Data from the trial showed that at usual doses as well as at step-down doses (i.e., 50 mg once a week or 50 mg twice a week for first 12 weeks, then 50 mg once a week), ENBREL provided significant improvement compared to baseline in joint symptoms in patients with active psoriatic arthritis in addition to achieving clearer skin.
Furthermore, the new data showed that ENBREL significantly relieved two painful and difficult-to-treat features of psoriatic arthritis, in which inflammation occurs in the fingers (dactylitis) and/or at any point where a tendon or ligament is inserted into bone, particularly the heel of the foot (enthesitis).
Efficacy results presented at EULAR showed - for joints:
- For physician global assessment of arthritis, HAQ and subject
global assessment of joint pain, arthritis activity and stiffness,
within-group improvements from baseline for the 2 regimens were
significant (p<0.001) at 12 and 24 weeks; between-group differences
were not
- In the ENBREL 50 mg BIW group, 77 percent were PsARC
responders at week 12 versus 76 percent in the ENBREL 50 mg QW group
(p=0.264). At week 24, PsARC responders were 82 percent and 80 percent
respectively (p=0.722).
Efficacy results presented at EULAR showed - for enthesitis and dactylitis:
- At weeks 12 and 24, patients with dactylitis at baseline from
both study groups showed comparable improvement, with the mean
number of digits affected substantially lower than at baseline:
ENBREL 50 mg BIW/QW 1.5 and 1.6 for ENBREL 50 mg QW/QW at week 12,
and ENBREL 50 mg BIW/QW 1.2 and 1.3 for ENBREL 50 mg QW/QW at
week 24
- In those patients with enthesitis at baseline, both step-down
and usual dose ENBREL regimens provided comparable improvements in
> 1 tendon or ligament insertion at weeks 12 and 24: 74 percent for
ENBREL 50 mg BIW/QW versus 70 percent 50mg QW/QW at week 12 and 81
percent for both groups at week 24. These improvements were
accompanied by improved quality of life
Efficacy results presented at EULAR showed - for skin:
- At week 24, PASI 75 improvement was achieved by 70 percent in
the BIW/QW group and 62 percent in the QW/QW group
- Similarly at week 24, the percentage of psoriasis responders,
clear or almost clear on the physician global assessment, was 56
percent for the ENBREL 50 mg BIW group and 50 percent for the 50
mg QW group
To participate in a virtual on-demand press briefing where you can hear expert commentary relating to the above data, please log on to the media centre at http://www.wyeth.eu. Further media information relating to this press release, additional information on ENBREL and future media announcements can also be found on the site.
Notes to editors
About ENBREL
ENBREL is a fully human soluble tumour necrosis factor (TNF) receptor antagonist. ENBREL was first approved in 1998 for moderate to rheumatoid arthritis and has since been used in 505,000 patients worldwide across indications.
ENBREL 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. ENBREL is also licensed in the European Union for treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
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