Maidenhead, England (ots/PRNewswire) -
- Data From Another Study Supported the use of ENBREL for up to
Five Years in Ankylosing Spondylitis Patients
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)
@@start.t1@@ - 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
- 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
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
Assessment of Etanercept and Sulphasalazine in Patients With
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
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<0.001). Also at 16 weeks,
nearly 60 percent of patients receiving ENBREL therapy achieved ASAS
40, versus nearly 33 percent of patients treated with
sulphasalazine(p<0.001). The Assessment in Ankylosing Spondylitis
(ASAS) is a composite measure of improvement in AS symptoms that
includes total back pain, patient assessment of disease activity,
inflammation and physical function. ASAS 20 or 40 response criteria
represent an improvement of at least 20 percent or 40 percent in AS
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<0.001). The
Bath Ankylosing Spondylitis Metrology Index (BASMI) is a composite
measure of spinal and pelvic mobility that includes erectness of
posture, neck rotation, forward flexion and side-to-side flexion of
the lower spine, and outward movement of the legs at the hip joints.
In addition, more than twice as many patients receiving ENBREL
achieved Partial Remission than patients receiving sulphasalazine
(p<0.001). Partial Remission is defined as a score of less than 20 on
a one-hundred point scale on each of the four AS measures. (1)
Overall, patients treated with ENBREL achieved an average 48
percent improvement in physical function, as measured by the Bath
Ankylosing Spondylitis Functional Index (BASFI), and these results
were sustained through 16 weeks. Patients treated with sulphasalazine
achieved an average 28 percent improvement during the same time
period (p<0.001). The BASFI is a 10-question, patient self-assessment
instrument consisting of 8 specific questions regarding physical
function in AS and two questions reflecting the patient's ability to
cope with everyday life. Each question is answered on a 10-cm
horizontal visual analog scale, the average of which gives the BASFI
In addition, patients treated with ENBREL achieved an average 54
percent improvement in disease activity, as measured by the Bath
Ankylosing Spondylitis Disease Activity Index (BASDAI). Patients
treated with sulphasalazine achieved an average 33 percent
improvement (p<0.001). The BASDAI consists of a one through 10 scale
that includes a daily activity composite and scores for fatigue,
pain, discomfort, and stiffness.
No new safety signals were identified in this study. In the
ENBREL group, seven people (1.8%) reported serious adverse events,
compared with four people (2.1%) receiving sulphasalazine treatment.
No cases of opportunistic infection, tuberculosis or demyelinating
disease were reported with ENBREL in this study.
"Ankylosing spondylitis is a chronic disease causing a lot of
back pain and decreased spinal mobility that may get progressively
worse if not treated appropriately," said lead investigator Dr.
Jürgen Braun, Medical Director, Rheumatology Medical Center,
Ruhrgebiet, Herne, Ruhr-University, Bochum, Germany. "These data show
that ENBREL may be an appropriate treatment option for AS patients
because, as demonstrated in this study, it can be more effective than
a traditional DMARD and work quickly to manage their symptoms and
improve their mobility."
Five-Year Efficacy and Safety Data For Etanercept in Active AS(2)
A second study presented was designed to assess whether long-term
safety, clinical efficacy, and patient-reported outcomes were
sustained in AS patients receiving ENBREL from week 108 (baseline of
this study) to week 264. This phase 4, 156-week open label extension
study consisted of patients with AS who completed a 12-week
randomized, placebo-controlled study followed by a 96-week open-label
study. Results presented at ACR were from baseline of the randomized
control trial through week 264 reporting data from active AS patients
who received 252 to 264 weeks of continuous ENBREL therapy.
In patients with AS, continued ENBREL treatment resulted in
improvements in clinical efficacy and patient-reported outcomes that
were sustained for up to 264 weeks. Overall, of the 59 patients who
were still in the trial, 75 percent (n=44) were ASAS20 responders at
week 264. In addition, 66 percent (n= 39) of patients achieved a 50
percent improvement in their BASDAI score at the end of the study.
The study also showed that improvements in patient-reported outcomes
(patient global assessment, back pain, and morning stiffness) were
sustained through 264 weeks of ENBREL treatment.
No new safety signals were reported throughout the study period.
Myocardial infarction and cholelithiasis occurred in two patients. No
cases of opportunistic infection, tuberculosis or demyelinating
disease were reported with ENBREL in this study.
