Original article
The effect of increasing the dose of hydroxychloroquine (HCQ) in patients with refractory cutaneous lupus erythematosus (CLE): An open-label prospective pilot study

https://doi.org/10.1016/j.jaad.2015.09.064Get rights and content

Background

Up to 30% of patients with cutaneous lupus erythematosus (CLE) fail to respond to hydroxychloroquine (HCQ).

Objectives

We sought to evaluate the efficacy of increased daily doses of HCQ on cutaneous response in refractory CLE.

Methods

We conducted an open-label prospective study between 2010 and 2014. Patients with CLE and HCQ blood level less than or equal to 750 ng/mL were included. The daily dose of HCQ was increased to reach blood concentrations greater than 750 ng/mL. The primary end point was the number of responders defined by an improvement of CLE Disease Area and Severity Index score (4 points or 20% decrease) in patients with HCQ blood concentration greater than 750 ng/mL.

Results

We included 34 patients (26 women; median age 45 [range 28-72] years). Two nonadherent patients were excluded. The median CLE Disease Area and Severity Index score before treatment was significantly improved after treatment (8 [range 2-30] vs 1.5 [range 0-30]), P < .001). The primary response criterion was reached in 26 (81%) of the 32 patients analyzed. A decrease in HCQ doses without further CLE flare (median follow-up 15.8 [range 3.06-77.4] months) was achieved in 15 of the 26 responders.

Limitations

The main limitations of the study are its open-label design and the limited number of patients included.

Conclusions

Increasing HCQ doses to reach blood concentrations greater than 750 ng/mL should be considered before addition of other treatments in refractory CLE.

Section snippets

Study design and settings

We conducted an open-label prospective study between 2010 and 2014, including patients with CLE followed up in 2 dermatology departments of French university hospitals (Hôpital Tenon, Paris, and Hôpital Saint-Eloi, Centre Hospitalier Régional Universitaire [CHRU] Montpellier).

Participants and inclusion criteria

Eligible patients were consecutively included if they had chronic, intermittent, or subacute CLE with pathological confirmation; received HCQ treatment for 3 months or longer; had active CLE defined by a CLE Disease Area

Patient characteristics

In our cohort of 74 patients with refractory CLE, 36 (49%) had HCQ blood concentration less than 750 ng/mL. Among them 34 were included in the study protocol. Two of these 34 patients were excluded from further analyses because they discontinued therapy as a result of poor adherence without reporting any side effect of HCQ. In all, 25 patients (78%) were women and the median age was 45 (range 28-72) years. The demographic and disease characteristics of the 32 patients analyzed are shown in

Discussion

In this study, increasing HCQ blood concentrations higher than 750 ng/mL was associated with a significant cutaneous improvement in 26 (81%) of 32 patients with refractory CLE. We believe this is an important message as refractory CLE represents approximately 30% of cases2 and is commonly treated by use of more toxic treatment that could therefore be avoided.

Monitoring of HCQ treatment through the development of whole-blood concentration measurement has highlighted significant

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  • Cited by (0)

    Supported by a grant of the French Society of Dermatology. There was no other financial support or other benefit from commercial sources. The sponsors had no role in the design and conduct of the study; in the collection, analysis, or interpretation of data; or in the preparation, review, or approval of the manuscript.

    Conflicts of interest: None declared.

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