Rheumatoid Arthritis (RA)

Brown AN —International Journal of Clinical Rheumatology, 2015

Acthar Gel was evaluated in patients with RA who had active disease despite previous treatments¹

Study Design

Results

STUDY OBJECTIVE

A retrospective case series of 5 patients with refractory RA who received Acthar Gel based on its proposed mechanism of action¹

Refractory disease was defined as failure to achieve disease remission with a previous treatment
Acthar Gel was used to manage active disease or as a bridge therapy to manage symptoms during transition to new treatment
The dose of Acthar Gel was individualized based on the disease and medical condition of the patient

Case Summary: Baseline Assessments

Mean age	Mean disease duration
62.4	5.8 years
Previous treatments
Adalimumab Etanercept Abatacept Rituximab Tofacitinib Infliximab Prednisone Tocilizumab Certolizumab
Concomitant treatments*
Methotrexate Hydroxychloroquine Folic acid

Mean age	Mean disease duration	Previous treatments	Concomitant treatments*
62.4	5.8 years	Adalimumab Etanercept Abatacept Rituximab Tofacitinib Infliximab Prednisone Tocilizumab Certolizumab	Methotrexate Hydroxychloroquine Folic acid

^*Not every patient was on the same concomitant treatments.

Study Limitations

Results are based on a retrospective case series of 5 patients and may not be fully representative of outcomes in the overall patient population. All patients were on other therapies. The clinical outcomes may not be solely attributable to Acthar Gel. Acthar Gel has not been formally studied in combination with other treatments.

Improvements in RA symptoms in patients treated with Acthar Gel¹

Acthar Gel improved inflammatory markers and patient-reported symptoms
Patients taking Acthar Gel saw an improvement in RA symptoms, such as less pain, joint swelling, and tenderness
- 4 patients saw improvement that continued during therapy and 1 patient had temporary improvement

Improved ESR scores

ESR score for RA patients treated with Acthar Gel graph

Improved CRP scores

CRP score for RA patients treated with Acthar Gel graph

Improved RAPID-3 scores

RAPID-3 score for RA patients treated with Acthar Gel graph

CRP=C-reactive protein; ESR=erythrocyte sedimentation rate; RAPID-3=Routine Assessment of Patient Index Data 3.

Case Summary: Treatment Outcomes

Patient characteristics	Treatment response			Safety
Case 1:	12 weeks/Acthar Gel 80 U 2x weekly ESR: 8 mm/h CRP: 1.3 mg/L Vectra: 55^† RAPID-3: 8.5 Pain: 4.5 Fatigue: 2	20 weeks/Acthar Gel 40 U 2x weekly ESR: 12 mm/h CRP: 1.8 mg/L Vectra: 54 RAPID-3: 10.5 Pain: 5 Fatigue: 5.5	28 weeks/Acthar Gel 20 U 3x weekly ESR: 11 mm/ CRP: 3.2 mg/L Vectra: - RAPID-3: 14.7 Pain: 6 Fatigue: 4	Patient experienced fluctuations in blood pressure throughout treatment
70-year-old male with hypertension Disease duration: 10 years
Case 2:	12 weeks/Acthar Gel 80 U 2x weekly ESR: 19 mm/h CRP: 1.5 mg/L Vectra: 50^‡ RAPID-3: 1.2 Pain: 0.5 Fatigue: 1	20 weeks/Acthar Gel 40 U 2x weekly ESR: 30 mm/h CRP: 1.7 mg/L Vectra: - RAPID-3: 2 Pain: 0.5 Fatigue: 0.5	30 weeks/Acthar Gel 40 U 2x weekly + tofacitinib 5mg 1x/day^§ ESR: 17 mm/h CRP: <0.5 mg/L Vectra: 49 RAPID-3: 2.3 Pain: 0.5 Fatigue: 0	There were no adverse events reported during the treatment period
75-year-old female Disease duration: 9 years
Case 3:	4 weeks/Acthar Gel 80 U 2x weekly ESR: 4 mm/h CRP: <0.5 mg/L Vectra: 42 RAPID-3: 16.5 Pain: 7 Fatigue: 5.5	10 weeks/Acthar Gel 40 U 2x weekly^‖ ESR: 4 mm/h CRP: <0.5 mg/L Vectra: 49 RAPID-3: 17.3 Pain: 7 Fatigue: 4		Experienced erythema on upper chest, weight gain, and elevated blood pressure during Acthar Gel treatment
50-year-old female Disease duration: 2 years
Case 4:	6 weeks/Acthar Gel 80 U 2x weekly ESR: 76 mm/h CRP: 1.8 mg/L RAPID-3: 7.7 Pain: 2.5 Fatigue: 2.5	12 weeks/Acthar Gel 80 U 2x weekly ESR: 38 mm/h CRP: 1.3 mg/L RAPID-3: 6.3 Pain: 2 Fatigue: 2		Experienced increased glucose levels before and during Acthar Gel treatment
62-year-old female Disease duration: 1 year
Case 5:	1 week/Acthar Gel 40 U 2x weekly ESR: 26 mm/h CRP: 1.3 mg/L RAPID-3: 15.7 Pain: 9 Fatigue: 9	8 weeks/Acthar Gel 40 U 2x weekly ESR: 16 mm/h CRP: 0.9 mg/L RAPID-3: 16.7 Pain: 5 Fatigue: 8.5		There were no adverse events reported during the treatment period
55-year-old female Disease duration: 7 years

