Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study). Issue 11 (10th November 2012)

• Record Type: Journal Article
• Authors: 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
• Other Names: Astudillo Leonardo author non-byline.; Belizna Cristina author non-byline.; Belmatoug Nadia author non-byline.; Benveniste Olivier author non-byline.; Benyamine Audrey author non-byline.; Bezanahary Holly author non-byline.; Blanco Patrick author non-byline.; Bletry Olivier author non-byline.; Bodaghi Bahram author non-byline.; Bourgeois Pierre author non-byline.; Brihaye Benoît author non-byline.; Chatelus Emmanuel author non-byline.; Damade Richard author non-byline.; Daugas Eric author non-byline.; de-Gennes Christian author non-byline.; Delfraissy Jean-François author non-byline.; Delluc Céline author non-byline.; Delluc Aurélien author non-byline.; Duhaut Pierre author non-byline.; Dupuy Alain author non-byline.; Durieu Isabelle author non-byline.; Hang-Korng EA author non-byline.; Farge Dominique author non-byline.; Funck-Brentano Christian author non-byline.; Gandjbakhch Frédérique author non-byline.; Gellen-Dautremer Justine author non-byline.; Ghillani-Dalbin Pascale author non-byline.; Godeau Bertrand author non-byline.; Goujard Cécile author non-byline.; Grandpeix Catherine author non-byline.; Grange Claire author non-byline.; Grimaldi Lamiae author non-byline.; Guettrot-Imbert Gaëlle author non-byline.; Guillevin Loïc author non-byline.; Hachulla Eric author non-byline.; Harle Jean-Robert author non-byline.; Haroche Julien author non-byline.; Hausfater Pierre author non-byline.; Jouquan Jean author non-byline.; Kaplanski Gilles author non-byline.; Keshtmand Homa author non-byline.; Khellaf Mehdi author non-byline.; Lambotte Olivier author non-byline.; Launay David author non-byline.; Levesque Hervé author non-byline.; Lidove Olivier author non-byline.; Liozon Eric author non-byline.; Kim LY author non-byline.; Mahevas Matthieu author non-byline.; Mariampillai Kubéraka author non-byline.; Mariette Xavier author non-byline.; Mathian Alexis author non-byline.; Mazodier Karin author non-byline.; Michel Marc author non-byline.; Morel Nathalie author non-byline.; Mouthon Luc author non-byline.; Ngack Rokiya author non-byline.; Ninet Jacques author non-byline.; Oksenhendler Eric author non-byline.; Pellegrin Jean-Luc author non-byline.; Peyr Olivier author non-byline.; Piette Anne-Marie author non-byline.; Poindron Vincent author non-byline.; Roux Fabienne author non-byline.; Saadoun David author non-byline.; Sahali Sabrinel author non-byline.; Saint-Marcoux Bernadette author non-byline.; Sarrot-Reynauld Françoise author non-byline.; Schoindre Yoland author non-byline.; Sellam Jérémie author non-byline.; Sene Damien author non-byline.; Serratrice Jacques author non-byline.; Seve Pascal author non-byline.; Sibilia Jean author non-byline.; Simon Claude author non-byline.; Sordet Christelle author non-byline.; Terrier Benjamin author non-byline.; Trad Salim author non-byline.; Viallard Jean-François author non-byline.; Vidal Elisabeth author non-byline.; Wechsler Bertrand author non-byline.; Weiller Pierre-Jean author non-byline.; Zahr Noël author non-byline.;
• Is Part Of: Annals of the rheumatic diseases. Volume 72:Issue 11(2013)
• Page Start: 1786
• Page End: 1792
• Publication Date: 2012-11-10
• Subjects: Systemic Lupus Erythematosus -- Pharmacokinetics -- Treatment; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2012-202322
• Languages: English
• ISSNs: 0003-4967

Abstract

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