Thursday

March 22, 2007

SESSION ONE

4:20 – 4:40

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COMBINATION TREATMENT FOR PSORIASIS

Dr. Leon Kircik

Utilization of Narrow-Band UVB Light Therapy and Etanercept for the Treatment of Psoriasis (UNITE): Charactheristics of PASI Responders

L Kircik1, C Elmets2, J Koo3, A Menter4, J Bagel5, N Korman6, AB Kimball7, YC Yang8, CF Chiou8, F Dann8, SR Stevens8

1Indiana University Medical Center, Louisville, KY; 2University of Alabama, Birmingham, AL; 3University of California, San Francisco Medical Center, San Francisco, CA; 4Baylor University Medical Center, Dallas, TX; 5Psoriasis Treatment Center of Central NJ, East Windsor, NJ; 6Case Western Reserve University, Cleveland, OH; 7Massachusetts General and Brigham and Women's Hospitals, 8Amgen Inc.,Thousand Oaks, CA

Clinical trials in psoriasis often use the Psoriasis Area and Severity (PASI) 75 score as a measure of response to therapy.  Scores range from 0 to 72, with higher scores indicating more extensive disease.  Because of the high rate of complete psoriasis clearance - as measured by attainment of PASI 100 scores - in the Utilization of NB-UVB Light Therapy and Etanercept for the Treatment of Psoriasis (UNITE) trial, we are able to examine the characteristics of patients with severe psoriasis who achieved these higher response rates when receiving the combination of etanercept with NB-UVB.

Adult patients with chronic plaque psoriasis and PASI score ≥15 at baseline received 50 mg etanercept twice-weekly (BIW) in combination with NB-UVB 3-times-weekly (TIW) for 12 weeks in this open-label, single-arm study. The primary endpoint was the proportion of patients achieving a PASI 75 response at week 12, while other analyses included the proportions of patients achieving PASI 90 and PASI 100.  Analyses included all patients who received at least 1 dose of etanercept and NB-UVB phototherapy; analyses were conducted using a last-observation-carried-forward approach.

Of the 86 patients who received treatment, 26% achieved a PASI 100 response at week 12.  The proportions of patients achieving PASI 75 and PASI 90 at week 12 were 85% and 58%, respectively.

Potential relationships between patient characteristics and the likelihood of achieving a PASI 100 in this study will be presented, including comparisons of baseline and treatment characteristics of patients in the top quartile of PASI responders through 12 weeks of treatment with the bottom quartile of responders. Data from the UNITE study offer a unique opportunity to examine the characteristics of patients with psoriasis who achieved a complete psoriasis clearance with a combination of etanercept BIW and NB-UVB therapy TIW. Analyses are being performed, and data are forthcoming.

Research funded by Immunex Corporation, a wholly owned subsidiary of Amgen Inc., and by Wyeth Pharmaceuticals.

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