RT Journal Article
SR Electronic
T1 Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study)
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 1786
OP 1792
DO 10.1136/annrheumdis-2012-202322
VO 72
IS 11
A1 Nathalie Costedoat-Chalumeau
A1 Lionel Galicier
A1 Olivier Aumaître
A1 Camille Francès
A1 Véronique Le Guern
A1 Frédéric Lioté
A1 Amar Smail
A1 Nicolas Limal
A1 Laurent Perard
A1 Hélène Desmurs-Clavel
A1 Du Le Thi Huong Boutin
A1 Bouchra Asli
A1 Jean-Emmanuel Kahn
A1 Jacques Pourrat
A1 Laurent Sailler
A1 Félix Ackermann
A1 Thomas Papo
A1 Karim Sacré
A1 Olivier Fain
A1 Jerome Stirnemann
A1 Patrice Cacoub
A1 Moez Jallouli
A1 Gaelle Leroux
A1 Judith Cohen-Bittan
A1 Marie-Laure Tanguy
A1 Jean-Sébastien Hulot
A1 Philippe Lechat
A1 Lucile Musset
A1 Zahir Amoura
A1 Jean-Charles Piette
A1 on behalf of Group PLUS
YR 2013
UL http://ard.bmj.com/content/72/11/1786.abstract
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