Study Addresses Possible Impact of H.P. Acthar® Gel on Use of Corticosteroids Among Patients with Rheumatoid Arthritis, Lupus, and Dermatomyositis/Polymyositis

-- Claims-based, retrospective data unveiled at the 2016 ACR/ARHP Annual Meeting--

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Nov 17, 2016, 04:30 ET

CHESTERFIELD, United Kingdom, Nov. 17, 2016 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today presented results of a retrospective, claims-based analysis that indicated the use of H.P. Acthar^® Gel (repository corticotropin injection) may be associated with reductions in corticosteroid (CS) requirements among patients with rheumatoid arthritis (RA), systemic lupus erythematosus (SLE) and dermatomyositis and polymyositis (DM/PM). The data was unveiled today at the 2016 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting Nov. 11-16 in Washington, D.C.

H.P. Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for use during an exacerbation or as maintenance therapy in select DM/PM or SLE patients. It is also approved as adjunctive therapy for short term administration in RA patients to tide patients over an acute episode or exacerbation.

The Mallinckrodt-sponsored analysis, titled "Effects of Repository Corticotropin Injection on Medication Use in Patients with Rheumatologic Conditions: A Claims Data Study" (abstract #2236), identified patients in the Symphony Health Solutions Patient Transactional Dataset from 2008 to 2015.

The study examined the demographics of those who used H.P. Acthar Gel and trends in other medications' use after H.P. Acthar Gel initiation (concomitant use), specifically prednisone – a corticosteroid – as well as other CS, biologics, non-steroidal anti-inflammatory drugs (NSAIDs) and disease-modifying anti-rheumatic drugs (DMARDs), all of which were reported. Patients were followed for concomitant medication use from two years prior to and one year after H.P. Acthar Gel initiation. Paired two-tailed t-tests (a statistical test of differences) were used to calculate the p values for the use of each drug class before/after H.P. Acthar Gel initiation.

Study Results
Out of 2.7 million rheumatologic patients in the database reviewed over the six-year period, 2,749 patients used Acthar – 1,269 RA patients, 874 SLE patients and 606 with DM/PM. SLE patients were on average younger than RA and DM/PM patients, and most patients were female for all three conditions. The majority of patients received 80 units of H.P. Acthar Gel twice weekly.

The analysis identified 504 RA, 322 SLE, and 222 DM/PM patients with sufficient follow-up time to evaluate concomitant medication use following H.P. Acthar Gel treatment. For all three conditions, the proportions of patients who used any CS were significantly lower after H.P. Acthar Gel initiation. Specifically:

Their CS use was reduced from 67% pre-index to 54% post-index for RA, 73% to 58% for SLE and from 76% to 58% for DM/PM (for all comparisons: p < 0.05);
The proportions of patients who received biologics and DMARDs were also significantly lowered after Acthar initiation;
Among patients who had taken CS consistently for 24 weeks before H.P. Acthar Gel initiation, dose reductions (in percentages) were statistically significant for RA (28%), and trended lower without statistical significance for SLE (25%) and DM/PM (25%).

Study Limitations
Limitations of the retrospective analysis include uncertainties in diagnosis, medication use, and factors influencing medication changes. Additional limitations with a retrospective design also include the ability to make causal inferences, reproducibility and generalizability.

The abstract is currently available on the 2016 ACR/ARHP Annual Meeting website. The poster is available on the Mallinckrodt website.

About 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.¹ An estimated 1.5 million U.S. adults are living with RA.²

About Systemic Lupus Erythematosus
SLE is an autoimmune disease in which the immune system produces antibodies to cells within the body leading to possible inflammation and tissue damage.³ It is the most common form of lupus, a condition that impacts an estimated 1.5 million Americans.⁴ Ninety percent of those diagnosed with lupus are women, often between the ages of 15-44.⁴ Lupus is characterized by periods of illness "flares" and remissions and the disease can affect the joints, skin, brain, lungs, kidneys, and blood vessels.³Symptoms may include fatigue, pain or swelling in joints, skin rashes, and fevers.³

About Dermatomyositis/Polymyositis
DM/PM are rare inflammatory diseases that cause progressive muscle weakness⁵, usually in the muscles closest to the trunk of the body.⁶ For instance, muscle weakness associated with PM involves those in the hips, thighs, shoulders, upper arms and neck⁷. DM also causes skin rashes.⁷People of all ages can be affected, though it usually occurs between the ages of 40-50 and is more common in women.^8,9

About H.P. Acthar^® Gel (repository corticotropin injection)
H.P. Acthar Gel is an injectable drug approved by the FDA for the treatment of 19 indications. Of these, today the majority of Acthar use is in these indications:

As an orphan monotherapy medication for the treatment of infantile spasms (IS) in infants and children under 2 years of age.
Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
Treatment of acute exacerbations of multiple sclerosis in adults.
Use during an exacerbation or as maintenance therapy in selected cases of SLE.
Use during an exacerbation or as maintenance therapy in selected cases of systemic DM (PM).
Use as adjunct therapy for short-term administration in select cases of RA, to tide patients over an acute episode or exacerbation.
Treatment of symptomatic sarcoidosis.

For more information about Acthar, please visit www.acthar.com. Full Prescribing Information may be accessed here.

Important Safety Information

Acthar should never be administered intravenously.
Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar.
Acthar is contraindicated where congenital infections are suspected in infants.
Acthar is contraindicated 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 origins.
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. Cushing's Syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms.
Monitor patients for elevation of blood pressure, salt and water retention, and hypokalemia.
Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and following discontinuation.
Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer with an increased risk for perforation with certain GI disorders. Monitor for signs of bleeding.
Acthar may be associated with central nervous system (CNS) effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, depression, and psychosis. Existing conditions may be aggravated.
Patients with comorbid disease may have that disease worsened. Caution should be used in patients with diabetes and myasthenia gravis.
Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections.
Acthar is immunogenic and prolonged use may increase the risk of hypersensitivity reactions.
There is an enhanced effect in patients with hypothyroidism and those with cirrhosis of liver.
Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients.
Decrease in bone density may occur. Monitor during long-term therapy.
Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Common adverse reactions include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve.

Please see full Prescribing Information here for additional Important Safety Information.

ABOUT MALLINCKRODT

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, pulmonology and ophthalmology; 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 ActharRA Web site. https://www.actharra.com/learn-about-acthar/what-is-ra
² What is Rheumatoid Arthritis? Arthritis Foundation. Available at: http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/what-is-rheumatoid-arthritis.php. Accessed November 3, 2016.
³ Systemic lupus erythematosus (SLE or lupus), The Centers for Disease Control and Prevention, Available at: http://www.cdc.gov/arthritis/basics/lupus.htm. Accessed November 3, 2016.
⁴ Lupus Foundation of America Press Kit. Statistics on Lupus. Available at: http://www.lupus.org/about/statistics-on-lupus. Accessed November 8, 2016.
⁵ Types of Myositis. The Myositis Association. http://www.myositis.org./learn-about-myositis/types-of-myositis. Accessed November 3, 2016.
⁶ Medline Plus. Myositis. https://medlineplus.gov/myositis.html. Accessed November 3, 2016.
⁷ Mayo Clinic. Polymyositis. http://www.mayoclinic.org/diseases-conditions/polymyositis/basics/symptoms/con-20020710. Accessed November 3, 2016
⁸ 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.
⁹ Pappu R, Seetharaman M. Polymyositis. Medscape Reference website. http://emedicine.medscape.com/article/335925-overview#a0156. Published February 20, 2013. Accessed November 3, 2016.