How was ENBREL tolerated by pediatric patients with JIA?
In general, the adverse events in pediatric patients were similar in frequency and type as those seen in adult patients (see WARNINGS and other sections under ADVERSE REACTIONS in the ENBREL Prescribing Information). Severe adverse reactions reported in 69 JIA patients ages 4 to 17 years included varicella (see also PRECAUTIONS, Immunizations in the ENBREL Prescribing Information), gastroenteritis, depression/personality disorder, cutaneous ulcer, esophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft-tissue and postoperative wound infection.1 Forty-three of 69 (62%) children with JIA experienced an infection while receiving ENBREL during 3 months of study (part 1, open-label), and the frequency and severity of infections were similar in 58 patients completing 12 months of open-label extension therapy. The types of infections reported in JIA patients were generally mild and consistent with those commonly seen in outpatient pediatric populations. T
