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Focus on adverse events of TNFα blockade in JIA in an open monocentric long-term prospective study of 163 patients.
  1. Valeria Gerloni (gerloni{at}
  1. Gaetano Pini Institute of orthopedic, Italy
    1. Irene Pontikaki (pontikaki{at}
    1. Gaetano Pini Institute, Milan, Italy
      1. Maurizio Gattinara (gattinara{at}
      1. Gaetano Pini Institute, Milan, Italy
        1. Flavio Fantini (flavio.fantini{at}
        1. University of Milan, Italy


          Objective: To report adverse events (AEs) seen in a large cohort of patients with Juvenile Idiopathic Arthritis (JIA) treated with TNFα blockers (Infliximab and Etanercept).

          Methods: All JIA patients treated with Infliximab or Etanercepet at the Paediatric Rheumatologic Centre of the G. Pini Institute (Milan) from November 1999 to February 2006, were enrolled in an open, monocenter, long-term prospective study.

          Results: 163 patients (68 Infliximab, 95 Etanercept) were enrolled. Mean onset age 6.4±4.8 years, mean age 17.19.2 years, mean therapy duration 22.9±17.6 months. 45 patients (32 Infliximab, 13 Etanercept) failed to respond to or did not tolerate the first biologic and switched to a second one. 208 treatments (81 Infliximab, 127 Etanercept) were done. 71 AEs occurred in 51 (62.9%) Infliximab patients and led to discontinuation in 26 (32.1%). 133 AEs occurred in 69 (54.3%) Etanercept patients and led to discontinuation in 18 (14.2%). Some AEs, such as thrombocytopenia, neuro-psychiatric disorders, new onset of Crohn’s disease, new onset or flare-up of chronic iridocyclitis (CIC), are unusual and have rarely been described before, yet proved to be significant in frequency and/or clinically noteworthy in the large population we followed.

          Conclusions: In our six-year experience, anti-TNFα agents Infliximab and Etanercept have been well-tolerated and safe, and may be associated with only few serious, but all reversible, AEs. However, such inhibitors are associated with various and numerous AEs. Children and young adults affected by JIA should be carefully monitored so as to limit the risk of AEs during anti-TNFα therapy as much as possible.

          • Juvenile Idiopathic Arthritis
          • adverse events
          • anti-TNF agents
          • etanercept
          • infliximab

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