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Medline ® Abstract for Reference 57

of 'Initial treatment of rheumatoid arthritis in adults'

Randomised placebo-controlled study of stopping second-line drugs in rheumatoid arthritis.
ten Wolde S, Breedveld FC, Hermans J, Vandenbroucke JP, van de Laar MA, Markusse HM, Janssen M, van den Brink HR, Dijkmans BA
Lancet. 1996;347(8998):347.
BACKGROUND: 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% CI 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.
Department of Rheumatology, University Hospital Leiden, Netherlands.