Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis
Identifieur interne : 002983 ( Main/Exploration ); précédent : 002982; suivant : 002984Randomised 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 :
- The Lancet [ 0140-6736 ] ; 1996.
English descriptors
- Teeft :
- Active movement, Arthritis, Arthritis rheum, Articular, Articular index, Azathioprine, Baseline, Baseline characteristics, Chloroquine, Clin rheumatol, Clinical trial, Continuedtreatment group, Continuous therapy, Cumulative incidence, Daily dose, Discontinuation, Disease activity, Disease activity indices, Disease characteristics, Drug group, Exclusion criteria, Flare, Flare patients, Flare rate, Foot radiographs, Gastrointestinal complaints, Gold therapy, Grip strength, High maintenance dose, Hospital pharmacy, Hydroxychloroquine, Independent committee, Joint tenderness, Kennemer gasthuis location, Laboratory tests, Logistic regression model, Longterm treatment, Medication, Methotrexate, Methotrexate therapy, Mild flare, More flares, Morning stiffness, Nsaid, Parenteral, Parenteral gold, Placebo, Placebo group, Placebo tablets, Present study, Protocol, Protocol medication, Randomisation, Randomised, Remission, Rheum, Rheumatoid, Rheumatoid arthritis, Rheumatoid factor, Rheumatoid flare, Rheumatol, Risk factors, Second line therapy, Serum creatinine, Serum gold concentrations, Severe flare, Severe flares, Significant risk factor, Soft tissue, Statistical analysis, Study centres, Sulphasalazine, Swollen joints, Treatment group, Treatment groups, Trial medication, University hospital leiden.
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>Arthritis</term>
<term>Arthritis rheum</term>
<term>Articular</term>
<term>Articular index</term>
<term>Azathioprine</term>
<term>Baseline</term>
<term>Baseline characteristics</term>
<term>Chloroquine</term>
<term>Clin rheumatol</term>
<term>Clinical trial</term>
<term>Continuedtreatment group</term>
<term>Continuous therapy</term>
<term>Cumulative incidence</term>
<term>Daily dose</term>
<term>Discontinuation</term>
<term>Disease activity</term>
<term>Disease activity indices</term>
<term>Disease characteristics</term>
<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>
<term>Independent committee</term>
<term>Joint tenderness</term>
<term>Kennemer gasthuis location</term>
<term>Laboratory tests</term>
<term>Logistic regression model</term>
<term>Longterm treatment</term>
<term>Medication</term>
<term>Methotrexate</term>
<term>Methotrexate therapy</term>
<term>Mild flare</term>
<term>More flares</term>
<term>Morning stiffness</term>
<term>Nsaid</term>
<term>Parenteral</term>
<term>Parenteral gold</term>
<term>Placebo</term>
<term>Placebo group</term>
<term>Placebo tablets</term>
<term>Present study</term>
<term>Protocol</term>
<term>Protocol medication</term>
<term>Randomisation</term>
<term>Randomised</term>
<term>Remission</term>
<term>Rheum</term>
<term>Rheumatoid</term>
<term>Rheumatoid arthritis</term>
<term>Rheumatoid factor</term>
<term>Rheumatoid flare</term>
<term>Rheumatol</term>
<term>Risk factors</term>
<term>Second line therapy</term>
<term>Serum creatinine</term>
<term>Serum gold concentrations</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>
<term>Treatment group</term>
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<front><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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