The Pharmaceutical Journal
Vol 280 No 7496 p392
5 April 2008

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Tocilizumab effective for arthritis

Evidence to support the effectiveness of tocilizumab — the first humanised interleukin-6-receptor monoclonal antibody — in patients with rheumatoid arthritis has been published in The Lancet (2008;371:987).

A separate article shows promising results for tocilizumab in patients with juvenile idiopathic arthritis (ibid, p998). An accompanying editorial (ibid, p961) suggests the results be greeted with cautious optimism.

The first study is a phase III trial of 623 patients with moderate to severe rheumatoid arthritis who had an incomplete response to methotrexate and were randomised to receive tocilizumab 8mg/kg, tocilizumab 4mg/kg or placebo intravenously every four weeks, along with methotrexate at pre-study doses.

At 24 weeks, 59 per cent of the higher dose group and 48 per cent of the lower dose group achieved a 20 per cent reduction in the number of swollen and tender joints (ACR20) compared with 26 per cent of the placebo group. Remission was achieved by 27 per cent in the high-dose group compared with 0.8 per cent in the placebo group.

In the second trial, also phase III, 56 children who had incomplete responses to conventional treatment received three doses of tocilizumab 8mg/kg at two-week intervals. After six weeks patients responding to the drug were randomised to continue fortnightly treatment or change to placebo. At week 18, 80 per cent of those receiving tocilizumab had maintained a 30 per cent reduction in symptoms on a paediatric scale compared with 17 per cent of those swapped to placebo.

In an editorial, Tim Bongartz of the Mayo Clinic College of Medicine, Rochester, Minnesota, points out that comparisons are needed between tocilizumab and other effective treatments. He also highlights a “significant increase” in low-density lipoprotein cholesterol in the rheumatoid arthritis patients taking the high-dose tocilizumab.

“On the basis of available information, thought and caution would influence my decision to initiate therapy in patients with rheumatoid arthritis or JIA with a new drug that significantly increases predictors of cardiovascular morbidity and mortality — especially if agents with similar efficacy are available that influence these predictors to a lesser extent,” he says.