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Golimumab Significantly Reduces Signs and Symptoms of Ankylosing Spondylitis: Reported at ACR By Bruce Sylvester BOSTON, MA -- November 12, 2007 -- Researchers report that more than half of patients receiving monthly injections of the investigative antitumor necrosis factor (TNF)-alpha monoclonal antibody, golimumab, achieved significant and sustained improvements in the signs and symptoms of ankylosing spondylitis (AS). Findings from the phase 3 study were presented here on November 9 at the 71st annual meeting of the American College of Rheumatology (ACR). "These findings confirm the efficacy of this TNF blocker in treating ankylosing spondylitis, and, notably, these were patients who had failed on other treatments," said investigator Desiree van der Heijde, MD, Professor of Medicine, Leiden University Medical Center, Leiden, The Netherlands. The investigators randomized 356 subjects with definite AS to receive subcutaneous injections every 4 weeks of either golimumab at doses of 50 or 100 mg, or placebo. The primary efficacy endpoint was the proportion of subjects achieving at least 20% improvement in the standard ASsessment in Ankylosing Spondylitis (ASAS) International Working Group criteria at week 14. At week 16, patients in the placebo or 50-mg groups who had achieved less than 20% improvement from baseline in measures of total back pain and morning stiffness entered early escape in a double-blind fashion. All other subjects stayed on prior medication until week 24. The investigators reported that the primary endpoint was achieved at all doses of golimumab (59.4%, 50 mg; 60%, 100 mg). The results were all statistically significant compared with placebo. The researchers also reported that subjects in the golimumab 50-mg and 100-mg groups showed significant and sustained improvements in physical function through 6 months as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI). The researchers noted that measures of clinical benefit were observed as early as 4 weeks after patients started golimumab treatment. Benefit was maintained through the end of the study at week 24. Dr. Van der Heijde added, "Golimumab potentially gives us an extra choice for patients. And the every-4-week subcutaneous mode of treatment will also be more convenient for many patients. This is very good news for patients, especially refractory patients, and clinicians." Funding for this study was provided by Centocor, Inc., a wholly-owned subsidiary of Johnson and Johnson. [Presentation title: Golimumab, a New, Human, TNF-alpha Antibody Administered as a Monthly Subcutaneous Injection in Ankylosing Spondylitis (AS): 24-Week Efficacy and Safety Results of the Randomized, Placebo-Controlled GO-RAISE Study. Poster 526] E-mail this page to a friend or colleague! To print, use this version