Etanercept en el embarazo y lactancia

Borrego, L.

doi:10.1016/S0001-7310(10)70016-8

Información del artículo

Resumen

Etanercept es un fármaco biológico, inhibidor del factor de necrosis tumoral indicado para el tratamiento de la psoriasis grave o moderada resistente a otras terapias. Debido a que su empleo cada vez está más extendido, deberíamos conocer sus posibles efectos teratogénicos. Los datos aportados por la literatura y los estudios previos a la comercialización del producto son muy escasos, por lo que se hace necesario profundizar en la presencia de posibles riesgos mediante la experimentación en modelos animales y la realización de estudios prospectivos prolongados en humanos. Con los conocimientos actuales parece ser que la suspensión del tratamiento un mes antes de la concepción daría un margen de seguridad adecuado y la mayoría de las pacientes que se han quedado embarazadas y han suspendido el etanercept, en el momento de conocer su estado, no han tenido complicaciones. Sin embargo, los datos necesarios para recomendar etanercept en el control de la psoriasis de una mujer embarazada son muy escasos y controvertidos.

Dado que no se conocen los efectos de un posible paso de etanercept a la leche materna, en un sistema inmune todavía inmaduro y de acuerdo con el principio riesgo/beneficio, no se debiera recomendar el empleo de etanercept en mujeres en periodo de lactancia.

Palabras clave:

Etanercept

Embarazo

Lactancia

Abstract

Etanercept is a biological drug, inhibitor of the Tumor Necrosis Factor indicated for the treatment of severe or moderate psoriasis resistant to other therapies. Because its use is becoming increasingly extended, we should know its possible teratogenic effects. The data provided by the literature and studies prior to the marketing of the product are very limited. Thus, it is necessary to study the presence of possible risks more through experiments in animal models and to conduct prolonged prospective studies in humans. With the current knowledge, it seems that suspension of the treatment from one month prior to becoming pregnant would provide an adequate safety margin, and that most of the patients who have become pregnant and have suspended etanercept as soon as they knew they were pregnant have not had any complications. However, the data needed to recommend etanercept for the control of psoriasis of a pregnant woman are very limited and controversial.

Since the effects of a possible transfer of etanercept to maternal milk in a still-immature immune system are not known, in accordance with the risk/benefit principle, the use of etanercept should not be recommended in breast-feeding women.

Keywords:

Etanercept

Pregnancy

Breast-feeding

El Texto completo está disponible en PDF

Bibliografía

[1.]

B. Martín, J.L. Sánchez-Carazo, A. Pérez-Ferriols, C. Laguna, V. Oliver, V. Alegre.

Etanercept en la psoriasis. Experiencia clínica.

Actas Dermosifiliogr, 99 (2008), pp. 540-545

Medline

[2.]

S. Weatherhead, S.C. Robson, N.J. Reynolds.

Management of psoriasis in pregnancy.

BMJ, 334 (2007), pp. 1218-1220

http://dx.doi.org/10.1136/bmj.39202.518484.80 | Medline

[3.]

C.S. Buhimschi, C.P. Weiner.

Medications in pregnancy and lactation: part 1. Teratology.

Obstet Gynecol, 113 (2009), pp. 166-188

http://dx.doi.org/10.1097/AOG.0b013e31818d6788 | Medline

[4.]

J. Lam, J.E. Polifka, M.A. Dohil.

Safety of dermatologic drugs used in pregnant patients with psoriasis and other inflammatory skin diseases.

J Am Acad Dermatol, 59 (2008), pp. 295-315

http://dx.doi.org/10.1016/j.jaad.2008.03.018 | Medline

[5.]

Resumen de características del producto: Enbrel European Medicine Agency (EMEA) 2009 (Consultado 29/06/2009). Disponible en: http://www.emea.europa.eu/humandocs/PDFs/EPAR/Enbrel/H-262-PI-es.pdf

[6.]

