8647
document
Step-down approach using either cyclosporin A or methotrexate as maintenance therapy in early rheumatoid arthritis . OBJECTIVE To evaluate the feasibility and outcome of the step-down approach using either cyclosporin A ( CSA ) or methotrexate ( MTX ) as maintenance therapy following 6 months treatment with these 2 agents in combination in early , nonerosive rheumatoid arthritis ( RA ) . METHODS Fifty-seven patients younger than 65 years with early , nonerosive RA were first treated with CSA and MTX in combination for 6 months . They were then randomly stepped down to single-agent maintenance treatment for another 18 months . Safety , clinical efficacy , survival on treatment , and radiographic progression were evaluated . RESULTS When being treated with combination therapy , 7 of the 57 patients ( 12.3 % ) withdrew because of adverse events . Of the remaining 50 patients , 42 ( 84.0 % ) were American College of Rheumatology ( ACR ) 20 % responders , 30 ( 60.0 % ) were ACR 50 % responders , and 23 ( 46.0 % ) were ACR 70 % responders . At month 6 , 22 patients were randomized to CSA and 27 to MTX . During this trial period , the treatment was discontinued by 16 patients taking CSA ( mainly because of loss of efficacy ) and by 4 taking MTX . At month 24 , the probability ( +/- SEM ) of survival on treatment was 0.273 +/- 0.09 for CSA and 0.852 +/- 0.07 for MTX . Of the 6 CSA patients who completed the trial , 4 ( 66.7 % ) were ACR 20 % responders , and 3 ( 50 % ) were both ACR 50 % and ACR 70 % responders . Of the 23 completers in the MTX arm , 21 ( 91.3 % ) were ACR 20 % responders , 18 ( 78.3 % ) were ACR 50 % , and 10 ( 43.5 % ) were ACR 70 % responders . The treatment was not responsible for severe adverse events . Radiography showed a slow progression in the damage score and number of eroded joints in both treatment groups . CONCLUSION Stepping down to single agent maintenance therapy following 6 months of combination treatment with CSA and MTX in early RA was only successful with MTX . Because this treatment did not prevent some radiographic progression , other approaches ( e.g. , step-up approach ) may be more appropriate in early RA .
8648
Intervention_Pharmacological
cyclosporin A
8649
Intervention_Pharmacological
methotrexate
8650
Intervention_Pharmacological
cyclosporin A ( CSA )
8651
Intervention_Pharmacological
methotrexate ( MTX )
8652
Intervention_Pharmacological
CSA
8653
Intervention_Pharmacological
MTX in combination
8654
Intervention_Physical
single-agent
8655
Intervention_Pharmacological
CSA
8656
Intervention_Pharmacological
MTX
8657
Intervention_Pharmacological
CSA
8658
Intervention_Pharmacological
MTX
8659
Intervention_Pharmacological
CSA
8660
Intervention_Pharmacological
MTX
8661
Intervention_Pharmacological
MTX
8662
Intervention_Pharmacological
CSA
8663
Intervention_Pharmacological
MTX
8664
Intervention_Pharmacological
MTX
8665
Outcome_Other
feasibility and outcome
8666
Outcome_Other
Safety , clinical efficacy
8667
Outcome_Mortality
survival on treatment
8668
Outcome_Physical
radiographic progression
8669
Outcome_Adverse-effects
adverse events
8670
Outcome_Other
efficacy
8671
Outcome_Mortality
survival
8672
Outcome_Adverse-effects
adverse events
8673
Outcome_Physical
damage score and number of eroded joints
8674
Outcome_Physical
radiographic progression
8675
Participant_Condition
rheumatoid arthritis .
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Participant_Condition
nonerosive RA
8677
Participant_Sample-size
7 of the 57 patients
8678
Participant_Condition
early RA