– Findings from a retrospective analysis suggest that treatment with Acthar Gel is associated with significant reductions in corticosteroid use compared to other fourth-line alternatives for patients with advanced sarcoidosis1 –
Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides. Acthar Gel is approved by the
Please see Important Safety Information for Acthar Gel below.
The retrospective analysis used data from a large administrative pharmacy and medical claims database (
George J. Wan, Ph.D., M.P.H., Vice President Health Economics and Outcomes Research at Mallinckrodt, said, "We're excited to share these data that not only provide valuable insight into the association between use of Acthar Gel and reduction in corticosteroid use, but also reinforce the importance of treatment adherence to help improve outcomes for patients with advanced sarcoidosis.1 We remain committed to addressing the unmet needs of critically ill patient populations and are proud to continue the collection of real-world data to help inform patients' treatment options."
In this retrospective analysis, patients treated with Acthar Gel also had significantly greater reduction of extended corticosteroid use at all dose levels compared to fourth-line treatment, with Acthar Gel above average adherence reduction better than below average (-9.5% vs. -5.7% for medium corticosteroid dose; -10.0% vs. -8.6% for high corticosteroid dose, respectively).1
Data collected in a retrospective analysis may have errors or omissions. Outcomes may be influenced by therapies not evaluated in the study and the clinical outcomes may not be solely attributable to Acthar.
This study was funded by Mallinckrodt Pharmaceuticals. Presentation details are as follows:
Presentation Title: Corticosteroid use and adherence in patients treated with Acthar Gel for advanced sarcoidosis
Presenter: Kyle Hayes, MS
Presentation Date: Thursday, March 23, 2023, at
Additional information is available on the
Sarcoidosis is a challenging and rare multisystem disease.5,6 In some cases the symptoms may come and go throughout one's lifetime. This is referred to as symptomatic sarcoidosis. In people living with sarcoidosis, the immune system overreacts, forming clumps of cells called granulomas that result in inflammation of the body's tissues.7 The disease can impact any organ but most often impacts the lungs, lymph nodes, eyes, and skin.5 Over 90% of people with sarcoidosis suffer lung problems.5,8 Concomitant involvement of organs outside of the lungs is common, occurring in as many as half of all sarcoidosis cases.8
IMPORTANT SAFETY INFORMATION
Acthar is contraindicated:
Warnings and Precautions
Please see full Prescribing Information for additional Important Safety Information.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning Acthar Gel® (repository corticotropin injection), including its potential impact on patients and anticipated benefits associated with its use, as well as related on-going studies. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the
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©2023 Mallinckrodt. US-2300120 03/23
1 Hayes K, et al. Corticosteroid use and adherence in patients treated with Acthar Gel for advanced sarcoidosis. Abstract to be presented at
2 Acthar® Gel (repository corticotropin injection) [prescribing information].
3 Baughman RP, Valeyre D, Korsten P, et al. ERS clinical practice guidelines on treatment of sarcoidosis. Eur Respir J. 2021; in press (doi.org/10.1183/13993003.04079-2020)
4 Rahaghi FF, Sweiss NJ, Saketkoo LA, et al. Management of repository corticotrophin injection therapy for pulmonary sarcoidosis: a Delphi study. Eur Respir Rev. 2020; 29:190147. doi.org/10.1183/16000617.0147- 2019.
5 Judson MA. The clinical features of sarcoidosis: a comprehensive review. Clin Rev Allerg Immunol. 2015;49:63-78.
6 Baughman RP, Field S, Costabel U, et al. Sarcoidosis in America. Analysis based on health care use. Ann Am Thorac Soc. 2016;13:1244-1252.
7 Baughman RP, Culver DA, Judson MA. A concise review of pulmonary sarcoidosis. Am J Respir Crit Care Med. 2011;183:573-581.
8 Shigemitsu H, Patel HV, Schreiber MP. Extrapulmonary sarcoidosis. In: Judson MA, ed. Pulmonary Sarcoidosis: A Guide for the Practicing Clinician. Vol 17.
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