Etanercept [package insert]. Seattle, WA: Immunex Corporation and Wyeth-Ayerst Pharmaceuticals; 2002. (Consultado 29/06/2009). Acceso: http://www.enbrel.com/pdf/enbrel_pi.pdf

[7.]

E.S. Sills, M. Perloe, M.J. Tucker, C.R. Kaplan, G.D. Palermo.

Successful ovulation induction, conception, and normal delivery after chronic therapy with etanercept: a recombinant fusion anti-cytokine treatment for rheumatoid arthritis.

Am J Reprod Immunol, 46 (2001),

[8.]

K.L. Hyrich, D.P. Symmons, K.D. Watson, A.J. Silmann.

the British Society of Rheumatology Biologics Register: Pregnancy outcome in women who were exposed to anti-tumor necrosis factor agents: results from a nation population register.

Arthritis Rheum, 54 (2006), pp. 2701-2702

http://dx.doi.org/10.1002/art.22028 | Medline

[9.]

J.S. Suominen, Y. Wang, A. Kaipia, J. Toppari.

Tumor necrosis factor- alpha (TNF-alpha) promotes cell survival during spermatogenesis, and this effect can be blocked by infliximab, a TNF-alpha antagonist.

Eur J Endocrinol, 151 (2004), pp. 629-640

Medline

[10.]

U. Mahadevan, J.P. Terdiman, J. Aron, S. Jacobsohn, P. Turek.

Infliximab and semen quality in men with inflammatory bowel disease.

Inflamm Bowel Dis, 11 (2005), pp. 395-399

Medline

[11.]

C.H. Roux, O. Brocq, V. Breuil, C. Albert, L. Euller-Ziegler.

Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)-alpha therapy.

Rheumatology (Oxford), 46 (2007), pp. 695-698

[12.]

J.E. Salmon, D. Alpert.

Are we coming to terms with tumor necrosis factor inhibition in pregnancy?.

Arthritis Rheum, 54 (2006), pp. 2353-2355

http://dx.doi.org/10.1002/art.22027 | Medline

[13.]

J.J. Cush.

Biological drug use: US perspectives on indications and monitoring.

Ann Rheum Dis, 64 (2005), pp. 18-23

[14.]

J. Yui, M. García-Lloret, T.G. Wegmann, L.J. Guilbert.

Cytotoxicity of tumour necrosis factor-alpha and gamma-interferon against primary human placental trophoblasts.

Placenta, 15 (1994), pp. 819-835

Medline

[15.]

S.A. Robertson, A.S. Care, R.J. Skinner.

Interleukin 10 regulates inflammatory cytokine synthesis to protect against lipopolysaccharide- induced abortion and fetal growth restriction in mice.

Biol Reprod, 76 (2007), pp. 738-748

http://dx.doi.org/10.1095/biolreprod.106.056143 | Medline

[16.]

J.S. Hunt, H.L. Chen, L. Miller.

Tumor necrosis factors: pivotal components of pregnancy?.

Biol Reprod, 54 (1996), pp. 554-562

Medline

[17.]

CRI Club Rhumatisme Inflammation (Consultado 29/06/2009) Disponible en: http://www.crinet.com/recherche/fichesPratiques/index_fiche_antitnf.asp

[18.]

J.M. Berthelot, M. De Bandt, P. Goupille, E. Solau-Gervais, F. Lioté, V. Goeb, CRI (Club Rhumatismes et Inflammation), et al.

Exposition to anti-TNF drugs during pregnancy: outcome of 15 cases and review of the literature.

Joint Bone Spine, 76 (2009), pp. 28-34

http://dx.doi.org/10.1016/j.jbspin.2008.04.016 | Medline

[19.]

B.E. Joven, A.J. García-González, T. Ruiz, E. Moreno, L. Cebrián, M. Valero.

Pregnancy in women receiving anti-TNF therapy. Experience in Spain.

Arthritis Rheum, 9 (2005), pp. S349

[20.]

A. Strangfeld, J. Listing, R. Rau, M. Schneider, F. Hierse, A. Krause.

Pregnancy outcome after exposure to biologics: results from the German Biologics Register RABBIT.

