Mallinckrodt plc announced the publication of two journal manuscripts reinforcing the clinical and economic evidence supporting the efficacy, safety profile, continued use, and cost-effectiveness of Acthar Gel for appropriate patients across a range of FDA-approved autoimmune and inflammatory disease indications. Mallinckrodt's clinical manuscript titled ?Acthar Gel Treatment for Patients with Autoimmune and Inflammatory Diseases: A Historical Perspective and Characterization of Clinical Evidence? was published on October 4, 2023 in the journal, Clinical Drug Investigation.

Mallinckrodt' health economics manuscript titled ?Acthar Gel (RCI): A Narrative literature Review of Clinical and Economic Evidence? was published on June 24, 2023 in ClinicoEconomics and Outcomes Research. Acthar is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.

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. Authored by Jeffrey Kaplan, M.D., Kansas City Multiple Sclerosis & Headache Center, and colleagues, ?Acthar Gel Treatment for patients with Autoimmune and Inflammator Diseases: A Historical Perspective and characterization of Clinical Evidence,? sought to review the history of Acthar and the findings of existing literature on preclinical and clinical studies that have investigated the mechanism of action, safety profile, efficacy, and real-world effectiveness of Acthar.

The indications addressed in the study include the treatment of inflammatory diseases such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), dermatomyositis and polymyositis (DM/PM), multiple sclerosis (MS) relapse, inflammatory ocular diseases, sarcoidosis, and nephrotic syndrome (NS). As a result of this analysis spanning more than 20 preclinical mechanistic studies and 15 clinical studies with a combined enrollment of approximately 900 patients, and the publication of over 500 manuscripts and abstracts to date, the findings reinforce the safety profile, efficacy, and usage of Acthar in appropriate patients with inflammatory diseases for whom standard treatments may have become ineffective or associated with intolerable side effects. This publication is accompanied by an Audiocast.

All six authors across specialties representing key Acthar Gel indications researched in this study discuss a brief overview of the manuscript, including the history of Acthar, its mechanism of action (MOA), and clinical characteristics, in addition to introductions on each author and reflections on their own personal experiences with Acthar in clinical practice. Authored by George J. Wan, Ph.D., M.P.H., Vice President, Evidence Generation and Data Sciences at Mallinckrodt, and colleagues, ?ActHar Gel (RCI): Aative literature Review of Clinical and economic Evidence? reviewed key studies of clinical efficacy and healthcare resource utilization and cost from 1956 to 2022 to summarize the key clinical and economic findings among nine FDA-approved Acthar Gel indications: infantile spasms (IS), MS relapse, RA, SLE, DM/PM, ocular inflammatory diseases (primary uveitis and severe keratitis), symptomaticsarcoidosis, and proteinuria in NS.

This analysis found that among patients with inflammatory diseases, and proteinuria in NS2.