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New Study Shows Ankylosing Spondylitis Patients With Additional Non-Joint Related Inflammatory Disease May Require Special Recognition and Therapeutic Consideration


AMSTERDAM, Netherlands, June 24 /PRNewswire/ --

- Study Results Presented at Major European Rheumatology Congress

Results from a new study of Ankylosing Spondylitis (AS) patients presented today at the 2006 European League Against Rheumatism Annual European Congress of Rheumatology (EULAR) suggest that patients who present with non-joint manifestations associated with AS may suffer from a different disease phenotype in terms of more peripheral articular disease than those that suffer from the primary disease alone. Additionally, a second arm of the study in Belgium found that of the 42 percent of AS patients presenting with at least one non-joint manifestation, 27 percent were also diagnosed with anterior uveitis, 11 percent with psoriasis and 10 percent with inflammatory bowel disease (IBD).

The ASPECT (Ankylosing Spondylitis Patients Epidemiological Cross-sectional Trial) found that nearly half of the 847 AS patients (42 percent) in the study presented with at least one non-joint manifestation, including uveitis, psoriasis or IBD and 5 percent suffered from more than one non-joint manifestation at the time of study entry. The study was designed to evaluate which clinical parameters contribute independently to the presence of non-joint manifestations in AS patients as defined by the NY criteria. Furthermore, a cross-sectional cohort of AS patients in Belgium were analyzed to determine the prevalence and severity of AS in their country.

"This study confirms that many patients who present with ankylosing spondylitis are also suffering from other non-joint related inflammatory diseases," said Dr. Filip Van den Bosch, ASPECT study investigator, University Hospital of Ghent in Belgium. "Clinicians should consider adjusting their approach to total disease management in these AS patients."

"More than 60 percent of patients with AS in this study who reported suffering from AS for more than 30 years experienced a range of inflammatory diseases, including psoriasis, uveitis and inflammatory bowel disease and 90 percent of these patients suffered from both axial and peripheral conditions," said Dr. Serge D. Steinfeld, Department of Rheumatology, Erasme Hospital, University of Brussels, Belgium. "This analysis clearly highlights the importance of recognizing and treating co-morbid inflammatory diseases in patients with ankylosing spondylitis."

These results correspond with new research that shows rheumatologists in Europe could be doing more to diagnose non-joint manifestations in AS patients. A recent Harris Interactive survey of 450 European rheumatologists concluded that the vast majority of rheumatologists surveyed (85 percent, 92 percent) agree that AS patients with one or more existing co-morbidities tend to have a poorer prognosis and quality of life, respectively, than patients suffering from axial and peripheral AS only. Yet, one out of three rheumatologists do not actively screen their AS patients for other inflammatory diseases, citing lack of clinical justification as their rationale.

About ASPECT

ASPECT was a random trial of AS patients (NY modified criteria) who were enrolled between February 2004 and February 2005 by 44 percent of the Belgian rheumatologist population to evaluate which clinical parameters contribute independently to the presence of extra-articular manifestations in patients with AS. Of the 847 patients fulfilling the NY criteria, 492 (58 percent) had no extra-articular manifestations, 224 (26.5 percent) had uveitis, 89 (10.5 percent) psoriasis, 84 (10 percent) IBD and 42 (5 percent) had more than one extra-articular manifestation. Uveitis-associated AS patients developed the disease at a younger age (24.3 vs. 27.3 years) as compared to primary AS patients (p = 0.0019). Furthermore, oligoarthritis (OR 1.49; 95% CI 1.08-2.05) and hip arthritis (OR 1.44; 1.02-2.03) were more frequent in those patients (p = 0.014 and 0.036). Similar results were observed when contrasting AS patients with IBD to those without IBD. A total of 52 percent of the AS patients with psoriasis presented oligoarthritis vs 31 percent in AS only patients (p = 0.029; OR 2.26 [1.32-3.87]). There were no significant differences seen in BASDAI, BASFI, BASMI, CRP, HLAB27 or sacroiliitis grading. As expected corticosteroid use and osteoporosis were more frequent in the IBD associated AS group.

Belgian Sub-Analysis of ASPECT

The aim of the ASPECT sub-analysis was to analyze in a cross-sectional fashion the prevalence and severity of AS in Belgium. Results concluded that 89 of the 204 rheumatologists participated in the study (44 percent of the total Belgian rheumatologist population). 79 percent worked in secondary care centers, 11 percent in academic centers and 10 percent in both. There were 847 patients diagnosed with AS according to the modified New York criteria. A total of 42 percent of patients presented extra-articular features of the disease: 27 percent had anterior uveitis, 11 percent had psoriasis and 10 percent had IBD. 34 percent of patients had a family member affected by AS and 46 percent had a family member affected by any spondyloarthropathy-related disease (AS, anterior uveitis, psoriasis and/or IBD). 99 percent of patients had received non-steroidal anti-inflammatory drugs (NSAIDs), and 58 percent had used at least 3 NSAIDs. 52 percent of patients had a history of corticosteroid use (intra-articular, oral and/or IV), 69 percent of any disease-modifying agent (19 percent methotrexate, 61 percent sulfasalazine, 4 percent azathioprine), and 12 percent had or were treated with anti-TNF agents.

About Ankylosing Spondylitis

AS is a painful and progressive form of spinal arthritis that usually affects people under the age of 35 years. It typically begins in the late teens and early twenties and can result in fusing of the spinal vertebrae, hips and other joints. Often misdiagnosed as "just back pain" (mechanical back pain) or undifferentiated arthritis, AS is a systemic inflammatory disease that in addition to its effect on the spine, can affect vision, internal organs, and peripheral joints. According to the Arthritis Research Campaign, AS affects up to 0.5 percent of the population. On the European continent, it is estimated that prevalence ranges from 0.2 to 1 percent of the entire population. The Spondylitis Association of America (SAA) estimates that between 350,000 and one million people in the United States suffer from AS or a related disease.

About Schering-Plough

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: This press release contains certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including statements related to the potential market for golimumab and the company's strategy. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, current and future branded, generic or over-the-counter competition and the regulatory process, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the company's third quarter 2005 10-Q.

Web site: http://www.schering-plough.com
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