Therapeutic Research

Abstract

Objective：To evaluate the general safety and effectiveness of hydroxychloroquine （HCQ）in Japanese patients with lupus erythematosus（LE）under Japanese good post‒marketing study practice（GPSP）regulation. 　Methods：This drug‒use results survey was designed to assess 1‒year general safety and effectiveness and at least 3 years of follow‒up for eye disorders. Patients with cutaneous（CLE）or systemic （SLE）LE and naïve to treatment with HCQ were eligible for enrollment. Basically, patients received HCQ as per the package insert. Safety was assessed, and effectiveness variables were determined from physician and patient impressions using the global improvement scale（GIS）for cutaneous symptoms. SLE patients evaluated fatigue and musculoskeletal pain on a visual analog scale（VAS）.　　Results：In interim 1‒year results from 1181 enrolled patients, safety and effectiveness were analyzed for 1007 and 863 patients, respectively. Mean（SD）treatment duration was 369.4（189.7）days, and HCQ dose was 259.1（60.3）mg/day. In the safety population, mean age（SD）was 41.7（14.9）years；CLE accounted for 7.15％ of patients and SLE for 92.45％；88.68％ were female. Incidence was 15.79％ for adverse drug reactions（ADRs）and 1.69％ for serious ADRs. Common ADRs were diarrhea（2.98％）, rash （2.88％）and drug eruption（2.09％）. All reported ADRs up to the 1‒year interim analysis were known. Improvement （improved or markedly improved）in cutaneous symptoms was rated at 50.3％ by physicians and 49.9％ by patients on the GIS after 52 weeks of HCQ treatment. From baseline to week 52, mean change（SD）was －1.24（2.06）for fatigue and －1.19（1.97）for musculoskeletal pain. 　　Conclusions：In this interim analysis, the use of HCQ in LE patients was associated with improved cutaneous symptoms, fatigue, and musculoskeletal pain. Safety results, monitored up to 1‒year after HCQ initiation, were consistent with the currently known safety profile. Nevertheless, long‒term safety, especially retinopathy, should be assessed in continuous surveillance.