Long-term Safety and Efficacy of Etanercept in the Treatment of Psoriasis

Zaragoza, V.; Pérez, A.; Sánchez, J.L.; Oliver, V.; Martínez, L.; Alegre, V.

doi:10.1016/S1578-2190(10)70579-5

Article information

Abstract

Background

Clinical experience has shown that, in patients with psoriasis, suspending treatment with etanercept at week 24, as indicated in the prescribing information, may lead to a rebound effect. Several clinical trials support long-term use of etanercept, which was shown to have a good safety and efficacy profile.

Material and methods

This was a retrospective, observational study of 43 patients with moderate to severe plaque psoriasis, with and without joint involvement, who received continuous treatment with etanercept for more than 24 weeks.

Results

Etanercept was administered for a mean of 57 weeks. Overall, the Psoriasis Area and Severity Index (PASI) score decreased from a baseline value of 22.5 to 4.3 after treatment. In addition, with continuous treatment, most patients maintained decreases in PASI scores of 50% and even of 75%. Some patients without significant improvement in their PASI score in the first 24 weeks did manage to achieve significant results after prolonged treatment. These outcomes were achieved with a low incidence of adverse effects (reported in 13 patients [30.2%]), which were generally mild.

Conclusions

We present our clinical experience with long-term etanercept treatment in patients with moderate to severe psoriasis, with and without associated joint involvement. The efficacy and safety profiles were found to be favorable.

Keywords:

Etanercept

Long-term treatment

Safety

Efficacy

Resumen

Introducción

La experiencia clínica demuestra que la suspensión del tratamiento con etanercept en pacientes con psoriasis en la semana 24, como indica la ficha técnica del fármaco, produce en algunos casos rebrote de la enfermedad. Existen diversos ensayos que avalan el uso de etanercept a largo plazo con un buen perfil de seguridad y eficacia.

Material y métodos

Estudio observacional, retrospectivo, en el que se recogió a 43 pacientes con psoriasis en placas de moderada a grave, con y sin artropatía, tratados con etanercept de forma continua durante más de 24 semanas.

Resultados

El etanercept se administró durante un tiempo promedio de 57 semanas, y disminuyó el PASI (Psoriasis Area Severity Index) de forma global de un valor basal de 22,5 a 4,3. Además, con el tratamiento continuo, la mayor parte de los pacientes mantuvieron puntuaciones PASI inferiores al 50% o incluso al 75%. Por otra parte, algunos pacientes que no alcanzaron mejorías significativas en su puntuación PASI en las primeras 24 semanas pueden conseguirlo prolongando el tratamiento. Todo ello con una baja incidencia de efectos adversos (13 pacientes [30,2%]) y de características leves.

Conclusiones

Exponemos nuestra experiencia clínica con el tratamiento con etanercept a largo plazo en pacientes con psoriasis de moderada a grave, con y sin artropatía asociada, y demostramos un perfil favorable de eficacia y seguridad.

Palabras clave:

Etanercept

Tratamiento a largo plazo

Seguridad

Eficacia

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References

[1.]

C. Ferrandiz, X. Bordas, V. García-Patos.

Prevalence of psoriasis in Spain (Epiderma Project: phase I).

J Eur Acad Dermatol Venereol, 15 (2001), pp. 20-23

Medline

[2.]

E. Herrera, S. Habicheyn.

Eficacia clínica del etanercept en psoriasis y artritis psoriásica.

Actas Dermosifiliogr, 96 (2005), pp. 10-24

[3.]

A. Romero-Maté, C. García-Donoso, S. Córdoba-Guijarro.

Efficacy and safety of etanercept in psoriasis/psoriatic arthritis: An updated review.

Am J Clin Dermatol, 8 (2007), pp. 143-155

Medline

[4.]

A.B. Gottlieb, R.T. Matheson, N. Lowe, G.G. Krueger, S. Kang, B.S. Goffe, et al.

A randomized trial of etanercept as monotherapy for psoriasis.

Arch Dermatol, 139 (2003), pp. 1627-1632

http://dx.doi.org/10.1001/archderm.139.12.1627 | Medline

[5.]