"These data show that treatment with ENBREL may provide AS
patients with sustained improvement in their symptoms," said
investigator Dr. Emilio Martin Mola, chief of the Rheumatology
Department, Hospital La Paz, Madrid, Spain. "Since AS is a chronic
disease that requires continuous treatment, these data are important
to physicians who are considering a long-term therapy option for
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Notes to editors
About Ankylosing Spondylitis
AS is a chronic, painful and progressive inflammatory disease
affecting the spine; it is a highly debilitating condition that tends
to affect people before the age of 30, and is more common in men. (4)
In patients with AS, tissue is gradually replaced by
fibrocartilage which then becomes ossified. When these lesions occur
in the spine, it causes irreversible damage as the outer fibres are
replaced by bone and the vertebrae become fused.(7)
The diagnosis of AS is commonly delayed by 8 to 11 years, after
the onset of symptoms. Diagnosing AS early before irreversible damage
has occurred is difficult as radiological proof of the disease is a
Individuals with AS suffer pain and disability similar to that of
patients with rheumatoid arthritis. Other symptoms include: lower
back pain and stiffness, early morning stiffness and pain, bone
tenderness and asymmetric arthritis of other joints and lower
ENBREL is a fully human soluble tumour necrosis factor (TNF)
ENBREL is approved in the EU for the following indications:
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
(JIA) 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
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
Treatment of adults with severe active ankylosing spondylitis who
have had an inadequate response to conventional therapy.
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.
The European Commission recently approved a new 50mg ENBREL
once-weekly dosage regimen as an alternative to the currently
approved 25mg ENBREL twice-weekly regimen for the treatment of
patients with moderate-to-severe plaque psoriasis.
Important Safety Information(8)
Serious infections, including tuberculosis, and sepsis have been
reported. Some of these infections have been fatal.
Do not start ENBREL in the presence of allergy to ENBREL or its
There have been rare reports of CNS demyelinating disorders,
although the causal relationship to ENBREL remains unclear.
Rare cases of pancytopenia, and very rare cases of aplastic
anemia, some fatal, have been reported in patients treated with
ENBREL. Exercise caution in patients who have a previous history of
significant hematologic abnormalities. Although the causal
relationship to ENBREL remains unclear, advise patients to seek
immediate medical attention if they develop signs or symptoms of
blood dyscrasias or infection. If significant hematologic
abnormalities are confirmed, discontinue ENBREL.
Reports of malignancies affecting various sites have been
received in the postmarketing period. Effects of ENBREL therapy on
the development or course of infection and malignancy are unknown. In
clinical trials of TNF antagonists, more cases of lymphoma were seen
compared to control patients; however, the risk of lymphoma may be
higher in RA patients.
Before initiation of therapy with ENBREL, any patient at
increased risk for tuberculosis (TB) should be evaluated for active
or latent infection. Prophylaxis of latent TB infection should be
initiated prior to therapy with ENBREL. Applicable local guidelines
should be consulted.
Reactivation of hepatitis B virus (HBV) in patients who are
chronic carriers of this virus who are receiving anti-TNF agents,
including ENBREL, has been reported. Patients at risk for HBV
infection should be evaluated for prior evidence of the virus before
initiating anti-TNF therapy. Although a causal relationship has not
been established for ENBREL, caution should be exercised when
administering ENBREL for patients identified as carriers for HBV.
There have been reports of worsening of hepatitis C in patients
receiving ENBREL, although a causal relationship with ENBREL has not
Wyeth Pharmaceuticals, a division of Wyeth, has leading products
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Wyeth is one of the world's largest research-driven
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Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal
1. Braun, J. et al. Assessment of Clinical Efficacy in a
Randomized, Double-Blind Study of Etanercept and Sulphasalazine in
Patients With Ankylosing Spondylitis. Abstract 08-A-2496-ACR from the
American College of Rheumatology (ACR) Scientific Meeting in San
Francisco, CA 24-29 October 2008.
2. Mola, E.M. et al. Five-Year Efficacy and Safety, Including
Patient-Reported Outcomes, With Etanercept in Ankylosing Spondylitis.
Abstract 08-A-591-ACR from the American College of Rheumatology (ACR)
Scientific Meeting in San Francisco, CA 24-29 October 2008.
3. Final Abbreviated Report: A Randomized, Double-blind Study
Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine
in Subjects with Ankylosing Spondylitis (ASCEND) CSR-72737.
4. Braun J. et al. Ankylosing spondylitis. Lancet. 2007 Apr
5. NY Presbyterian Hospital Website (Ankylosing Spondylitis).
Last accessed at http://www.childrensnyp.org/mschony/fp/health/ankylo
sing-spondylitis.html on September 25, 2008.
6. Shaikh S. Ankylosing spondylitis: Recent breakthroughs in
diagnosis and treatment. JCCA J Can Chiropr Assoc. 2007
7. Sieper J, Braun J et al. Ankylosing spondylitis: an overview.
Ann Rheum Dis 2002; 61 (Supple III):iii8-iii18.
8. ENBREL EMEA SPC.
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