Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosus flares patient

Woman, aged 46 years, with chronic, active SLE, experiencing flares¹

Image not of an actual patient.

Patient Diagnosis

Treatment and Outcomes

Safety

Patient Diagnosis

Disease duration

7 years

Previous treatments included

Methylprednisolone intramuscularly
Hydroxychloroquine

ACR criteria at SLE diagnosis

Antinuclear antibody positivity
Nonerosive arthritis
Discoid rash
Pleurisy
Mucosal ulcers

Disease duration	Previous treatments included	ACR criteria at SLE diagnosis
7 years	Methylprednisolone intramuscularly Hydroxychloroquine	Antinuclear antibody positivity Nonerosive arthritis Discoid rash Pleurisy Mucosal ulcers

These results are based on a single patient and may not be fully representative of outcomes in the overall patient population. The patient was on multiple therapies. The clinical outcomes may not be solely attributable to Acthar Gel.

Treatment and Outcomes

Patient received Acthar Gel 80 U daily for 15 days
For 4 weeks prior to Acthar Gel, patient was on stable doses of prednisone, belimumab, and sulfasalazine

Concomitant treatments with Acthar Gel for SLE case study chart

The patient showed overall improvement in SLE disease activity, including a reduction in SLEDAl‑2K score from 8 to 6 at Day 28

The patient experienced a reduction in the number of joint manifestations, including painful, tender, and swollen joints, from baseline to Day 28
Physician Global Assessment, Patient Global Assessment, and BILAG Index scores also improved from baseline to Day 28

Measure	Baseline	Day 14	Day 28
Erythrocyte sedimentation rate, mm/h	40	18	31
C-reactive protein, mg/dL	0.94	—	0.73

Measure	Baseline	Day 14	Day 28
Erythrocyte sedimentation rate, mm/h	40	18	31
C-reactive protein, mg/dL	0.94	—	0.73

Safety Findings

The patient was assessed weekly for adverse events for 28 days and could also report adverse events at any time during the study
During the study, the physician reported no adverse events

Adapted from Fiechtner JJ, Montroy T. Lupus. 2014.

Additional patients from this study

Patient Case 1¹

Patient Diagnosis

Disease duration

16 years

Previous treatments included

Leflunomide
Prednisone
Methotrexate
Hydroxychloroquine
Mycophenolate mofetil
Methylprednisolone acetate
Belimumab

ACR criteria at SLE diagnosis

Antinuclear antibody positivity
Double-stranded deoxyribonucleic acid
Nonerosive arthritis
Mucosal ulcers
Malar rash
Photosensitivity
Pleurisy

Disease duration	Previous treatments included	ACR criteria at SLE diagnosis
16 years	Leflunomide Prednisone Methotrexate Hydroxychloroquine Mycophenolate mofetil Methylprednisolone acetate Belimumab	Antinuclear antibody positivity Double-stranded deoxyribonucleic acid Nonerosive arthritis Mucosal ulcers Malar rash Photosensitivity Pleurisy

Treatment and Outcomes

	Baseline	Day 14	Day 28
Physician Global Assessment	2.1	1.7	1.5
Patient Global Assessment	8	4	6

	Baseline	Day 14	Day 28
Physician Global Assessment	2.1	1.7	1.5
Patient Global Assessment	8	4	6

Adapted from Fiechtner JJ, Montroy T. Lupus. 2014.

Patient Case 2¹

Patient Diagnosis

Disease duration

15 years

Previous treatments included

Thalomidomide
Belimumab
Methotrexate
Azathioprine
Quinacrine
Hydroxychloroquine
Prednisone
Mycophenolate mofetil

ACR criteria at SLE diagnosis

Antinuclear antibody positivity
Malar rash
Discoid rash
Mucosal ulcers
Nonerosive arthritis
Photosensitivity

Disease duration	Previous treatments included	ACR criteria at SLE diagnosis
15 years	Thalomidomide Belimumab Methotrexate Azathioprine Quinacrine Hydroxychloroquine Prednisone Mycophenolate mofetil	Antinuclear antibody positivity Malar rash Discoid rash Mucosal ulcers Nonerosive arthritis Photosensitivity

Treatment and Outcomes

	Baseline	Day 14	Day 28
Physician Global Assessment	2.2	1.2	0.8
Patient Global Assessment	7	2	1

	Baseline	Day 14	Day 28
Physician Global Assessment	2.2	1.2	0.8
Patient Global Assessment	7	2	1

Adapted from Fiechtner JJ, Montroy T. Lupus. 2014.

Patient Case 3¹

Patient Diagnosis

Disease duration

1 year

Previous treatments included

Methylprednisolone acetate
Prednisone

ACR criteria at SLE diagnosis

Antinuclear antibody positivity
Malar rash
Mucosal ulcers
Nonerosive arthritis

Disease duration	Previous treatments included	ACR criteria at SLE diagnosis
1 year	Methylprednisolone acetate Prednisone	Antinuclear antibody positivity Malar rash Mucosal ulcers Nonerosive arthritis

Treatment and Outcomes

	Baseline	Day 14	Day 28
Physician Global Assessment	2.2	1.9	1.9
Patient Global Assessment	8	4	6

	Baseline	Day 14	Day 28
Physician Global Assessment	2.2	1.9	1.9
Patient Global Assessment	8	4	6

Adapted from Fiechtner JJ, Montroy T. Lupus. 2014.

