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document
Infliximab in ankylosing spondylitis : alone or in combination with methotrexate ? A pharmacokinetic comparative study . 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 ( AUC ( 0-18 ) ) . 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 AUC ( 0-18 ) 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 .
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Intervention_Pharmacological
Infliximab
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Intervention_Pharmacological
methotrexate
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Intervention_Pharmacological
Methotrexate
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Intervention_Pharmacological
infliximab
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Intervention_Pharmacological
infliximab
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Intervention_Pharmacological
MTX on infliximab
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Intervention_Pharmacological
infliximab alone
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Intervention_Pharmacological
or infliximab combined with MTX
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Intervention_Pharmacological
Infliximab
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Intervention_Pharmacological
infliximab
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Intervention_Pharmacological
infliximab + MTX
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Intervention_Pharmacological
infliximab
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Outcome_Physical
Infliximab concentrations
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Outcome_Physical
individual cumulative area under the concentration versus time curves ( AUC )
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Outcome_Physical
infliximab concentration
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Outcome_Other
Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) score
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Outcome_Physical
infliximab concentration
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Outcome_Other
AUC
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Outcome_Physical
( 0-18 )
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Outcome_Other
BASDAI scores