BERLIN, June 12 /PRNewswire-FirstCall/ -- Researchers from the Free University Berlin and the Rheumazentrum Ruhrgebiet in Herne, Germany, are the first to provide data confirming the safety and efficacy of treatment with infliximab over a three-year period for patients with ankylosing spondylitis (AS), a debilitating inflammatory disease of the spine. The results were presented today at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology.
AS is characterized by inflammation of the joints in the spine that causes painful stiffening of the spine and eventual fusion of the vertebrae. The disorder affects up to 1 percent of the population in the European Union. Symptoms include severe back pain, loss of spinal mobility, deformity, disability, peripheral arthritis, enthesitis, uveitis and severe fatigue, which may all contribute to definite decreases in quality of life.
"Patients with ankylosing spondylitis have limited treatment options, with no therapy previously proven to be safe and effective over an extended period of time," said Professor Jurgen Braun, M.D., lead physician at the Rheumazentrum Ruhrgebiet and Professor at the Free University of Berlin. "Our results confirm the long term safety and efficacy of infliximab in the treatment of this debilitating disease."
Study Design and Results
The trial assessed the continuous safety and efficacy of infliximab therapy among 46 patients who had completed two years of an earlier randomized trial. Efficacy data were collected at 152 weeks (three-year follow-up) and compared to each patients' baseline (BL) and one- and two-year follow-up (FU1 and FU2) results. The primary endpoint was clinical response after 152 weeks of treatment with infliximab.
Forty-six patients of the initial 69 patients were enrolled in the third year of follow-up, with 42 completing the full 152 weeks. At the three-year follow-up (FU3), treatment with infliximab demonstrated sustained improvements in disease activity, patient's and physician's global assessment and spinal mobility.
After three years, patients on infliximab had a 60% regression of their disease activity according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) compared to baseline (FU3: 2.6 + or - 2.0; BL: 6.5, FU1: 2.6, FU2: 2.7). Scores based on scales measuring patient's (PatGA) and physician's (PhysGA) global assessment (1-10 cm; 10=very bad) were reduced by 62.3% and 71.4% respectively compared to baseline (PatGA: FU3: 2.6 + or - 2.2, BL: 6.9, FU1 and FU: 2.9, and PhysGA: FU3: 1.8 + or - 1.5, BL: 6.3, FU1: 2.2 and FU2: 2.1). Patients showed a 24.3% improvement in spinal mobility according to the Bath Ankylosing Spondylitis Metrology Index (BASMI) compared to baseline (FU3: 2.8 + or -2.1, BL: 3.7, FU1: 2.4, FU2: 2.6). Higher BASMI scores indicate more severe limitations of movement for patients with AS.
Further, mean levels of the inflammatory protein CRP (mg/l) decreased 88.4% compared to baseline (FU3: 2.9 + or - 6.8, BL: 25, FU1: 4.5, FU2: 6.5). No major changes in mean erythrocyte sedimentation rate (ESR, mm/1hr) were observed (FU3: 11.2 + or - 11). The clinical efficacy of infliximab did not decrease and no major side effects occurred during the third year of infliximab therapy.
Infliximab was approved by the European Union in May 2003 for the treatment of AS patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
About Ankylosing Spondylitis
Ankylosing spondylitis (AS), also known as Bechterew's disease in Germany, is a painful and progressive rheumatic disease that causes arthritis of the axial skeleton (spine and sacroiliac joints) and sometimes inflammation of the peripheral joints, eyes, lungs, and heart valves. (1) Symptoms of AS typically persist for more than three months and continue to persist for decades in the majority of patients. Symptoms include gradual onset of back pain and stiffness, which wears off during the day with light exercise, as well as pain in other areas of the body such as the buttocks or neck. (2) According to the Arthritis Research Campaign, AS affects up to 0.5 percent of the population. (3)
The Rheumazentrum Ruhrgebiet is a highly specialized hospital for rheumatic diseases. All rheumatic diseases including inflammatory, degenerative and metabolic diseases and also fibromyalgia and osteoporosis are diagnosed and treated here. It is located in Herne, a city in the center of the Ruhrgebiet, the former main coal-mining region in West-Germany. Founded in 1908, it holds 130 beds and is one of the greatest hospitals of its kind in Germany. Besides the in-patient treatment center, there is an efficient out-patient department. Furthermore, since 1987, it is connected with a solwater-bath which is extended to the central institution for physical therapy in the hospital.
(1) American College of Rheumatology. Available at
Accessed on March 23, 2004.
(2) Spondylitis Association of America. Available at
http://www.spondylitis.org/about/as/symptoms.aspx. Accessed on March
(3) Arthritis Research Campaign. Available at
http://www.arc.org.uk/newsviews/arctdy/105/ankyspon.htm. Accessed on
March 22, 2004.