A randomized, multicenter, controlled trial using intravenous pulses of methylprednisolone in the initial treatment of simple forms of giant cell arteritis: a one year followup study of 164 patients.

Objective. (1) To evaluate the corticosteroid sparing effect of an initial intravenous (iv) pulse of mcthyl-prednisolone (MP) in the treatment of simple forms of giant cell arteritis (GCA), (2) To analyze corticosteroid response, steroid related side effects, and GCA complications. Methods. Patients received a 240 mg iv pulse of MP followed by 0.7 mg/kg/day oral prednisone (Group 1), or 0.7 mg/kg/day prednisone without an iv pulse (Group 2, controls), or a 230 mg iv pulse of MP followed by 0.5 mg/kg/day prednisone (Group 3). Corticosteroid dosage was reduced after normalization of 2 biological inflammatory variables to obtain half-dosage after 3 weeks in Groups 1 and 2 and 20 mg/day after 2 weeks in Group 3. Tapering was systematically attempted from the 6th month of treatment. Results, One hundred sixty-four patients were included in the trial (1992-96). Cumulative doses of corticosteroids after one year were identical for all groups (p = 0.39). No significant differences were observed in the time required for normalization of C-reactive protein, corticosteroid resistance (13.5%), and corticosteroid related side effects (39% of patients; p = 0.37). Corticosteroid resistant patients received larger doses and showed a high risk of GCA related complications (p = 0.02). Conclusion. MP pulses have no significant longterm, corticosteroid sparing effects in the treatment of simple forms of GCA and should be limited to complicated forms. Moreover, corticosteroid resistance is a real risk; factor for GCA complications.