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Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study).

Nathalie Costedoat-Chalumeau 1 Lionel Galicier 2 Olivier Aumaître 3 Camille Francès 4 Véronique Le Guern 5, 6 Frédéric Lioté 7 Amar Smail Nicolas Limal Laurent Perard Hélène Desmurs-Clavel Du Le Thi Huong Boutin Bouchra Asli Jean-Emmanuel Kahn 8 Jacques Pourrat 9 Laurent Sailler Félix Ackermann Thomas Papo 10 Karim Sacré Olivier Fain 11 Jerome Stirnemann 12 Patrice Cacoub 13, 14 Moez Jallouli Gaelle Leroux 15 Judith Cohen-Bittan Marie-Laure Tanguy 16 Jean-Sébastien Hulot 17 Philippe Lechat Lucile Musset 18 Zahir Amoura 13, 19 Jean-Charles Piette 13 Aurelien Delluc 20, 21, 22
1 I3 - Immunologie - Immunopathologie - Immunothérapeutique
2 Service d'immunologie clinique
3 Service de Médecine Interne [CHU Clermont-Ferrand]
4 Service de dermatologie et allergologie [CHU Tenon]
5 CHU Saint-Antoine [AP-HP]
6 Service de Médecine Interne
7 Service Rhumatologie
8 EA 2686 - Laboratoire d'Immunologie
9 Service de Néphrologie - Immunologie Clinique [Toulouse]
10 Hôpital Bichat - Claude Bernard
11 Service de médecine interne
12 U738 / UMR_S738 - Modèles et méthodes de l'évaluation thérapeutique des maladies chroniques
13 Service de médecine interne [CHU Pitié-Salpétrière]
14 BTPI - Biologie et thérapeutique des pathologies immunitaires
15 IMN - Institut des Maladies Neurodégénératives [Bordeaux]
16 BIOSPIM - Département de Biostatistique, Santé Publique et Information Médicale [CHU Pitié-Salpêtrière]
17 Physiopathologie, génétique et pharmacologie du remodelage cardiovasculaire
18 Service d'Immunologie [CHU Pitié-Salpétrière]
19 Immunité et Infection
20 DMIP - Brest - Département de Médecine Interne et Pneumologie [Brest]
21 GETBO - Groupe d'Etude de la Thrombose de Bretagne Occidentale
22 CIC - Brest - Centre d'Investigation Clinique
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.
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Submitted on : Monday, January 20, 2014 - 11:59:12 AM
Last modification on : Friday, May 20, 2022 - 11:06:36 AM

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Nathalie Costedoat-Chalumeau, Lionel Galicier, Olivier Aumaître, Camille Francès, Véronique Le Guern, et al.. Hydroxychloroquine in systemic lupus erythematosus: results of a French multicentre controlled trial (PLUS Study).. Annals of the Rheumatic Diseases, BMJ Publishing Group, 2013, 72 (11), pp.1786-92. ⟨10.1136/annrheumdis-2012-202322⟩. ⟨hal-00933279⟩

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