P.J. Mease, B.S. Goffe, J. Metz, A. VanderStoep, B. Finck, D.J. Burge.

Etanercept in the treatment of psoriatic arthritis and psoriasis: A randomized trial.

Lancet, 356 (2000), pp. 385-390

http://dx.doi.org/10.1016/S0140-6736(00)02530-7 | Medline

[6.]

C.L. Leonardi, J.L. Powers, R.T. Matheson, B.S. Goffe, R. Zitnik, A. Wang, Etanercept Psoriasis Study Group, et al.

Etanercept as monotherapy in patients with psoriasis.

N Engl J Med, 3 (2003), pp. 2014-2022

[7.]

K.A. Papp, S. Tyring, M. Lahfa, J. Prinz, C.E. Griffiths, A.M. Nakanishi, Etanercept Psoriasis Study Group, et al.

A global phase II randomized controlled trial of etanercept in psoriasis: Safety, efficacy, and effect of dose reduction.

Br J Dermatol, 1 (2005), pp. 1304-1312

[8.]

Wyeth. Ficha técnica de Enbrel®. Spain; 2005.

[9.]

W.H. Boehncke, R.A. Brasie, J. Barker, S. Chimenti, E. Daudén, M. de Rie, European Dermatology Expert Group, et al.

Recommendations for the use of etanercept in psoriasis: A European dermatology expert group consensus.

JEADV, 20 (2006), pp. 988-998

http://dx.doi.org/10.1111/j.1468-3083.2006.01707.x | Medline

[10.]

K.A. Papp.

The long-term efficacy and safety of new biological therapies for psoriasis.

Arch Dermatol Res, 298 (2006), pp. 7-15

http://dx.doi.org/10.1007/s00403-006-0660-6 | Medline

[11.]

G.G. Krueger, B. Elewski, K.A. Papp, A. Wang, R. Zitnik, A. Jahreis.

Patients with psoriasis respond to continuous open-label etanercept treatment after initial incomplete response in a randomized, placebo-controlled trial.

J Am Acad Dermatol, 54 (2006), pp. S112-S119

http://dx.doi.org/10.1016/j.jaad.2005.10.054 | Medline

[12.]

B. Elewski, B. Strober, S. Tyring, et al.

Etanercept 50mg once weekly sustains safety and efficacy for up to 96 weeks in plaque psoriasis patient (poster).

15th Congress of the European Academy of Dermatology and Venereology,

[13.]

B. Elewski, C. Leonardi, A. Gottlieb, et al.

Etanercept dose escalation to 50mg twice weekly sustains safety and efficacy for up to 48 weeks in psoriasis patients who had incomplete response to 50mg once weekly (poster).

15th Congress of the European Academy of Dermatology and Venereology,

[14.]

B. Elewski, C. Leonardi, A. Gottlieb, et al.

Sustained long-term clinical efficacy and safety for up to 2,5 years of etanercept in patients with psoriasis (poster).

64th Annual Meeting of the American Academy of Dermatology,

[15.]

C.E.M. Griffiths, K. Papp, J. Koo, et al.

Long-term patient-reported outcomes: Etanercept therapy in patients with psoriasis (poster).

64th Annual Meeting of the American Academy of Dermatology,

[16.]

B. Elewski, C. Leonardi, P. Van de Kerkhof, et al.

Evaluation of clinical efficacy of etanercept at two different dosages with and without interruption in patients with moderate to severe plaque psoriasis (poster).

15th Congress of the European Academy of Dermatology and Venereology,

[17.]

S. Tyring, Y. Poulin, R. Langley, et al.

A 96-week phase 3 study of safety and efficacy of etanercept 50mg twice weekly in patients with psoriasis (poster).

64th Annual Meeting of the American Academy of Dermatology,

[18.]

R. Gamo, J.L. López-Estebaranz.

Terapia biológica y psoriasis.

Actas Dermosifiliogr, 97 (2006), pp. 1-17

Medline

[19.]

B. Martín, et al.