Wyeth’s DART Study Results Demonstrate Dose Escalation With Enbrel(R)(etanercept) is Significantly Lower Than Other Commonly Used Anti-TNF Agents in Patients With Rheumatoid Arthritis(1)

LIVERPOOL, England, April 24 /PRNewswire/ -- New pan-European data presented today at the British Society of Rheumatology’s annual meeting in Liverpool demonstrate that patients treated with Enbrel® (etanercept) required significantly lower dose escalation than patients treated with infliximab and adalimumab in the first 12 months of therapy. The latter two anti-TNF agents (ATAs) for the treatment of rheumatoid arthritis are monoclonal antibodies while etanercept is a soluble TNF receptor.

The DART* study assessed current clinical practice in the treatment of rheumatoid arthritis patients by comparing potential dose escalation in three selected ATAs and their associated costs of treatment.(1) The results of the 44 European centre study showed that the dose escalation to maintain clinical response was less than 1 per cent with etanercept compared to 8 per cent with adalimumab and 29 per cent with infliximab in the first 12 months. In those study centres where there were no restrictions to prescribing ATAs, the results showed a 2 per cent dose escalation with etanercept versus 11 per cent and 35 per cent respectively, indicating that associated cost increments were negligible with etanercept.(1)

“The results of the DART study add to the body of evidence that etanercept achieves sustained efficacy without the need for dose escalation in 99 per cent of patients studied and thus demonstrates a cost effective treatment option for patients with rheumatoid arthritis over both the short and long term,” said Professor Robert Moots, Professor of Rheumatology, University of Liverpool, Liverpool, United Kingdom and DART study investigator. “The current perception of biological therapy for inflammatory conditions such as rheumatoid arthritis is that it can be costly, however if the long term outlook and patient quality of life is taken into consideration, biologics such as etanercept are extremely cost effective. This is important both for physicians and patients as treatment can be maintained without the concern of rising cost increments.”

The minimal dose escalation observed in patients treated with etanercept may be due to its molecular structure which makes the development of neutralizing antibodies less likely than in patients treated with adalimumab and infliximab.(2,3,4,5,6) Recent studies have shown that physicians find that efficacy with some biological therapies diminishes or wears off over a period of time and hence may lead to the need for dose escalation and subsequent increased costs of treatment.(2,3,4) This may be partially due to the development of neutralizing antibodies.

To assist in the analysis of current clinical practice, an investigator survey was conducted to assess restriction on dose adjustment and the preferred strategy when an inadequate clinical response was observed. Two in five investigators felt restrictions prevented them from increasing the dose or frequency of anti-TNF agents. Despite these restrictions a similar pattern of dose escalation was observed in these centres compared to the overall dose escalation results. Adding, or increasing the dose of a DMARD, was used in some countries when restrictions prohibited the dose escalation of ATAs.(1)

In conclusion the DART study investigators report that the results suggest that patients receiving the monoclonal antibodies to TNF (infliximab and adalimumab), have a significantly higher rate of dose escalation than patients receiving the soluble TNF receptor etanercept, even in a restrictive budgetary environment and despite lower initial or concurrent DMARD use in etanercept patients.

Source: Wyeth Pharmaceuticals Limited

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