Switching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: Efficacy and safety results from an open-label study - 10/08/11
, Yves Poulin, MD b, Francisco A. Kerdel, MD c, Richard G. Langley, MD d, Yihua Gu, MS e, Shiraz R. Gupta, PharmD, MPH e, Martin M. Okun, MD, PhD e, Kim A. Papp, MD, PhD f
Reprint requests: Bruce E. Strober, MD, PhD, New York University School of Medicine, 560 First Ave, TCH-158, New York, NY 10016.Abstract |
Background |
Strategies for transitioning patients with psoriasis from suboptimal therapy have not been delineated.
Objective |
We sought to determine the efficacy and safety of transitioning to adalimumab for the treatment of psoriasis in patients with suboptimal response to prior therapy with etanercept, methotrexate (MTX), or narrowband (NB)-ultraviolet (UV)B phototherapy.
Methods |
In this 16-week, open-label, phase IIIb trial, patients with chronic plaque psoriasis discontinued suboptimal therapy between 11 and 17 days (etanercept) or between 4 and 10 days (MTX and NB-UVB) before initiating adalimumab (80 mg at week 0, then 40 mg every other week from week 1). The primary end point was the percentage of patients achieving a Physician Global Assessment of “clear” or “minimal” at week 16.
Results |
At week 16, Physician Global Assessment of “clear” or “minimal” was achieved by 52% of all enrolled patients (79 of 152) and 49%, 61%, and 48% in the etanercept, MTX, and NB-UVB subgroups, respectively. Four patients (2.6%) experienced at least 125% worsening of Psoriasis Area and Severity Index score relative to screening value at any study visit. The adalimumab safety profile was consistent with results from other psoriasis clinical trials.
Limitations |
This study is limited by its relatively short 16-week duration, small patient enrollment, and open-label design.
Conclusion |
Patients who had a suboptimal response to etanercept, MTX, or NB-UVB phototherapy experienced a similar, approximately 50% likelihood of achieving a clinically relevant response to adalimumab. Immediate transition to adalimumab from prior suboptimal therapy, with no dosage tapering or overlap, had a low risk of psoriasis flare.
Le texte complet de cet article est disponible en PDF.Key words : adalimumab, etanercept, flare, methotrexate, narrowband ultraviolet B, phototherapy, psoriasis, psoriatic arthritis, switching, therapy
Abbreviations used : AE, biw, CI, CRP, DLQI, MTX, NB, PASI, PGA, PsA, QOL, REVEAL, TB, TNF, UV, VAS
Plan
| 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. |
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| 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. |
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| Trial registration: www.clinicaltrials.gov NCT00566722. |
Vol 64 - N° 4
P. 671-681 - avril 2011 Retour au numéro
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