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Báo cáo y học: "Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học General Psychiatry cung cấp cho các bạn kiến thức về ngành y đề tài: Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study. | Mulleman et al. Arthritis Research Therapy 2011 13 R82 http arthritis-research.eom content 13 3 R82 RESEARCH ARTICLE Open Access Infliximab in ankylosing spondylitis alone or in combination with methotrexate A pharmacokinetic comparative study 1.2 1.2 3.4 1.5 1.2 Denis Mulleman Francine Lauferon Daniel Wendling David Ternant Emilie Ducourau Gilles Paintaud1 5 and Philippe Goupille1 2 6 Abstract Introduction Methotrexate MTX has been shown to modify infliximab pharmacokinetics in rheumatoid arthritis. However its combination with infliximab in the treatment of ankylosing spondylitis AS is not recommended. The objective of this study was to examine the influence of MTX on infliximab exposure in patients with AS. Methods Patients with AS patients who had predominantly axial symptoms were randomised to receive infliximab alone infusions of 5 mg kg at weeks 0 2 6 12 and 18 or infliximab combined with MTX 10 mg week . Infliximab concentrations were measured before and 2 hours after each infusion and at 1 3 4 5 8 10 14 and 18 weeks. We estimated individual cumulative area under the concentration versus time curves AUC for infliximab concentration between baseline and week 18 AUC0-18 . Clinical and laboratory evaluations were performed at each visit. The Bath Ankylosing Spondylitis Disease Activity Index BASDAI score was the primary end point for clinical response. Results Twenty-six patients were included infliximab group n 12 infliximab MTX group n 14 and 507 serum samples were available for measurement of infliximab concentration. The two groups did not differ with regard to AUC0-18 or evolution of BASDAI scores and biomarkers of inflammation. Conclusions The combination of MTX and infliximab does not increase the exposure to infliximab over infliximab alone in patients with AS. Trial registration ClinicalTrials.gov NCT00507403 Introduction Infliximab a chimeric monoclonal antibody to TNF-a showed efficacy for ankylosing spondylitis AS in a randomised placebo-controlled