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Roche claims arthritis drug tops rival in trials

RoActemra reduces RA symptoms more effectively than Humira in phase IV trial

Roche has said that preliminary results from a phase IV clinical trial of RoActemra/Actemra suggest it reduces rheumatoid arthritis (RA) symptoms more effectively than Abbott's rival product Humira.

Top-line results from the head-to-head study - called ADACTA - indicate that monotherapy with RoActemra (tocilizumab) performed better on all primary and secondary measures of efficacy compared to Humira (adalimumab).

Preliminary safety analysis showed adverse event rates were similar between the two groups.

That is an important finding for Roche, which has been trying to win market share for RoActemra in the competitive market for biologic therapies for arthritis, currently dominated by Humira and other anti-TNF agents. RoActemra is an antibody targeting interleukin-6.

Last year the product grew by 73 per cent to 618m Swiss francs ($675m), with growth mainly coming from the US market, but it has a long way to go before it can rival Humira's 2011 turnover of $7.9bn.

The ADACTA results showed that patients who received Roche's drug achieved a significantly greater reduction in disease activity, assessed by the mean change of DAS281 rating scale, after 24 weeks than those given Humira monotherapy.

RoActemra also performed significantly better on key secondary endpoints, including DAS28 remission and low disease activity, ACR20, 50 and 702, all of which are standard criteria to assess effectiveness of treatments for RA.

One barrier to the take-up of RoActemra in the marketplace is thought to be its mode of administration, which currently requires an hour-long intravenous infusion every four weeks.

In contrast, Humira and other TNF inhibitors are delivered by subcutaneous injection every other week, so patients do not have to have access to infusion facilities and can receive it at home.

Roche is working on a subcutaneous injection version of its drug but, although phase III data were presented last year showing non-inferiority to the intravenous formulation this is not due to be filed for approval until later this year.

Uptake of RoActemra is also obstructed by restricted labelling in the US, where it is only approved for second-line use after failure of anti-TNF-based therapy.

5th March 2012

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