학술논문
Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study)
Document Type
Academic Journal
Author
Costedoat-Chalumeau, Nathalie; Galicier, Lionel; Aumaître, Olivier; Francès, Camille; Le Guern, Véronique; Lioté, Frédéric; Smail, Amar; Limal, Nicolas; Perard, Laurent; Desmurs-Clavel, Hélène; Boutin, Du Le Thi Huong; Asli, Bouchra; Kahn, Jean-Emmanuel; Pourrat, Jacques; Sailler, Laurent; Ackermann, Félix; Papo, Thomas; Sacré, Karim; Fain, Olivier; Stirnemann, Jerome; Cacoub, Patrice; Jallouli, Moez; Leroux, Gaelle; Cohen-Bittan, Judith; Tanguy, Marie-Laure; Hulot, Jean-Sébastien; Lechat, Philippe; Musset, Lucile; Amoura, Zahir; Piette, Jean-Charles; Astudillo, Leonardo; Belizna, Cristina; Belmatoug, Nadia; Benveniste, Olivier; Benyamine, Audrey; Bezanahary, Holly; Blanco, Patrick; Bletry, Olivier; Bodaghi, Bahram; Bourgeois, Pierre; Brihaye, Benoît; Chatelus, Emmanuel; Damade, Richard; Daugas, Eric; de-Gennes, Christian; Delfraissy, Jean-François; Delluc, Céline; Delluc, Aurélien; Duhaut, Pierre; Dupuy, Alain; Durieu, Isabelle; Hang-Korng, EA; Farge, Dominique; Funck-Brentano, Christian; Gandjbakhch, Frédérique; Gellen-Dautremer, Justine; Ghillani-Dalbin, Pascale; Godeau, Bertrand; Goujard, Cécile; Grandpeix, Catherine; Grange, Claire; Grimaldi, Lamiae; Guettrot-Imbert, Gaëlle; Guillevin, Loïc; Hachulla, Eric; Harle, Jean-Robert; Haroche, Julien; Hausfater, Pierre; Jouquan, Jean; Kaplanski, Gilles; Keshtmand, Homa; Khellaf, Mehdi; Lambotte, Olivier; Launay, David; Levesque, Hervé; Lidove, Olivier; Liozon, Eric; Kim, LY; Mahevas, Matthieu; Mariampillai, Kubéraka; Mariette, Xavier; Mathian, Alexis; Mazodier, Karin; Michel, Marc; Morel, Nathalie; Mouthon, Luc; Ngack, Rokiya; Ninet, Jacques; Oksenhendler, Eric; Pellegrin, Jean-Luc; Peyr, Olivier; Piette, Anne-Marie; Poindron, Vincent; Roux, Fabienne; Saadoun, David; Sahali, Sabrinel; Saint-Marcoux, Bernadette; Sarrot-Reynauld, Françoise; Schoindre, Yoland; Sellam, Jérémie; Sene, Damien; Serratrice, Jacques; Seve, Pascal; Sibilia, Jean; Simon, Claude; Sordet, Christelle; Terrier, Benjamin; Trad, Salim; Viallard, Jean-François; Vidal, Elisabeth; Wechsler, Bertrand; Weiller, Pierre-Jean; Zahr, Noël
Source
Annals of the Rheumatic Diseases. Nov 01, 2013 72(11):1786-1792
Subject
Language
English
ISSN
0003-4967
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. CLINICALTRIALS.GOV: NCT00413361