INTENTION-TO-TREAT ANALYSIS OF 200 PATIENTS WITH RHEUMATOID-ARTHRITIS12 YEARS AFTER RANDOM ALLOCATION TO EITHER SULFASALAZINE OR PENICILLAMINE

Objective. To assess existing disease modifying antirheumatic drugs (D MARD) using a strategy aiming for sustained suppression of inflammatio n. Methods. We conducted intention-to-treat analysis of open randomize d study [sulfasalazine (SASP) or penicillamine (PEN)], followup 12 yea rs, conducted at specialist rheumatology clinics in Glasgow, Scotland. Subjects were 200 patients with rheumatoid arthritis (RA) with establ ished disease. In this ''true to life'' approach, comorbidity was not an exclusion criterion unless it prejudiced assessment of drug toxicit y. The main outcome measure was the Health Assessment Questionnaire (H AQ) functional score. Results. Over 12 year followup 95 (47.5%) patien ts died; this was the commonest reason for study groups being unfulfil led. There was one drug related death (methotrexate). Patients who wer e socially disadvantaged were more likely to die prematurely. HAQ did not deteriorate significantly in those who continued taking their orig inal DMARD, or in the SASP intention-to-treat group over 12 years. Sus tained suppression of disease activity was possible in the entire grou p available for followup at 12 years. Most toxicity occurred early and no unexpected side effects were observed. Conclusion. High premature mortality in RA was confirmed and an association between mortality and deprivation was demonstrated. Sustained reduction in acute phase resp onse was possible using sequential single DMARD. This study provides u seful baseline and longterm information against which to evaluate comb ination therapy or new agents.