Dr. van der Heijde has received consulting fees, speaking fees, and/or honoraria (less than $10,000 each) from Abbott, Amgen, Bristol-Myers Squibb, Centocor, UCB, and Wyeth. Dr. Gladman has received consulting fees and speaking fees (less than $10,000 each) from Schering Canada and Abbott Canada. Dr. Antoni owns stock/stock options in Schering-Plough. Drs. Guzzo, Zhou, Dooley, and Beutler own stock/stock options in Johnson & Johnson. Drs. Zhou, Dooley, and Beutler own stock/stock options in Centocor, Dr. de Vlam has received speaking fees (less than $10,000) from Schering-Plough, Corp., and has received honoraria as a member of the advisory board for Wyeth. Dr. Birbara has received speaking fees (less than $10,000) from Bristol-Myers Squibb; he also is a member of the Genentech Speakers' Bureau.
Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through one year of treatment: Results from the induction and maintenance psoriatic arthritis clinical trial 2†
Version of Record online: 30 JUL 2007
Copyright © 2007 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 56, Issue 8, pages 2698–2707, August 2007
How to Cite
van der Heijde, D., Kavanaugh, A., Gladman, D. D., Antoni, C., Krueger, G. G., Guzzo, C., Zhou, B., Dooley, L. T., de Vlam, K., Geusens, P., Birbara, C., Halter, D., Beutler, A. and IMPACT 2 Study Group (2007), Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through one year of treatment: Results from the induction and maintenance psoriatic arthritis clinical trial 2. Arthritis & Rheumatism, 56: 2698–2707. doi: 10.1002/art.22805
ClinicalTrials.gov identifier: NTC00051623
- Issue online: 30 JUL 2007
- Version of Record online: 30 JUL 2007
- Manuscript Accepted: 30 APR 2007
- Manuscript Received: 2 NOV 2006
- Centocor, Inc.
- Schering-Plough Corp.
To evaluate the effect of infliximab on progression of structural damage over 1 year in patients with active psoriatic arthritis (PsA) enrolled in the Induction and Maintenance Psoriatic Arthritis Clinical Trial 2.
In this double-blind, placebo-controlled study, 200 patients with active PsA were randomly assigned (1:1 ratio) to receive infusions of infliximab (5 mg/kg) or placebo at weeks 0, 2, and 6, and every 8 weeks thereafter through week 54. At week 24, patients initially assigned to receive placebo crossed over to receive infliximab (5 mg/kg). Based on predefined criteria, patients randomized to receive placebo could enter early escape by receiving infliximab (5 mg/kg) starting at week 16, and patients randomized to receive infliximab could have the dose increased to 10 mg/kg starting at week 38. Patients were analyzed according to the treatment they were randomized to receive. Radiographs of hands and feet were obtained at baseline and at weeks 24 and 54. Two readers blinded to treatment assignment and radiograph sequence independently evaluated erosions and joint space narrowing using the Sharp/van der Heijde scoring method modified for PsA.
At week 24, patients randomized to receive infliximab 5 mg/kg had significantly less radiographic progression compared with patients randomized to receive placebo, with mean ± SD changes from baseline in the total Sharp/van der Heijde score of −0.70 ± 2.53 and 0.82 ± 2.62, respectively (P < 0.001). At week 54, mean ± SD changes from baseline in the total Sharp/van der Heijde score were −0.94 ± 3.40 in patients randomized to receive infliximab and 0.53 ± 2.60 in those receiving placebo/infliximab (P = 0.001).
Infliximab significantly inhibits radiographic progression in patients with PsA as early as 6 months after starting treatment, and the beneficial effect continues through 1 year of infliximab therapy.