FDA News

FDA approves Actemra subcutaneous injection for active systemic JIA

Sandra Horning, MD
Sandra Horning

The FDA has approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients aged 2 years and older, according to a press release from Genentech.

Often characterized by inflammation in one or more joints, and a daily, spiking fever for at least 2 weeks that is sometimes accompanied by a skin rash, systemic juvenile idiopathic arthritis is the rarest form of juvenile arthritis, affecting approximately 30,000 children in the United States. Prior studies have determined that other accompanying symptoms can include anemia, enlargement of the liver or spleen, as well as inflammation of the lining of the heart and/or lungs.

“Systemic juvenile idiopathic arthritis is a rare, debilitating disease with limited treatment options,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “We are pleased to now offer physicians the flexibility to prescribe for children 2 years of age and older either Actemra IV, administered in a medical office, or Actemra subcutaneous, a prefilled syringe that can be injected at home.”

The FDA has approved the subcutaneous formulation of tocilizumab for the treatment of active systemic JIA in patients aged 2 years and older, according to a press release.
Credit: Shutterstock

According to the company, Actemra (tocilizumab) can be administrated as monotherapy or in combination with methotrexate in patients with systemic juvenile idiopathic arthritis. In 2011, the FDA approved the IV formulation of the drug for patients with active systemic juvenile idiopathic arthritis aged 2 years and older.

The FDA based its approval on findings from the phase 1b JIGSAW-118 study, a 52-week, open-label, multicenter trial to determine the appropriate dosing of tocilizumab across a range of body weights in children with systemic juvenile idiopathic arthritis. The researchers recruited 51 patients with systemic juvenile idiopathic arthritis aged 1 to 17 years who had previous inadequate response or intolerance to NSAIDs and corticosteroids. 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 2 weeks or 10 days, and those weighing 30 kg or more received the same amount weekly for 52 weeks.

According to the press release, the observed safety profile of subcutaneous tocilizumab was consistent with that of the IV formulation, with the exception of higher frequency of injection site reactions among patients treated with the subcutaneous drug, with a frequency rate of 41% compared with patients treated for other approved indications. All reactions were mild in severity, and none required treatment withdrawal or dose interruption.

Subcutaneous tocilizumab’s efficacy in patients with systemic juvenile idiopathic arthritis 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.

Sandra Horning, MD
Sandra Horning

The FDA has approved the subcutaneous formulation of tocilizumab for the treatment of active systemic juvenile idiopathic arthritis in patients aged 2 years and older, according to a press release from Genentech.

Often characterized by inflammation in one or more joints, and a daily, spiking fever for at least 2 weeks that is sometimes accompanied by a skin rash, systemic juvenile idiopathic arthritis is the rarest form of juvenile arthritis, affecting approximately 30,000 children in the United States. Prior studies have determined that other accompanying symptoms can include anemia, enlargement of the liver or spleen, as well as inflammation of the lining of the heart and/or lungs.

“Systemic juvenile idiopathic arthritis is a rare, debilitating disease with limited treatment options,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “We are pleased to now offer physicians the flexibility to prescribe for children 2 years of age and older either Actemra IV, administered in a medical office, or Actemra subcutaneous, a prefilled syringe that can be injected at home.”

The FDA has approved the subcutaneous formulation of tocilizumab for the treatment of active systemic JIA in patients aged 2 years and older, according to a press release.
Credit: Shutterstock

According to the company, Actemra (tocilizumab) can be administrated as monotherapy or in combination with methotrexate in patients with systemic juvenile idiopathic arthritis. In 2011, the FDA approved the IV formulation of the drug for patients with active systemic juvenile idiopathic arthritis aged 2 years and older.

The FDA based its approval on findings from the phase 1b JIGSAW-118 study, a 52-week, open-label, multicenter trial to determine the appropriate dosing of tocilizumab across a range of body weights in children with systemic juvenile idiopathic arthritis. The researchers recruited 51 patients with systemic juvenile idiopathic arthritis aged 1 to 17 years who had previous inadequate response or intolerance to NSAIDs and corticosteroids. 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 2 weeks or 10 days, and those weighing 30 kg or more received the same amount weekly for 52 weeks.

According to the press release, the observed safety profile of subcutaneous tocilizumab was consistent with that of the IV formulation, with the exception of higher frequency of injection site reactions among patients treated with the subcutaneous drug, with a frequency rate of 41% compared with patients treated for other approved indications. All reactions were mild in severity, and none required treatment withdrawal or dose interruption.

Subcutaneous tocilizumab’s efficacy in patients with systemic juvenile idiopathic arthritis 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.