Abstract

Although several therapeutic agents are available for psoriatic arthritis (PsA), each has limitations. Acthar® Gel (repository corticotropin injection) is FDA-approved for treatment of acute episodes or exacerbation of PsA, but no clinical trials have investigated it for those uses. This 28-week, prospective, single-center, open-label trial included subjects with moderately to severely active PsA. The primary outcome measure was ACR20 at Week 12. Secondary outcomes included ACR20 at Week 24, ACR50, ACR70, Clinical Disease Activity Index (CDAI), Psoriasis Area and Severity Index (PASI) 50, PASI 75, Physician Global Assessment, Patient Global Assessment, Tender and Swollen Joint Count, Visual Analog Scale (VAS) for measurement of pain, acute erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and pre-injection and post-injection cortisol levels at Weeks 12 and 24. Safety, including adverse events and vital signs, were monitored throughout. Among subjects initially enrolled (n = 15), 8 completed Week 12; 7 finished Week 24. All 8 achieved ACR20 at Week 12. At Weeks 12 and 24 there were significant improvements in CDAI, Physician Global Assessment, Patient Global Assessment, Tender and Swollen Joint Count, and VAS (all P ≤ 0.001). At Week 12, 87.5% of subjects reached ACR50, ACR70, PASI50, and PASI75, and 100% did at Week 24. There were no differences in pre-injection or post-injection cortisol levels, ESR, or CRP. Three subjects withdrew early (2 worse psoriasis, 1 depression), but no other adverse events were observed. The remaining 4 patients withdrew for logistical reasons only.

Authors and Affiliations