A RANDOMIZED DOUBLE-BLIND CONTROLLED TRIAL OF SULFASALAZINE COMBINED WITH PULSES OF METHYLPREDNISOLONE OR PLACEBO IN THE TREATMENT OF RHEUMATOID-ARTHRITIS

Thirty-eight patients with rheumatoid arthritis meeting American Colle ge of Rheumatism (ACR) criteria were entered in a randomized controlle d trial (RCT) of 6 months to assess whether monthly treatment with i.v . methylprednisolone (MP) enhances or accelerates the efficacy of sulp hasalazine (SSZ). All patients had failed at least one second-line age nt and were randomized to receive SSZ (2 g/day) and pulses of MP (5 mg /kg), or SSZ (2 g/day) and pulses of saline (SA). A single infusion of 2 h was carried out in both groups for a total of three times (0, 1 a nd 2 months). The two groups were comparable at baseline regarding the ir demographic and clinical characteristics. Disease activity was eval uated every 2 months by means of: (1) joint count; (2) morning stiffne ss; (3) grip strength;(4) visual analogue pain score; (5) health asses sment questionnaire; and (6) erythrocyte sedimentation rate. All outco me measures improved significantly in both groups (P < 0.001). Evaluat ion at each follow-up visit showed no significant differences between the groups in any of the adverse effects attributable to SSZ therapy ( one SA vs two MP). Adverse effects attributable to SA/MP therapy were rare and mild. We concluded that repeated pulses of MP during the firs t 3 months of treatment did not improve the efficacy of SSZ. Therefore , there is no justification for using MP in this way during the induct ion phase of SSZ therapy.