A real-world descriptive study of screening practices for hydroxychloroquine retinopathy in Japan using an insurance claims database

Abstract

Since 2015, hydroxychloroquine (HCQ) has been widely used as a standard treatment for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) under the national health insurance system in Japan. However, the status of routine ophthalmological screening for retinopathy, which is a notable safety concern of HCQ, remains unclear. In this retrospective study using the nationwide health insurance claims database, we aimed to investigate the status of ophthalmological screening in routine clinical practice in Japan. A total of 2567 patients with SLE or CLE were included in the analysis. The proportion of ophthalmology visits was 88.0% at the initiation of HCQ prescription, decreased to 76.3% after one year, and then remained constant. Moreover, only 50% of the patients underwent spectral-domain optical coherence tomography (SD-OCT) and automated visual field (VF) tests, which are useful for the early detection of HCQ retinopathy-related changes. Importantly, the proportion of ophthalmology visits remained consistently high among patients who visited an ophthalmologist in the previous year, ranging from 77.3% to 90.2%. These findings highlight the need to improve screening adherence and promote regular ophthalmological evaluations, particularly for patients without prior ophthalmology visits, to enhance the early detection of HCQ retinopathy.

Keywords: Hydroxychloroquine; Lupus erythematosus; Ophthalmological screening; Retinopathy; Safety.

Fig. 1

The proportion of annual ophthalmology visits. Ophthalmology visits were defined as having a record of any of the six screening examinations (visual acuity test, intraocular pressure test, slit-lamp microscopy, spectral-domain optical coherence tomography, automated visual field test, or color vision test) stated in the hydroxychloroquine package insert.

Fig. 2

The proportion of ophthalmology visits by dose per actual body weight. Patients were stratified into two groups according to the mean dose of hydroxychloroquine per actual body weight. The number of patients in each group is shown below the graph.

Fig. 3

The proportion of follow-up visits by ophthalmology visits status in the previous year. The table shows the number of patients who visited ophthalmologists at the initiation of HCQ prescription, at one year, and five years. The graph illustrates the proportion of ophthalmology visits in the subsequent year (i.e., one, two, and six years later) categorized by ophthalmology visit status in the previous year.