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Gut. Jun 2005; 54(6): 890.
PMCID: PMC1774554

Adalimumab use in pregnancy

Infliximab, a chimeric antibody to tumour necrosis factor alpha (TNF-α), has demonstrated efficacy for the induction and maintenance of remission in patients with Crohn’s disease.1,2 Antibodies to the chimeric component of infliximab can lead to infusion reactions and possible loss of response.3 A human recombinant monoclonal antibody to TNF-α, adalimumab, has recently demonstrated safety and efficacy for induction of remission in Crohn’s disease.4 It has also been effective in patients who have lost response to infliximab.5 Currently, this drug is FDA approved for the treatment of rheumatoid arthritis but it is being administered off label to patients with Crohn’s disease who are intolerant of infliximab. The safety profile during pregnancy is not well known for either drug. We report a patient who has had two successful pregnancies, one while on infliximab and the other while on adalimumab.

A 34 year old woman with longstanding ileocolonic and perianal Crohn’s disease had severe disease activity at the time of conception. She had been on mesalamine, budesonide, and prednisone, and was unable to attain remission. She was intolerant of purine analogues. Infliximab had been successful in the past but she lost response over time. Adalimumab was started and she was on a maintenance regimen approximately one month prior to conception. During her pregnancy, she received a total of 38 doses of adalimumab at 40 mg subcutaneously every week. She continued on adalimumab following delivery and breast fed while on the drug. She had severely active disease at conception but had mild improvement by the first trimester and had moderately active disease throughout the third trimester. Post partum, she had mild to inactive disease. She successfully tapered her prednisone from 15 mg daily to 2.5 mg every other day by one month post partum. The pregnancy was uncomplicated and surveillance sonograms revealed normal growth without visible congenital anomalies. Due to a history of perianal disease, an elective Caesarean section was performed without complications at 38.5 weeks. No neonatal abnormalities were noted, and APGAR scores were 8 and 9. The child is now six months with normal growth and development.

This case is the first report of maintenance adalimumab use during pregnancy. With infliximab, animal studies for treatment of rheumatoid arthritis have not revealed fetotoxicity or teratogenicity.6 Katz et al reported on 96 human pregnancies exposed to infliximab with known outcomes.7 Of 100 progeny, 69 were live births, 13 were miscarriages, and 18 were elective terminations. This is similar to what is expected in the general Crohn’s population. We reported 10 women who had maintenance infliximab use during pregnancy8: all ended in live births with three premature infants and one with low birth weight.

While the health of the mother is our priority as gastroenterologists, the safety of inflammatory bowel disease medications during the childbearing years is always of concern. As biological agents are increasingly being used for maintenance therapy in Crohn’s disease, more patients are healthy enough to consider conception. Careful data collection and prospective study is required to be able to guide the management of men and women with inflammatory bowel disease desiring conception to ensure the health of the parent and child.

Supplementary Material

[Competing interest statement]

References

1. Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn’s disease. Crohn’s Disease cA2 Study Group. N Engl J Med 1997;337:1029–35. [PubMed]
2. Hanauer SB, Feagan BG, Lichtenstein GR, et al. Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial. Lancet 2002;359:1541–9. [PubMed]
3. Baert F, Noman M, Vermeire S, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn’s disease. N Engl J Med 2003;348:601–8. [PubMed]
4. Hanauer SB, Lukas M, MAcIntosh D. et al A randomized, double-blind, placebo controlled trial of the human anti-TNF alpha monoclonal antibody adalimumab for the induction of remission in patients with moderate to severely active Crohn’s disease. Gastroenterology 2004;127:332.
5. Sandborn W, Hanuer S, Loftus E, et al. An open-label study of the human anti-TNF monoclonal antibody adalimumab in subjects with prior loss of response or intolerance to infliximab for Crohn’s disease. Gastroenterology 2004;126:A53. [PubMed]
6. Treacy G . Using an analogous monoclonal antibody to evaluate the reproductive and chronic toxicity potential for a humanized anti-TNFalpha monoclonal antibody. Hum Exp Toxicol 2000;19:226–8. [PubMed]
7. Katz JA, Antoni C, Keenan GF, et al. Outcome of pregnancy in women receiving infliximab for the treatment of Crohn’s disease and rheumatoid arthritis. Am J Gastroenterol 2004;99:2385–92. [PubMed]
8. Mahadevan U, Kane S, Sandborn W, et al. Intentional infliximab use during pregnancy for induction or maintenance of remission in Crohn’s disease. Aliment Pharmacol Ther 2005; (in press). [PubMed]

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