LONDON – Children with systemic juvenile idiopathic arthritis continued to improve on treatment with the interleukin-6 inhibitor tocilizumab, as their time on the drug extended to 1 year in follow-up of the open-label phase of a pivotal trial for this disease.
During continued treatment, the percent of sJIA patients with an ACR 90 response and no fever rose from 37% of the treated group at the end of the 12-week randomized trial, to about 55% after 40 more weeks of open-label treatment.
There was no active joint disease in 49 of the 99 patients (49%) treated for 52 weeks; the children appeared to be in full remission, Dr. Fabrizio De Benedetti said. In addition, 52 of the patients treated for 52 weeks fully withdrew from treatment with oral corticosteroids.
At their entry onto tocilizumab treatment, their average corticosteroid dosage was 0.30 mg/kg per day.
Tocilizumab also had an “acceptable” safety profile.
Thirteen patients had a serious adverse event, and six had an adverse event leading to withdrawal from treatment.
“There was no increase in the rate of serious adverse events between weeks 12 and 52.
“It is reassuring that there was no accumulation of safety issues with time. But it's still only 1 year, so we still need more time” to fully assess safety, said Dr. De Benedetti, director of the division of rheumatology at Ospedale Pediatrico Bambino Gesù in Rome and lead investigator for the TENDER trial and extension.
Based on results from the 12-week randomized phase III trial, Roche – which developed and markets tocilizumab (Actemra) – in April received approval from the Food and Drug Administration for an expanded indication for tocilizumab to treat sJIA. It received FDA approval last year for treatment of rheumatoid arthritis.
Dr. De Benedetti sees tocilizumab as a reasonable first-line agent.
However, another new treatment approach that warrants investigation for treating sJIA are the IL-1 inhibitors, such as anakinra (Kineret) and canakinumab (Ilaris), he added.
The TENDER trial was sponsored by Roche, the company that markets tocilizumab.
Dr. De Benedetti said he has been a consultant to Bristol-Myers Squibb, Hoffmann-La Roche, and Pfizer, and he has received research support from Hoffmann-La Roche.
It is reassuring that there was no increase in the rate of serious adverse events between weeks 12 and 52.
Source DR. DE BENEDETTI