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| |  WCD: Infliximab Thwarts Psoriasis Recurrence in Responding Patients By Jill Stein Special to DG News PARIS, FRANCE -- July 5, 2002 -- Treatment with a three-dose infliximab induction regimen produces rapid clearance in the treatment of moderate to severe plaque psoriasis and is associated with a durable response through 26 weeks, a recent extension study has found. Dr. Alice Gottlieb, with the University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical School in New Brunswick, New Jersey, United States, presented the results here today at the 20th World Congress of Dermatology (WCD). The data also show that infliximab is safe and well tolerated. An earlier 10-week, double-blind, placebo-controlled trial of 33 patients with moderate to severe psoriasis demonstrated that infliximab was well tolerated and provided substantial clinical benefit without significant toxicity. Twenty-one patients responded to treatment: nine of 11 receiving infliximab 5 mg/kg, 10 of 11 receiving infliximab 10 mg/kg, and two of 11 receiving placebo. Responders achieved a good, excellent, or clear rating on physician global assessment at week 10. A greater than 75 percent improvement in the Psoriasis Area Severity Index (PASI) score was observed for nine patients receiving infliximab 5 mg/kg, eight receiving infliximab 10 mg/kg, and two receiving placebo. Dr. Gottlieb reported the results of an open-label extension phase of the study that determined the durability of response in the 21 responders. She presented unblinded outcome data in 19 infliximab and two placebo responders observed for up to 10 months after their last infusion at week 6. Results of the post-induction phase of the open-label follow-up showed that 55 percent of patients maintained at least a 50 percent improvement in PASI through week 26. Also, 48 percent of patients treated with a three-dose induction regimen of infliximab maintained at least a 75 percent improvement in PASI through week 26. Infusion reactions were observed in four patients. However, the reactions were mild, transient, and preventable. There were no autoimmune, cytopenic, or neurologic events related to infliximab treatment. Dr. Gottlieb said larger phase II and III dose and efficacy trials are needed to confirm these short- and long-term observations. The study was sponsored by Centocor Inc. in Malvern, Pennsylvania.
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