Effectiveness and safety of hydroxychloroquine therapy with or without corticosteroid in patients with systemic lupus erythematosus.

Abstract

The effectiveness and safety of hydroxychloroquine (HCQ) have not been fully validated in Japanese patients with systemic lupus erythematosus (SLE) in the clinical setting. This study evaluated the short-term effectiveness and continuation rate of HCQ therapy in Japanese patients with SLE in the clinical setting for 12 months. The primary endpoint was defined as the continuation rate up to 12 months after the introduction of HCQ in 122 patients with SLE. The secondary endpoints included changes in the SLE Disease Activity Index (SLEDAI) and the British Isles Lupus Assessment Group (BILAG) index, and the effect on concomitant corticosteroid (CS) dose reduction. The primary endpoint, continuation rate up to 12 months after the introduction of HCQ, was 79.5%. Of 25 patients who discontinued HCQ, 23 patients terminated the therapy within 2 months. The secondary endpoints (SLEDAI, BILAG index, and concomitant CS dose [mg/day, prednisolone equivalent]) all showed a significant decrease. SLEDAI and BILAG index scores indicated significant improvement during the remission induction phase, maintenance phase, and HCQ monotherapy phase. The results of this study suggested that, with attention paid to possible adverse events immediately after initiation, HCQ may be initiated as a mainstay of SLE therapy in Japanese patients, either as a concomitant medication in the remission induction phase, as a maintenance therapy, or as a monotherapy.