Results from a multicenter, randomized, double‐blind, placebo‐controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids

Wynn, Daniel; Goldstick, Lawrence; Bauer, William R.; Zhao, Enxu; Tarau, Eva; Cohen, Jeffrey A.; Robertson, Derrick; Miller, Aaron

doi:10.1111/cns.13789

Cited by 6 publications

(7 citation statements)

References 26 publications

(63 reference statements)

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“…No serious AEs or deaths were reported. It was concluded that Acthar was effective for patients with MS that was not responsive to corticosteroid treatment (Table 4 ) [ 52 ].…”

Section: Clinical Studies Of Acthar: 2014–2022mentioning

confidence: 99%

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

Kaplan,

Askanase,

Chu

et al. 2023

Clin Drug Investig

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Acthar ® Gel (repository corticotropin injection) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides that is believed to have both steroidogenic and nonsteroidogenic immunomodulatory effects via activation of melanocortin receptors in various cells throughout the body. Since 1952, Acthar has been approved by the US Food and Drug Administration to treat a variety of autoimmune and inflammatory diseases. Since 2014, Mallinckrodt Pharmaceuticals has conducted a large number of preclinical, clinical, and real-world-evidence studies of Acthar for the treatment of rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis and polymyositis, multiple sclerosis relapse, ophthalmic disorders, sarcoidosis, and nephrotic syndrome. To date, Acthar has been the subject of more than 500 publications, many of which demonstrate the safety and efficacy of Acthar in patients with inflammatory diseases for whom standard treatments were ineffective or intolerable. Here, we review the history of Acthar and the findings of studies that have investigated the mechanism of action, safety, efficacy, and real-world effectiveness of Acthar for the treatment of inflammatory diseases. Supplementary Information The online version contains supplementary material available at 10.1007/s40261-023-01303-5.

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“…No serious AEs or deaths were reported. It was concluded that Acthar was effective for patients with MS that was not responsive to corticosteroid treatment (Table 4 ) [ 52 ].…”

Section: Clinical Studies Of Acthar: 2014–2022mentioning

confidence: 99%

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

Kaplan,

Askanase,

Chu

et al. 2023

Clin Drug Investig

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“…1 Controlled clinical trials have shown that RCI increases recovery rates and improves disability scores in patients with acute MS relapse. 25 In the multicenter, randomized, double-blind, placebo-controlled, parallel-group OPTIONS trial, 35…”

Section: Clinical Benefitsmentioning

confidence: 99%

Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence

Wan¹,

Niewoehner²,

Hayes³

2023

CEOR

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Acthar ® Gel (repository corticotropin injection [RCI]) is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides used to treat patients with serious and rare inflammatory and autoimmune conditions. This narrative review summarizes the key clinical and economic findings among 9 indications: infantile spasms (IS), multiple sclerosis (MS) relapses, rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), dermatomyositis and polymyositis (DM/PM), ocular inflammatory diseases (primarily uveitis and severe keratitis), symptomatic sarcoidosis, and proteinuria in nephrotic syndrome (NS). Key studies of clinical efficacy and healthcare resource utilization and cost from 1956 to 2022 are discussed. Evidence supports the efficacy of RCI across all 9 indications. RCI is recommended as first-line treatment for IS and is associated with improved outcomes for the other 8 indications, including increased recovery rates in MS relapse; improved disease control in RA, SLE, and DM/PM; realworld effectiveness in patients with uveitis and severe keratitis; improved lung function and reduced corticosteroid use in symptomatic sarcoidosis; and increased rates of partial remission of proteinuria in NS. For many indications, RCI may improve clinical outcomes during exacerbations or when conventional treatments have failed to show a benefit. RCI is also associated with a reduction in the use of biologics, corticosteroids, and disease-modifying antirheumatic drugs. Economic data suggest RCI is a cost-effective, value-based treatment option for MS relapse, RA, and SLE. Other economic benefits have been demonstrated for IS, MS relapses, RA, SLE, and DM/PM, including reduced hospitalizations, lengths of stay, inpatient and outpatient services, and emergency department visits. RCI is considered safe and effective and features economic benefits for numerous indications. Its ability to control relapse and disease activity makes RCI an important nonsteroid treatment option that could help preserve functioning and well-being among patients with inflammatory and autoimmune conditions.

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“…Clinical studies have demonstrated the efficacy of Acthar in patients with inflammatory diseases that are refractory to glucocorticoid treatment (Askanase et al, 2020 ; Baughman et al, 2017 ; Fleischmann et al, 2020 ; Wynn et al, 2022 ). Acthar also can directly inhibit B cell proliferation and antibody production (Olsen et al, 2015 ).…”

Section: Introductionmentioning

confidence: 99%

Acthar Gel Inhibits the Activation of CD4⁺ and CD8⁺ T Cells

Wright

Hayes

2023

Journal of Interferon & Cytokine Research

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Several inflammatory diseases are characterized by elevated T cell counts and high pro-inflammatory cytokine levels. Inhibiting T cell activity may reduce tissue damage associated with these diseases. Acthar ® Gel has potent anti-inflammatory properties, yet little is known about its effect on T cells. This study compared the effects of Acthar, synthetic adrenocorticotropic hormone 1–24 (ACTH 1–24 ) depot, and prednisolone in a murine model of T cell activation. Assessments of CD4 + helper and CD8 + cytotoxic T cells and plasma concentrations of interferon-γ (IFN-γ), interleukin-2 (IL-2), and tumor necrosis factor-α (TNF-α) were made following anti-CD3-activation. Acthar significantly reduced the number of activated CD4 + and CD8 + T cells at amounts comparable to synthetic ACTH 1–24 depot or prednisolone. However, Acthar reduced production of IFN-γ, IL-2, and TNF-α significantly more than the other drugs, suggesting that the in vivo immunomodulatory effects of Acthar on T cells are distinct from synthetic ACTH 1–24 depot or prednisolone.

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Results from a multicenter, randomized, double‐blind, placebo‐controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri bution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 6 publications

References 26 publications

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

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

Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence

Acthar Gel Inhibits the Activation of CD4⁺ and CD8⁺ T Cells

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Results from a multicenter, randomized, double‐blind, placebo‐controlled study of repository corticotropin injection for multiple sclerosis relapse that did not adequately respond to corticosteroids

Abstract: This is an open access article under the terms of the Creat ive Commo ns Attri bution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Cited by 6 publications

References 26 publications

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

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

Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence

Acthar Gel Inhibits the Activation of CD4+ and CD8+ T Cells

Contact Info

Product

Resources

About

Acthar Gel Inhibits the Activation of CD4⁺ and CD8⁺ T Cells