Infliximab receives expanded psoriatic arthritis indication.
In August, the Food and Drug Administration approved infliximab for "inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis." This is in addition to reducing the signs and symptoms of active arthritis in this population, the indication approved in May 2005.
Infliximab, the tumor necrosis factor-[alpha] (TNF-[alpha]) blocking agent marketed as Remicade by Centocor, was first approved for Crohn's disease in 1998, followed by rheumatoid arthritis (1999) and ankylosing spondylitis (2004). The recommended dosage for psoriatic arthritis is 5 mg/kg administered in an intravenous infusion, with similar doses 2 and 6 weeks later, and then every 8 weeks.
Elevated levels of TNF-[alpha] have been found in the tissues and fluids of patients with psoriatic arthritis and other inflammatory conditions. After treatment with infliximab, patients with psoriatic arthritis have been found to have reductions in T cells and blood vessels in the synovium and psoriatic skin, and a reduction in macrophages in the synovium, according to the drug's label.
The latest approval is based on the findings from two double-blind placebo-controlled trials, 2-year data from the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT), and 1-year data from the Induction and Maintenance of Psoriatic Arthritis Clinical Trial 2 (IMPACT 2), according to Centocor.
In IMPACT 2, those on infliximab had significantly less progression of structural damage at 24 weeks, compared with those on placebo, based on changes from baseline in the van der Heijde-Sharp (vdH-S) score, assessed radiographically. (The vdH-S score was modified for psoriatic arthritis by adding a measurement for distal interphalangeal joints of the hands.) In addition, those on infliximab had less progression in joint erosions and joint space narrowing, based on the vdH-S scores. And at 54 weeks, those who remained on infliximab continued to show inhibition of structural damage.
The impact on physical function was measured by the HAQ Disability Index (HAQ-DI) and the SF-36 Health Survey. In the IMPACT-2 trial, the median improvement in the HAQ-DI score was 43% from those on infliximab at week 14, vs. 0% for those on placebo. At 24 weeks, 54% of those on infliximab had achieved a clinically meaningful improvement in the HAQ-DI score vs. 22% of those on placebo.
In the IMPACT-2 study, 12% of those on infliximab had serious adverse events, during an average follow-up of 43 weeks, vs. 6% among those on placebo, who were followed for an average of 20 weeks, according to Centocor. There were no deaths, tuberculosis cases, or other opportunistic infections or serious infusion reactions; there was one case of stage 1 Hodgkin's lymphoma in a patient on infliximab.
BY ELIZABETH MECHCATIE
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|Publication:||Internal Medicine News|
|Article Type:||Disease/Disorder overview|
|Date:||Oct 1, 2006|
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