Ustekinumab. Análisis de efectos adversos infecciosos

Herranz-Pinto, P.; Sendagorta, E.

doi:10.1016/S0001-7310(12)70005-4

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A pesar de ser la terapia de uso más reciente en dermatología, es el fármaco que mayor número de pacientes ha aportado en su desarrollo clínico en psoriasis. Gracias a esta experiencia acumulada, se ha confirmado que el perfil de seguridad de ustekinumab frente a eventos infecciosos demuestra un riesgo similar a placebo y equiparable a la población general en cuanto a incidencia absoluta, infecciones severas y requerimientos de antibioterapia adicional. 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Información del artículo

Estadísticas

Resumen

Ustekinumab es el primer representante de un nuevo grupo de fármacos biológicos, cuyo mecanismo de acción principal es la inhibición selectiva de la actividad de las interleucinas 12 y 23. A pesar de ser la terapia de uso más reciente en dermatología, es el fármaco que mayor número de pacientes ha aportado en su desarrollo clínico en psoriasis. Gracias a esta experiencia acumulada, se ha confirmado que el perfil de seguridad de ustekinumab frente a eventos infecciosos demuestra un riesgo similar a placebo y equiparable a la población general en cuanto a incidencia absoluta, infecciones severas y requerimientos de antibioterapia adicional. Este comportamiento inicial se confirma durante el seguimiento a 3 y 4 años en pacientes con psoriasis moderada a severa.

A pesar de este perfil favorable de seguridad, el carácter inmunosupresor selectivo de ustekinumab aconseja mantener un seguimiento estricto de los pacientes en tratamiento, como el despistaje de infecciones activas o latentes, similar a los aplicados en el caso de los fármacos anti factor de necrosis tumoral.

Palabras clave:

Ustekinumab

Psoriasis

Efectos adversos

Seguridad

Infecciones

Abstract

Ustekinumab is the first of a new class of biologic agents whose main mechanism of action involves the selective inhibition of IL-12 and IL-23. Although ustekinumab is the latest biologic to be approved for use in dermatology, its approval was based on the largest clinical development program conducted to date in psoriasis. Safety data accumulated during the clinical development phase showed the risk of infection to be similar in patients in the ustekinumab and placebo groups. The use of additional antibiotics and the rates of overall infection and serious infection in patients on ustekinumab and the general population were also comparable. Subsequent studies confirmed the safety of this drug in patients with moderate to severe psoriasis treated for 3 or 4 years. Despite its favorable safety profile, ustekinumab is a selective immunosuppressant. Clinicians should therefore closely monitor patients and apply screening measures similar to those used during anti-TNF therapy to detect de novo infections or the reactivation of latent infections.

Keywords:

Ustekinumab

Psoriasis

Adverse effects

Safety

Infections

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References

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F.O. Nestle, D.H. Kaplan, J. Barker.

Psoriasis.

N Engl J Med, 361 (2009), pp. 496-509

http://dx.doi.org/10.1056/NEJMra0804595 | Medline

[2.]

M. Lebwohl.

New developments in the treatment of psoriasis.

Arch Dermatol., 138 (2002), pp. 686-688

Medline

[3.]

A. Di Cesare, P. Di Meglio, F.O. Nestle.

The IL-23/Th17 axis in the immunopathogenesis of psoriasis.

J Invest Dermatol, 129 (2009), pp. 1339-1350

http://dx.doi.org/10.1038/jid.2009.59 | Medline

[4.]

C.L. Leonardi, A.B. Kimball, K.A. Papp, N. Yeilding, C. Guzzo, Y. Wang, PHOENIX 1 study investigators, et al.

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