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Vol. 101. Issue 2.
Pages 156-163 (March 2010)
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Vol. 101. Issue 2.
Pages 156-163 (March 2010)
Original Article
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Adverse Reactions During Biological Therapy for Psoriasis: Results of a Survey of the Spanish Psoriasis Group
Efectos Adversos Observados Durante la Terapia Biológica en la Psoriasis. Resultados de una Encuesta al Grupo Español de Psoriasis
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M. Sánchez-Regañaa,
Corresponding author
ez.reg@terra.es

Corresponding author.
, E. Dilméa, Ll. Puigb, X. Bordasc, J.M. Carrascosa,d, M. Ferrane, P. Herranzf, M. García-Bustinduyg, J.L. López Estebaranzh, M. Alsinai, M.A. Rodríguezj, M. Riberad, E. Fernández-Lópezk, J.C. Morenol, I. Belinchón Romerom, D. Vidaln
a Hospital Universitari Sagrat Cor, Barcelona, Spain
b Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
c Hospital Universitari de Bellvitge, Barcelona, Spain
d Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
e Hospital del Mar, Barcelona, Spain
f Hospital Universitario la Paz, Madrid, Spain
g Hospital Universitario de Canarias, La Laguna, Tenerife, Spain
h Fundación Hospital Alcorcón, Madrid, Spain
i Hospital Clínic, Barcelona, Spain
j Hospital de León, León, Spain
k Hospital Universitario de Salamanca, Salamanca, Spain
l Hospital Universitario Reina Sofía, Córdoba, Spain
m Hospital General Universitario de Alicante, Alicante, Spain
n Hospital Dos de Maig, Barcelona, Spain
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Abstract
Background

Biologic therapies have been a major breakthrough in the treatment of psoriasis because they are more selective and have a better short-term and medium-term safety profile. There are reliable data to support both the efficacy and the safety of these drugs. However, it is always useful to report the clinical experience of dermatologists who are experts in the use of biologic agents to treat psoriasis, particularly with regard to their safety.

Material and methods

We present the results of a survey administered to the members of Spanish Psoriasis Group and based on a series of questions referring to the clinical safety of these agents. A total of 988 patients treated with efalizumab, infliximab, etanercept, and adalimumab were reported by 15 members of the group.

Results

There was a particularly high proportion of reactions (34%) to infliximab infusions. Blood test abnormalities were detected in 13.25% of patients and infections in 12.24%, with one case of pulmonary tuberculosis. Attention is drawn to the adverse effects profile of efalizumab: de novo arthritis in 5.8% and rebound in 20.9% of patients.

Conclusion

The safety data provided by our study should be taken into account in view of the large number of patients recruited by dermatologists experienced in the use of this type of therapy.

Keywords:
Psoriasis
Biologic agents
Survey
Safety
Adverse reactions
Resumen
Introducción

La terapia biológica ha representado un avance muy importante en el tratamiento de la psoriasis, al tratarse de una generación de fármacos más selectivos y con mejor perfil de seguridad a corto y medio plazo. Existen datos sólidos a favor de la eficacia de cada uno de estos fármacos, así como de su seguridad. A pesar de ello, siempre es útil aportar la experiencia clínica de dermatólogos expertos en el tratamiento de la psoriasis con biológicos, en especial en lo referente a su seguridad.

Material y métodos

Se realizó una encuesta a los miembros del Grupo Español de Psoriasis (GEP) basada en una serie de ítems relativos a aspectos referentes a la seguridad clínica de estos fármacos, cuyos resultados se presentan en este artículo. Un total de 988 pacientes tratados con efalizumab, etanercept, infliximab y adalimumab fueron recogidos por parte de 15 miembros del GEP.

Resultados

Entre los resultados obtenidos destaca la elevada proporción de reacciones a infliximab (34%). Se observaron alteraciones analíticas en el 13,25% de los pacientes e infecciones en el 12,24%, con un único caso de tuberculosis pulmonar. Es de destacar el perfil de efectos secundarios de efalizumab: artritis de novo en el 5,8% y rebote en el 20,9%.

Conclusión

Los datos de seguridad aportados por nuestro trabajo deben tenerse en consideración, habida cuenta del importante número de pacientes reclutados por un grupo de dermatólogos expertos en el manejo de este tipo de fármacos.

