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Analysis of blood hydroxychlorochine levels in patients with primary Sjogren Syndrome and possible correlation with the disease activity

Grant number: 20/09367-8
Support Opportunities:Scholarships in Brazil - Doctorate (Direct)
Effective date (Start): August 01, 2020
Effective date (End): February 28, 2022
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Sandra Gofinet Pasoto
Grantee:Lorena Elizabeth Betancourt Villamarín
Host Institution: Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
Associated research grant:15/03756-4 - Assessment of relevance of blood levels of drugs in the monitoring rheumatic autoimmune diseases: safety, effectiveness and adherence to therapy, AP.TEM


Primary Sjögren's Syndrome (pSS) is an autoimmune disease characterized by chronic inflammatory infiltration of the salivary and lacrimal glands causing dry eye and mouth. Multiple systemic manifestations can also occur. Hydroxychloroquine (HCQ), an antimalarial immunomodulator, has been used for the treatment of arthralgias, myalgia and constitutional symptoms resulting from pSS. However, there are no studies that evaluated whether blood levels of HCQ could influence in the therapeutic response, as has been reported in Systemic Lupus Erythematosus (SLE). Objectives: To analyze in patients with pSS receiving HCQ as part of their treatment: blood levels of HCQ; adherence using a questionnaire versus blood levels and the possible correlation of blood levels with the disease activity score in a cross-sectional evaluation followed by a longitudinal six-month assessment. Patients and methods: Observational cross-sectional evaluation followed by a six-month longitudinal assessment, including patients with pSS receiving HCQ for at least 3 months at study admission. Patients will be evaluated clinically and the HCQ blood level measured at the beginning of the study (T0), at 3 months (T3), and at 6 months (T6). As there are no previous studies on blood levels of HCQ in patients with pSS, the sample of 75 patients was calculated based on the percentage of these patients currently using HCQ in our service (nearly 50%) and in the number of patients in current follow-up (about 150). We will evaluate 75 adult patients with pSS according to the classification criteria of the American-European Consensus Group 2002 and/or the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) 2016, of both sexes and followed up regularly at the Sjögren Syndrome outpatient Clinic of the Rheumatology Service of "Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)". The following tools will be used in the clinical evaluation: the xerostomia Inventory; the xerophthalmia questionnaire - Ocular Surface Disease Index (OSDI); the EULAR Sjögren Syndrome Reported Index (ESSPRI); the EULAR Sjögren Syndrome Disease Activity Index (ESSDAI); the Sjögren's Syndrome Disease Damage Index (SSDDI); the non-stimulated and stimulated salivary flow and the 8-item Morisky Medication Adherence Scale. Blood levels of HCQ will be measured by high performance liquid chromatography and Tandem mass spectrometry. (AU)

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Scientific publications (4)
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
PASOTO, SANDRA GOFINET; HALPERN, ARI STIEL RADU; NORONHA GUEDES, LISSIANE KARINE; MEDEIROS RIBEIRO, ANA CRISTINA; FIGUEIREDO YUKI, EMILY NEVES; SCHAHIN SAAD, CARLA GONCALVES; ALMEIDA DA SILVA, CLOVIS ARTUR; KANDA KUPA, LEONARD DE VINCI; BETANCOURT VILLAMARIN, LORENA ELIZABETH; DE OLIVEIRA MARTINS, VICTOR ADRIANO; et al. Inactivated SARS-CoV-2 vaccine in primary Sjogren's syndrome: humoral response, safety, and effects on disease activity. CLINICAL RHEUMATOLOGY, v. 41, n. 7, p. 11-pg., . (20/11677-5, 20/09367-8, 19/17272-0, 17/14352-7, 15/03756-4, 18/09937-9, 21/08455-3)
ROSA M.R. PEREIRA; MARILIA A. DAGOSTIN; VALERIA F. CAPARBO; LUCAS P. SALES; SANDRA G. PASOTO; CLOVIS A. SILVA; EMILY F.N. YUKI; CARLA G.S. SAAD; ANA C. MEDEIROS-RIBEIRO; LEONARD V.K. KUPA; et al. Anti-SARS-CoV-2 inactivated vaccine in patients with ANCA-associated vasculitis: Immunogenicity, safety, antibody decay and the booster dose. Clinics, v. 78, . (19/17272-0, 15/03756-4, 20/09367-8, 18/09937-9, 21/08455-3)
SILVA, CLOVIS A.; MEDEIROS-RIBEIRO, ANA C.; KUPA, LEONARD V. K.; YUKI, EMILY F. N.; PASOTO, SANDRA G.; SAAD, CARLA G. S.; FUSCO, SOLANGE R. G.; PEREIRA, ROSA M. R.; SHINJO, SAMUEL K.; HALPERN, ARI S. R.; et al. Immunogenicity decay and case incidence six months post Sinovac-CoronaVac vaccine in autoimmune rheumatic diseases patients. NATURE COMMUNICATIONS, v. 13, n. 1, p. 9-pg., . (15/03756-4, 18/09937-9, 20/09367-8, 19/17272-0)
AIKAWA, NADIA EMI; KANDA KUPA, LEONARD DE VINCI; MEDEIROS-RIBEIRO, ANA CRISTINA; SCHAHIN SAAD, CARLA GONCALVES; NEVES YUKI, EMILY FIGUEIREDO; PASOTO, SANDRA GOFINET; ROJO, PRISCILA TAGLIAFERRO; RODRIGUES PEREIRA, ROSA MARIA; SHINJO, SAMUEL KATSUYUKI; SAMPAIO-BARROS, PERCIVAL DEGRAVA; et al. Increment of immunogenicity after third dose of a homologous inactivated SARS-CoV-2 vaccine in a large population of patients with autoimmune rheumatic diseases. ANNALS OF THE RHEUMATIC DISEASES, v. 81, n. 7, p. 8-pg., . (20/09367-8, 19/17272-0, 15/03756-4, 18/09937-9)
Academic Publications
(References retrieved automatically from State of São Paulo Research Institutions)
VILLAMARÍN, Lorena Elizabeth Betancourt. Assessment of hydroxychloroquine blood levels in patients with Sjögren\'s disease: medication adherence and clinical correlations. 2024. Doctoral Thesis - Universidade de São Paulo (USP). Faculdade de Medicina (FM/SBD) São Paulo.

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