-- Retrospective analyses evaluated healthcare resource utilization and costs with Acthar in dermatomyositis/polymyositis symptoms and rheumatoid arthritis --
CHESTERFIELD, United Kingdom – June 20, 2016 - Mallinckrodt plc (NYSE: MNK), a leading global specialty biopharmaceutical company, today announced the results from two Mallinckrodt-sponsored retrospective analyses of claims data providing health economic information regarding the use of H.P. Acthar® Gel (repository corticotropin injection) in two distinct patient populations: dermatomyositis and polymyositis (DM/PM), and as an adjunct therapy for short-term administration in select cases of rheumatoid arthritis (RA). The results of each study were presented in poster sessions at the American Society of Health-System Pharmacists Summer Meetings, held June 11-15, in Baltimore.
Both abstracts can be accessed at link (pages 70 and 145).
Dermatomyositis and Polymyositis (DM/PM) Retrospective Analysis
“Medical Resource Utilization in Dermatomyositis/Polymyositis Patients Treated with Repository Corticotropin Injection, Intravenous Immunoglobulin, and/or Rituximab” (Knight R, Bond C, Popelar B, Wang L, Philbin M, Poster 36-M), compared non-medication-related medical resource use between patients treated with Acthar and patients treated with intravenous immunoglobulin (IVIG) and/or rituximab for DM/PM. Claims data of DM/PM patients were analyzed from the combination of three commercial health insurance databases in the U.S. from July 1, 2009 to June 30, 2014.
Findings from this retrospective, observational study among DM/PM patients include:
Limitations of the Study
This study examined only non-medication medical resource use and associated non-medication costs. Other endpoints such as indirect healthcare costs, patient experience and quality-of-life measures, and effectiveness were not examined. Propensity score matching was used to control for potential confounders; however, the use of propensity scores will not correct for biases from unmeasured variables.
Dermatomyositis and polymyositis (DM/PM) are rare inflammatory diseases that cause progressive muscle weakness, usually in the neck, upper arms, hips, and thighs. Dermatomyositis also causes skin rashes. 2,3 People of all ages can be affected, though it usually occurs between the ages of 40-50 and is more common in women. 4,5,6 There is no cure for DM/PM, but certain treatments can improve muscle strength and function. 1 Corticosteroids and corticosteroid-sparing agents are used early in the treatment paradigm to improve muscle function.1 Acthar is the only medication approved by the U.S. Food and Drug Administration (FDA) for DM/PM other than corticosteroids.1
Rheumatoid Arthritis (RA) Retrospective Analysis
“Real-World Treatment Patterns and Demographic, Clinical and Economic Characteristics of Rheumatoid Arthritis Patients Initiating Repository Corticotropin Injection Therapy” (Wu B, Deshpande G, Popelar B, Wan G, Philbin M, Poster 33-T), describes the profile of adult patients with RA initiating Acthar treatment, including baseline characteristics, treatment patterns and healthcare costs. Patients age 18 and older with two or more diagnoses for RA between July 1, 2006 and April 30, 2015, were identified from a nationally representative HealthCore Integrated Research DatabaseSM.
Findings from this retrospective, cohort study among RA patients in a commercially insured population include:
* Number of patients per 1,000 patient year
+ Number of encounters per patient year
Limitations of the Study
This study estimated costs from a commercial payer’s perspective, which may underestimate the overall cost burden of the disease. These results may have limited generalizability to a non-commercially insured population.
About Rheumatoid Arthritis (RA)
Rheumatoid arthritis (RA) is an autoimmune disease. It is a chronic condition that causes pain, stiffness, and swelling of the joints-all symptoms caused by inflammation. An estimated 1.5 million U.S. adults are living with RA.7 Treatment is aimed at stopping inflammation to put the disease in remission and relieve symptoms.7 Nonsteroidal anti-inflammatory drugs (NSAIDs) are used to ease symptoms whereas corticosteroids, disease modifying anti-rheumatic drugs (DMARDs) and biologics are used to slow down the disease activity.8
About H.P. Acthar Gel (repository corticotropin injection)
H.P. Acthar Gel (repository corticotropin injection), is an injectable drug approved by the FDA for the treatment of 19 indications. Of these 19 indications, the following are currently promoted:
Important Safety Information
Please see full Prescribing Information here for additional important safety information.
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
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1 The Myositis Association. Retrieved from: http://www.myositis.org. Last accessed: April 27, 2016.
2 Medline Plus. Myositis. http://www.nih.gov/medlineplus/myositis.html. Accessed April 15, 2013.
3 Mayo Clinic. Polymyositis. http://www.mayoclinic.com/health/polymyositis/DS00334. Accessed April 15, 2013.
4 Bernatsky S, Joseph L, Pineau CA, et al. Estimating the prevalence of polymyositis and dermatomyositis from administrative data: age, sex and regional differences. Ann Rheum Dis. 2009;68:1192-1196.
5 Miller ML. Clinical manifestations and diagnosis of adult dermatomyositis and polymyositis. UpToDate website. http://www.uptodate.com/contents/clinical-manifestations-and-diagnosis-of-adult-dermatomyositis-and-polymyositis?source=search_result&search=dermatomyositis&selectedTitle=1~124. Published September 23, 2010. Accessed March 6, 2014.
6 Pappu R, Seetharaman M. Polymyositis. Medscape Reference website. http://emedicine.medscape.com/article/335925-overview#a0156. Published February 20, 2013. Accessed April 15, 2013.
7 What is Rheumatoid Arthritis? Arthritis Foundation. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed June 2, 2016.
8 Arthritis Foundation. Rheumatoid Arthritis Treatment. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/treatment.php [Accessed on July 14, 2015].