Efficacy and safety of adalimumab for the treatment of Crohn's disease in adults.
ABSTRACT Biologic agents offer potentially disease-modifying benefits that address long-term symptom control. Adalimumab was developed to be a fully human monoclonal antibody and an advancement over previously developed biologics. Adalimumab induces and maintains long-term clinical response and remission in patients with moderate-to-severe Crohn's disease (CD) who had failed to respond to conventional therapy. In addition, adalimumab is effective in patients who cannot tolerate or who have lost response to infliximab therapy. Clinical trials demonstrate that adalimumab reduces the risk of CD-related hospitalization, maintains rapid complete fistula closure and is steroid-sparing, especially when administered early in the course of the disease. Adalimumab is generally well-tolerated by patients with moderate-to-severe CD. Opportunistic infections occurred in approximately 2% of adalimumab-treated patients and malignant neoplasms occurred in approximately 1% of patients, with no differences compared with placebo during the randomized, placebo-controlled portions of the adalimumab trials. This article reviews the efficacy and safety of adalimumab in the treatment of adult patients with CD and discusses the role of adalimumab in the current and future management of CD.
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ABSTRACT: The aim of this article is to critically review available data regarding the safety of immunomodulators and biological therapies during pregnancy and breast-feeding in women with inflammatory bowel disease. Methotrexate and thalidomide can cause congenital anomalies and are contraindicated during pregnancy (and breast-feeding). Although thiopurines have a Food and Drug Administration (FDA) rating D, available data suggest that these drugs are safe and well tolerated during pregnancy. Although traditionally women receiving azathioprine or mercaptopurine have been discouraged from breast-feeding because of theoretical potential risks, it seems that these drugs may be safe in this scenario. Treatment with cyclosporine for steroid-refractory ulcerative colitis (UC) during pregnancy can be considered safe and effective, and the use of this drug should be considered in cases of severe UC as a means of avoiding urgent surgery. Breast-feeding is contraindicated for patients receiving cyclosporine. Biological therapies appear to be safe in pregnancy, as no increased risk of malformations has been demonstrated. Therefore, the limited clinical results available suggest that the benefits of infliximab and adalimumab in attaining response and maintaining remission in pregnant patients might outweigh the theoretical risks of drug exposure to the fetus. Stopping therapy in the third trimester may be considered, as it seems that transplacental transfer of infliximab is low prior to this. Certolizumab differs from infliximab and adalimumab in that it is a Fab fragment of an antitumor necrosis factor alpha monoclonal antibody, and therefore it may not be necessary to stop certolizumab in the third trimester. The use of infliximab is probably compatible with breast-feeding.Inflammatory Bowel Diseases 01/2010; 16(5):881-95. DOI:10.1002/ibd.21154 · 5.48 Impact Factor
- Revista Brasileira de Coloproctologia 01/2010; 30(2). DOI:10.1590/S0101-98802010000200003