TY - JOUR
T1 - A Prospective International Study on Adherence to Treatment in 305 Patients With Flaring SLE
T2 - Assessment by Drug Levels and Self-Administered Questionnaires
AU - Costedoat-Chalumeau, Nathalie
AU - Houssiau, Frédéric
AU - Izmirly, Peter
AU - Le Guern, Véronique
AU - Navarra, Sandra
AU - Jolly, Meenakshi
AU - Ruiz-Irastorza, Guillermo
AU - Baron, Gabriel
AU - Hachulla, Eric
AU - Agmon-Levin, Nancy
AU - Shoenfeld, Yehuda
AU - Dall'Ara, Francesca
AU - Buyon, Jill
AU - Deligny, Christophe
AU - Cervera, Ricard
AU - Lazaro, Estibaliz
AU - Bezanahary, Holy
AU - Leroux, Gaëlle
AU - Morel, Nathalie
AU - Viallard, Jean François
AU - Pineau, Christian
AU - Galicier, Lionel
AU - Van Vollenhoven, Ronald
AU - Tincani, Angela
AU - Nguyen, Hanh
AU - Gondran, Guillaume
AU - Zahr, Noel
AU - Pouchot, Jacques
AU - Piette, Jean Charles
AU - Petri, Michelle
AU - Isenberg, David
N1 - Funding Information:
We thank the URC-CIC Paris Descartes Necker/Cochin (Ms. Séverine Poignad and Leyya Mansoor) for implementation, monitoring, and data management of the study as well as Ms. Kubéraka Mariampillai, Séverine Nieuwland-Husson, and Ada Clarke for their assistance. This study was funded by a research grant from the French Ministry of Health (PHRC 2012: n812-002-0114), and sponsored by the Département de la Recherche Clinique et du Développement de l’Assistance Publique– Hôpitaux de Paris. The Hopkins Lupus Cohort was funded and supported by NIH AR 43727 and AR 69572Z.
PY - 2018/6
Y1 - 2018/6
N2 - Nonadherence to treatment is a major cause of lupus flares. Hydroxychloroquine (HCQ), a major medication in systemic lupus erythematosus, has a long half-life and can be quantified by high-performance liquid chromatography. This international study evaluated nonadherence in 305 lupus patients with flares using drug levels (HCQ <200 ng/ml or undetectable desethylchloroquine), and self-administered questionnaires (MASRI <80% or MMAS-8 <6). Drug levels defined 18.4% of the patients as severely nonadherent. In multivariate analyses, younger age, nonuse of steroids, higher body mass index, and unemployment were associated with nonadherence by drug level. Questionnaires classified 39.9% of patients as nonadherent. Correlations between adherence measured by questionnaires, drug level, and physician assessment were moderate. Both methods probably measured two different patterns of nonadherence: self-administered questionnaires mostly captured relatively infrequently missed tablets, while drug levels identified severe nonadherence (i.e., interruption or erratic tablet intake). The frequency with which physicians miss nonadherence, together with underreporting by patients, suggests that therapeutic drug monitoring is useful in this setting. (Trial registration: ClinicalTrials.gov: NCT01509989.).
AB - Nonadherence to treatment is a major cause of lupus flares. Hydroxychloroquine (HCQ), a major medication in systemic lupus erythematosus, has a long half-life and can be quantified by high-performance liquid chromatography. This international study evaluated nonadherence in 305 lupus patients with flares using drug levels (HCQ <200 ng/ml or undetectable desethylchloroquine), and self-administered questionnaires (MASRI <80% or MMAS-8 <6). Drug levels defined 18.4% of the patients as severely nonadherent. In multivariate analyses, younger age, nonuse of steroids, higher body mass index, and unemployment were associated with nonadherence by drug level. Questionnaires classified 39.9% of patients as nonadherent. Correlations between adherence measured by questionnaires, drug level, and physician assessment were moderate. Both methods probably measured two different patterns of nonadherence: self-administered questionnaires mostly captured relatively infrequently missed tablets, while drug levels identified severe nonadherence (i.e., interruption or erratic tablet intake). The frequency with which physicians miss nonadherence, together with underreporting by patients, suggests that therapeutic drug monitoring is useful in this setting. (Trial registration: ClinicalTrials.gov: NCT01509989.).
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U2 - 10.1002/cpt.885
DO - 10.1002/cpt.885
M3 - Article
C2 - 28925027
AN - SCOPUS:85033481352
VL - 103
SP - 1074
EP - 1082
JO - Clinical Pharmacology and Therapeutics
JF - Clinical Pharmacology and Therapeutics
SN - 0009-9236
IS - 6
ER -