Background

Information about these 2 rare inflammatory conditions.

Disease Definition and Symptoms

Dermatomyositis and polymyositis are rare inflammatory diseases1,2

Signs and symptoms of these conditions are varied and can have significant physiological effect on disease3,4

Dermatomyositis

  • Gradual onset of proximal muscle weakness
  • Weight loss, low-grade fever, inflammation in the lungs, light sensitivity
  • Characteristic dermatologic manifestations:
    • Purple heliotrope rash on or around eyelids
    • Red, inflamed erythematous rash on face, trunk, and/or extremities
    • Raised lesions on fingers or rashes on connective skin (Gottron’s papules/sign)
    • Roughened, dry skin on palms and fingers (mechanic’s hands)

Polymyositis

  • Gradual onset of proximal muscle weakness
  • Fatigue, general discomfort, weight loss, low-grade fever

Acthar is an FDA-approved therapeutic option for use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis and polymyositis.5

Prevalence6-8

  • Dermatomyositis and polymyositis prevalence of 21.5 per 100,000
    • This is based upon a population-wide epidemiological study
    • Previous non–population-based estimates were lower
  • The peak incidence in adults occurs between the ages of 40 and 50, but individuals of any age may be affected
  • Dermatomyositis and polymyositis are two times as common in women than in men
  • Lowest occurrence is in Asians, highest is in African-Americans

Acthar is an FDA-approved therapeutic option for use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis and polymyositis.5

Additional Treatment Options

Despite current therapies, some patients with dermatomyositis and polymyositis may still need additional treatment options9

  • Rheumatologists reported that approximately 50% of their patients with these conditions continue to experience disease exacerbations10*

Patients may need additional options to treat their dermatomyositis or polymyositis.11

*From a Mallinckrodt Pharmaceuticals dermatomyositis and polymyositis trends study conducted with 100 rheumatologists in June 2013.

Acthar is an FDA-approved therapeutic option for use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis and polymyositis.5

IMPORTANT SAFETY INFORMATION

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Contraindications

  • 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

INDICATIONS

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H.P. Acthar® Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for:

  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus
  • The treatment of symptomatic sarcoidosis
  • Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)