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Arthritis Drug Actemra (Tocilizumab) Gets Expanded Indication
The FDA has approved Actemra (tocilizumab; Genentech) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA). The drug can be used alone or in combination with methotrexate in children 2 years of age and older with active disease.
PJIA is a form of juvenile idiopathic arthritis (JIA), also known as juvenile rheumatoid arthritis — a chronic disease of childhood. JIA affects approximately 100 in every 100,000 children, of which PJIA accounts for about 30%. PJIA is characterized by inflammation in five or more joints within the first 6 months of the disease and most commonly affects the small joints in the body, such as the hands and feet.
Actemra (tocilizumab) was the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with active, moderate-to-severe rheumatoid arthritis (RA) who have experienced an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Actemra is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA).
The expanded indication for Actemra in children with PJIA was based on data from the phase III CHERISH trial, which had an open-label phase, followed by a randomized double-blind placebo-controlled withdrawal phase. The study demonstrated that children treated with Actemra experienced clinically meaningful improvements in the signs and symptoms of PJIA. At 4 months, a 30% improvement in the tender or swollen joint count — defined by American College of Rheumatology criteria (ACR30) — was achieved by 91% of the patients taking Actemra plus methotrexate, and by 83% of the patients taking Actemra alone. In the withdrawal phase of the trial, Actemra-treated patients experienced significantly fewer disease flares compared with placebo-treated patients (26% [21/82] vs. 48% [39/81], respectively).
Source: Genentech; April 30, 2013.