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New data reinforce safety profile of Enbrel (etanercept).

Enbrel (etanercept) was recently approved for use in South Africa for the treatment of moderate to severe plaque psoriasis. Its efficacy and safety for this condition have been reconfirmed in a recent study summarised below.

A study confirming the established safety profile of Enbrel (etanercept) for up to 2.5 years was presented at the 15th European Academy of Dermatology and Venereology (EADV) Congress. Enbrel acts on one of the root causes of psoriasis by targeting one of the key mediators of the inflammatory process, and is now approved either as a 50 mg once weekly dosing option or 25 mg twice weekly dosing, offering flexibility to tailor treatment to patient needs.

According to Bruce Strober, co-director of the Psoriasis and Psoriatic Arthritis Center at New York University, 'These results are important because they confirm the safety profile of Enbrel, which is key information in the context of wider discussion about the long-term use of biologics.'

'The study revealed an important, practical characteristic of Enbrel in showing that patients on interrupted treatment, after reinitiating therapy, regained similar positive efficacy results as the patients with uninterrupted treatment,' said Dr Wolfram Sterry, professor and chairman, department of dermatology, University Hospital Charite, Humboldt University, Germany. 'In real life, treatment of psoriasis patients is often suspended for a variety of reasons and then restarted.'

Enbrel is approved for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. It is also indicated for reducing signs and symptoms and inhibiting the progression of structural damage of active arthritis in patients with psoriatic arthritis. It can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

European physicians have become familiar with the benefits and long-term tolerability profile of Enbrel since it was approved 6 years ago. Worldwide, 441 000 patients have been treated with Enbrel.

In post-marketing use, serious infections and sepsis, including fatalities, have been reported. Discontinue Enbrel in patients with serious infections or sepsis. Do not start treatment in the presence of sepsis, infections (including chronic or localised), or allergy to Enbrel or its components. Use caution in patients predisposed to infection.

Cases of CNS demyelinating disorders have been reported, although the causal relationship to Enbrel remains unclear. Rare cases of pancytopenia, including aplastic anaemia, some fatal, have been reported in patients with rheumatoid arthritis. Exercise caution in patients who have a previous history of significant haematological abnormalities. Although the causal relationship to Enbrel remains unclear, advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infections. If significant haematological abnormalities are confirmed, discontinue Enbrel. Long-term side effects of Enbrel therapy on the development or course of infection and malignancy are unknown.

The most frequent adverse events in 5 double-blind, controlled clinical trials in patients with RA were infections, injection-site reactions, headaches and respiratory disorders. Malignancies were rare.

The most common adverse events observed during the double-blind, placebo-controlled portions of three clinical trials in patients with psoriasis were infections, injection-site reactions, headaches, and injection-site ecchymoses. There were no reports of opportunistic infections or tuberculosis during 662 patient exposure years. Twenty-three malignancies were reported in patients with plaque psoriasis treated with Enbrel in double-blind and open-label studies of up to 15 months involving 1 261 patients treated with Enbrel.

Enquiries: Dr Nini Ramasamy, Medical Director, Wyeth SA, tel (011) 655-2600.
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Title Annotation:Pulse: the heartbeat of the marketplace
Publication:South African Medical Journal
Geographic Code:6SOUT
Date:Apr 1, 2007
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