NEJM -- Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis

Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis

Christopher E.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

ABSTRACT

Background Biologic 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 compared two 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-dose etanercept (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 the treatment 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 at week 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<0.001, respectively). Similarly, 65.1% of patients who received 45 mg of ustekinumab and 70.6% of patients who received 90 mg of ustekinumab had cleared or minimal disease according to the physician's global assessment, as compared with 49.0% of those who received etanercept (P<0.001 for both comparisons). Among patients who did not have a response to etanercept, 48.9% had at least 75% improvement in the PASI within 12 weeks after crossover to ustekinumab. One or more adverse events occurred through week 12 in 66.0% of patients who received 45 mg of ustekinumab and 69.2% of patients who received 90 mg of ustekinumab and in 70.0% who received etanercept; 1.9%, 1.2%, and 1.2%, respectively, had serious adverse events. Safety patterns were similar before and after crossover from etanercept to ustekinumab.

Conclusions The efficacy of ustekinumab at a dose of 45 or 90 mg was superior to that of high-dose etanercept over a 12-week period in patients with psoriasis. (ClinicalTrials.gov number, NCT00454584 [ClinicalTrials.gov] .)



Source Information

From the University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom (C.E.M.G.); New York University Medical Center, New York (B.E.S.); University Hospital Nijmegen, Nijmegen, the Netherlands (P.K.); University of British Columbia, Vancouver, BC, Canada (V.H.); Incyte Corporation, Wilmington, DE (R.F.-G.); Centocor Research and Development (N.Y., C.G., Y.X., B.Z., S.L., L.T.D.) and Precision Research (N.H.G.) — both in Malvern, PA; and the Psoriasis Research Unit, Baylor University Medical Center, Dallas (A.M.).

Address reprint requests to Dr. Griffiths at the Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester M6 8HD, United Kingdom, or at christopher.griffiths@manchester.ac.uk.

Full Text of this Article
http://content.nejm.org/cgi/content/full/362/2/118

This article has been cited by other articles:
(2010). Biological Battles. Journal Watch Dermatology 2010: 1-1 [Full Text]
http://dermatology.jwatch.org/cgi/content/full/2010/113/1

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NEJM -- Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis