Selection of suitable patients for second-line therapy in rheumatoid arthritis

Investigators studying second-line drugs often try to enroll 'ideal' patients with a high ESR, short disease duration and who have received no previous second-line therapy. In this paper we investigate the influence of gender, disease duration, previous second-line therapy, and initial ESR in 150 rheumatoid patients with clinically-active disease treated with sulphasalazine. Clinical improvement was seen in all subgroups and no difference in toxicity could be demonstrated. Haematological response was absent in patients with an initial low ESR although these patients improved clinically. Thus, patients with clinically-active disease suggesting a need for second-line drugs should benefit from sulphasalazine therapy irrespective of any of the above variables. The implications for clinical trial design regarding patients with low ESR, however, may be more complex.