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document
Multiple courses of rituximab produce sustained clinical and radiographic efficacy and safety in patients with rheumatoid arthritis and an inadequate response to 1 or more tumor necrosis factor inhibitors : 5-year data from the REFLEX study . OBJECTIVE This 5-year observational posthoc analysis of the REFLEX study and its open-label extension assessed clinical efficacy , radiographic response , and safety of rituximab ( RTX ) in patients with rheumatoid arthritis ( RA ) who had an inadequate response to tumor necrosis factor ( TNF ) inhibitors . METHODS Patients in REFLEX were originally randomized to placebo ( PBO ) + methotrexate ( MTX ; PBO-randomized ) or RTX + MTX ( RTX-randomized ) . PBO-randomized patients were rescued with RTX as appropriate . Patients responding to initial RTX treatment could receive further RTX courses . For clinical efficacy and safety analyses , PBO-randomized patients were re-baselined prior to first RTX treatment and the data were pooled with RTX-randomized patient data . Efficacy outcomes 24 weeks after each course were calculated relative to first RTX pretreatment baseline . Radiographic outcomes were assessed relative to randomization baseline for both PBO-randomized and RTX-randomized groups . RESULTS A total of 480 patients received ≥ 1 RTX course . At 24 weeks , American College of Rheumatology 20/50/70 responses were 62.0 % , 30.8 % , and 13.0 % , respectively at course 1 ( n = 400 ) and 70.3 % , 41.8 % , and 22.0 % at course 5 ( n = 91 ) . European League Against Rheumatism good/moderate responses were 77.2 % and 84.4 % at courses 1 ( n = 390 ) and 5 ( n = 90 ) . Rates of adverse events ( AE ) , serious AE , and infections generally remained stable . Rate of progressive joint damage ( PJD ; change in mean Total Sharp Score ) decreased over time in both PBO-randomized ( n = 79 ) and RTX-randomized ( n = 105 ) groups . Mean change from baseline in PJD over 5 years was greater in PBO-randomized versus RTX-randomized patients ( 5.51 vs 3.21 ) . CONCLUSION RTX re-treatment over 5 years is associated with maintained or improved efficacy , continued inhibition of PJD , and a safety profile consistent with that previously reported . A delay in initiating RTX treatment may result in increased PJD .
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Intervention_Pharmacological
rituximab
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Intervention_Physical
tumor necrosis factor inhibitors
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Intervention_Pharmacological
rituximab ( RTX )
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Intervention_Physical
tumor necrosis factor ( TNF ) inhibitors
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Intervention_Control
placebo
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Intervention_Pharmacological
+ methotrexate ( MTX ; PBO-randomized ) or RTX + MTX ( RTX-randomized )
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Intervention_Pharmacological
RTX
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Intervention_Pharmacological
RTX
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Intervention_Pharmacological
RTX
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Intervention_Pharmacological
RTX-randomized
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Intervention_Pharmacological
RTX
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Intervention_Pharmacological
RTX-randomized
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Outcome_Adverse-effects
adverse events ( AE )
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Outcome_Adverse-effects
serious AE
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Outcome_Adverse-effects
infections
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Outcome_Physical
progressive joint damage
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Outcome_Physical
PJD
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Participant_Condition
rheumatoid arthritis and an inadequate response to 1 or more tumor necrosis factor inhibitors
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Participant_Condition
rheumatoid arthritis ( RA )
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Participant_Condition
inadequate response to tumor necrosis factor ( TNF ) inhibitors
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Participant_Sample-size
480