Patient Case 4¹

Patient Diagnosis

Disease duration

1.5 years

Previous treatments included

Prednisone
Methylprednisolone acetate

ACR criteria at SLE diagnosis

Antinuclear antibody positivity
Nonerosive arthritis
Malar rash
Mucosal ulcers

Disease duration	Previous treatments included	ACR criteria at SLE diagnosis
1.5 years	Prednisone Methylprednisolone acetate	Antinuclear antibody positivity Nonerosive arthritis Malar rash Mucosal ulcers

Treatment and Outcomes

	Baseline	Day 14	Day 28
Physician Global Assessment	2.2	1.1	1.8
Patient Global Assessment	8	3	3

	Baseline	Day 14	Day 28
Physician Global Assessment	2.2	1.1	1.8
Patient Global Assessment	8	3	3

Adapted from Fiechtner JJ, Montroy T. Lupus. 2014.

Patient Case 5¹

Patient Diagnosis

Disease duration

2 years

Previous treatments included

Prednisone
Methylprednisolone acetate

ACR criteria at SLE diagnosis

Antinuclear antibody positivity
Nonerosive arthritis
Photosensitivity
Malar rash
Pleurisy
Mucosal ulcers

Disease duration	Previous treatments included	ACR criteria at SLE diagnosis
2 years	Prednisone Methylprednisolone acetate	Antinuclear antibody positivity Nonerosive arthritis Photosensitivity Malar rash Pleurisy Mucosal ulcers

Treatment and Outcomes

	Baseline	Day 14	Day 28
Physician Global Assessment	2.3	2.0	0.2
Patient Global Assessment	8	8	1

	Baseline	Day 14	Day 28
Physician Global Assessment	2.3	2.0	0.2
Patient Global Assessment	8	8	1

Adapted from Fiechtner JJ, Montroy T. Lupus. 2014.

Patient Case 6¹

Patient Diagnosis

Disease duration

7 years

Previous treatments included

Methotrexate
Belimumab*
Hydroxychloroquine
Methylprednisolone acetate

ACR criteria at SLE diagnosis

Antinuclear antibody positivity
Nonerosive arthritis
Malar rash
Mucosal ulcers
Photosensitivity

Disease duration	Previous treatments included	ACR criteria at SLE diagnosis
7 years	Methotrexate Belimumab* Hydroxychloroquine Methylprednisolone acetate	Antinuclear antibody positivity Nonerosive arthritis Malar rash Mucosal ulcers Photosensitivity

Treatment and Outcomes

	Baseline	Day 14	Day 28
Physician Global Assessment	1.9	0.5	1.4
Patient Global Assessment	7	3	8

	Baseline	Day 14	Day 28
Physician Global Assessment	1.9	0.5	1.4
Patient Global Assessment	7	3	8

Adapted from Fiechtner JJ, Montroy T. Lupus. 2014.

*1 time weekly >15 months in open-label research protocol.

Patient Case 7¹

Patient Diagnosis

Disease duration

10 years

Previous treatments included

Prednisone
Methylprednisolone acetate

ACR criteria at SLE diagnosis

Antinuclear antibody positivity
+Smith antibody
Nonerosive arthritis
Mucosal ulcers
Malar rash
Photosensitivity

Disease duration	Previous treatments included	ACR criteria at SLE diagnosis
10 years	Prednisone Methylprednisolone acetate	Antinuclear antibody positivity +Smith antibody Nonerosive arthritis Mucosal ulcers Malar rash Photosensitivity

Treatment and Outcomes

	Baseline	Day 14	Day 28
Physician Global Assessment	2.1	0.2	0.3
Patient Global Assessment	7	1	1

	Baseline	Day 14	Day 28
Physician Global Assessment	2.1	0.2	0.3
Patient Global Assessment	7	1	1

Adapted from Fiechtner JJ, Montroy T. Lupus. 2014.

Patient Case 8¹

Patient Diagnosis

Disease duration

3 years

Previous treatments included

Methotrexate

ACR criteria at SLE diagnosis

Antinuclear antibody positivity
Malar rash
Photosensitivity
Nonerosive arthritis
Mucosal ulcers

Disease duration	Previous treatments included	ACR criteria at SLE diagnosis
3 years	Methotrexate	Antinuclear antibody positivity Malar rash Photosensitivity Nonerosive arthritis Mucosal ulcers

Treatment and Outcomes

	Baseline	Day 14	Day 28
Physician Global Assessment	2.4	0.3	1.1
Patient Global Assessment	8	2	6

	Baseline	Day 14	Day 28
Physician Global Assessment	2.4	0.3	1.1
Patient Global Assessment	8	2	6

Adapted from Fiechtner JJ, Montroy T. Lupus. 2014.

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References

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IMPORTANT SAFETY INFORMATION

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 origin

INDICATIONS

Acthar^® Gel (repository corticotropin injection) is indicated for:

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

Warnings and Precautions

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. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment
Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium, and potassium levels may need to be monitored
Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding
Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated
Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms
Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity
There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
Decrease in bone density may occur. Bone density should be monitored for patients on 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

Adverse Reactions

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
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 masks other seizures, which become visible once the clinical spasms from IS resolve

Other adverse events reported are included in the full Prescribing Information.

Please see full Prescribing Information for additional Important Safety Information.

Woman, aged 46 years, with chronic, active SLE, experiencing flares1

Patient Diagnosis

Treatment and Outcomes

Safety Findings

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Patient Case 31

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Patient Case 41

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Patient Case 51

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Patient Case 61

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Patient Case 71

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IMPORTANT SAFETY INFORMATION

Contraindications

INDICATIONS

IMPORTANT SAFETY INFORMATION

Contraindications

INDICATIONS

Warnings and Precautions

Adverse Reactions

Woman, aged 46 years, with chronic, active SLE, experiencing flares¹

Patient Case 1¹

Patient Case 2¹

Patient Case 3¹

Patient Case 4¹

Patient Case 5¹

Patient Case 6¹

Patient Case 7¹

Patient Case 8¹