TY - JOUR
T1 - Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis
AU - Griffiths, Christopher E M
AU - Strober, Bruce E.
AU - Van De Kerkhof, Peter
AU - Ho, Vincent
AU - Fidelus-Gort, Roseanne
AU - Yeilding, Newman
AU - Guzzo, Cynthia
AU - Xia, Yichuan
AU - Zhou, Bei
AU - Li, Shu
AU - Dooley, Lisa T.
AU - Goldstein, Neil H.
AU - Menter, Alan
PY - 2010/1/14
Y1 - 2010/1/14
N2 - 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 α), 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
AB - 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 α), 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
U2 - 10.1056/NEJMoa0810652
DO - 10.1056/NEJMoa0810652
M3 - Article
C2 - 20071701
SN - 1533-4406
VL - 362
SP - 118
EP - 128
JO - New England Journal Of Medicine
JF - New England Journal Of Medicine
IS - 2
ER -
