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document
Evidence of radiographic benefit of treatment with infliximab plus methotrexate in rheumatoid arthritis patients who had no clinical improvement : a detailed subanalysis of data from the anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study . OBJECTIVE To assess the relationship between inflammation and joint destruction in rheumatoid arthritis ( RA ) patients who have not responded clinically to treatment . METHODS Changes from baseline to week 54 in clinical variables and measures of radiographic progression were compared between patients who received infliximab ( 3 mg/kg or 10 mg/kg every 4 or 8 weeks ) plus methotrexate ( MTX ) and those who received MTX plus placebo in the Anti-Tumor Necrosis Factor Trial in RA with Concomitant Therapy trial . RESULTS At week 54 , patients who did not show 20 % improvement by American College of Rheumatology criteria ( ACR20 nonresponders ) while receiving infliximab plus MTX exhibited mild but statistically significant improvement in clinical variables , including the 28-joint Disease Activity Score ( DAS28 ) ( P < 0.001 ) , tender joint count ( P = 0.014 ) , swollen joint count ( P < 0.001 ) , and C-reactive protein ( CRP ) level ( P < 0.001 ) . Whereas the clinical and CRP changes among ACR20 nonresponders to infliximab plus MTX were small and much lower than among ACR20 responders to this treatment , radiographic progression among ACR20 nonresponders to infliximab plus MTX was significantly inhibited ( P < 0.001 ) compared with ACR20 nonresponders to MTX plus placebo . Radiographic progression was much greater in patients receiving MTX plus placebo than in patients receiving infliximab plus MTX , irrespective of ACR response status ( mean change in modified Sharp/van der Heijde score 6.0 in ACR20 responders and 7.2 in ACR20 nonresponders in the MTX plus placebo-treated group , versus 0.1 in ACR20 responders and 1.2 in ACR20 nonresponders in the infliximab plus MTX-treated group ) . Furthermore , among patients who were ACR20 nonresponders through week 54 , patients who were DAS nonresponders at weeks 30 and 54 , and patients without any improvement in individual clinical variables , those receiving infliximab plus MTX still demonstrated inhibition of structural damage that was statistically significant compared with inhibition in patients who received MTX plus placebo ( P < 0.05 to P < 0.001 ) . CONCLUSION Even in patients without clinical improvement , treatment with infliximab plus MTX provided significant benefit with regard to the destructive process , suggesting that in such patients these 2 measures of disease are dissociated .
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Intervention_Pharmacological
infliximab plus methotrexate
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Intervention_Pharmacological
infliximab
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Intervention_Pharmacological
methotrexate ( MTX )
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Intervention_Control
MTX plus placebo
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Intervention_Pharmacological
infliximab plus MTX
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Intervention_Pharmacological
infliximab plus MTX
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Intervention_Pharmacological
infliximab plus MTX
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Intervention_Control
MTX plus placebo
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Intervention_Pharmacological
MTX
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Intervention_Pharmacological
infliximab plus MTX-treated
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Intervention_Pharmacological
infliximab plus MTX
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Intervention_Control
MTX plus placebo
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Intervention_Pharmacological
infliximab plus MTX
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Outcome_Other
radiographic benefit
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Outcome_Other
assess the relationship
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Outcome_Physical
clinical variables and measures of radiographic progression
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Outcome_Other
improvement by American College of Rheumatology criteria
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Outcome_Physical
28-joint Disease Activity Score ( DAS28 )
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Outcome_Physical
tender joint count
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Outcome_Physical
swollen joint count
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Outcome_Physical
C-reactive protein ( CRP ) level
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Outcome_Physical
radiographic progression
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Outcome_Physical
ACR response status ( mean change in modified Sharp/van der Heijde score
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Outcome_Physical
clinical improvement
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Participant_Condition
rheumatoid arthritis
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Participant_Condition
rheumatoid arthritis ( RA )