"Infliximab Significantly Improves and Sustains Productivity in Psoriasis Patients: Presented at AAD"
By Bruce Sylvester
WASHINGTON, DC -- February 6, 2007 -- Patients with moderate to severe plaque psoriasis who were treated with infliximab (Remicade) showed significant improvements in productivity at week 10, which were sustained through week 50, investigators reported here at the 65[th annual meeting of the American Academy of Dermatology (AAD).
"Psoriasis can be a disabling disease, and the results of this study are critically important because they show that treatment can help people return to the mainstream of life," said investigator and presenter Steven Feldman, MD, PhD, professor of dermatology and public health sciences, Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, North Carolina.
To evaluate the impact of infliximab therapy on patient productivity the investigators conducted a retrospective analysis of data from the Evaluation of Infliximab for Psoriasis in an Efficacy and Safety Study (EXPRESS II), a multicenter, randomized, double-blind, placebo-controlled study conducted in North America and Europe.
The EXPRESS II investigators randomized 835 patients with moderate to severe psoriasis to induction doses of infliximab 3mg/kg, 5mg/kg, or placebo at weeks 0, 2 and 6.
Subjects in the infliximab treatment groups were then randomized at week 14 to either scheduled treatment (every 8 weeks) or "as-needed" (PRN) maintenance treatment at the same dose administered during induction period.
Placebo subjects crossed over to infliximab at week 14.
The investigators measured the impact of treatment using the Productivity Visual Analog Scale, with 0 indicating very impaired productivity and 10 cm indicating no impairment.
Baseline productivity scores among infliximab 3 mg/kg and 5 mg/kg and the placebo group were comparable, at 5.7, 5.6 and 5.6, respectively, indicating impaired productivity in all groups.
The researchers measured whether work/daily activities were being affected by physical health using the physical domain scores on the Short Form 36 Health Survey (SF-36). This survey measures 8 domains of health -- physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Scores on the SF-36 were low at baseline, with a score of 47.5 with infliximab 3 mg/kg, 46.6 with infliximab 5 mg/kg, and 44.8 with placebo.
At week 10, the infliximab groups showed significant increases from baseline on the Productivity Visual Analog Scale -- 2.9 (3 mg/kg) and 3.1 (5 mg/kg) -- compared with a mean decrease of 0.1 for the placebo subjects (P < .001 for both infliximab groups).
The researchers also observed physical domain increases from baseline on the SF-36 survey of 4.1 for the 3 mg/kg infliximab group and 5.1 for the 5 mg/kg infliximab group, compared with a mean increase of 0.8 for placebo subjects (P < .001 for both infliximab groups).
Among subjects randomized to infliximab at week 14, improvement in productivity was maintained more successfully in the scheduled-dose infliximab groups compared with the "as-needed" maintenance groups.
The investigators reported the best productivity improvement through week 50 in the group on infliximab 5 mg/kg every 8 weeks. Mean productivity improvement from this group from baseline to week 50 was 2.6.
The placebo crossover (at week 16) group also showed improved productivity.
Dr. Feldman added, "These results are not only important for doctors and patients but also for insurers. This drug can have a dramatic effect on quality of life of psoriasis patients, and that is what good medical practice and health insurance are meant to enable."
The study was supported by Centocor, Inc.
[Presentation title: Infliximab Therapy Improves Patient Productivity Among Those With Moderate to Severe Psoriasis. Poster 2715]
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