RT Journal Article
SR Electronic
T1 Two-year efficacy and safety of infliximab treatment in patients with active psoriatic arthritis: findings of the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT).
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 869
OP 876
VO 35
IS 5
A1 Antoni, Christian E
A1 Kavanaugh, Arthur
A1 van der Heijde, Désirée
A1 Beutler, Anna
A1 Keenan, Gregory
A1 Zhou, Bei
A1 Kirkham, Bruce
A1 Tutuncu, Zuhre
A1 Burmester, Gerd R
A1 Schneider, Udo
A1 Furst, Daniel E
A1 Molitor, Jerry
A1 Keystone, Edward
A1 Gladman, Dafna D
A1 Manger, Bernhard
A1 Wassenberg, Siegfried
A1 Weier, Ralf
A1 Wallace, Daniel J
A1 Weisman, Michael H
A1 Kalden, Joachim R
A1 Smolen, Josef S
YR 2008
UL http://www.jrheum.org/content/35/5/869.abstract
AB 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.