NutritionWyeth Presents New Analyses Of Data From Three Studies Of ENBREL(R) At The European League Against Rheumatism (EULAR) Annual Meeting
Analyses of data from three studies provide insight into the use of ENBREL®(etanercept) in the treatment of three conditions for which ENBREL is indicated: moderate-to-severe rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). These analyses, presented this week during the European League Against Rheumatism (EULAR) Annual Meeting in Copenhagen, add to the body of evidence that supports treatment with ENBREL for patients with these conditions.
Analyses from three separate trials of ENBREL -- COMET*, ASCEND** and PRESTA*** -- showed that:
The group of patients with early-active moderate-to-severe RA treated with ENBREL and methotrexate, who achieved and sustained a halt of progressive joint damage, maintained this level at two years, according to the COMETstudy
In patients with AS (including those with and without peripheral joint involvement), ENBREL therapy significantly improved signs, symptoms, function, and mobility when compared to treatment with the DMARD sulfasalazine, according to the ASCEND study
At step-down and usual doses, ENBREL provided significant improvement in joint symptoms compared to baseline in patients with active PsA in addition to achieving clearer skin, according to the PRESTA study
"Inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis significantly impact the daily lives of the patients who live with these conditions. These analyses support the role of etanercept therapy in the management of these diseases. The EULAR congress provides an important platform to present new information regarding ENBREL as a treatment option for patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis," said Maxime Dougados, Professor of Rheumatology, RenÓ© Descartes University Paris, France.
*The COMET Study
The COMET (COmbination of Methotrexate and ETanercept in early rheumatoid arthritis) study was designed to compare the clinical efficacy and safety of ENBREL and methotrexate combination therapy (EM) with methotrexate alone (M) on clinical disease activity and progressive joint damage in patients with early active rheumatoid arthritis. COMET was the first published study to use clinical remission as a primary endpoint.
Subjects were randomised at baseline. Those who completed 1 year of treatment entered year 2 (n=411). The original combination group either continued combination (EM/EM; n=111) or received ENBREL monotherapy (EM/E; n=111) in year 2; the original methotrexate monotherapy group either received combination (M/EM; n=90) or continued monotherapy (M/M; n=99). Efficacy endpoints included clinical remission (DAS28**The ASCEND Study
Ankylosing spondylitis (AS) is a debilitating condition that affects three times as many men as women. It typically causes inflammation and pain in the spine (known as axial disease), but can also affect the peripheral joints. As a result of this pain, patients with AS are three times more likely to stop working than the general population.
The ASCEND study compared the efficacy of ENBREL with the DMARD sulfasalazine in subjects with AS, including those with peripheral joint involvement. It was the first published study to use an active comparator.
A post-hoc analysis compared the efficacy of ENBREL 50 mg once weekly with sulfasalazine up to 3 g daily in subjects with and without swollen peripheral joint involvement from a 10-week randomized, double-blind study in subjects with AS.
Regardless of swollen peripheral joint involvement, subjects receiving ENBREL showed significantly greater improvement than subjects receiving sulfasalazine in all efficacy assessments, including physical function and spinal mobility. In particular, 76 percent of patients taking ENBREL versus 53 percent of patients taking sulfasalazine, achieved an ASAS 20 (p***The PRESTA Study
Psoriatic arthritis (PsA) is a disabling form of arthritis that occurs in up to 30 per cent of patients with plaque psoriasis.
The PRESTA study was designed to determine the efficacy of two ENBREL dosing regimens in treating PsA, as measured by PsA response criteria (PsARC), arthritic symptoms, skin manifestations and physical function of subjects with psoriasis and PsA over 24 weeks.
In this study, a randomised double-blind phase was followed by an open-label period. Patients received either ENBREL 50 mg once weekly (QW) or 50 mg twice weekly (BIW) for 12 weeks (double blind), followed by 50 mg QW for all patients for 12 weeks (open label).
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 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.
Wyeth