Dermatomyositis and Polymyositis (DM/PM)

Levine T ―Drug Design, Development and Therapy. 2012

Acthar Gel was evaluated in DM/PM patients who were experiencing ongoing disease exacerbations and decrease in muscle strength1

STUDY OBJECTIVE

A retrospective case series of 5 patients with either DM or PM who experienced a disease exacerbation and either failed or exhibited tolerability issues with previous treatments1

  • All patients had received ≥3 previous treatments
  • All 5 patients were also being treated with stable doses of at least 1 other commonly used therapy for dermatomyositis or polymyositis
  • These medications had been prescribed for at least 60 days before and were maintained during and after Acthar Gel treatment
  • 4 patients received 80 U twice weekly for 12 weeks; 1 patient received 80 U once weekly for 12 weeks
  • Manual muscle testing (MMT) was performed to assess muscle strength at baseline and 3 months

Patient Characteristics

Myositis Age range
3 patients with DM
2 patients with PM
25-68 years
Mean duration of disease Concomitant treatments*
6 years Prednisone 
Methotrexate 
Intravenous immunoglobulin 
Mycophenolate mofetil 
Azathioprine 
Cyclosporine
Myositis Age range Mean duration of disease Concomitant treatments*
3 patients with DM
2 patients with PM
25-68 years 6 years Prednisone
Methotrexate
Intravenous immunoglobulin
Mycophenolate mofetil
Azathioprine
Cyclosporine

*Not every patient was on the same concomitant treatments.

Study Limitations

These results are based on a retrospective 5-patient case series and may not be fully representative of outcomes in the overall patient population. All 5 patients were on multiple therapies. The clinical outcomes may not be solely attributable to Acthar Gel.

5 of 5 patients treated with Acthar Gel demonstrated improvement in MMT scores at Week 12

Patient Muscle tested Baseline At assessment
Patient 1: 
45-year-old, DM
Iliopsoas 
Quadriceps
3
3
4+
4+
Patient 2: 
25-year-old, DM
Iliopsoas 
Quadriceps

3-

4+
Patient 3: 
43-year-old, DM
Deltoids 
Triceps
2
3
4
4
Patient 4: 
55-year-old, PM
Deltoids 
Triceps
3
3
4+
4+
Patient 5: 
68-year-old, PM
Iliopsoas 
Quadriceps
4
4
4+
Patient Muscle tested Baseline At assessment
Patient 1:
45-year-old, DM
Iliopsoas
Quadriceps

3
3

4+
4+
Patient 2:
25-year-old, DM
Iliopsoas
Quadriceps

3
3-

4
4+

Patient 3:
43-year-old, DM
Deltoids
Triceps

2
3

4
4

Patient 4:
55-year-old, PM
Deltoids
Triceps

3
3

4+
4+

Patient 5:
68-year-old, PM
Iliopsoas
Quadriceps

4
4

4+
5

MMT was performed using the Medical Research Council scale (1-5). Patients were treated for 12 weeks and MMT was performed at different times of assessment. All 5 patients were on stable doses of at least 1 commonly used therapy for dermatomyositis or polymyositis.

Safety Findings

  • Patients receiving Acthar Gel were examined for significant side effects, including: hyperglycemia, diabetic ketoacidosis, and hyperosmolar states
  • No significant adverse events as defined in the study methods were reported by the investigator in any of the 5 patients