22653
document
Longterm safety , efficacy , and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis . OBJECTIVE To evaluate safety , efficacy , and radiographic progression in patients with early rheumatoid arthritis ( RA ) undergoing longterm treatment with etanercept . METHODS Patients with early RA ( disease duration of 3 years or less ) who had completed a 2-year efficacy study comparing etanercept and methotrexate ( MTX ) were followed in an extension where they received 25 mg etanercept twice weekly . Safety was summarized descriptively and compared with data from the efficacy study . Efficacy and radiographic progression were assessed using American College of Rheumatology response criteria , disease activity scores , and Total Sharp Score ( TSS ) . RESULTS Rates of serious adverse events and serious infections did not increase with longterm exposure to etanercept , and were similar to rates reported for the blinded portion of the efficacy study . Efficacy was sustained in patients who completed 5 years of etanercept treatment at the time of this report ( N = 201 ) , even in those who decreased or discontinued use of MTX or corticosteroids . No radiographic progression ( change in TSS < or = 0 ) was seen in 55 % of patients with 5-year radiographs ; negative change ( TSS < 0 ) was seen in 11 % . CONCLUSION Etanercept treatment in patients with early RA was generally well tolerated for up to 5 years . The results indicate sustained efficacy and decreased rate of radiographic progression . The rate of radiographic progression was low compared with other studies , emphasizing the benefit gained in patients with early aggressive RA who undergo longterm treatment with etanercept .
22654
Intervention_Pharmacological
etanercept
22655
Intervention_Pharmacological
etanercept
22656
Intervention_Pharmacological
etanercept
22657
Intervention_Pharmacological
methotrexate
22658
Intervention_Pharmacological
etanercept
22659
Intervention_Pharmacological
etanercept
22660
Intervention_Pharmacological
Etanercept
22661
Intervention_Pharmacological
etanercept
22662
Outcome_Other
Longterm safety
22663
Outcome_Other
efficacy
22664
Outcome_Other
radiographic outcome
22665
Outcome_Other
safety , efficacy
22666
Outcome_Other
radiographic progression
22667
Outcome_Other
Safety
22668
Outcome_Other
Efficacy
22669
Outcome_Other
radiographic progression
22670
Outcome_Adverse-effects
Rates of serious adverse events and serious infections
22671
Outcome_Other
Efficacy
22672
Outcome_Other
radiographic progression
22673
Outcome_Other
efficacy
22674
Outcome_Other
rate of radiographic progression
22675
Outcome_Other
rate of radiographic progression
22676
Participant_Condition
early rheumatoid arthritis
22677
Participant_Condition
early rheumatoid arthritis ( RA )
22678
Participant_Condition
early RA
22679
Participant_Condition
etanercept and methotrexate ( MTX )
22680
Participant_Condition
patients who completed 5 years of etanercept treatment
22681
Participant_Condition
patients with early RA
22682
Participant_Condition
patients with early aggressive RA