Published experiences of TNF-α inhibition during pregnancy consist of a limited number of case reports, series and ongoing registry data in patients with arthritis and inflammatory bowel disease. A 28-year-old woman – with psoriasis vulgaris since she was 8 years of age and generalized pustular psoriasis during her first pregnancy (partially controlled with ciclosporin, oral prednisone and topical corticosteroids, when lupus anticoagulant was detected at another hospital) – presented 4 months after delivery with severe psoriasis (PASI = 15.4) that did not respond to ciclosporin (3 mg/kg/day). Ten days after the first infusion of infliximab (5 mg/kg), when the patient became aware that she was pregnant again, there was PASI75 response, and the patient wished to continue this treatment after being fully informed. Complete blanching was achieved by week 6 of treatment, and was maintained thereafter until the moment of writing (19 months after the start of treatment). She gave birth by caesarean delivery to a healthy female baby, who was breastfed for 1 month and has developed normally. The current report extends the available evidence on successful infliximab treatment in pregnant women, with the first case of a patient with psoriasis who presented impetigo herpetiformis during her previous pregnancy. No detectable adverse effects were detected in the neonate, despite potential exposure to infliximab throughout gestation and breastfeeding. Even though absolute safety is difficult to prove, available data suggest that women who become pregnant while taking infliximab or other anti-TNFα agents can be reassured regarding the continuation of pregnancy.

1.
Weatherhead S, Robson SC, Reynolds NJ: Management of psoriasis in pregnancy. BMJ 2007;334:1218–1220.
2.
Ben-David G, Sheiner E, Hallak M, Levy A: Pregnancy outcome in women with psoriasis. J Reprod Med 2008;53:183–187.
3.
Lam J, Polifka JE, Dohil MA: Safety of dermatologic drugs used in pregnant patients with psoriasis and other inflammatory skin diseases. J Am Acad Dermatol 2008;59:295–315.
4.
Chambers CD, Tutuncu ZN, Johnson D, Jones KL: Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data. Arthritis Res Ther 2006;8:215.
5.
Sheth N, Greenblatt DT, Acland K, Barker J, Teixeira F: Generalized pustular psoriasis of pregnancy treated with infliximab. Clin Exp Dermatol 2009;34:521–522.
6.
Cush JJ: Biological drug use: US perspectives on indications and monitoring. Ann Rheum Dis 2005;64(suppl 4):iv18–iv23.
7.
Berthelot JM, De Bandt M, Goupille P, Solau-Gervais E, Lioté F, Goeb V, et al: CRI (Club Rhumatismes et Inflammation): exposition to anti-TNF drugs during pregnancy: outcome of 15 cases and review of the literature. Joint Bone Spine 2009;76:28–34.
8.
Katz JA, Antoni C, Keenan GF, Smith DE, Jacobs SJ, Lichtenstein GR: Outcome of pregnancy in women receiving infliximab for the treatment of Crohn’s disease and rheumatoid arthritis. Am J Gastroenterol 2004;99:2385–2392.
9.
Carter JD, Valeriano J, Vasey FB: Tumor necrosis factor-alpha inhibition and VATER association: a causal relationship. J Rheumatol 2006;33:1014–1017.
10.
Chakravarty EF, Sanchez-Yamamoto D, Bush TM: 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 2003;30:241–246.
11.
Carter JD, Ladhani A, Ricca LR, Valeriano J, Vasey FB: A safety assessment of tumor necrosis factor antagonists during pregnancy: a review of the Food and Drug Administration database. J Rheumatol 2009;36:635–641.
12.
Koren G, Inoue M: Do tumor necrosis factor inhibitors cause malformations in humans? J Rheumatol 2009;36:465–466.
13.
Lichtenstein GR, Cohen RD, Feagan BG, Sandhorn WJ, Salzberg BA, Chen DM, et al: Safety of infliximab in Crohn’s disease: data from the 5,000-patient TREAT registry. Gastroenterology 2004;126(suppl 2):A54.
14.