Case Summary: Treatment Outcomes

Case 1

Patient characteristics

Case 1:

70-year-old male with hypertension
Disease duration: 10 years

Treatment response

12 weeks/Acthar Gel 80 U 2x weekly
ESR: 8 mm/h
CRP: 1.3 mg/L
Vectra: 55^†
RAPID-3: 8.5
Pain: 4.5
Fatigue: 2

20 weeks/Acthar Gel 40 U 2x weekly
ESR: 12 mm/h
CRP: 1.8 mg/L
Vectra: 54
RAPID-3: 10.5
Pain: 5
Fatigue: 5.5

28 weeks/Acthar Gel 20 U 3x weekly
ESR: 11 mm/h
CRP: 3.2 mg/L
Vectra: -
RAPID-3: 14.7
Pain: 6
Fatigue: 4

Safety

Patient experienced fluctuations in blood pressure throughout treatment

Case 2

Patient characteristics

Case 2:

75-year-old female
Disease duration: 9 years

Treatment response

12 weeks/Acthar Gel 80 U 2x weekly
ESR: 19 mm/h
CRP: 1.5 mg/L
Vectra: 50^‡
RAPID-3: 1.2
Pain: 0.5
Fatigue: 1

20 weeks/Acthar Gel 40 U 2x weekly
ESR: 30 mm/h
CRP: 1.7 mg/L
Vectra: -
RAPID-3: 2
Pain: 0.5
Fatigue: 0.5

30 weeks/Acthar Gel 40 U 2x weekly
+ tofacintinib 5 mg 1x/day^§
ESR: 17 mm/h
CRP: <0.5 mg/L
Vectra: 49
RAPID-3: 2.3
Pain: 0.5
Fatigue: 0

Safety

There were no adverse events reported during the treatment period

Case 3

Patient characteristics

Case 3:

50-year-old female
Disease duration: 2 years

Treatment response

4 weeks/Acthar Gel 80 U 2x weekly
ESR: 4 mm/h
CRP: <0.5 mg/L
Vectra: 42
RAPID-3: 16.5
Pain: 7
Fatigue: 5.5

10 weeks/Acthar Gel 40 U 2x weekly^‖
ESR: 4 mm/h
CRP: <0.5 mg/L
Vectra: 49
RAPID-3: 17.3
Pain: 7
Fatigue: 4

Safety

Experienced erythema on upper chest, weight gain, and elevated blood pressure during Acthar Gel treatment

Case 4

Patient characteristics

Case 4:

62-year-old female
Disease duration: 1 year

Treatment response

6 weeks/Acthar Gel 80 U 2x weekly
ESR: 76 mm/h
CRP: 1.8 mg/L
RAPID-3: 7.7
Pain: 2.5
Fatigue: 2.5

12 weeks/Acthar Gel 80 U 2x weekly
ESR: 38 mm/h
CRP: 1.3 mg/L
RAPID-3: 6.3
Pain: 2
Fatigue: 2

Safety

Experienced increased glucose levels before and during Acthar Gel treatment

Case 5

Patient characteristics

Case 5:

55-year-old female
Disease duration: 7 years

Treatment response

1 week/Acthar Gel 40 U 2x weekly
ESR: 26 mm/h
CRP: 1.3 mg/L
RAPID-3: 15.7
Pain: 9
Fatigue: 9

8 weeks/Acthar Gel 40 U 2x weekly
ESR: 16 mm/h
CRP: 0.9 mg/L
RAPID-3: 16.7
Pain: 5
Fatigue: 8.5

Safety

There were no adverse events reported during the treatment period

^†Score from 8 weeks earlier.

^‡Score from 1 month earlier.

^§Inflammatory markers continued to decrease so tofacitinib 5 mg once daily was added, and the Acthar Gel dose was further reduced and then discontinued.

^‖After this, patient experienced weight gain and elevated blood pressure so Acthar Gel treatment was discontinued and tofacitinib once daily was added.

Safety Findings

3 patients experienced fluctuations in blood pressure, weight, and/or glucose levels
1 patient discontinued Acthar Gel due to adverse event

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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.

Acthar Gel was evaluated in patients with RA who had active disease despite previous treatments1

STUDY OBJECTIVE

A retrospective case series of 5 patients with refractory RA who received Acthar Gel based on its proposed mechanism of action1

Case Summary: Baseline Assessments

Study Limitations

Improvements in RA symptoms in patients treated with Acthar Gel1

Improved ESR scores

Improved CRP scores

Improved RAPID-3 scores

Case Summary: Treatment Outcomes

Case Summary: Treatment Outcomes

Case 1

Case 2

Case 3

Case 4

Case 5

Safety Findings

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IMPORTANT SAFETY INFORMATION

Contraindications

INDICATIONS

IMPORTANT SAFETY INFORMATION

Contraindications

INDICATIONS

Warnings and Precautions

Adverse Reactions

Acthar Gel was evaluated in patients with RA who had active disease despite previous treatments¹

A retrospective case series of 5 patients with refractory RA who received Acthar Gel based on its proposed mechanism of action¹

Improvements in RA symptoms in patients treated with Acthar Gel¹