STUDY OBJECTIVE

A 28-week, prospective, single-site, open-label trial of 15 patients to assess the efficacy and safety of Acthar Gel as adjunctive therapy in patients with moderately to severely active PsA¹

• 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 Gel
• Patients receiving any DMARDs or biologic agents had to have been treated for ≥8 weeks
• Acthar Gel 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

*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 Gel and not exceeded the equivalent of 10 mg of prednisone per day.¹

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

Study Assessments

Primary outcome measure

• Primary outcome measure in this study was ACR20 at Week 12¹

Secondary outcome measures

• 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 patients². 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

Acthar Gel reduced disease severity in patients with moderately to severely active PsA

Primary outcome measure

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

Secondary outcome measures

• 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 PASI75
• 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

Safety Findings

• 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