Relevance of Monitoring Blood and Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases
Condition: Systemic Lupus Erythematosus (SLE); Juvenile SLE; Cutaneous Lupus
MeSH terms: Lupus Erythematosus, Systemic; Autoimmune Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      No drug treatment is completely free of risk and lack of response, adverse events and poor
      adherence may affect its effectiveness. Within this context, this project aims to evaluate
      the importance of monitoring blood levels and salivary drug used in rheumatic autoimmune
      diseases in the monitoring of adherence to therapy. In addition, this project intends to use
      the monitoring of drug levels, based on pharmacokinetic studies and
      pharmacokinetics/pharmacodynamics modeling, to broaden the understanding of the possible
      cellular, tissue and immunological mechanisms involved in efficacy and adverse effects of
      these drugs with the prospect of reducing the damage and maintain therapeutic efficacy. The
      high-performance liquid chromatography (HPLC) coupled to mass spectrometry, which will be
      used to evaluate hydroxychloroquine, thalidomide, glucocorticoids, is considered the gold
      standard technology to qualitative and quantitative analysis of drugs in blood and its
      comparison with the dosage in the saliva is an improvement in simplification of the process.
      For biological agents the focus will be on the understanding the loss of efficacy and the
      possible role of anti-TNF antibodies using ELISA capture methodology.This project will be
      divided into four sections with their respective sub-projects according to the medications
      that will be studied: hydroxychloroquine, thalidomide, biologic agents and glucocorticoids.
    

Detailed description: 
      No drug treatment is completely free of risk and lack of response, adverse events and poor
      adherence may affect its effectiveness. There is also a large inter-individual variability in
      response to treatments with regard to efficacy and toxicity, and for many drugs, there is
      also a period of weeks to months to establish its efficacy. Within this context, this project
      aims to evaluate the importance of monitoring blood levels and salivary drug used in
      rheumatic autoimmune diseases in the monitoring of adherence to therapy. In addition, this
      project intends to use the monitoring of drug levels, based on pharmacokinetic studies and
      pharmacokinetics/pharmacodynamics modeling, to broaden the understanding of the possible
      cellular, tissue and immunological mechanisms involved in efficacy and adverse effects of
      these drugs with the prospect of reducing the damage and maintain therapeutic efficacy. The
      high-performance liquid chromatography (HPLC) coupled to mass spectrometry, which will be
      used to evaluate hydroxychloroquine, thalidomide, glucocorticoids, is considered the gold
      standard technology to qualitative and quantitative analysis of drugs in blood and its
      comparison with the dosage in the saliva is an improvement in simplification of the process.
      The implementation of this methodology dedicated to research in our center, with the
      necessary training of human resources, will enable the standardization and availability of
      this advanced technology to other muldisciplinary projects in various areas of science. For
      biological agents the focus will be on the understanding the loss of efficacy and the
      possible role of anti-TNF antibodies using ELISA capture methodology.This thematic project
      will be divided into four sections with their respective sub-projects according to the
      medications that will be studied: hydroxychloroquine, thalidomide, biologic agents and
      glucocorticoids.
    

Intervention name(s): Thalidomide; Hydroxychloroquine reduced; standard dose of HCQ
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Thalidomide 100 mg/day; Hydroxychloroquine 2.5 mg/kg/day; Hydroxychloroquine 5.0 mg/kg/day
Other intervention name(s): Thalidomide 100 mg; HCQ reduced; HCQ standard
Intervention MeSH terms: Hydroxychloroquine; Thalidomide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study includes 3 subprojects that will assess serum drug levels for efficacy and toxicity. In the first two subprojects, hydroxychloroquine will be studied in SLE population. In the third subproject, thalidomide and SLE and cutaneous lupus will be studied.
Masking: None (Open Label)
Primary purpose: Treatment