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Treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two Phase III randomized studies
BACKGROUND: Biologics are effective for the treatment of psoriasis. However, treatment outcomes may differ among biologic‐naive patients and those switched from previous biological therapies. OBJECTIVES: The study's objective was to investigate efficacy and safety of ixekizumab, a high‐affinity...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5412924/ https://www.ncbi.nlm.nih.gov/pubmed/27696577 http://dx.doi.org/10.1111/jdv.13990 |
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author | Gottlieb, A.B. Lacour, J.‐P. Korman, N. Wilhelm, S. Dutronc, Y. Schacht, A. Erickson, J. Zhang, L. Mallbris, L. Gerdes, S. |
author_facet | Gottlieb, A.B. Lacour, J.‐P. Korman, N. Wilhelm, S. Dutronc, Y. Schacht, A. Erickson, J. Zhang, L. Mallbris, L. Gerdes, S. |
author_sort | Gottlieb, A.B. |
collection | PubMed |
description | BACKGROUND: Biologics are effective for the treatment of psoriasis. However, treatment outcomes may differ among biologic‐naive patients and those switched from previous biological therapies. OBJECTIVES: The study's objective was to investigate efficacy and safety of ixekizumab, a high‐affinity anti‐interleukin‐17A antibody, in patients with psoriasis with and without previous exposure to biologics. METHODS: Data were integrated from the 12‐week induction phase of two etanercept‐controlled Phase III trials. Patients received 80 mg ixekizumab every 2 weeks (IXE Q2W; N = 736) or every 4 weeks (IXE Q4W; N = 733) following a 160‐mg starting dose, or placebo (N = 361). Etanercept (50 mg twice weekly; N = 740) was administered as active control. Psoriasis Area and Severity Index (PASI) 75, PASI 90 and PASI 100 response rates at week 12 were evaluated in patients with or without previous exposure to biologics. Treatment effects were analysed with the Cochran–Mantel–Haenszel test stratified by study; missing values were imputed as non‐response. RESULTS: Overall, 497 (19.3%) patients had prior exposure to biologics and 2073 (80.7%) were naive to biologic therapy. PASI 75 was achieved by 91.5% of biologic‐experienced patients and 87.7% of biologic‐naive patients for IXE Q2W, 76.2% and 82.2% for IXE Q4W, respectively, and 34.6% and 50.7%, respectively, for etanercept. Higher response rates favouring each ixekizumab dose over etanercept within subgroups were also seen regarding PASI 90 and PASI 100. CONCLUSIONS: Contrary to etanercept, the efficacy of ixekizumab was similarly high in patients with and without previous exposure to biologics when administered 80 mg every 2 weeks. |
format | Online Article Text |
id | pubmed-5412924 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-54129242017-05-15 Treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two Phase III randomized studies Gottlieb, A.B. Lacour, J.‐P. Korman, N. Wilhelm, S. Dutronc, Y. Schacht, A. Erickson, J. Zhang, L. Mallbris, L. Gerdes, S. J Eur Acad Dermatol Venereol Original Articles and Short Reports BACKGROUND: Biologics are effective for the treatment of psoriasis. However, treatment outcomes may differ among biologic‐naive patients and those switched from previous biological therapies. OBJECTIVES: The study's objective was to investigate efficacy and safety of ixekizumab, a high‐affinity anti‐interleukin‐17A antibody, in patients with psoriasis with and without previous exposure to biologics. METHODS: Data were integrated from the 12‐week induction phase of two etanercept‐controlled Phase III trials. Patients received 80 mg ixekizumab every 2 weeks (IXE Q2W; N = 736) or every 4 weeks (IXE Q4W; N = 733) following a 160‐mg starting dose, or placebo (N = 361). Etanercept (50 mg twice weekly; N = 740) was administered as active control. Psoriasis Area and Severity Index (PASI) 75, PASI 90 and PASI 100 response rates at week 12 were evaluated in patients with or without previous exposure to biologics. Treatment effects were analysed with the Cochran–Mantel–Haenszel test stratified by study; missing values were imputed as non‐response. RESULTS: Overall, 497 (19.3%) patients had prior exposure to biologics and 2073 (80.7%) were naive to biologic therapy. PASI 75 was achieved by 91.5% of biologic‐experienced patients and 87.7% of biologic‐naive patients for IXE Q2W, 76.2% and 82.2% for IXE Q4W, respectively, and 34.6% and 50.7%, respectively, for etanercept. Higher response rates favouring each ixekizumab dose over etanercept within subgroups were also seen regarding PASI 90 and PASI 100. CONCLUSIONS: Contrary to etanercept, the efficacy of ixekizumab was similarly high in patients with and without previous exposure to biologics when administered 80 mg every 2 weeks. John Wiley and Sons Inc. 2016-11-02 2017-04 /pmc/articles/PMC5412924/ /pubmed/27696577 http://dx.doi.org/10.1111/jdv.13990 Text en © 2016 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles and Short Reports Gottlieb, A.B. Lacour, J.‐P. Korman, N. Wilhelm, S. Dutronc, Y. Schacht, A. Erickson, J. Zhang, L. Mallbris, L. Gerdes, S. Treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two Phase III randomized studies |
title | Treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two Phase III randomized studies |
title_full | Treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two Phase III randomized studies |
title_fullStr | Treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two Phase III randomized studies |
title_full_unstemmed | Treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two Phase III randomized studies |
title_short | Treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two Phase III randomized studies |
title_sort | treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of two phase iii randomized studies |
topic | Original Articles and Short Reports |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5412924/ https://www.ncbi.nlm.nih.gov/pubmed/27696577 http://dx.doi.org/10.1111/jdv.13990 |
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