Results From The First And Largest Collaborative Study Confirm Role Of Enbrel® In Psoriatic Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Eczema / Psoriasis
Article Date: 04 Dec 2008 - 5:00 PDT

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New data presented today at the 'Gene to Clinic' meeting taking place at the Royal College of Physicians in London, England, reinforce Enbrel's ability to clear skin in patients with psoriatic arthritis, an inflammatory and progressive disease associated with psoriasis. Results from the pioneering PRESTA (Psoriasis Randomized Etanercept STudy in Subjects with Psoriatic Arthritis) study showed that at 24 weeks, two out of three patients with psoriatic arthritis (70% taking 50mg Enbrel twice-weekly and 62% taking 50mg once-weekly) showed a 75% improvement in the psoriasis area-and-severity index (PASI 75)1. PRESTA is the first and largest study of its kind where both dermatologists and rheumatologists have come together to investigate the positive effects of Enbrel in this specific patient population.

Psoriatic arthritis is an inflammatory disease that affects both the skin and joints, where the skin symptoms usually appear before the joint symptoms. Despite the potentially serious impact of the disease, it is difficult to make an accurate diagnosis.

Prof Wolfram Sterry, PRESTA study investigator and Director of the Clinic for Dermatology, Venereology and Allergology at the Charité Berlin, Germany, says: "Up to 40% of psoriasis patients will go on to develop psoriatic arthritis and therefore dermatologists are in an ideal position to screen for psoriatic arthritis and provide early therapeutic intervention or referral in order to prevent disease progression."

The PRESTA study results demonstrated that Enbrel 50mg once-weekly or twice-weekly provides improvement of skin symptoms which continue to improve over time. In particular:

• At only 12 weeks, over half (55%) of patients taking Enbrel 50mg twice-weekly and more than one third (36%) of patients taking Enbrel 50mg once-weekly showed a 75% improvement in the psoriasis area-and-severity index (PASI 75)1
  
  
• After 24 weeks, over two thirds (70%) of patients taking Enbrel (50mg twice-weekly for 12 weeks, followed by 50mg once-weekly for 12 weeks) showed a 75% improvement in the psoriasis area-and-severity index (PASI 75), demonstrating that skin clearance continues to improve with Enbrel, even after Enbrel's dose is reduced1
  
  
• Almost two thirds (62%) of patients treated throughout with 50mg once-weekly also went on to achieve PASI 75 by week 241
  
  
• In addition, approximately three out of four patients (72-77%) taking Enbrel showed joint improvement, as measured by the Psoriatic Arthritis Response Criteria (PsARC), at only 12-weeks and maintained this improvement at 24-weeks (shown in both arms of the study)1

Previous research has shown that the skin symptoms in psoriasis patients are associated with a low quality of life comparable to, or even worse than those individuals with other chronic medical disorders, including heart disease2. Further results from the PRESTA study presented today demonstrate that Enbrel not only clears skin, but can also improve patients' quality of life3.

Professor Sterry concluded: "The PRESTA study confirms that treating psoriatic arthritis early and aggressively with Enbrel can effectively clear skin, providing patients with meaningful improvements to their daily lives and offering the hope of preventing irreversible damage to joints."

Both Enbrel dose regimens were well tolerated up to 24 weeks with no new safety signals noted.

Enbrel has a long-established safety profile with over 16 years of proven clinical experience, and is currently the number one prescribed biologic worldwide.

Notes:

PRESTA Study

This randomised, multicentre study enrolled patients with both psoriasis and psoriatic arthritis from 110 global sites. In the double-blind period, patients received either Enbrel 50mg twice weekly (BiW) or 50mg once-weekly (QW) for 12 weeks; in the subsequent open-label period, patients received 50mg once weekly for 12 weeks.

Results showed:

	% Patients
	ETN 50 mg BiW/QW		ETN 50 mg QW		P-value
PASI	Wk 12	Wk 24	Wk 12	Wk 24	Wk 12	Wk 24
≥50%	80	86	74	83	0.049	0.185
≥75%	55	70	36	62	<0.001	0.026
≥90%	27	46	15	35	<0.001	0.002
PsARC	76	77	72	75	0.264	0.722

Results from the quality of life investigation showed:

• The mean Dermatology Life Quality Index (DLQI) total score was 12 for both Enbrel groups - a substantially reduced quality of life at baseline.
  
  
• At week 12, the 50mg twice-weekly (BiW) group had a mean DLQI of 4.42, and the 50mg once-weekly (QW) group had a mean DLQI of 5.47, representing a significant improvement after only 12 weeks, and sustained over 24 weeks.

ABOUT ENBREL

Enbrel is a fully human soluble tumour necrosis factor (TNF) receptor. Enbrel was first approved in 1998 for moderate to severe rheumatoid arthritis and has since been administered to nearly 500,000 patients worldwide across indications.

Enbrel in the EU is approved for the following indications:

Rheumatoid arthritis

Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.

Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.

Polyarticular juvenile idiopathic arthritis

Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 4 years.

Psoriatic arthritis

Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.

Ankylosing spondylitis

Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Plaque psoriasis

Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA

ABOUT WYETH:

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REFERENCES

1. Poster P29 from the Gene to Clinic meeting, December 2008. Sterry. W. et al. Results of a Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Etanercept in Patients with Psoriasis and Psoriatic Arthritis: The PRESTA Trial

2. Richards HL et al. The contribution of perceptions of stigmatization to disability in patients with psoriasis. J Psychosom Res. 2001;50:11-15.

3. Poster P30 from the Gene to Clinic meeting, December 2008. Barker, J. et al. Improvement in the Dermatology Life Quality Index for Patients With Psoriasis and Psoriatic Arthritis Treated with Etanercept

Source:
Gill Markham
Wyeth