Open pilot study of the addition of sulfasalazine to methotrexate in patients with rheumatoid arthritis inadequately controlled with methotrexate alone.

The safety and efficacy of the sequential addition of sulfasalazine to baseline methotrexate was assessed in patients with active rheumatoid arthritis inadequately controlled by methotrexate alone. Nineteen patients were recruited in a pilot, prospective, open label, uncontrolled clinical trial. One patient was lost to follow-up, four dropped out due to toxicity, one dropped out due to inefficacy, and five violated the protocol. A modified intent-to-treat analysis was performed by carrying forward the clinical data before drop-out or protocol violation to the final visit for the 18 evaluable patients. Swollen and tender joint counts, physicians's and patient's global scores were significantly improved (p < 0.021 to 0.001). Forty-two percent of patients (8/19) demonstrated >/= 20% improvement and 26% (5/19) showed >/= 50% improvement in 4 or more clinical parameters at 6 month's follow-up. Rheumatoid factor negative patients were more likely (p < 0.025) to complete the trial. A controlled clinical trial will be necessary to determine the effectiveness of this combination and the value of sequential addition chemotherapy in patients with recalcitrant rheumatoid arthritis.