Palabras clave:
Psoriasis
Biológicos
Encuesta
Seguridad
Efectos adversos
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References
[1.]
C. Ferrándiz.
Nuevos tratamientos en la psoriasis.
Med Clin (Barc), 129 (2007), pp. 377-378
[2.]
S.R. Rapp, S.R. Feldman, M.L. Exum, A.B. Fleisxe, D.M. Reboussin.
Psoriasis causes as much disability as other major medical diseases.
J Am Acad Dermatol, 41 (1999), pp. 401-407
[3.]
W. Sterry, J. Baker, W.H. Boehncke, J.D. Bos, S. Chimenti, E. Christophers, et al.
Biological therapies in the systemic management of psoriasis; International Consensus Conference.
Br J Dermatol, 151 (2004), pp. 3-17
[4.]
D. Thaci.
Long-term data in the treatment of psoriasis.
Br J Dermatol, 159 (2008), pp. 18-24
[5.]
R. Gamo, J.L. López -Estebaranz.
Terapia biológica y psoriasis.
Actas Dermosifiliogr, 97 (2006), pp. 1-17
[6.]
L. Puig, J.M. Carrascosa, E. Daudén, J.L. Sánchez-Carazo, C. Ferrándiz, M. Sánchez-Regaña, et al.
Directrices españolas basadas en la evidencia para el tratamiento de la psoriasis moderada a grave con agentes biológicos.
Actas Dermosifiliogr, 100 (2009), pp. 386-413
[7.]
C. Leonardi, A. Menter, T. Hamilton, I. Caro, B. Xing, A.B. Gottlieb.
Efalizumab: results of a 3-year continuous dosing study for the long-term control of psoriasis.
Br J Dermatol, 158 (2008), pp. 1107-1116
[8.]
A. Costanzo, K. Peris, M. Talamonti, A. Di Cesare, M. Concetta Fargnoli, E. Botti, et al.
Long-term treatment of plaque psoriasis with efalizumab: an Italian experience.
Br J Dermatol, 156 (2007), pp. 17-23
[9.]
C. Antoniou, I. Stefanaki, A. Stratigos, G. Avgerinou, P. Stavropoulos, I. Potouridou, et al.
The Greek experience with efalizumab in psoriasis from a University Dermatologic Hospital.
Br J Dermatol, 156 (2007), pp. 12-16
[10.]
N. Selenko-Gebauer, F. Karlhoer, G. Stingl.
Efalizumab in routine use: a clinical experience.
Br J Dermatol, 156 (2007), pp. 1-6
[11.]
K. Kragballe.
Efalizumab in the treatment of chronic plaque psoriasis: experiences from the largest psoriasis treatment centre in Denmark.
Br J Dermatol, 156 (2007), pp. 7-11
[12.]
A.B. Gottlieb, C.L. Leonardi, B.S. Goffe.
Etanercept monotherapy in patients with psoriasis: A summary of safety, based on an integrated multistudy database.
J Am Acad Dermatol, 54 (2006), pp. S92-S100
[13.]
S. Tyring, K.B. Gorgon, Y. Poulin, R.G. Langley, A.B. Gottlieb, M. Dunn, et al.
Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis.
Arch Dermatol, 143 (2007), pp. 719-726
[14.]
J.P. Ortonne, C. Griffiths, E. Daudén, R. Strohal, D. Robertson, R. Pedersen, et al.
Comparación de la eficacia y seguridad del tratamiento continuo e intermitente con etanercept en pacientes con psoriasis moderada a grave durante 54 semanas: estudio CRYSTEL.
Expert Rev Dermatol, 3 (2008), pp. 657-666
[15.]
J.M. Ko, A.B. Gottlieb, J.F. Kerbleski.
Induction and exacerbation of psoriasis with TNF-blockade therapy: a review and analysis of 127 cases.
J Dermatol Treat, 20 (2009), pp. 100-108
[16.]
K. Reich, C. Griffiths, J. Barber, S. Chimenti, E. Daudén, A. Giannetti, et al.
Recommendations for the long-term treatment of psoriasis with infliximab: a dermatology expert group consensus.
Dermatology, 217 (2008), pp. 268-275
[17.]
L. Puig, E. Sáez, M.J. Lozano, X. Bordas, J.M. Carrascosa, F. Gallardo, et al.
Reacciones a la infusión de infliximab en pacientes dermatológicos.
Actas Dermosifiliogr, 100 (2009), pp. 103-112
[18.]
R.B. Warren, B.C. Brown, D. Lavery, D.M. Ashcroft, C.E.M. Griffiths.
Biologic therapies for psoriasis: practical experience in a UK tertiary referral centre.
Br J Dermatol, 160 (2008), pp. 162-169
[19.]
J.H. Saurat, G. Stingl, L. Dubertret, K. Papp, R.G. Langley, J.P. Ortonne, et al.
Efficacy and safety results from the comparative study of adalimumab (HUMIRA) versus methotrexate versus placebo in psoriasis patients (CHAMPION).
Br J Dermatol, 158 (2008), pp. 558-566
[20.]
K.B. Gordon, R.G. Langley, C. Leonardi, D. Toth, M.A. Menter, S. Kang, et al.
Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study.
J Am Acad Dermatol, 55 (2006), pp. 598-606
Copyright © 2010. Academia Española de Dermatología y Venereología and Elsevier España, S.L.
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