AMERICAN COLLEGE OF RHEUMATOLOGY: Tocilizumab responses durable to 2 years in juvenile idiopathic arthritis

February 1, 2012

In patients with severe, refractory, persistent systemic juvenile idiopathic arthritis (JIA), long-term treatment with tocilizumab induces significant, durable responses with acceptable toxicity, according to results from a multicenter phase 3 trial presented at the annual scientific meeting of the American College of Rheumatology, Chicago.

In patients with severe, refractory, persistent systemic juvenile idiopathic arthritis (JIA), long-term treatment with tocilizumab induces significant, durable responses with acceptable toxicity, according to results from a multicenter phase 3 trial presented at the annual scientific meeting of the American College of Rheumatology, Chicago.

Two-year results from the ongoing 5-year study were presented by Fabrizio De Benedetti, MD, from IRCCS Ospedale Pediatrico Bambino Gesu in Rome.

In the trial, 112 children aged 2 to 17 years old with disease activity for at least 6 months were randomly assigned to receive placebo or tocilizumab, with dosage based on body weight. Tocilizumab was given intravenously every 2 weeks at doses of 12 mg/kg for children with a body weight <30 kg or 8 mg/kg for children ≥30 kg. Concomitant stable doses of methotrexate, nonsteroidal anti-inflammatory drugs, and corticosteroids were permitted. Most children presented with very active disease.

Sixty-one patients received at least 104 weeks of tocilizumab treatment. Among these patients, more than 60% achieved a JIA ACR90 response, 88% achieved a JIA ACR70 response, and 60% were able to discontinue oral corticosteroids by week 104. The rate of serious infections was 22 per 100 person-years and the overall rate of serious adverse events remotely, possibly, or probably due to tocilizumab was 15 per 100 person-years.

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