Lupus and Observance

Study Overview
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Brief Summary
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A poor therapeutic observance is described between 3 and 76% cases in systemic lupus. It is associated with an increased risk of relapses, hospitalizations, morbidity and poor renal prognosis. New treatment protocols exist and are indicated in second intention in case of good compliance. An assessment of therapeutic adherence is therefore essential. Patients with systemic lupus diagnosed for at least 6 months, or skin lupus, who have been prescribed with Plaquenil (hydroxychloroquine), will be included in the study. The study primary objective is to determine risk factors for non-observance The secondary objectives are to: Measure the observance rate of patients with systemic lupus in Martinique. Describe the parameters that influence observance: evaluation of the disease and associated comorbidities, psychosocial assessment, assessment of the doctor-patient relationship, evaluation of the disease representations.

Official Title
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Lupus and Observance

Conditions
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Systemic Lupus, Skin Lupus

Intervention / Treatment
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* Biological: Hydroxychloroquine dosage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Systemic lupus defined according to the diagnostic criteria of the American College of Rheumatology  1997, diagnosed for at least 6 months; Or Skin Lupus Consultation or hospitalization at the University Hospital of Martinique, in either services of Internal Medicine, Rheumatology or Dermatology. Prescription of hydroxychloroquine (Plaquenil®) for at least 6 months Affiliate or beneficiary of a social security scheme. Patient not opposed to participate in the study Exclusion Criteria: Age <18 years or patient under guardianship Patient not speaking and / or not understanding French No prescription and/or contraindication to hydroxychloroquine Systemic lupus outbreak with neurological impairment defined by SLEDAI score by a psychosis (disruption of normal activity in relation to a severe alteration of the perception of reality. Includes: hallucinations, incoherence, impoverishment of the content of thought, illogical reasoning, bizarre behavior, disorganized or catatonic) or brain damage (with impairment of mental functions with impaired orientation, memory or other brutal appearance and fluctuating evolution). History of psychiatric disorders: personality disorders, psychoses, severe depression Hospitalization with a life-threatening clinical condition that does not allow to answer questions Non affiliated patient or beneficiary of a social security scheme. Patient refusing to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Hydroxychloroquine dosage|Blood sample from a 6 ml tube, performed in the common practice.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is based on a blood dosage of hydroxychloroquine (HCQ) | The HCQ dosage is assayed on whole blood (6ml) by high-pressure liquid chromatography performance, reproducible and inexpensive method. Only one laboratory centralizes the sampling. A dosage below 200 ng/ml or 0.2 mg/l defines a non-observing patient within the 40 days above. | Reflects the Plaquenil intake during the 40 previous days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients considered as observing and non-observing will be compared according to the activity of the disease | Activity of the disease : Systemic lupus considered as active for a SELENA-SLEDAI score ≥ 6 | 40 days | 
| Patients considered as observing and non-observing will be compared according to number of prescribed medication |  | 40 days | 
| Patients considered as observing and non-observing will be compared according to the presence of anxiety and/or depressive disorders | Presence of anxiety and/or depressive disorders, according to the Hospital Anxiety And Depression Scale (HAD), a score > to 10 | 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic lupus erythematosus, observance, hydroxychloroquine dosage, risk factors of non-observance, SLICC score, SLEDAI score