USTEKINUMAB FOR THE TREATMENT OF PSORIASIS: REVIEW OF THREE MULTICENTER CLINICAL TRIALS

被引:21
作者
Farhi, D. [1 ]
机构
[1] Cabinet Dermatol Med & Chirurg Venereol, F-75013 Paris, France
关键词
INTERLEUKIN-12/23; MONOCLONAL-ANTIBODY; DOUBLE-BLIND; EFFICACY; SAFETY;
D O I
10.1358/dot.2010.46.4.1464839
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Ustekinumab, a fully human monoclonal antibody that binds to the p40 subunit of IL-12 and IL-23, has been recently approved in Europe and the U.S. for the treatment of moderate to severe plaque psoriasis. The efficacy and safety of ustekinumab have been demonstrated in three randomized phase III clinical trials, which are reviewed herein. In the PHOENIX 1 and 2 trials, significantly more patients achieved a PASI 75 response at week 12 on ustekinumab 45 mg (67.1% and 66.7%, respectively) or 90 mg (66.4% and 75.7%, respectively) than on placebo (3.1% and 3.7%, respectively; P < 0.0007 for each comparison versus placebo, in both trials). In the ACCEPT trial, PASI 75 was achieved at week 12 by 675% of patients on ustekinumab 45 mg, 73.8% on ustekinumab 90 mg and 56.8% on etanercept (comparison versus etanercept: P = 0.01 and P < 0.007, respectively). Injection-site reactions were significantly more common on etanercept than on ustekinumab. These results show that ustekinumab is significantly more effective than placebo and etanercept in the short-term treatment of moderate to severe psoriasis. Its safety has also been demonstrated during 76 weeks in patients without active infection or malignancy Long-term safety data should be provided by the ongoing follow-up of the PHOENIX 1 and 2 cohorts.
引用
收藏
页码:259 / 264
页数:6
相关论文
共 10 条
  • [1] Ustekinumab for chronic plaque psoriasis
    Bartlett, Brenda L.
    Tyring, Stephen K.
    [J]. LANCET, 2008, 371 (9625) : 1639 - 1640
  • [2] Biologic therapies in the treatment of psoriasis
    Farhi, David
    Dupin, Nicolas
    [J]. PRESSE MEDICALE, 2009, 38 (05): : 832 - 843
  • [3] FINLAY AY, 1995, BRIT J DERMATOL, V132, P236
  • [4] Biologic therapies in psoriasis: A new therapeutic approach
    Gisondi, Paolo
    Girolomoni, Giampiero
    [J]. AUTOIMMUNITY REVIEWS, 2007, 6 (08) : 515 - 519
  • [5] Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis
    Griffiths, Christopher E. M.
    Strober, Bruce E.
    van de Kerkhof, Peter
    Ho, Vincent
    Fidelus-Gort, Roseanne
    Yeilding, Newman
    Guzzo, Cynthia
    Xia, Yichuan
    Zhou, Bei
    Li, Shu
    Dooley, Lisa T.
    Goldstein, Neil H.
    Menter, Alan
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2010, 362 (02) : 118 - 128
  • [6] Poor agreement between self-reported and dermatologists' diagnoses for five common dermatoses
    Jagou, M.
    Bastuji-Garin, S.
    Bourdon-Lanoy, E.
    Penso-Assathiany, D.
    Roujeau, J-C.
    [J]. BRITISH JOURNAL OF DERMATOLOGY, 2006, 155 (05) : 1006 - 1012
  • [7] Leonardi CL, 2008, LANCET, V371, P1665, DOI 10.1016/S0140-6736(08)60725-4
  • [8] Psoriasis vulgaris lesions contain discrete populations of Th1 and Th17 T cells
    Lowes, Michelle A.
    Kikuchi, Toyoko
    Fuentes-Duculan, Judilyn
    Cardinale, Irma
    Zaba, Lisa C.
    Haider, Asifa S.
    Bowman, Edward P.
    Krueger, James G.
    [J]. JOURNAL OF INVESTIGATIVE DERMATOLOGY, 2008, 128 (05) : 1207 - 1211
  • [9] Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2)
    Papp, Kim A.
    Langley, Richard G.
    Lebwohl, Mark
    Krueger, Gerald G.
    Szapary, Philippe
    Yeilding, Newman
    Guzzo, Cynthia
    Hsu, Ming-Chun
    Wang, Yuhua
    Li, Shu
    Dooley, Lisa T.
    Reich, Kristian
    [J]. LANCET, 2008, 371 (9625) : 1675 - 1684
  • [10] Treatments for psoriasis and the risk of malignancy
    Patel, Rita V.
    Clark, Lily N.
    Lebwohl, Mark
    Weinberg, Jeffrey M.
    [J]. JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2009, 60 (06) : 1001 - 1017