Major Finding: Patients with systemic juvenile idiopathic arthritis randomized to biweekly infusions of tocilizumab for 12 weeks had an 91% rate of an ACR30 response and no fever, compared with a 24% rate of this primary end point in patients randomized to placebo.
Data Source: A multicenter, randomized, placebo-controlled trial of intravenous tocilizumab in 112 patients with systemic juvenile idiopathic arthritis.
Disclosures: Dr. De Benedetti said that he has been a consultant to and has received research funding from Roche.
ROME — Patients with systemic juvenile idiopathic arthritis who were treated with the interleukin 6-inhibitor drug tocilizumab produced strong responses in a randomized, multicenter, placebo-controlled trial.
After 12 weeks of treatment in the 112-patient study, the children in the tocilizumab arm had response rates that significantly surpassed those of patients in the placebo arm, Dr. Fabrizio De Benedetti said at the annual European Congress of Rheumatology (see table).
In addition, the response rates were “still going up” at 12 weeks. “I hope that the 1-year data will show even better benefit,” Dr. De Benedetti said in an interview.
“A vast body of evidence suggests that IL [interleukin]-6 drives systemic JIA. These data are a proof of principle that the majority of patients appear to benefit [from blocking IL-6],” said Dr. De Benedetti, a rheumatologist at Bambino Gesù Pediatric Hospital here.
“In our experience, tocilizumab is a dramatically beneficial drug,” commented Dr. Taunton Southwood, professor of pediatric rheumatology at the University of Birmingham (England), who was not involved in the study.
The new study in children and adolescents with systemic JIA was sponsored by Roche, which markets tocilizumab (Actemra).
The trial enrolled patients aged 2-17 years who had been diagnosed with systemic JIA for at least 6 months at several centers worldwide.
The average age of the 112 enrolled patients was 10 years, and they had been diagnosed for a median of 5 years. The researchers randomized 75 patients to tocilizumab and 37 to placebo. Patients who weighed less than 30 kg received 12 mg/kg tocilizumab as an intravenous infusion every 2 weeks; patients who weighed 30 kg or more received 8 mg/kg on the same schedule. Seventeen patients in the placebo group (46%) and 72 patients in the tocilizumab group (96%) completed all 12 weeks of treatment.
The study's primary end point was the fraction of patients who achieved an ACR30 response and had no fever at 12 weeks, calculated on an intention to treat basis.
“We tested a different dosing regimen from adults [who receive the drug every 4 weeks], because the disease is different and the pharmacokinetics of the drug is different compared with adults,” Dr. De Benedetti said.
The primary end point occurred in 24% of the placebo patients and 91% of those in the tocilizumab arm, a statistically significant difference.
Vitals
Source Elsevier Global Medical News