This article is more than 5 years old. Information may no longer be current.
Tocilizumab reduced severity of systemic JIA; adverse events warrant further research
Click Here to Manage Email Alerts
Patients with systemic juvenile idiopathic arthritis were more responsive to tocilizumab therapy than placebo patients but experienced more adverse events, including infection and neutropenia, according to study results.
In an ongoing 5-year, multicenter study, researchers conducted a trial of 112 patients who had been diagnosed with active, systemic juvenile idiopathic arthritis (JIA) for more than 6 months. All patients, aged 2 to 17 years, had responded inadequately to nonsteroidal anti-inflammatory drugs and glucocorticoids. In the first of the two-phase study, patients were randomly assigned to tocilizumab (n=75) or placebo (n=37) for 12 weeks. Dosage was weight-based and ranged from 8 mg/kg to 12 mg/kg every 2 weeks. Placebo patients were transitioned to open-label tocilizumab at week 12 for the second phase.
At the primary endpoint more patients in the tocilizumab group showed loss of fever and reached ACR 30 response criteria for JIA (improvement of 30% or greater in at least three of six ACR variables with no more than one variable regressing by up to 30%) than placebo patients (85% vs. 24%; P<.001). After 52 weeks, 80% of tocilizumab patients experienced at least 70% improvement, including absence of fever, and 59% reached JIA ACR 90 response.
Adverse events were common among tocilizumab patients in the double-blind and cumulative extension phases. There were 159 AEs, including 60 infections, in phase 1, while placebo patients experienced 15 infections among 38 AEs. In both phases, patients receiving tocilizumab were affected by 39 serious AEs, including 18 serious infections, while 19 patients developed neutropenia (17 with Grade 3; two with Grade 4) and 21 registered alanine aminotransferase levels that were at least 2.5 times beyond the normal-range limit.
“Inhibition of interleukin-6 with tocilizumab is efficacious in severe, persistent, and unresponsive systemic JIA,” the researchers concluded. “The benefits of this treatment must be weighed against the risks of infection, neutropenia, and abnormalities in results of liver-function tests. Longer-term safety data are warranted.”
Disclosure: See the study for a full list of relevant disclosures.
Click Here to Manage Email Alerts