L. Kemeny, M. Amaya, P. Cetkovska, N. Rajatanavin, and W-R. Lee report no competing interests.
L. Marshall, E. Y. Mahgoub, and E. Aldinç are all employees of Pfizer, which sponsored the original trial and this subpopulation analysis.
A. Szumski is an employee of Inventiv Health Inc who is a paid contract worker to Pfizer in the development of this manuscript.
This study was sponsored by Pfizer.
LK, MA, PC, NR, and W-RL were all active investigators on the PRISTINE trial, recruited and treated patients in their respective countries, participated in the design and interpretation of this subset analysis, helped draft the manuscript, and approved the final manuscript. LM, EYM, and EA participated in the design and interpretation of this subset analysis, helped draft the manuscript, and approved the final manuscript. AS carried out the statistical analysis, participated in the interpretation of this subset analysis, helped draft the manuscript, and approved the final manuscript.
Psoriasis prevalence and characteristics in Asia, Central Europe, and Latin America have not been thoroughly investigated and there are no large trials for biologic treatments for patients from these regions. The goal of this analysis was to report clinical response to anti-tumor necrosis factor-alpha treatment in these patients.
Patients from Argentina, Czech Republic, Hungary, Mexico, Taiwan, and Thailand (N = 171) were included in this subset analysis of the PRISTINE trial. Patients with stable moderate-to-severe plaque psoriasis were blinded and randomized to receive etanercept 50 mg once weekly (QW) or biweekly (BIW) for 12 weeks, followed by 12 weeks of open-label QW treatment with etanercept 50 mg through week 24 (QW/QW vs. BIW/QW). Concomitant methotrexate (≤20 mg/week) and mild topical corticosteroids or other agents were permitted at the physician’s discretion, in accordance with therapeutic practice.
As early as week 8, 26.7 % in the etanercept QW group and 44.0 % in the BIW group achieved Psoriasis Area and Severity Index (PASI) 75. At weeks 12 and 24, respectively, PASI 75 increased to 39.5 % and 62.8 % in the QW/QW group and 66.7 % and 83.3 % in the BIW/QW group. PASI 75 was significantly different between treatment groups from week 8 through the end of study (p < 0.05). The Kaplan-Meier estimate of the proportions achieving PASI 75 in QW/QW and BIW/QW groups, respectively, was 27.4 % and 45.8 % through week 8; 41.9 % and 68.7 % through week 12; and 72.5 % and 95.2 % through week 24.
Treatment with etanercept 50 mg provided rapid relief of psoriasis symptoms in patients from Asia, Central Europe, and Latin America. A more rapid response was observed in patients who received BIW treatment for the first 12 weeks which was sustained after reducing to QW dosing for the subsequent 12 weeks. Response rates were similar to those observed in the overall PRISTINE population.
ClinicalTrials.gov identifier NCT00663052.
Ding X, Wang T, Shen Y, Wang X, Zhou C, Tian S, et al. Prevalence of psoriasis in China: a population-based study in six cities. Eur J Dermatol. 2012;22(5):663–7. PubMed
Nast A, Boehncke W-H, Mrowietz U, Ockenfels H-M, Philipp S, Reich K, et al. S3 – Guidelines on the treatment of psoriasis vulgaris (English version). Update. J German Soc Dermatol. 2012;10:S1–s95.
Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol. 2010;62(1):114–35. CrossRefPubMed
Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826–50. CrossRefPubMed
Menter A. The status of biologic therapies in the treatment of moderate to severe psoriasis. Cutis. 2009;84(4 Suppl):14–24. PubMed
Strohal R, Puig L, Chouela E, Tsai TF, Melin J, Freundlich B, et al. The efficacy and safety of etanercept when used with as-needed adjunctive topical therapy in a randomised, double-blind study in subjects with moderate-to-severe psoriasis (the PRISTINE trial). J Dermatolog Treat. 2013;24(3):169–78. CrossRefPubMed
EuroQol--a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy . 1990; 16(3):199–208.
Cetkovská P, Kojanová M. Czech recommendations for biological therapy of severe plaque psoriasis. Čes-slov Derm. 2012;87(1):1–76.
Amaya-Guerra M, Barba F, Blancas González F, Gómez Flores M, Gómez Trigo A, González Soto R, et al. Consenso Mexicano para el Manejo de Terapia Biológica en Psoriasis. Rev Cent Dermatol Pascua. 2004;13(3):172–84.
- Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial
E. Y. Mahgoub
- BioMed Central
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