Anti-TNF Therapy and Fetal Risk: A Systematic Review of the Literature

Marchioni, Renée; Kerner, Caroline; Lichtenstein, Gary R.

doi:10.1016/s0016-5085(11)63204-6

Cited by 3 publications

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“…Similar results come from a recent systematic review of the literature on anti-TNF-α use and fetal risk, in which 38 studies were included, for a total number of 437 women (189 infliximab, 230 adalimumab, 18 certolizumab pegol). The rates of congenital abnormalities (3.4%), fetal deaths (8.5%), and preterm births (2.7%) were similar to the rates in the general population 44. Safety during breastfeeding is unknown, but little evidence is available on excretion of adalimumab in breast milk 45…”

Section: Safetymentioning

confidence: 70%

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Update on the management of inflammatory bowel disease: specific role of adalimumab

Guidi¹,

Pugliese²,

Armuzzi³

2011

CEG

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Anti-tumor necrosis factor alpha (TNF-α) medications are a class of biologics employed in the treatment of patients with inflammatory bowel disease (IBD). Adalimumab is the first fully human monoclonal immunoglobulin directed against TNF-α, which binds with high affinity and specificity to membrane and soluble TNF. Adalimumab administered subcutaneously has demonstrated efficacy in the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and severe chronic psoriasis. Studies have shown that adalimumab is effective for inducing and maintaining remission of moderate-to-severe active Crohn’s disease (CD) patients at an induction dose of 160/80 mg (week 0 and 2) and at a maintenance dose of 40 mg every other week. The efficacy of adalimumab as a second-line therapy has also been documented for patients with loss of response or intolerance to infliximab. Adalimumab is also superior to placebo for inducing and maintaining complete perianal fistula closure. It also seems effective for reducing extraintestinal manifestations. The safety profile is similar to that of other anti-TNF therapy in CD patients, with lower immunogenicity and rate of adverse injection reactions than infliximab. Adalimumab is not approved for the treatment of ulcerative colitis (UC). Recently, however, the results of the first randomized, controlled trial on adalimumab for UC showed that adalimumab at 160/80 mg induction dose was safe and effective for inducing remission and clinical response after 8 weeks in patients with moderately-to-severely active UC failing treatment with corticosteroids and/or immunosuppressants. More data are necessary to clarify the therapeutic role of adalimumab in UC. This review of the literature summarizes available data on the efficacy and safety profile adalimumab in patients with IBD.

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Section: Safetymentioning

confidence: 70%

“…The rates of congenital abnormalities (3.4%), fetal deaths (8.5%), and preterm births (2.7%) were similar to the rates in the general population. 44 Safety during breastfeeding is unknown, but little evidence is available on excretion of adalimumab in breast milk. 45 …”

Section: Safetymentioning

confidence: 99%

Update on the management of inflammatory bowel disease: specific role of adalimumab

Guidi¹,

Pugliese²,

Armuzzi³

2011

CEG

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“…Further, there is no increased risk of infections in the offspring of mothers on biologic treatment during pregnancy. However, it should be emphasized that immunosuppression of the offspring contraindicate the use of live vaccines until the biologic agent is no longer detectable in the child’s circulation, because of the risk of fatal infections [63,93,94]. …”

Section: Discussionmentioning

confidence: 99%

Safety of TNF-α inhibitors during IBD pregnancy: a systematic review

Nielsen

Loftus

Jess

2013

BMC Med

119

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BackgroundTumor necrosis factor (TNF)-α inhibitors are increasingly being used in inflammatory bowel disease (IBD). Because this chronic intestinal disorder often affects women of fertile age, it is essential to assess the effect of biologics on pregnancy outcome.MethodsWe performed a systematic review of the English-language literature to investigate if treatment with TNF-α blockers during pregnancy in women with IBD increases the risk of spontaneous abortions, preterm delivery, stillbirth, low birth weight, congenital malformations, or risk of infections in the offspring. Of 552 articles and abstracts reviewed, 58 articles or abstracts with unique content were identified and included in this systematic review. However, most presentations were case reports or case series supplied by a limited number of observational studies. No randomized controlled studies were available.ResultsTNF-α inhibitors do not seem to affect either outcome of pregnancy in mothers with IBD, or the outcome in the offspring (congenital malformations and immunosuppression). Further, recent data have not identified any increased risk of infections in the first year of life in the offspring of mothers who received biologics, even in combination with immunomodulators (thiopurines).ConclusionsFrom the present systematic review, no association was found between administration of TNF inhibitors for IBD during pregnancy and adverse pregnancy outcome or congenital abnormalities. Further, no increased relative risk of infections has been reported in the first year of life in offspring of mothers who received biologics. Biologics should be discontinued during pregnancy solely if the IBD is in remission using the same stopping criteria as for patients with IBD in general, as uncontrolled activity of IBD may expose the mother and child to a risk greater than those only potentially coming from the use of TNF-α inhibitors. In such cases, inoculation of the offspring with live vaccines is contraindicated until the biologic agent is no longer detectable in the child’s circulation.

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My Treatment Approach to the Management of Ulcerative Colitis

Katz

2013

Mayo Clinic Proceedings

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Anti-TNF Therapy and Fetal Risk: A Systematic Review of the Literature

Cited by 3 publications

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Update on the management of inflammatory bowel disease: specific role of adalimumab

Update on the management of inflammatory bowel disease: specific role of adalimumab

Safety of TNF-α inhibitors during IBD pregnancy: a systematic review

My Treatment Approach to the Management of Ulcerative Colitis

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