Mahadevan U, Kane S, Sandborn WJ, Cohen RD, Hanson K, Terdiman JP, et al: Intentional infliximab use during pregnancy for induction or maintenance of remission in Crohn’s disease. Aliment Pharmacol Ther 2005;21:733–738.
15.
O’Donnell S, O’Morain C: Review article: use of antitumour necrosis factor therapy in inflammatory bowel disease during pregnancy and conception. Aliment Pharmacol Ther 2008;27:885–894.
16.
Hyrich KL, Symmons DP, Watson KD, Silman AJ, British Society for Rheumatology Biologics Register: Pregnancy outcome in women who were exposed to anti-tumor necrosis factor agents: results from a national population register. Arthritis Rheum 2006;54:2701–2702.
17.
Roux CH, Brocq O, Breuil V, Albert C, Euller-Ziegler L: Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)-alpha therapy. Rheumatology (Oxford) 2007;46:695–698.
18.
Rosner I, Haddad A, Boulman N, Feld J, Avshovich N, Slobodin G, et al: Pregnancy in rheumatology patients exposed to anti-tumour necrosis factor (TNF)-alpha therapy. Rheumatology (Oxford) 2007;46:1508.
19.
Simister NE: Placental transport of immunoglobulin G. Vaccine 2003;21:3365–3369.
20.
Kane S, Ford J, Cohen R, Wagner C: Absence of infliximab in infants and breast milk from nursing mothers receiving therapy for Crohn’s disease before and after delivery. J Clin Gastroenterol 2009;43:613–616.
21.
Vasiliauskas EA, Church JA, Silverman N, Barry M, Targan SR, Dubinsky MC: Case report: evidence for transplacental transfer of maternally administered infliximab to the newborn. Clin Gastroenterol Hepatol 2006;4:1255–1258.
22.
Mahadevan U, Terdiman JP, Church J, Vasiliauskas E, Gitis A, Dubinsky MC: Infliximab levels in infants born to women with inflammatory bowel disease. Gastroenterology 2007;132(suppl 2):A144.
23.
Martin PL, Cornacoff JB, Treacy G, Eirikas E, Marini J, White KL Jr, et al: Effects of administration of a monoclonal antibody against mouse tumor necrosis factor alpha during pregnancy and lactation on the pre- and postnatal development of the mouse immune system. Int J Toxicol 2008;27:341–347.
24.
Martin PL, Oneda S, Treacy G: Effects of an anti-TNF-alpha monoclonal antibody, administered throughout pregnancy and lactation, on the development of the macaque immune system. Am J Reprod Immunol 2007;58:138–149.
25.
Mottet C, Juillerat P, Pittet V, Gonvers JJ, Froehlich F, Vader JP, et al: Pregnancy and breastfeeding in patients with Crohn’s disease. Digestion 2007;76:149–160.
26.
Stengel JZ, Arnold HL: Is infliximab safe to use while breastfeeding? World J Gastroenterol 2008;14:3085–3087.
27.
Wang W, Wang EQ, Balthasar JP: Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther 2008;84:548–558.
28.
Ostensen M, Eigenmann GO: Etanercept in breast milk. J Rheumatol 2004;31:1017–1018.
29.
Ramos-Casals M, Brito-Zeron P, Soto MJ, Cuadrado MJ, Khamashta MA: Autoimmune diseases induced by TNF-targeted therapies. Best Pract Res Clin Rheumatol 2008;22:847–861.
30.
Remicade Summary of Product Characteristics (EMEA). www.emea.europa.eu/humandocs/Humans/EPAR/remicade/remicade.htm.
31.
Reich K, Griffiths C, Barker J, Chimenti S, Daudén E, Giannetti A, et al: Recommendations for the long-term treatment of psoriasis with infliximab: a dermatology expert group consensus. Dermatology 2008;217:268–275.
32.
Skomsvoll JF, Wallenius M, Koksvik HS, Rødevand E, Salvesen KA, Spigset O, et al: Drug insight: anti-tumor necrosis factor therapy for inflammatory arthropathies during reproduction, pregnancy and lactation. Nat Clin Pract Rheumatol 2007;3:156–164.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.