The US Food and Drug Administration (FDA) has approved the interleukin 6 inhibitor tocilizumab (Actemra, Genentech) for the treatment of polyarticular juvenile idiopathic arthritis (JIA) in children aged 2 years and older with active disease, the company announced today. Tocilizumab can be given as monotherapy or in combination with methotrexate (MTX).
JIA is the most common form of arthritis in children, affecting roughly 100 in 100,000 children, of which polyarticular JIA accounts for about 30%.
Polyarticular JIA is characterized by inflammation in 5 or more joints within the first 6 months of onset and most commonly affects the small joints in the hands and feet, although weight-bearing joints such as the knees, hips, and ankles may also be affected.
Polyarticular JIA is a "rare, debilitating condition in children that worsens over time," Hal Barron, MD, chief medical officer and head of global product development at Genentech, said in a statement. "We are pleased to offer Actemra to doctors and parents of children aged 2 or older as an important medicine to help improve the signs and symptoms of this often painful disease."
The approval of tocilizumab for polyarticular JIA was based largely on data from the phase 3 CHERISH study that showed clinically meaningful improvement in signs and symptoms of the disease with tocilizumab therapy.
According to the company, 91% of patients taking tocilizumab plus MTX and 83% of those taking tocilizumab alone achieved at least a 30% improvement in signs and symptoms of JIA (an American College of Rheumatology [ACR] 30 response) at week 16 compared with baseline.
In the randomized double-blind placebo-controlled withdrawal phase of the trial, tocilizumab-treated patients experienced significantly fewer disease flares compared with placebo-treated patients (26% vs 48%).
The safety data collected to date for tocilizumab in polyarticular JIA is consistent with those observed in previous studies in tocilizumab-treated patients, the company said. In the CHERISH study, infections were the most common adverse events. Laboratory abnormalities known to occur with tocilizumab were also seen, including decreases in white blood cell counts and platelet counts and elevation in liver enzyme levels.
The CHERISH results were presented at the ACR Annual Meeting in 2012, as reported by Medscape Medical News at that time.
On April 25, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of tocilizumab for polyarticular JIA, as Medscape Medical News also reported.
The FDA approval marks the second tocilizumab indication in children. It is already approved to treat systemic JIA in children aged 2 years and older.
Tocilizumab is also approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs.
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Cite this: FDA Approves Tocilizumab for Polyarticular JIA - Medscape - May 01, 2013.