OBJECTIVES: Infliximab, an antibody that binds to tumor necrosis factor-alpha (TNF-alpha) is indicated for the treatment of rheumatoid arthritis (RA). In August 2001, the prescribing information for infliximab in RA was broadened, allowing both dose titration (3-10 mg/kg) and infusion interval modification (every 4-8 weeks). A retrospective, observational study of infliximab dosing patterns in rheumatology practices was conducted to assess the impact of this label change. METHODS: Rheumatology practices with multiple calls to the infliximab Health Connections Hotline were surveyed and participated (n = 40). Each practice identified 3 patients pre-label change (group 1) and 3 patients post-label change (group 2) in a blinded, randomized fashion. Data on demographics, insurance, diagnosis code, prior medication use and infliximab infusion history was collected. RESULTS: Of 249 responses, 206 (82.7%) were evaluated and analyzed with no statistical differences between groups 1 (n = 98) and 2 (n = 108). The median infliximab dose in the induction phase and first maintenance dose was 3.0 mg/kg for both groups. By maintenance dose 3, the group 1 median dose remained at 3.0 mg/kg while group 2 showed a nonsignificant increase to 4.0 mg/kg, although both groups reported significant steroid discontinuation. The mean number of vials administered at this time was 3.2 (group 1) and 3.7 (group 2). The majority (>75%) of patients received £5 mg/kg every 8 weeks by maintenance dose 3. CONCLUSIONS: Dose flexibility did not significantly increase infliximab dose or decrease dosing interval in this cohort. The majority of RA patients receive an infliximab dose of £5 mg/kg every 8 weeks with concomitant steroid discontinuation.