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Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis

Identifieur interne : 002983 ( Main/Exploration ); précédent : 002982; suivant : 002984

Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis

Auteurs : S. Ten Wolde [Pays-Bas] ; F. C. Breedveld [Pays-Bas] ; B. A. C. Dijkmans [Pays-Bas] ; J. Hermans [Pays-Bas] ; J. P. Vandenbroucke [Pays-Bas] ; M. A. F. J. Van De Laar [Pays-Bas] ; H. M. Markusse [Pays-Bas] ; M. Janssen [Pays-Bas] ; H. R. Van Den Brink [Pays-Bas]

Source :

RBID : ISTEX:03F637C3AFE50B8ED82EAE153E91E46760717FC9

English descriptors

Abstract

Abstract: SummaryBackground A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.Methods A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n=142) or received a placebo (n=143). The endpoint was a flare, defined as recurrence of synovitis.Findings At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p=0·002). The risk of a flare was 2·0 times higher for patients receiving placebo than for those continuing the second-line drug (95% Cl 1·27 to 3·17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.Interpretation Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.

Url:
DOI: 10.1016/S0140-6736(96)90535-8


Affiliations:


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Le document en format XML

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<term>Active movement</term>
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<term>Articular</term>
<term>Articular index</term>
<term>Azathioprine</term>
<term>Baseline</term>
<term>Baseline characteristics</term>
<term>Chloroquine</term>
<term>Clin rheumatol</term>
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<term>Cumulative incidence</term>
<term>Daily dose</term>
<term>Discontinuation</term>
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<term>Drug group</term>
<term>Exclusion criteria</term>
<term>Flare</term>
<term>Flare patients</term>
<term>Flare rate</term>
<term>Foot radiographs</term>
<term>Gastrointestinal complaints</term>
<term>Gold therapy</term>
<term>Grip strength</term>
<term>High maintenance dose</term>
<term>Hospital pharmacy</term>
<term>Hydroxychloroquine</term>
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<term>Logistic regression model</term>
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<term>Methotrexate</term>
<term>Methotrexate therapy</term>
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<term>More flares</term>
<term>Morning stiffness</term>
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<term>Parenteral gold</term>
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<term>Rheumatoid</term>
<term>Rheumatoid arthritis</term>
<term>Rheumatoid factor</term>
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<term>Rheumatol</term>
<term>Risk factors</term>
<term>Second line therapy</term>
<term>Serum creatinine</term>
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<term>Severe flares</term>
<term>Significant risk factor</term>
<term>Soft tissue</term>
<term>Statistical analysis</term>
<term>Study centres</term>
<term>Sulphasalazine</term>
<term>Swollen joints</term>
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<div type="abstract" xml:lang="en">Abstract: SummaryBackground A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.Methods A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n=142) or received a placebo (n=143). The endpoint was a flare, defined as recurrence of synovitis.Findings At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p=0·002). The risk of a flare was 2·0 times higher for patients receiving placebo than for those continuing the second-line drug (95% Cl 1·27 to 3·17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.Interpretation Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.</div>
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