The effect of increasing the dose of hydroxychloroquine (HCQ) in patients with refractory cutaneous lupus erythematosus (CLE): An open-label prospective pilot study
- J Am Acad Dermatol. 2016 Apr;74(4):693-9.e3. doi: 10.1016/j.jaad.2015.09.064.
- 1. Assistance Publique Hôpitaux de Paris (AP-HP), Service de Dermatologie et d'Allergologie, Hôpital Tenon, F-75020, Paris, France.
- 2. Inserm Unité mixte de Recherche-S (UMR-S) 1136, Groupe Recherche (GR-08), Institut Pierre Louis d'Epidémiologie et de Santé Publique, Hôpital Pitié-Salpêtrière, F-75013, Paris, France; Sorbonne Universités, Université Pierre et Marie Curie (UPMC) Université Paris 06, F-75013, Paris, France.
- 3. Université René Descartes Paris V, F-75005, Paris, France; AP-HP, Centre de Référence Maladies Auto-immunes et Systémiques Rares, Service de Médecine Interne Pôle Médecine, Hôpital Cochin, F-75014, Paris, France.
- 4. AP-HP, Service de Pharmacologie, Hôpital Pitié-Salpêtrière, F-75013, Paris, France.
- 5. Université Montpellier, Service de Dermatologie, Centre Hospitalo-Universitaire de Montpellier, Institut National de la Santé et de la Recherche Médicale (INSERM) 1058, Montpellier, France.
- 6. Assistance Publique Hôpitaux de Paris (AP-HP), Service de Dermatologie et d'Allergologie, Hôpital Tenon, F-75020, Paris, France. Electronic address: [email protected].
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.