Efficacy in Psoriatic Arthritis

Use the links below to browse through clinical experience with Acthar.

Acthar is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in psoriatic arthritis.

Fiechtner (2016): A Single-site, Open-label Trial of Patients With Moderately to Severely Active PsA (N=15)

Brown (2016): Retrospective Case Series of Patients With Refractory PsA (N=9)

Fiechtner (2016): A Single-site, Open-label Trial of Patients With Moderately to Severely Active Psoriatic Arthritis (PsA) (N=15)

Study Design

  • A 28-week, prospective, single-site, open-label trial of 15 patients to assess the efficacy and safety of Acthar as adjunctive therapy in patients with moderately to severely active PsA who had not responded adequately to treatment1
  • Primary outcome measure in this study was ACR20 at Week 121
  • Secondary outcome measures included ACR20 at Week 24 and the following assessments at Weeks 12 and 241:
    • ACR50 and ACR70
    • Clinical Disease Activity Index (CDAI)
    • Psoriasis Area and Severity Index (PASI)*
    • Physician global assessment
    • Patient global assessment
    • Tender/swollen joint count
    • Visual analogue scale (VAS) for measurement of pain by patients
    • Erythrocyte sedimentation rate (ESR)
    • C-reactive protein (CRP)

*The Psoriasis Area and Severity Index (PASI) is a combination of assessment measures in psoriatic patients. PASI assesses the severity of disease into a single score accounting for lesions and the area affected. The score ranges from 0 (no disease) to 72 (maximal disease).2

Includes the PASI50 and PASI75 to determine if patients achieve 50% and 75% improvements respectively.1,3

Patient overview1

All patients had to meet ACR criteria for PsA and have moderately to severely active disease that required either an increase in steroid dose or an add-on steroid despite standard-of-care therapy.§

Patients who were receiving NSAIDs must have been on stable doses for ≥4 weeks prior to initiation of Acthar, and those receiving any DMARDs or biologic agents had to have been treated for ≥8 weeks.

Previous treatments for patients who completed through Week 12

All noted brand names are registered trademarks of their respective owners.

Patients were diagnosed with PsA according to the Classification of Psoriatic Arthritis (CASPAR) study group criteria ≥6 months prior to screening, had ≥6 tender and ≥6 swollen joint counts, and had ≥30 minutes of morning joint stiffness.1

§Doses of oral corticosteroids must have been stable for ≥2 weeks prior to initiation of Acthar and not exceeded the equivalent of 10 mg of prednisone per day.1

Treatment overview1

  • Acthar was administered to patients from Week 0 through Week 24 via a single dose of 80 units/mL delivered subcutaneously twice weekly||
  • Patients received injections at the clinic at Week 0, Week 12, and Week 24. All other injections were self-administered
  • 8 of the 15 patients completed treatment through Week 12, and 7 completed treatment through Week 24

||The dose of 80 units twice weekly was based upon the authors’ previous experience with a 6-month lupus trial.

Treatment Results

Primary outcome measure: ACR20 at Week 121

All of the patients who completed treatment through Week 12 (n=8) achieved the primary outcome measure of ACR20.

Secondary outcome measures1

  • 7 out of 8 patients achieved ACR50, ACR70, PASI50, and PASI75 at Week 12
  • All of the patients who completed the entire study achieved ACR50, ACR70, PASI50, and PSASI75
  • At Week 12, and Week 24, all of the patients except for 1 reached the score of 0 on at least 1 of the assessments, and 2 scored 0 on all of the assessments
  • 5 patients reached 0 on the physician global assessment
  • 4 patients reached 0 on the patient global assessment, swollen joint count, and VAS
  • There were no significant changes in ESR or CRP

Percentage of patients who achieved ACR20, ACR50, and ACR70

Clinical and lab assessments for patients who completed treatment through week 24

CDAI=Clinical Disease Activity Index; CRP=C-reactive protein; ESR=erythrocyte sedimentation rate; VAS=visual analogue scale; PASI=Psoriasis Area and Severity Index.

