title: Safety and efficacy of adalimumab in pediatric patients with Crohn disease.
abstract: OBJECTIVE
  Adalimumab has recently become available for adult patients with Crohn disease (CD) as a viable alternative tumor necrosis factor-alpha inhibitor to infliximab. To our knowledge, there have been no studies reviewing the use of adalimumab in pediatric patients with CD. Our aim was to examine the safety and efficacy of adalimumab therapy in pediatric patients with CD.
  
  
  METHODS
  We performed a retrospective chart review of 15 pediatric patients with CD who received adalimumab at a single institution between January 2003 and March 2007. All of the patients had a history of an attenuated response or anaphylaxis to infliximab. Each patient's chart was reviewed for age at diagnosis, sex, extent of disease, age at start of adalimumab therapy, course of therapy, side effects noted during therapy, concurrent medications, and response to adalimumab. Clinical response to adalimumab was classified as complete, partial, or no response based on the patients' ability to be weaned from steroids, increased or decreased need for steroids, or need for surgery during the course of treatment. This study was approved by the Cleveland Clinic Institutional Review Board.
  
  
  RESULTS
  Fifteen pediatric patients with CD received adalimumab for a 33-month period. Of those, 14 patients had adequate follow-up, and 1 patient was lost to follow-up. The mean age at initiation of therapy was 16.6 years (median 17.9 years, range 10.3-21.8 years, SD 3.1 years). The majority of patients received an 80-mg loading dose administered subcutaneously and 40-mg doses subsequently every 2 weeks. The median duration of therapy was 6.5 months (range 1-31 months). A total of 272 injections were given. Of the 14 patients with sufficient data for follow-up, 7 (50%) had a complete response, 2 (14%) had a partial response, and 5 (36%) had no response to adalimumab. Complete response was achieved after a median of 5 injections (range 3-11). Of the 14 patients with adequate follow-up, 5 had fistulizing disease; 3 of these maintained fistula closure, 1 had temporary closure, and 1 required surgery to assist with closure. Twenty-six adverse events occurred during therapy. Eight (57%) patients had at least 1 adverse effect. The most common events were abdominal pain and nausea. No serious adverse events were reported, no serious infections occurred, and no adverse events required discontinuation of adalimumab.
  
  
  CONCLUSIONS
  Adalimumab was well tolerated in pediatric patients with CD. Complete or partial response was observed in 64% of patients. No serious adverse events occurred during therapy. Additional studies are needed to evaluate the efficacy and to determine optimal dosing of adalimumab in the pediatric population with CD.
authors.affiliation: Department of Pediatric Gastroenterology and Nutrition, Children's Hospital, Cleveland Clinic, Cleveland, OH 44195, USA.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Wyneski
authors.forename: Alex
authors.initials: A
authors.lastname: Green
authors.forename: Marsha
authors.initials: M
authors.lastname: Kay
authors.forename: Robert
authors.initials: R
authors.lastname: Wyllie
authors.forename: Lori
authors.initials: L
authors.lastname: Mahajan
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced / Q000453:epidemiology; D000068879:Adalimumab; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002648:Child; D003257:Consumer Product Safety; D003424:Crohn Disease / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology; D012074:Remission Induction; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014409:Tumor Necrosis Factor-alpha; D000068879:Adalimumab