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Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study).

Nathalie Costedoat-Chalumeau 1 Lionel Galicier 2 Olivier Aumaître 3 Camille Francès 4 Véronique Le Guern 5, 6 Frédéric Lioté 7 Amar Smail Nicolas Limal Laurent Perard Hélène Desmurs-Clavel Du Le Thi Huong Boutin Bouchra Asli Jean-Emmanuel Kahn 8 Jacques Pourrat 9 Laurent Sailler Félix Ackermann Thomas Papo 10 Karim Sacré Olivier Fain 11 Jerome Stirnemann 12 Patrice Cacoub 13, 14 Moez Jallouli Gaelle Leroux 15 Judith Cohen-Bittan Marie-Laure Tanguy 16 Jean-Sébastien Hulot 17 Philippe Lechat Lucile Musset 18 Zahir Amoura 13, 19 Jean-Charles Piette 13 Aurelien Delluc 20, 21, 22
Abstract : INTRODUCTION: Hydroxychloroquine (HCQ) is an important medication for treating systemic lupus erythematosus (SLE). Its blood concentration ([HCQ]) varies widely between patients and is a marker and predictor of SLE flares. This prospective randomised, double-blind, placebo-controlled, multicentre study sought to compare standard and adjusted HCQ dosing schedules that target [HCQ] ≥1000 ng/ml to reduce SLE flares. PATIENTS AND METHODS: [HCQ] was measured in 573 patients with SLE (stable disease and SELENA-SLEDAI≤12) treated with HCQ for at least 6 months. Patients with [HCQ] from 100 to 750 ng/ml were randomised to one of two treatment groups: no daily dose change (group 1) or increased HCQ dose to achieve the target [HCQ] (group 2). The primary end point was the number of patients with flares during 7 months of follow-up. RESULTS: Overall, mean [HCQ] was 918±451 ng/ml. Active SLE was less prevalent in patients with higher [HCQ]. A total of 171 patients were randomised and followed for 7 months. SLE flare rates were similar in the two groups (25% in group 1 vs 27.6% in group 2; p=0.7), but a significant spontaneous increase in [HCQ] in both groups between inclusion and randomisation strongly suggested improved treatment adherence. Patients at the therapeutic target throughout follow-up tended to have fewer flares than those with low [HCQ] (20.5% vs 35.1%, p=0.12). CONCLUSIONS: Although low [HCQ] is associated with higher SLE activity, adapting the HCQ dose did not reduce SLE flares over a 7-month follow-up.
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Submitted on : Monday, January 20, 2014 - 11:59:12 AM
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Nathalie Costedoat-Chalumeau, Lionel Galicier, Olivier Aumaître, Camille Francès, Véronique Le Guern, et al.. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study).. Annals of the Rheumatic Diseases, BMJ Publishing Group, 2013, 72 (11), pp.1786-92. ⟨10.1136/annrheumdis-2012-202322⟩. ⟨hal-00933279⟩

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