RANDOMIZED PLACEBO-CONTROLLED STUDY OF STOPPING 2ND-LINE DRUGS IN RHEUMATOID-ARTHRITIS

Background A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in sh ort-term studies, The present investigation addresses the question of whether RA patients with a good response to long-term treatment with s econd-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 patie nts either continued the second-line drug (n=142) or received a placeb o (n=143). The endpoint was a flare, defined as recurrence of synoviti s. Findings At entry into the study median duration of second-line dru g therapy was 5 years (range 2-33). At 52 weeks the cumulative inciden ce 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 d rug (95% CI 1.27 to 3.17). The same trend was found for each second-li ne drug separately, with the exception of d-penicillamine. Side-effect s that necessitated dose reduction or discontinuation occurred in 2 pa tients in each group. Interpretation Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.