New safety and efficacy data for active ankylosing spondylitis (AS)
patients treated with ENBREL(R) (etanercept) were presented at the American
College of Rheumatology (ACR) Scientific Meeting, 24-29 October, in San
Francisco, CA: (1),(2)
- As discussed in an oral presentation, clinical data showed that ENBREL
was effective in treating the signs and symptoms of active AS in
significantly more patients than those receiving sulphasalazine, a
disease modifying antirheumatic drug (DMARD) and significant
differences were reported as early as 2 weeks. (Presentation #673, Oral
Session) (1),(3)
- Data from a separate study presented at ACR showed that active AS
patients treated with ENBREL experienced improvement in the signs and
symptoms of their disease that were achieved and maintained for up to
five years (252 to 264 weeks) of therapy. (Presentation #1119, Poster
Board #380)(2)
AS, which affects between 0.1 percent to 1.4 percent of the worldwide
population,(4) is a chronic, painful and progressive inflammatory disease
affecting spine and joints, which can lead to loss of mobility, impaired
physical function and postural deformity. It is characterised by persistent
lower back pain and progressive stiffness of the spine.(5),(6) The diagnosis
of AS is often delayed because inflammatory back pain can be mistaken for
mechanical (common) back pain.(6) Unlike other forms of arthritis, AS
frequently affects younger individuals and it tends to affect more men than
women.(6)
Assessment of Etanercept and Sulphasalazine in Patients With Active AS(1)
This study was a randomized, double-blind clinical trial designed to
compare the efficacy of ENBREL with sulphasalazine over 16 weeks in nearly
600 patients with active AS who had failed one or more non-steroidal
anti-inflammatory drugs (NSAIDs) taken for at least three months.(3)
In this study, ENBREL was demonstrated to be more efficacious than
sulphasalazine in helping patients to achieve improvement in pain, physical
function and spinal mobility. These improvements were validated by multiple
measures of efficacy and were seen at all time points throughout the
study.(3)
At week 16, nearly 76 percent of the 378 patients treated with ENBREL
achieved an ASAS 20 response, compared with 51 percent of the 187 patients
who received sulphasalazine (p
The study also showed that patients treated with ENBREL had an average 25
percent improvement in their BASMI score, versus 7 percent improvement in
patients treated with sulphasalazine (p
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