Arthritis Rheum, 9 (2007), pp. S311

[21.]

C.D. Chambers, D.L. Johnson, K.L. Jones.

Pregnancy outcome in women exposed to anti-TNF-alpha medications: The OTIS Rheumatoid Arthritis in Pregnancy Study.

Arthritis Rheum, 50 (2004), pp. S479-S480

[22.]

D.L. Johnson, K.L. Jones, C.D. Chambers.

Pregnancy outcomes in women exposed to etanercept: The OTIS Autoimmune Diseases in Pregnancy Project.

Arthritis Rheum, 58 (2008), pp. S682

[23.]

D.J. Wallace.

The use of etanercept and other tumor necrosis factor-alpha blockers in infertility: it's time to get serious.

J Rheumatol, 30 (2003), pp. 1897-1899

Medline

[24.]

E.E. Winger, J.L. Reed.

Treatment with tumor necrosis factor inhibitors and intravenous immunoglobulin improves live birth rates in women with recurrent spontaneous abortion.

Am J Reprod Immunol, 60 (2008), pp. 8-16

http://dx.doi.org/10.1111/j.1600-0897.2008.00585.x | Medline

[25.]

J.D. Carter, J. Valeriano, F.B. Vasey.

Tumor necrosis factor-alpha inhibition and VATER association: a causal relationship.

J Rheumatol, 33 (2006), pp. 1014-1017

Medline

[26.]

J.D. Carter, A. Ladhani, L.R. Ricca, J. Valeriano, F.B. Vasey.

A safety assessment of tumor necrosis factor antagonists during pregnancy: a review of the Food and Drug Administration database.

J Rheumatol, 36 (2009), pp. 635-641

http://dx.doi.org/10.3899/jrheum.080545 | Medline

[27.]

G. Koren, M. Inoue.

Do tumor necrosis factor inhibitors cause malformations in humans?.

J Rheumatol, 36 (2009), pp. 465-466

http://dx.doi.org/10.3899/jrheum.081083 | Medline

[28.]

H. Shiels, X. Li, P.T. Schumacker, P.A. Padrid, A. Sperling, C.B. Thompson, et al.

TRAF4 deficiency leads to tracheal malformation with resulting alterations in air flow to the lungs.

Am J Pathol, 157 (2000), pp. 679-688

http://dx.doi.org/10.1016/S0002-9440(10)64578-6 | Medline

[29.]

C.H. Regnier, R. Masson, V. Kedinger, J. Textoris, I. Stoll, M.P. Chenard, et al.

Impaired neural tube closure, axial skeleton malformations, and tracheal ring disruption in TRAF4-deficient mice.

Proc Natl Acad Sci USA, 99 (2002), pp. 5585-5590

http://dx.doi.org/10.1073/pnas.052124799 | Medline

[30.]

E.F. Chakravarty, D. Sánchez-Yamamoto, T.M. Bush.

The use of disease modifying antirheumatic drugs in women with rheumatoid arthritis of childbearing age: a survey of practice patterns and pregnancy outcomes.

J Rheumatol, 30 (2003), pp. 241-246

Medline

[31.]

I. Otermin, G. Elizondo, J. Zabaleta, A. Amigot.

Etanercept y embarazo.

An Sist Sanit Navar, 30 (2007), pp. 491-493

Medline

[32.]

I. Rosner, A. Haddad, N. Boulman, J. Feld, N. Avshovich, G. Slobodin, et al.

Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)-alpha therapy.

Rheumatology (Oxford), 46 (2007), pp. 1508

[33.]

Nonclinical Pharmacology and Toxicology Review of BLA 98-0286. Data on file at the FDA. 1998. (Consultado 29/06/2009). Disponible en: http://www.fda.gov/cder/biologics/review/etanimm110298r5.pdf.

Indexada en:

Síguenos:

Indexada en:

Síguenos:

Suscríbase a la newsletter