Intention-to-treat analysis of 200 patients with rheumatoid arthritis 12 years after random allocation to either sulfasalazine or penicillamine.

Abstract

To assess existing disease modifying antirheumatic drugs (DMARD) using a strategy aiming for sustained suppression of inflammation. We conducted intention-to-treat analysis of open randomized study [sulfasalazine (SASP) or penicillamine (PEN)], followup 12 years, conducted at specialist rheumatology clinics in Glasgow, Scotland. Subjects were 200 patients with rheumatoid arthritis (RA) with established disease. In this "true to life" approach, comorbidity was not an exclusion criterion unless it prejudiced assessment of drug toxicity. The main outcome measure was the Health Assessment Questionnaire (HAQ) functional score. Over 12 year followup 95 (47.5%) patients died; this was the commonest reason for study groups being unfulfilled. There was one drug related death (methotrexate). Patients who were socially disadvantaged were more likely to die prematurely. HAQ did not deteriorate significantly in those who continued taking their original DMARD, or in the SASP intention-to-treat group over 12 years. Sustained suppression of disease activity was possible in the entire group available for followup at 12 years. Most toxicity occurred early and no unexpected side effects were observed. High premature mortality in RA was confirmed and an association between mortality and deprivation was demonstrated. Sustained reduction in acute phase response was possible using sequential single DMARD. This study provides useful baseline and longterm information against which to evaluate combination therapy or new agents.