Open-label 24-month study evaluating infliximab therapy in patients with psoriatic spondyloarthropathy.
Psoriatic spondyloarthropathy (PsSA) is a common and relatively typical form of spondyloarthropathy, affecting the axial skeleton with peripheral synovitis. Also, extraarticular as well as skin manifestations are sometimes difficult to diagnose and to treat. Recent studies demonstrated that anti-tumor necrosis factor therapies are useful in treating and controlling disease activity. We conducted an open-label 2-year study in 16 patients to evaluate the efficacy and safety of long-term compliance with intravenous infliximab therapy in patients with severe skin and refractory PsSA, with an incomplete response to methotrexate, azathioprine, cyclosporine, and/or sulfasalazine. Patients continued to receive only weekly methotrexate therapy during the study that included 16 patients (9 men, 7 women; mean age 38 +/- 12.5 years [SD]) with psoriatic spondyloarthropathy for 16.4 +/- 9.2 years. Each patient underwent complete physical examination before treatment and at each visit until the end of the study. Results of patient global pain assessment (VAS scale), investigator opinion on global assessment of disease activity (100 mm VAS), patient body weight and blood pressure, ACR response (20%, 50%, and 70%), laboratory parameters (CRP, ESR, WBC, RBC, liver enzymes, etc.), and PASI (skin score) were recorded. We conclude that infliximab therapy was effective in controlling joint and skin disease, having an acceptable safety profile and very good compliance when considering this type of patient. However, further long-term, double-blind, placebo-controlled trials are necessary to validate these results.