New trial results highlight benefit of Enbrel treatment for improving the symptoms of anxiety and depression in psoriasis patients with psoriatic arthritis

ROME, May 14, 2010 - Data from the PRESTA trial presented today at the 7thEADV Spring Symposium (13-16 May, Cavtat, Croatia) demonstrate that treatment with Enbrel (etanercept) can alleviate both the physical and psychological symptoms of psoriasis and psoriatic arthritis, and provide an overall improvement in patient reported quality of life.1,2 Treatment with etanercept over 24 weeks achieved mean reductions of 25-30 per cent in symptoms of anxiety and depression in patients with moderate/severe psoriasis and psoriatic arthritis1 in addition to significant improvements in both skin and joint symptoms and quality of life of patients with dactylitis and enthesitis.2

These results support recently presented data from the 18th Congress of the European Academy of Dermatology and Venereology (EADV) Autumn Congress and 2009 Annual American College of Rheumatology (ACR) Scientific Meeting which highlighted the seriously impaired quality of life of patients with psoriasis and psoriatic arthritis at baseline including significant levels of anxiety and depression3, pain and discomfort, mobility issues and problems undertaking daily activities.3-5At baseline, more than half of patients in the PRESTA study had anxiety symptoms and more than an third had symptoms of depression, as measured by the Hospital Anxiety and Depression Scale (HADS).1

Following treatment with etanercept 50 mg BIW/QW or 50 mg QW/QW, patients within the PRESTA study displayed effective skin clearance at weeks 12 and 246, significant reduction in joint inflammation including symptoms of enthesitis and dactylitis5,6and overall improvement in quality of life,3,4 with mean quality of life improvements after 24 weeks that were five times the accepted minimally important difference.3

New PRESTA data presented at the 7thEADV Spring Symposium add to previous results published in the British Medical Journal6 and show that treatment with either etanercept regimen helped patients achieve a mean improvement in symptoms of anxiety and depression of 25-30 per cent.1 Pooling across the two treatment regimen arms, 54% of all patients had at least mild anxiety symptoms at baseline, compared to 32% at week 24; 37% had at least mild depression symptoms at baseline, compared to 23% at week 24.1

Etanercept was well tolerated throughout the trial period with no significant differences seen in the incidence of adverse events between the two treatment groups. The most common adverse events reported were consistent with other trials of etanercept and included injection site reaction, infection and headache. No cases or tuberculosis, other opportunistic infections, or demyelinating disorders were reported.6

“Psoriatic diseases pose a significant burden on patients' lives and may lead to anxiety associated with participation in public activities. Recent studies have demonstrated the substantial improvement that biologics such as Enbrel can offer to patients. By addressing the physical impact of psoriasis as well as the associated symptoms of anxiety and depression, patients have the possibility of an efficacious treatment that can help improve overall quality of life. These new findings are particularly important for patient satisfaction and may help to promote public interaction,” said Prof. Dr. Jürgen Wollenhaupt, Professor of Rheumatology and Head of the Department for Rheumatology and Clinical Immunology at the Schoen-Klinik Hamburg, Germany.

The PRESTA trial is unique in its collaboration between dermatologists and rheumatologists for the treatment of both the skin and joint symptoms of psoriasis and psoriatic arthritis.6The success of this cooperative approach, alongside the established efficacy and safety of both etanercept regimens, should benefit patients and in addition encourage care to be individualised according to disease severity and therapeutic response.

-Ends-

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NOTES TO EDITORS

About the PRESTA Trial6 The PRESTA trial was designed to compare the efficacy over 12 weeks of two different etanercept regimens in treating the skin manifestations of psoriasis in patients who also have psoriatic arthritis and to evaluate efficacy and safety over an additional 12 weeks of open label etanercept treatment.

PRESTA was a randomised, double-blind, multicentre outpatient trial involving 752 patients with both psoriasis (evaluated by dermatologists) and psoriatic arthritis (evaluated by rheumatologists) from across Europe, Latin America and the Asia Pacific region.

During the blinded portion of the study, participants were randomised to receive etanercept 50 mg twice weekly (n=379) or 50 mg once weekly (n=373) for 12 weeks by subcutaneous injection. All participants then received open label etanercept 50 mg once weekly for 12 additional weeks, while remaining blinded to the regimen that they had had previously.

About ENBREL7 For full information about ENBREL go to: www.ema.europa.eu/humandocs/PDFs/EPAR/Enbrel/emea-combined-h262en.pdf<http://www.ema.europa.eu/humandocs/PDFs/EPAR/Enbrel/emea-combined-h262en.pdf>

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References

1. Wollenhaupt J. et al. Improvement in Anxiety and Depression Symptoms with Etanercept in Subjects with both Moderate/Severe Psoriasis and Psoriatic Arthritis: Results of the PRESTA Study. Abstract from the 7th EADV Spring Symposium 2010, 13-16 May, Cavtat, Croatia. 2. Ormerod A. et al. Response to Etanercept Treatment in Subjects Who Had Dactylitis With or Without Co-morbid Enthesitis. . Abstract from the 7th EADV Spring Symposium 2010, 13-16 May, Cavtat, Croatia. 3. Thaci D. et al. Rapid improvement of poor quality of life with etanercept therapy in subjects with both psoriasis and psoriatic arthritis (PRESTA Trial). 18th Annual EADV Congress, 7-11 October 2009 4. Kirkham B. et al. Predicting major quality of life improvement via PASI or HAQ in psoriatic arthritis patients. Poster 529 from the Annual Scientific Meeting ACR / ARHP, 15-21 October 2009. 5. Kirkham B. et al. Etanercept Therapy Improves Enthesitis and Dactylitis in Subjects With Psoriasis and Psoriatic Arthritis: The PRESTA Trial. Oral presentation at Annual EADV Congress, Friday 9 October 2009. 6. Sterry W. et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010;340:c147. doi:10.1136/bmj.c147. 7. Enbrel EMEA SPC. www.ema.europa.eu/humandocs/PDFs/EPAR/Enbrel/emea-combined-h262en.pdf<http://www.ema.europa.eu/humandocs/PDFs/EPAR/Enbrel/emea-combined-h262en.pdf> Last accessed May 2010.

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Posted: May 2010

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