MAIDENHEAD, England, October 27 /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)
- 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<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 symptoms, respectively.
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 score (0-10).(1)
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 their patients."
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