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document
Etanercept treatment in adults with established rheumatoid arthritis : 7 years of clinical experience . OBJECTIVE To evaluate safety and efficacy of longterm etanercept treatment in patients with disease modifying antirheumatic drug ( DMARD ) refractory rheumatoid arthritis ( RA ) . METHODS Safety results are reported for 714 patients who received etanercept in one of 7 initial trials or a longterm extension . Efficacy results are reported for 581 patients who enrolled in the extension . RESULTS Of the 714 patients enrolled in the initial trials , 581 ( 81 % ) enrolled in the extension , and 388 ( 54 % ) patients are continuing to receive etanercept therapy . The longest individual treatment was 8.2 years , with 3139 total patient-years of etanercept exposure . Rates of serious adverse events ( overall rate=14.8 events/100 patient-yrs ) , serious infections ( overall rate=4.2 events/100 patient-yrs ) , cancer ( overall rate=1.0 events/100 patient-yrs ) , and deaths ( overall rate=0.7 events/100 patient-yrs ) were stable each year , through 8 years of etanercept exposure . For 356 patients who completed 6 years of etanercept treatment , response rates were ACR20=73 % , ACR50=52 % , ACR70=27 % , DAS28 CRP good response=52 % , and DAS28 CRP remission=37 % of patients . Similar responses occurred in 167 patients who completed Year 7 . Doses of concomitant methotrexate or corticosteroids were reduced in many patients who maintained clinical responses . CONCLUSION The safety profile of etanercept was consistent over time , with rates of adverse events similar to those reported for patients with RA in general . Durable clinical responses were observed in some patients for 7 years or more . The benefit-to-risk ratio for longterm etanercept treatment remains highly favorable .
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Intervention_Pharmacological
Etanercept
25691
Intervention_Pharmacological
etanercept
25692
Intervention_Pharmacological
etanercept
25693
Intervention_Pharmacological
etanercept
25694
Intervention_Pharmacological
etanercept
25695
Intervention_Pharmacological
etanercept
25696
Outcome_Other
safety
25697
Outcome_Other
efficacy
25698
Outcome_Adverse-effects
Rates of serious adverse events
25699
Outcome_Adverse-effects
serious infections
25700
Outcome_Physical
cancer
25701
Outcome_Mortality
deaths
25702
Outcome_Other
response rates
25703
Outcome_Other
Doses
25704
Outcome_Other
safety profile
25705
Outcome_Adverse-effects
rates of adverse events
25706
Participant_Age
adults
25707
Participant_Condition
rheumatoid arthritis :
25708
Participant_Condition
disease modifying antirheumatic drug ( DMARD ) refractory rheumatoid arthritis ( RA )
25709
Participant_Sample-size
714
25710
Participant_Sample-size
581
25711
Participant_Sample-size
714
25712
Participant_Sample-size
581
25713
Participant_Sample-size
388
25714
Participant_Sample-size
356
25715
Participant_Sample-size
167
25716
Participant_Condition
RA