THERAPY FOR THE MAINTENANCE OF REMISSION IN 65 PATIENTS WITH GENERALIZED WEGENER GRANULOMATOSIS - METHOTREXATE VERSUS TRIMETHOPRIM SULFAMETHOXAZOLE/

Objective. To compare the efficacy of low-dose intravenous (IV) methot rexate (MTX; 0.3 mg/kg once weekly), both with and without concomitant prednisone, versus daily oral trimethoprim/sulfamethoxazole (T/S; 160 mg of trimethoprim + 800 mg of sulfamethoxazole twice a day), with an d without prednisone, in maintaining remission in patients with genera lized Wegener's granulomatosis (WG). Methods. In this study, 65 patien ts with generalized WG whose disease had entered remission,vith cyclop hosphamide (CYC) and prednisone therapy were started on one of the fol lowing remission-maintenance regimens: MTX alone (group A; n = 22), T/ S alone (group B; n = 24), MTX plus concomitant prednisone (group C; n = 11), and T/S plus concomitant prednisone (group D; n = 8), Clinical , radiographic, and seroimmunologic data were evaluated to assess the efficacy of the 4 regimens and to seek possible predictive factors con cerning outcome in each group. Results. Partial or complete remission was maintained in 86% of the patients in group A, but in only 58% of t hose in group B (P < 0.05), In group C, 91% of patients remained in re mission, which is in sharp contrast to group D, in which all patients experienced a relapse after a median of 14.5 months (P < 0.005), Side effects occurred twice as often with MTX (n = 12) as with T/S (n = 6) treatment and could usually be resolved by supplemental folinic acid, Two patients taking MTX and 3 patients taking T/S were withdrawn from the study medication because of side effects, In none of the patients were the adverse effects life threatening, No statistically significan t factors predictive of poor outcome emerged in any group. Conclusion. Low-dose MTX was found to be superior to T/S for the safe and effecti ve maintenance of remission in patients with generalized WG. The use o f concomitant prednisone was not associated with a worse outcome with MTX treatment, Since T/S, especially with concomitant prednisone, seem ed to increase the chance of relapse, neither T/S alone nor T/S plus p rednisone can be recommended for the maintenance of remission in patie nts with generalized WG.