PT  - JOURNAL ARTICLE
AU  - Nathalie Costedoat-Chalumeau
AU  - Lionel Galicier
AU  - Olivier Aumaître
AU  - Camille Francès
AU  - Véronique Le Guern
AU  - Frédéric Lioté
AU  - Amar Smail
AU  - Nicolas Limal
AU  - Laurent Perard
AU  - Hélène Desmurs-Clavel
AU  - Du Le Thi Huong Boutin
AU  - Bouchra Asli
AU  - Jean-Emmanuel Kahn
AU  - Jacques Pourrat
AU  - Laurent Sailler
AU  - Félix Ackermann
AU  - Thomas Papo
AU  - Karim Sacré
AU  - Olivier Fain
AU  - Jerome Stirnemann
AU  - Patrice Cacoub
AU  - Moez Jallouli
AU  - Gaelle Leroux
AU  - Judith Cohen-Bittan
AU  - Marie-Laure Tanguy
AU  - Jean-Sébastien Hulot
AU  - Philippe Lechat
AU  - Lucile Musset
AU  - Zahir Amoura
AU  - Jean-Charles Piette
AU  - on behalf of Group PLUS
TI  - Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study)
AID  - 10.1136/annrheumdis-2012-202322
DP  - 2013 Nov 01
TA  - Annals of the Rheumatic Diseases
PG  - 1786--1792
VI  - 72
IP  - 11
4099  - http://ard.bmj.com/content/72/11/1786.short
4100  - http://ard.bmj.com/content/72/11/1786.full
SO  - Ann Rheum Dis2013 Nov 01; 72
AB  - 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