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EULAR 2013: Interim results from the CHERISH trial of resistent juvenile idiopathic arthritis show lasting efficacy for monthly doses of 8 or 10 mg/kg of tocilizumab.
Interim results from an ongoing clinical trial of the IL-6 blocker toclizumab (Actemra) among children with polyarticular juvenile idiopathic arthritis (pcJIA) shows the drug is not only safe and effective, but that monthly dosing leads to a sustained, clinically-meaningful improvement.
These results, from the two-year international, multi-center CHERISH trial, involving children ages 2 to 17 with active pcJIA unresponsive after more than six months of methotrexate (MTX) treatment, were reported at the 2013 annual meeting of the European League Against Rheumatism (EULAR) in Madrid, Spain.
In part 1 of CHERISH, a 16-week open-label study, 188 young patients (a majority female) received either placebo or monthly tocilizumab (TCZ) in one of three IV doses based on body weight; 79% were on concurrent MTX and 46% on oral corticosteroids.
The dose of TCZ was 8 mg/kg for a body weight of ≥30 kg; for a body weight of <30 kg, participants were randomly assigned to 8 mg/kg or 10 mg/kg (n=119, n=34, and n=35, respectively). Twenty-two children withdrew from this phase, 15 due to insufficient responses and 3 due to adverse events, mostly infections.
At 16 weeks, the researchers decided efficacy was superior for the two higher doses of TCZ (8 mg/kg for lighter patients and 10 mg/kg for patients >30 kg) than for the 8 mg/dose for the latter. The safety profile is consistent with that seen in other patients on TCZ.
A total of 166 children achieved the primary endpoint of at least a 30% improvement in signs and symptoms of pcJIA (JIA ACR30) by 16 weeks and moved on to part 2, a 24-week study in which they were randomized to remain on the same doses of TCZ or placebo. Responses of JIA ACR30/50/70 were also significantly higher in the TCZ group, with as many as 65% realizing an ACR70 response.
Fewer patients in the TCZ group had a flare by week 40 (25.6% vs 48.1% for placebo).
CHERISH part 3 is an open-label studythat is continuing at 58 centers in 15 countries.