Mallinckrodt Announces Journal Publication of Real-World Data on Acthar® Gel (repository corticotropin injection) to Treat Symptomatic Sarcoidosis in African American and Non-African American Patients


– Retrospective analysis suggests Acthar Gel treatment was associated with similar improvement in health status and overall symptom reduction in African Americans and non-African Americans with symptomatic sarcoidosis1 –  

 – Findings on treatment response and physician-reported outcomes indicate that Acthar Gel may be a viable treatment option for both African American and non-African American sarcoidosis patients1 –

DUBLIN, March 11, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the publication of findings from a retrospective chart review of Acthar® Gel (repository corticotropin injection) treatment outcomes for African American and non-African American patients with symptomatic sarcoidosis – including treatment patterns, co-medication use, and overall health outcomes.1 This analysis suggested that Acthar Gel treatment was associated with similar improvements in health outcomes, a reduction in symptoms, and reduced co-medication use in both African Americans and non-African Americans with symptomatic sarcoidosis.1 The manuscript was recently published online in Therapeutics & Clinical Risk Management.

Mallinckrodt logo

This research builds upon findings from a study investigating the clinical and real-world outcomes of Acthar Gel treatment in a subgroup of African Americans with symptomatic sarcoidosis, previously presented at the 2022 American Thoracic Society Annual International Conference in San Francisco, CA, and published in Therapeutic Advances in Respiratory Disease in 2019.2

Acthar is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.3 Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of several autoimmune disorders and medical conditions known to cause inflammation, including symptomatic sarcoidosis.3

Please see additional indications and Important Safety Information below.

"The results of this retrospective medical chart review highlight unmet needs that exist for African American patients with symptomatic sarcoidosis, who are disproportionately affected by the disease, and reinforce Acthar Gel's potential to help improve health outcomes for appropriate patients,"1,4,5 said George Wan, Ph.D., M.P.H., Vice President, Evidence Generation and Data Sciences, Mallinckrodt. "This research reflects Mallinckrodt's commitment to collecting real-world data on the relationship between patient characteristics, treatment patterns, and outcomes to support clinicians' treatment decisions and address disparities in symptomatic sarcoidosis care."1

About the Study:1

In this retrospective analysis, a national database of Acthar Gel prescribers and the American Medical Association Physician Masterfile listing were merged to obtain a sample of 98 physicians to provide data on the last 6 consecutive patients seen who met the study's eligibility criteria. The medical records were extracted for adult patients (≥18 years) with a diagnosis of advanced symptomatic sarcoidosis, who had ≥1 symptom, and who had either completed at least one course of Acthar Gel or had received Acthar Gel for at least 6 months during data collection.

A total of 272 patients with symptomatic sarcoidosis were included in this analysis (African American (AA): n=168; non-African American (non-AA): n=104). Most patients in both race groups were diagnosed with stage 3 or 4 sarcoidosis based on chest imaging and biopsy (AA: 61.3%, n=103 vs. non-AA: 68.3%, n=71; p=0.2453).

Per an assessment of patient characteristics and Acthar Gel treatment patterns, this analysis suggests that the average time since the first diagnosis of sarcoidosis was slightly longer among AA than non-AA (mean ± SD: 5.2 ± 7.6 years vs. 4.3 ± 5.1 years; p>0.05).1 Further, a lower proportion of AA vs. non-AA had completed a course of Acthar Gel therapy (44%, n=74 vs. 55.8%, n=58; p=0.0602) during the data collection period,1 and the duration of Acthar Gel treatment was slightly longer among AA vs. non-AA (mean ± SD: 31.7 ± 32 vs. 29 ± 27.4 weeks; p>0.05).1

"This research underscores the importance of conducting real-world studies to provide data that helps to recognize the disparities in symptomatic sarcoidosis care and address unmet needs to better support health outcomes for all appropriate patients," said Mary McGowan, Chief Executive Officer, Foundation for Sarcoidosis Research (FSR). FSR is the leading international organization dedicated to finding a cure for sarcoidosis and improving care for sarcoidosis patients through research, education, and support.   

Key Findings:Co-Medication Utilization Patterns1

  • Significantly fewer patients among both race groups were on any co-medication after Acthar Gel initiation (p