Previous | Volume 362:118-128 | | January 14, 2010 | | Number 2 |
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Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis
ChristopherE.M. Griffiths, M.D., Bruce E. Strober, M.D., Ph.D., Peter van de Kerkhof, M.D., Vincent Ho, M.D., Roseanne Fidelus-Gort, Ph.D., Newman Yeilding, M.D., Cynthia Guzzo, M.D.,Yichuan Xia, Ph.D., Bei Zhou, Ph.D., Shu Li, M.S., Lisa T. Dooley, Dr.P.H., Neil H. Goldstein, M.D., Alan Menter, M.D., for the ACCEPT Study Group
BackgroundBiologic agents offer a range of new therapeutic options for patients with psoriasis; however, the relative benefit–risk profiles of such therapies are not well known. We comparedtwo biologic agents, ustekinumab (an interleukin-12 and interleukin-23 blocker) and etanercept (an inhibitor of tumor necrosis factor ), for the treatment of psoriasis.Methods We randomly assigned 903 patients with moderate-to-severe psoriasis to receive subcutaneous injections of either 45 or 90 mg of ustekinumab (at weeks 0 and 4) or high-doseetanercept (50 mg twice weekly for 12 weeks). The primary end point was the proportion of patients with at least 75% improvement in the psoriasis area-and-severity index (PASI)at week 12; a secondary end point was the proportion with cleared or minimal disease on the basis of the physician's global assessment. Assessors were unaware of thetreatment assignments. The efficacy and safety of a crossover from etanercept to ustekinumab were evaluated after week 12.
Results There was at least 75% improvement in the PASI atweek 12 in 67.5% of patients who received 45 mg of ustekinumab and 73.8% of patients who received 90 mg, as compared with 56.8% of those who received etanercept (P=0.01 and P
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