Document Detail

Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study).
MedLine Citation:
PMID:  23144449     Owner:  NLM     Status:  Publisher    
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.
Nathalie Costedoat-Chalumeau; Lionel Galicier; Olivier Aumaître; Camille Francès; Véronique Le Guern; Frédéric Lioté; Amar Smail; Nicolas Limal; Laurent Perard; Hélène Desmurs-Clavel; Du Le Thi Huong Boutin; Bouchra Asli; Jean-Emmanuel Kahn; Jacques Pourrat; Laurent Sailler; Félix Ackermann; Thomas Papo; Karim Sacré; Olivier Fain; Jerome Stirnemann; Patrice Cacoub; Moez Jallouli; Gaelle Leroux; Judith Cohen-Bittan; Marie-Laure Tanguy; Jean-Sébastien Hulot; Philippe Lechat; Lucile Musset; Zahir Amoura; Jean-Charles Piette;
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-10
Journal Detail:
Title:  Annals of the rheumatic diseases     Volume:  -     ISSN:  1468-2060     ISO Abbreviation:  Ann. Rheum. Dis.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-12     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372355     Medline TA:  Ann Rheum Dis     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
1UPMC, Université Paris 6, Paris, France.
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