Initial CRP and ESR were conducted at screening, not Week 0.

#Patient 12 did not complete treatment through Week 24 for an unknown reason.

Study limitations1

Results are based on a single-site trial of 15 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. Acthar has not been formally studied in combination with other commonly used therapies for PsA.

Safety findings1

8 of the 15 patients completed treatment through Week 12.

  • Of the 7 patients who withdrew prior to Week 12, 3 experienced potential treatment-related adverse events: 2 had psoriasis that worsened and 1 had depression
  • The remaining 4 patients withdrew for other reasons unrelated to adverse events: 1 was lost to follow-up, 1 missed 2 weeks of dosing and was then lost to follow-up, 1 withdrew due to travel commitments, and 1 was noncompliant due to work schedule
  • There were no other potentially treatment-related adverse events identified during this study. In addition, there were no changes in blood pressure, body temperature, or blood glucose levels observed among any of the participating patients

7 of the 8 remaining patients completed treatment through Week 24.

  • 1 patient did not complete the treatment for an unknown reason

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.4

Brown (2016): A Retrospective Case Series of Patients With Refractory Psoriatic Arthritis (PsA) (N=9)

Study Design5

Acthar was evaluated in a retrospective case series of 9 patients treated for refractory* PsA.

Patient overview5

  • Patients had previously failed 1 or more therapies and were experiencing ongoing disease activity prior to treatment with Acthar
  • 6 patients were evaluated using Routine Assessment of Patient Index Data 3 (RAPID3)

*Refractory PsA was defined as failure to achieve disease remission with previous treatment.

The RAPID3 score is the sum of 3 patient self-reported scores on the Multidimensional Health Assessment Questionnaire (MDHAQ). Pain, physical function, and patient global assessment are rated by the patient on a 0-10 visual analogue scale (VAS).6 The score does not include physician assessment of tender or swollen joint count, peripheral joint symptoms, skin symptoms, dactylitis, enthesitis, nail symptoms, or spine symptoms typically associated with PsA.5,7 The final score is calculated by the treating healthcare professional and recorded on a 0-30 scale: 1-3=near remission; 4-6=low severity; 7-12=moderate severity; and 13-30=high severity.6,8

Treatment overview5

  • Acthar was initiated to help manage active disease or as a bridge therapy to manage symptoms during transition to new treatment
  • Acthar was initiated at 80 IU subcutaneously (SC) twice weekly (BIW) and titrated based on patient response

Treatment Outcomes

Results5

A majority of patients experienced improvement with Acthar:

  • Of 9 patients with joint disease, 8 experienced improvement that continued during treatment; 1 experienced short-term improvement
  • Of 8 patients with active skin disease, 6 experienced lasting improvement that continued during treatment; 2 experienced short-term improvement

Study limitations5

Results are based on a retrospective case series of 9 patients and may not be fully representative of outcomes in the overall patient population. Some patients were on other therapies. The clinical outcomes may not be solely attributable to Acthar.

RAPID3=Routine Assessment of Patient Index Data 3; ESR=erythrocyte sedimentation rate; CRP=C-reactive protein.

Dosage and frequency of Acthar should be individualized according to the medical condition, severity of the disease, and initial response of the patient. Recommended dosing from the Acthar label is 40-80 units (0.5-1 mL) subcutaneously or intramuscularly every 1-3 days.4

Safety findings

  • 3 patients discontinued due to worsening of preexisting conditions or other adverse effects, including hypertension (n=2), hyperglycemia (n=1), and weight gain (n=2)5
  • No other adverse events were reported during treatment with Acthar5

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.4

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

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

Warning 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-axis (HPA) 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, and 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 mask 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.

Indications

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 lupus erythematosus
  • Treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis)
  • 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)
  • Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in psoriatic arthritis
  • The treatment of symptomatic sarcoidosis
References