OBJECTIVE: To investigate longterm efficacy/safety of infliximab over 2 years in patients with active psoriatic arthritis (PsA). METHODS: Initially, 104 patients were randomized to receive blinded infusions of infliximab 5 mg/kg or placebo at Weeks 0, 2, 6, and 14. At Week 16, all patients received infliximab 5 mg/kg every 8 weeks through Week 46. Seventy-eight of the 87 patients completing the first year continued into the open-label longterm extension and receivedinfliximab 5 mg/kg at Weeks 54, 62, 70, 78, 86, and 94. The primary efficacy endpoint for the study extension was the proportion of patients with at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at Week 98. Radiographic progression was assessed by the PsA-modified van der Heijde-Sharp score in patients with radiographs available at baseline and Week 98 (n = 43). RESULTS: At Week 98, 62% (48/78) of infliximab-treated patients achieved an ACR20 response; 45% (35/78) and 35% (27/78) of patients achieved ACR50 and ACR70 responses, respectively. Among patients with baseline Psoriasis Area and Severity Index scores >or= 2.5, 64% (16/25) achieved > 75% improvement from baseline to Week 98. The average estimated annual radiographic progression with infliximab treatment was significantly reduced versus the estimated baseline rate of progression. No new safety issues were observed during the second year of the study. CONCLUSION: Therapy with infliximab 5 mg/kg through Week 94 produced sustained improvement in joint and skin symptoms, inhibited radiographic progression, and continued to exhibit a favorable benefit-risk ratio in this population with treatment-refractory PsA.
RCT Entities:
OBJECTIVE: To investigate longterm efficacy/safety of infliximab over 2 years in patients with active psoriatic arthritis (PsA). METHODS: Initially, 104 patients were randomized to receive blinded infusions of infliximab 5 mg/kg or placebo at Weeks 0, 2, 6, and 14. At Week 16, all patients received infliximab 5 mg/kg every 8 weeks through Week 46. Seventy-eight of the 87 patients completing the first year continued into the open-label longterm extension and received infliximab 5 mg/kg at Weeks 54, 62, 70, 78, 86, and 94. The primary efficacy endpoint for the study extension was the proportion of patients with at least 20% improvement in the American College of Rheumatology response criteria (ACR20) at Week 98. Radiographic progression was assessed by the PsA-modified van der Heijde-Sharp score in patients with radiographs available at baseline and Week 98 (n = 43). RESULTS: At Week 98, 62% (48/78) of infliximab-treated patients achieved an ACR20 response; 45% (35/78) and 35% (27/78) of patients achieved ACR50 and ACR70 responses, respectively. Among patients with baseline Psoriasis Area and Severity Index scores >or= 2.5, 64% (16/25) achieved > 75% improvement from baseline to Week 98. The average estimated annual radiographic progression with infliximab treatment was significantly reduced versus the estimated baseline rate of progression. No new safety issues were observed during the second year of the study. CONCLUSION: Therapy with infliximab 5 mg/kg through Week 94 produced sustained improvement in joint and skin symptoms, inhibited radiographic progression, and continued to exhibit a favorable benefit-risk ratio in this population with treatment-refractory PsA.