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| |  Infliximab Monotherapy Effective for Long-Term Treatment of Spondyloarthritis: Presented at EULAR By Bruce Sylvester PARIS -- June 15, 2008 -- Infliximab monotherapy is very effective for the long-term treatment of spondyloarthritis, with low discontinuation rates, researchers from Spain reported. "Concomitant treatment with methotrexate or sulfasalazine is not necessary," said Maria Carpena, MD, Hospital Gregorio, Madrid, Spain, in her presentation on June 13 at EULAR 2008, the Annual Congress of the European League Against Rheumatism. All patients with spondyloarthritis treated with infliximab over a 7-year period in the rheumatology department at the Hospital Gregorio in Madrid, Spain, were included in this prospective, open-label, uncontrolled study. The 170 patients received infliximab 5 mg/kg every 6 to 8 weeks. The investigators recorded data on patient demographics, treatment efficacy, tolerability, concomitant therapy, adverse events, and drug discontinuation. They evaluated survival data using standard statistical analysis tools. The investigators analysed data on the subjects for a total of 438.9 patient-years. Of these subjects, 108 (63.5%) were diagnosed with ankylosing spondylitis, 31 (18.2%) with psoriatic arthritis, 17 (10%) with undifferentiated spondyloarthritis, and 14 (8.2%) with arthritis associated with inflammatory bowel disease. The researchers reported that 55 of the subjects (32.4%) were also treated with methotrexate or sulfasalazine at baseline. Infliximab was the first anti-TNF used to treat 162 (95.3%) of the subjects. The investigators reported a mean survival time of 63.9 months (95% confidence interval [CI] 57.5-70.2). They also found that 62.4% of the subjects participating in the study for over 5 years were still using infliximab. Overall, 50/170 (29.4%) discontinued infliximab, 16/170 (9.4%) due to lack of efficacy, 17/170 (10%) due to an infusion-reaction event, 9/170 (5.3%) due to an adverse event, and 8/170 (4.7%) for another reason. Health Assessment Questionnaire (HAQ) results at baseline were the only variable explaining the survival model (HR 2.9; 95% CI 1.7-4.9). Spondyloarthritis diagnosis, C-reactive protein measure, or methotrexate or sulfasalazine treatment were not significant variables for survival. The same finding on HAQ and survival pertained to the subset of 108 ankylosing spondylitis subjects (HR 2.8; 95% CI 1.4-5.6). Methotrexate or sulfasalazine treatment was not significant in infusion reaction or adverse event discontinuation. The authors noted that females had a slightly, but significant, higher risk for discontinuation due to infusion reactions (HR 4.4; 95% CI 1.1-17.3). [Presentation title: Long-Term Results of Infliximab Therapy in Spondyloarthritis: A Seven Years Follow-Up. Abstract FRI0323]
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