Degree and extent of response to sulphasalazine or penicillamine therapy for rheumatoid arthritis: results from a routine clinical environment over a two-year period.

An attempt was made to audit the clinical usefulness of sulphasalazine and penicillamine in patients with rheumatoid arthritis (RA) managed in a routine out-patient setting with assistance from general practitioners and to ascertain whether clinically significant differences can be shown between these two 'second-line' agents. The degree and extent of change in, and the usefulness of, various parameters of disease activity were also evaluated. Two hundred patients with active rheumatoid arthritis were randomly allocated to either sulphasalazine or penicillamine and monitored for a minimum of two years. Fifty-one percent of the 102 patients who received sulphasalazine continued treatment for two years, compared with 40 per cent of the 98 patients allocated to penicillamine. The proportion of patients stopping therapy because of adverse reactions or due to lack or loss of effect was similar in the two groups. There was no difference between the two groups in the extent of improvement in clinical and laboratory variables at one and two years. The majority of patients showed improvement in most measured parameters; very few showed global improvement. The degree of improvement varied with the parameter assessed, being greatest in relatively easily measured variables such as duration of morning stiffness and ESR, and least for functional index. The effect and toxicity of these two agents in this setting was as anticipated. No clinically relevant difference could be demonstrated between the two drugs.

RCT Entities:   Population Interventions Outcomes