Case study: 55-year-old female patient with active polymyositis1,2*

She was part of a retrospective case series in which Acthar was evaluated in 5 patients with dermatomyositis or polymyositis1:

History

55-year-old female patient with active polymyositis

  • Added Acthar 80 U 2x/wk SC for 12 weeks to existing regimen
  • Patient achieved improved proximal MMT scores

Disease and treatment history

  • Diagnosed in 2007 (muscle biopsy confirmation)
  • Presentation included mild proximal muscle weakness in arms
  • Disease exacerbations: 2009
  • From 2007-2009, treatment included:
    • Prednisone
    • Mycophenolate mofetil (MMF)
    • Intravenous immunoglobulin (IVIG)
  • Patient experienced tolerability issues

Treatment considerations

At the time of Acthar initiation, patient had:

  • Decreased arm and leg strength
  • Normal creatine phosphokinase (CPK) and aldolase levels

Treatment and Outcomes

Treatment with Acthar

  • The patient self-administered Acthar 80 U (1 mL) 2x/wk SC for 12 weeks
  • For 60 days prior to and during treatment with Acthar, patient was on stable dose of MMF

Dosage and frequency should be individualized according to the medical condition, severity of the disease, and initial response of the patient.

Physician-measured outcomes*

  • Increased proximal MMT scores in deltoids and triceps from 3/5 to 4+/5

Safety Findings

Safety*

  • Patient was examined for the following significant side effects: hyperglycemia, diabetic ketoacidosis, and hyperosmolar states
  • No significant adverse events as defined in the study methods were reported by the investigator

Follow-up

  • Since completing Acthar treatment, patient has been well-managed with MMF and IVIG

Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.

Contributed by Todd Levine, MD, Phoenix Neurologic Associates, Director of Neurophysiology at Banner Good Samaritan Medical Center, Phoenix, Arizona.

Patients were also described in a retrospective case series. Levine T. Treating refractory dermatomyositis or polymyositis with adrenocorticotropic hormone [ACTH] gel: a retrospective case series. Drug Des Devel Ther. 2012;5:133-139.

*These results are based on individual patients and may not be fully representative of outcomes in the overall patient population. These patients were on multiple therapies. The clinical outcomes may not be solely attributable to Acthar.

The case studies provided here are for general medical education purposes only and are not to be used as a substitute for independent medical judgment for a specific patient's medical condition.

Acthar is indicated for use during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis).

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)