving patient outcomes.
Notably, while the insights provided through this physician-reported chart review are promising, there are limitations to consider. These include the small sample size, variations in methodologies employed, and potential for inaccuracies. The review did not include safety outcomes, and many patients had previously undergone treatments that may have coincided with Acthar Gel administration. Thus, the clinical outcomes may not be entirely attributed to Acthar Gel alone.
Overall, the study highlights valuable information and offers insights that are crucial for healthcare professionals treating patients impacted by systemic lupus erythematosus. As research advances in the field of autoimmune conditions, findings like those presented at LUPUS 2025 will play a pivotal role in shaping therapeutic strategies and improving patient care.
Presentation Details: The abstract titled "Treatment Patterns and Outcomes of Acthar Gel in Systemic Lupus Erythematosus: A Physician-Reported Chart Review," will be presented by Johanna Purcell, PhD, from May 23 to May 24, 2025, at the Exhibition Room. This presentation will encapsulate the essence of the findings and discuss further implications for practice in the management of SLE.
As the conference approaches, the expectation surrounding the outcomes discussed reflects anticipation not only for healthcare professionals but also for the many individuals living with this chronic condition. The pursuit of better treatments and optimal outcomes continues to drive research and innovation within the pharmaceutical field.