Abstract
Efficacy and safety of TCZ, an IL-6 receptor inhibitor, were previously demonstrated at wk 40 of CHERISH, a phase 3 trial in patients (pts) with pcJIA [1].
Highlights
Efficacy and safety of TCZ, an IL-6 receptor inhibitor, were previously demonstrated at wk 40 of CHERISH, a phase 3 trial in patients with polyarticularcourse juvenile idiopathic arthritis (pcJIA) [1]
ALT and AST elevations ≥3 × upper limit of normal occurred in 6.4% and 2.7% of pts, respectively
Efficacy of TCZ was maintained through 2 years of treatment in pts with pcJIA, with no change in safety profile from that reported previously [1]
Summary
To investigate efficacy and safety of TCZ over 104 wks of treatment in pcJIA. 188 pts with 307 pt years (PY). To investigate efficacy and safety of TCZ over 104 wks of treatment in pcJIA. Rates/100PY of AEs and serious AEs (SAEs) were 406.5 and 11.1, respectively; infections were the most common AE (151.4) and SAE (5.2). ALT and AST elevations ≥3 × upper limit of normal occurred in 6.4% and 2.7% of pts, respectively. Grade 3 neutropenia and grade 2/3/4 thrombocytopenia occurred in 5.9% and 1.6% of pts, respectively. LDL cholesterol ≥110 mg/dl occurred in 16.2% of pts
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