Original articleSwitching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: Efficacy and safety results from an open-label study
Section snippets
Patients
Institutional review board approval was obtained for each participating medical center. All patients provided written informed consent before any study-related procedures were performed. Eligibility requirements were an age of 18 years or older, a clinical diagnosis of chronic plaque psoriasis for at least 6 months, and a suboptimal response to prior psoriasis therapy. Three patient populations constituted the study population: those with a suboptimal response to treatment with etanercept
Patients
Between December 28, 2008, and April 14, 2009, a total of 152 patients were enrolled: 82 into substudy E, 41 into substudy M, and 29 into substudy P (Fig 1). Patient demographics and disease activity characteristics at screening are shown in Table I. Greater percentages of patients in substudies E and M had PsA (57.3% and 41.5%, respectively) compared with patients in substudy P (24.1%). Patients in substudy E had a longer median duration of suboptimal therapy use (20 months) compared with
Discussion
This 16-week, open-label study of adalimumab demonstrated that approximately half of patients with psoriasis who experienced a suboptimal response to prior therapy with etanercept, MTX, or NB-UVB phototherapy achieved a PGA score of “clear” or “minimal” when switched to adalimumab. The likelihood of achieving this clinically meaningful improvement was similar regardless of which prior therapy had been suboptimal. The strategy of abruptly discontinuing prior therapy and starting adalimumab after
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Cited by (0)
The clinical study and analysis reported in this article were supported by research grants from Abbott Laboratories. The analysis reported in this article is based on a phase IIIb trial and pertains to a commercial product (Humira [adalimumab]). Funding for manuscript development was provided by Abbott Laboratories, with medical writing services provided by Teresa R. Brtva, PhD, of Arbor Communications Inc., and Deborah Roney, MA, of Abbott. Yuzhen Wang, of Abbott, provided statistical assistance.
Disclosure: Dr Strober has served as an advisory board member and investigator for Abbott, Amgen, Astellas, Centocor, and Genentech; has received research and fellowship grants from Abbott, Amgen, and Centocor; and has served as a member of the speakers bureaus of Abbott, Amgen, Astellas, and Genentech. Dr Poulin has received research grants from Abbott, Amgen/Wyeth, Astellas/Biogen, Boehringer Ingelheim, Celgene, Centocor, EMD Serono, Isotechnika, and Schering-Plough. Dr Kerdel has received research grants from Abbott, Amgen/Wyeth, Centocor, Merck, Novartis, and Stiefel; has served on advisory boards for Abbott, Amgen/Wyeth, Astellas, and Centocor; and has served as a member of the speakers bureaus of Abbott, Amgen, Centocor, and Stiefel. Dr Langley has served as an advisory board member and investigator for Abbott, Amgen, Astellas, Boehringer Ingelheim, Centocor, EMD Serono, Genentech, and Isotechnika; he has received lecture fees from Abbott, Amgen/Wyeth, Astellas, Genentech, Novartis, and Schering-Plough. Dr Papp has received consulting fees from Abbott, Amgen, Centocor, Isotechnika, Johnson & Johnson, MedImmune, Merck-Serono, and Wyeth; has received investigator research funding from Abbott, Amgen, Astellas, Biogen, Boehringer Ingelheim, Celgene, Centocor, EMD Serono, Genentech, Isotechnika, and Schering-Plough; has served on advisory boards for Abbott, Amgen, Centocor, EMD Serono, Genentech, Isotechnika, and Schering-Plough; and has served as a member of the speakers bureaus of Abbott, Amgen, EMD Serono, Genentech, Isotechnika, Schering-Plough, and Wyeth. Ms Gu, Dr Gupta, and Dr Okun are employees of Abbott Laboratories and own Abbott stock.
Trial registration: www.clinicaltrials.gov NCT00566722.