| Autor: |
Gordon, K. B, Blauvelt, A., Papp, K. A., Langley, R. G., Luger, T., Ohtsuki, M., Reich, K., Amato, D., Ball, S. G., Braun, D. K., Cameron, G. S., Erickson, J., Konrad, R. J., Muram, T. M., Nickoloff, B. J., Osuntokun, O. O., Secrest, R. J., Zhao, F., Mallbris, L., Leonardi, C. L., Uncover, 1 Study Group: Holly Hake Harris, Matheson, Robert T., Michael, Bukhalo, John H., Tu, Crowley, Jeffrey J., Grande, Kimberly K., Adnan, Nasir, Boni Elizabeth Elewski, James Alan Solomon, Liebhild, Stratmann, Claudia, Buettner, Thomas Peter Dirschka, Margrit Ruth Simon, Jens, Ulrich, Christine, Grigat, Mathias, Augustin, Andrei, Khariouzov, Gerhard, Sattler, Hans Michael Ockenfels, Fredrick Richard Behringer, Hector, Wiltz, Francisco, Flores, Kuettel, Kevin D., Ira Hughes Thorla, Jeffrey Keith Moore, Waterman, Gary L., George Joji Murakawa, Scott Alfred Fretzin, Frankel, Ellen H., Sunil Sharan Dhawan, Lucyna, Leszniewska, Maria, Poznanska, Anna Sobieszek Kundro, Chodorowska, Grazyna M., Katarzyna Turek Urasinska, Romuald, Maleszka, Andrzej, Kaszuba, Lidia, Rajzer, Elizbieta Barbara Szymanska, Lidia, Rudnicka, Neil James Korman, Jamie Debra Weisman, Truett, Artis P., Jeffry, Jacqmein, Steven Robert Cohen, Heller, Gary L., Jenkin, Peter J., Abe, Marcadis, George Sorin Tiplica, Anca Aghinitei Zbranca Toporas, Simona Laura Ianosi, Ion, Florea, Claus, Zachariae, Lars, Iversen, Annalisa, Patrizi, Romanelli, Marco, Christopher, Griffiths, John Berth Jones, John, Foerster, Savin, Ronald C., Nelson, Christopher G., Lyn Carol Chamberlain Guenther, Albrecht, Lorne E., Hong, Chih ho H., Arnon, Katz, Mani, Raman, Adam, David N., Aamir, Butt, Stephen Peter Shumack, Kurt Aaron Josef Gebauer, Lynda Jane Spelman, Shireen Kaur Sidhu, Michael George Freeman, Peter Anthony Foley, Lajos, Kemeny, Eva, Remenyik, Zsuzsanna, Karolyi, Marc, Bourcier, Wayne Douglas Carey, Victoria, Taraska, Derek, Haaland, Aditya Kumar Gupta, Catherine, Maari, Darryl Paul Toth, Michael, Sebastian, Sandra, Philipp, Roland, Kaufmann, Diamant, Thaci, Thomas Andreas Werfel, Leila, Parise, Ingo, Haase, Petra Staubach Renz, Shinichi, Imafuku, Juichiro, Nakayama, Tadashi, Terui, Hideki, Nakajima, Shigetoshi, Sano, Uncover, 2 Study Group, Uncover, 3 Study Group |
| Rok vydání: |
2016 |
| Předmět: |
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| Zdroj: |
New England Journal of Medicine. 375:345-356 |
| ISSN: |
1533-4406
0028-4793 |
| Popis: |
BACKGROUND Two phase 3 trials (UNCOVER-2 and UNCOVER-3) showed that at 12 weeks of treatment, ixekizumab, a monoclonal antibody against interleukin-17A, was superior to placebo and etanercept in the treatment of moderate-to-severe psoriasis. We report the 60-week data from the UNCOVER-2 and UNCOVER-3 trials, as well as 12-week and 60-week data from a third phase 3 trial, UNCOVER-1. METHODS We randomly assigned 1296 patients in the UNCOVER-1 trial, 1224 patients in the UNCOVER-2 trial, and 1346 patients in the UNCOVER-3 trial to receive subcutaneous injections of placebo (placebo group), 80 mg of ixekizumab every 2 weeks after a starting dose of 160 mg (2-wk dosing group), or 80 mg of ixekizumab every 4 weeks after a starting dose of 160 mg (4-wk dosing group). Additional cohorts in the UNCOVER-2 and UNCOVER-3 trials were randomly assigned to receive 50 mg of etanercept twice weekly. At week 12 in the UNCOVER-3 trial, the patients entered a long-term extension period during which they received 80 mg of ixekizumab every 4 weeks through week 60; at week 12 in the UNCOVER-1 and UNCOVER-2 trials, the patients who had a response to ixekizumab (defined as a static Physicians Global Assessment [sPGA] score of 0 [clear] or 1 [minimal psoriasis]) were randomly reassigned to receive placebo, 80 mg of ixekizumab every 4 weeks, or 80 mg of ixekizumab every 12 weeks through week 60. Coprimary end points were the percentage of patients who had a score on the sPGA of 0 or 1 and a 75% or greater reduction from baseline in Psoriasis Area and Severity Index (PASI 75) at week 12. RESULTS In the UNCOVER-1 trial, at week 12, the patients had better responses to ixekizumab than to placebo; in the 2-wk dosing group, 81.8% had an sPGA score of 0 or 1 and 89.1% had a PASI 75 response; in the 4-wk dosing group, the respective rates were 76.4% and 82.6%; and in the placebo group, the rates were 3.2% and 3.9% (P |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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