Document Detail


Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study).
MedLine Citation:
PMID:  23144449     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-11-10
Journal Detail:
Title:  Annals of the rheumatic diseases     Volume:  72     ISSN:  1468-2060     ISO Abbreviation:  Ann. Rheum. Dis.     Publication Date:  2013 Nov 
Date Detail:
Created Date:  2013-10-04     Completed Date:  2013-11-26     Revised Date:  2014-05-12    
Medline Journal Info:
Nlm Unique ID:  0372355     Medline TA:  Ann Rheum Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  1786-92     Citation Subset:  IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00413361
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MeSH Terms
Descriptor/Qualifier:
Adult
Antirheumatic Agents / administration & dosage*,  blood
Dose-Response Relationship, Drug
Double-Blind Method
Drug Monitoring / methods
Female
France
Humans
Hydroxychloroquine / administration & dosage*,  blood
Lupus Erythematosus, Systemic / drug therapy*
Male
Middle Aged
Prospective Studies
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antirheumatic Agents; 4QWG6N8QKH/Hydroxychloroquine
Investigator
Investigator/Affiliation:
Leonardo Astudillo / ; Cristina Belizna / ; Nadia Belmatoug / ; Olivier Benveniste / ; Audrey Benyamine / ; Holly Bezanahary / ; Patrick Blanco / ; Olivier Bletry / ; Bahram Bodaghi / ; Pierre Bourgeois / ; Benoît Brihaye / ; Emmanuel Chatelus / ; Richard Damade / ; Eric Daugas / ; Christian de-Gennes / ; Jean-François Delfraissy / ; Céline Delluc / ; Aurélien Delluc / ; Pierre Duhaut / ; Alain Dupuy / ; Isabelle Durieu / ; Ea Hang-Korng / ; Dominique Farge / ; Christian Funck-Brentano / ; Frédérique Gandjbakhch / ; Justine Gellen-Dautremer / ; Pascale Ghillani-Dalbin / ; Bertrand Godeau / ; Cécile Goujard / ; Catherine Grandpeix / ; Claire Grange / ; Lamiae Grimaldi / ; Gaëlle Guettrot-Imbert / ; Loïc Guillevin / ; Eric Hachulla / ; Jean-Robert Harle / ; Julien Haroche / ; Pierre Hausfater / ; Jean Jouquan / ; Gilles Kaplanski / ; Homa Keshtmand / ; Mehdi Khellaf / ; Olivier Lambotte / ; David Launay / ; Hervé Levesque / ; Olivier Lidove / ; Eric Liozon / ; Ly Kim / ; Matthieu Mahevas / ; Kubéraka Mariampillai / ; Xavier Mariette / ; Alexis Mathian / ; Karin Mazodier / ; Marc Michel / ; Nathalie Morel / ; Luc Mouthon / ; Rokiya Ngack / ; Jacques Ninet / ; Eric Oksenhendler / ; Jean-Luc Pellegrin / ; Olivier Peyr / ; Anne-Marie Piette / ; Vincent Poindron / ; Fabienne Roux / ; David Saadoun / ; Sabrinel Sahali / ; Bernadette Saint-Marcoux / ; Françoise Sarrot-Reynauld / ; Yoland Schoindre / ; Jérémie Sellam / ; Damien Sene / ; Jacques Serratrice / ; Pascal Seve / ; Jean Sibilia / ; Claude Simon / ; Christelle Sordet / ; Benjamin Terrier / ; Salim Trad / ; Jean-François Viallard / ; Elisabeth Vidal / ; Bertrand Wechsler / ; Pierre-Jean Weiller / ; Noël Zahr /

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