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FDA approves Actemra subcutaneous injection for polyarticular JIA
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The FDA has approved the subcutaneous formulation of Actemra for the treatment of polyarticular juvenile idiopathic arthritis in patients aged 2 years and older, according to a press release from Genentech.
“Polyarticular juvenile idiopathic arthritis (PJIA) is a rare, often painful disease in children,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “With this approval, we are pleased Actemra offers an alternative delivery option to physicians and parents of children aged two or older to treat this debilitating disease.”
According to the company, Actemra (tocilizumab) can be administrated as monotherapy or in combination with methotrexate in patients with PJIA. In 2013, the FDA approved the IV formulation of the drug for patients with PJIA aged 2 years and older.
The approval was based on findings from the phase 1 JIGSAW-117 study, a 52-week, open-label, multicenter trial to determine the appropriate dosing of tocilizumab across a range of juvenile body weights in children with PJIA. The researchers recruited 52 patients with PJIA aged 1 to 17 years who had previous inadequate response or intolerance to methotrexate. In addition, participants either had never received tocilizumab or were being treated with the IV formulation with adequate disease control.
Patients were treated with open-label, subcutaneous tocilizumab in doses based on body weight: those weighing less than 30 kg received 162 mg every 3 weeks, and those weighing 30 kg or more received the same amount every 2 weeks.
According to the press release, the observed safety profile of subcutaneous tocilizumab was consistent with that of the IV formulation, with two exceptions. First, there was a higher frequency of injection site reactions among patients treated with the subcutaneous drug, with a frequency rate of 28.8%, compared to the IV version. All reactions were mild in severity, and none required treatment withdrawal or dose interruption.
Second, a decrease in neutrophil counts below 1 × 109 per L occurred in 15.4% of patients during routine laboratory monitoring. According to the press release, the decrease was more frequently observed in patients who weighed less than 30 kg, compared with those who weighed 30 kg or more.
Subcutaneous tocilizumab’s efficacy in patients with PJIA aged 2 to 17 years is based on pharmacokinetic exposure and extrapolation of established data from the IV drug, as well as the subcutaneous version in patients with rheumatoid arthritis.
According to the press release, PJIA accounts for approximately 30% of all children with JIA.