Adalimumab for the treatment of pediatric Crohn’s disease

Abstract

Inflammatory bowel diseases are characterized by a chronic relapsing course, high morbidity and impaired quality of life. Their incidence is rising, and about 25% of cases are diagnosed in pediatric age. Anti-TNF-α antibodies, such as infliximab and adalimumab (ADA), are usually administered in patients refractory to conventional therapies. However, increasing evidence suggests that they can be introduced earlier in the course of the disease, especially in patients with aggressive and extensive disease since diagnosis. ADA is a fully human anti-TNF-α antibody recently approved for pediatric Crohn’s disease not only in patients unresponsive to infliximab, but also as a first-line anti-TNF-α therapy. In this review, we aim to summarize the current knowledge on the use of ADA in pediatric Crohn’s disease and to discuss open issues regarding safety as well as future perspectives.

Keywords:

• adalimumab
• anti-TNF-α antibodies
• efficacy
• inflammatory bowel disease
• pediatric Crohn’s disease
• safety

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Inflammatory bowel diseases (IBDs) occur in 25–30% of cases during pediatric age.

• The aggressive nature and the evolution of IBD in childhood make anti-TNF-α antibodies an attractive option for many pediatric patients with IBD.

• Adalimumab (ADA), a completely human anti-TNF-α antibody, has been recently approved for pediatric Crohn’s disease refractory to previous therapies.

• ADA in pediatric Crohn’s disease induces and maintains clinical remission, facilitates mucosal healing and improves growth and quality of life by achieving steroid-sparing remission.

• The efficacy of ADA in early IBD, and the actual effectiveness of combination of ADA with immunosuppressants, need to be confirmed in large randomized controlled trials.

• The risk of fatal lymphoma (hepatosplenic T-cell lymphoma) in young males treated with combination therapy with azathioprine, and the risk for opportunistic infections should be carefully considered in pediatric IBD.

• Future research should focus on the identification of reliable predictors of response and on clear indicators for patients who can withdraw immunosuppressive treatment due to long-term deep remission.