title: Efficacy and safety of adalimumab as the first and second biologic agent in juvenile idiopathic arthritis: the German Biologics JIA Registry.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of adalimumab in patients with juvenile idiopathic arthritis (JIA).
  
  
  METHODS
  Baseline demographic and clinical characteristics and disease activity parameters were prospectively documented in the German Biologics JIA Registry. Efficacy was determined using the American College of Rheumatology (ACR) Pediatric (Pedi) response criteria and the Juvenile Arthritis Disease Activity Score based on a 10-joint count (JADAS-10). Safety assessments were based on adverse event reports from the responsible physician.
  
  
  RESULTS
  Two hundred eighty-nine patients with a total of 1,046 visits were identified (435.7 patient-years). A high proportion of patients demonstrated a significant response to treatment, with a marked decrease in the JADAS-10 score in both the biologics-naive group (which consisted of patients who had not received therapy with a biologic agent prior to initiation of adalimumab) and the biologic-switcher group (which consisted of patients who had been treated with a different biologic agent prior to initiation of adalimumab). The median JADAS-10 score at treatment start was significantly higher in the biologics-naive group than in the biologic-switcher group (12.9 versus 8.5; P = 0.00044), although the score in the biologics-naive group was lower over the course of adalimumab treatment. ACR Pedi 30, 50, 70, and 90 scores were achieved in 63.4%, 61.0%, 48.8%, and 34.2% of biologics-naive patients, respectively, at 6 months of treatment, while ACR Pedi 30, 50, 70, and 90 scores were achieved in 47.6%, 38.1%, 21.9%, and 15.2% of biologic-switcher patients, respectively. Forty-eight patients experienced 222 adverse events (50.9 per 100 patient-years). Eleven were reported as serious (2.5 per 100 patient-years). No malignancies were observed during adalimumab exposure. There were 16 uveitis flares in 11 patients. Treatment was discontinued in 58 patients for the following reasons: inefficacy 11.1%, adverse events 5.2%, remission 4.5%, patient request 11.8%, and other reasons 7.9%.
  
  
  CONCLUSIONS
  Adalimumab appears to be highly effective in children and adolescents with JIA who have been previously treated with biologic agents and in children and adolescents who switched biologic agents. The treatment is safe and its efficacy is similar to that of other biologic agents used to treat JIA. Few patients discontinued therapy due to intolerance or inefficacy.
authors.affiliation: Alberta Children's Hospital and University of Calgary, Calgary, Alberta, Canada.
authors.forename: Heinrike
authors.initials: H
authors.lastname: Schmeling
authors.forename: Kirsten
authors.initials: K
authors.lastname: Minden
authors.forename: Ivan
authors.initials: I
authors.lastname: Foeldvari
authors.forename: Gerd
authors.initials: G
authors.lastname: Ganser
authors.forename: Tony
authors.initials: T
authors.lastname: Hospach
authors.forename: Gerd
authors.initials: G
authors.lastname: Horneff
mesh_terms: D000068879:Adalimumab; D000293:Adolescent; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D012042:Registries; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D001688:Biological Products; D000068879:Adalimumab