Mallinckrodt to Present New Retrospective Data on Effect of Acthar® Gel (Repository Corticotropin Injection) to Reduce Corticosteroid Use and Burden for Advanced Sarcoidosis at the Academy of Managed Care Pharmacy (AMCP) 2023 Annual Meeting
– 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:
- For intravenous administration
- In infants under 2 years of age who have suspected congenital infections
- With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar
- In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin
Warnings and Precautions
- The adverse effects of Acthar are related primarily to its steroidogenic effects
- Acthar may increase susceptibility to new infection or reactivation of latent infections
- Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment
Cushing'ssyndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
- Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels
- Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
- Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding
- Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated
- Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
- Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms
- Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the post marketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity
- There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
- Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
- Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy
- Commonly reported post marketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased
- The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with
ISprogress to other forms of seizures; ISsometimes masks these seizures, which may become visible once the clinical spasms from ISresolve
- Acthar may cause fetal harm when administered to a pregnant woman
Please see full Prescribing Information for additional Important Safety Information.
Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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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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Global Corporate Controller & Chief Investor Relations Officer
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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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