4.2 Review

Acthar® Gel Treatment for Patients with Autoimmune and Inflammatory Diseases: An Historical Perspective and Characterization of Clinical Evidence

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Summary: This study aimed to evaluate the efficacy and safety of repository corticotropin injection (RCI) in patients with pulmonary sarcoidosis and validate endpoints for use in future clinical trials. The results showed that RCI had greater improvement in disease and reduction in glucocorticoid use compared to placebo. The study also provided validation of efficacy endpoints that may be used in larger trials for pulmonary sarcoidosis.

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A Narrative Review of Repository Corticotropin Injection for the Treatment of Systemic Lupus Erythematosus

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Repository Corticotropin Injection as an Alternative Treatment for Refractory Ocular Mucous Membrane Pemphigoid

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Pharmacokinetics and Pharmacodynamics of Repository Corticotropin Injection Compared With Synthetic ACTH1-24 Depot and Methylprednisolone in Healthy Subjects

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Results from a Prospective, Open-Label, Phase 4 Pilot Study of Repository Corticotropin Injection for Moderate and Severe Dry Eye Disease

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Post Hoc Biomarker Analyses from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Repository Corticotropin Injection (Acthar® Gel) for Persistently Active Systemic Lupus Erythematosus

Anca D. Askanase et al.

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Distinct binding and signaling activity of Acthar Gel compared to other melanocortin receptor agonists

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Summary: The study compared the binding and agonistic activity of Acthar Gel and synthetic MCR agonists, finding that Acthar Gel exhibited different activity levels in various MCRs. Specifically, it showed the lowest level of full agonist activity at MC2R, which may result in lower corticosteroid production.

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Comparison of Steroidogenic Exposure Following the Administration of Repository Corticotropin Injection With a Synthetic ACTH1-24 Depot and Methylprednisolone in Healthy Subjects

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Summary: This study compared the steroidogenic exposure of repository corticotropin injection and synthetic ACTH(1-24) depot in healthy adults at therapeutic doses, finding that repository corticotropin injection had substantially lower steroidogenic exposure compared to synthetic ACTH(1-24) depot, suggesting that the pharmacological effects of the two drugs are not identical.

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Patient Characteristics and Indicators of Treatment Initiation with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis: A Claims Database Analysis

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Individual pituitary neuropeptides do not recapitulate the effects of repository corticotropin (Acthar®) on human B cells in vitro

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Summary: Research suggests that the direct effects of repository corticotropin injection on human B cells may require complementary signals from multiple components of the preparation.

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Treatment of Noninfectious Retinal Vasculitis Using Subcutaneous Repository Corticotropin Injection

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