Evidence map›Paper›PMID 38294544›Full record

Observational studyRheumatology international2024

Assessment of hydroxychloroquine blood levels in Sjögren's disease patients: drug adherence and clinical associations.

Sandra Gofinet Pasoto, Lorena Elizabeth Betancourt Villamarín, Léonard de Vinci Kanda Kupa, Giordano Bruno Henriques Deveza, Carolina Torres Ribeiro, Nádia Emi Aikawa, Elaine Pires Leon, Victor Adriano de Oliveira Martins, Clovis Artur Silva, Eloisa Bonfa

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Rheumatology international, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Sandra Gofinet PasotoRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil. sandra.pasoto@hc.fm.usp.br.ORCID http://orcid.org/0000-0002-7343-6804
Lorena Elizabeth Betancourt VillamarínRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.ORCID http://orcid.org/0000-0001-8382-1119
Léonard de Vinci Kanda KupaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.ORCID http://orcid.org/0000-0002-8827-1360
Giordano Bruno Henriques DevezaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.ORCID http://orcid.org/0000-0003-4277-3821
Carolina Torres RibeiroRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.ORCID http://orcid.org/0000-0002-2039-1649
Nádia Emi AikawaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.ORCID http://orcid.org/0000-0002-7585-4348
Elaine Pires LeonRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.ORCID http://orcid.org/0000-0001-9457-3317
Victor Adriano de Oliveira MartinsRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.ORCID http://orcid.org/0000-0002-5926-3388
Clovis Artur SilvaPediatric Rheumatology Unit, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.ORCID http://orcid.org/0000-0001-9250-6508
Eloisa BonfaRheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.ORCID http://orcid.org/0000-0002-0520-4681

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 303116/2022-6Conselho Nacional de Desenvolvimento Científico e Tecnológico 304984/2020-5Conselho Nacional de Desenvolvimento Científico e Tecnológico 305242/2019-9Fundação de Amparo à Pesquisa do Estado de São Paulo 2015/03756-4Fundação de Amparo à Pesquisa do Estado de São Paulo 2018/09937-9Fundação de Amparo à Pesquisa do Estado de São Paulo 2019/17272-0Fundação de Amparo à Pesquisa do Estado de São Paulo 2019/21173-7Fundação de Amparo à Pesquisa do Estado de São Paulo 2020/09367-8Fundação de Amparo à Pesquisa do Estado de São Paulo 2020/11677-5
6 · The paper itself

Abstract

Hydroxychloroquine (HCQ) has been used to treat Sjögren's disease (SjD) patients. However, there are no studies evaluating drug adherence through HCQ blood levels, pharmacy refill (PR) and medication adherence questionnaires. The relationship of HCQ blood levels with glandular/extraglandular disease parameters was also poorly assessed. This cross-sectional observational study included 74 adult SjD patients, who were receiving a stable HCQ dose (4-5.5 mg/kg/day, actual weight) for at least 3 months before study inclusion. HCQ blood levels were quantified by high-performance liquid chromatography coupled to mass spectrometry. Adherence was assessed by PR and Medida de Adesão aos Tratamentos (MAT) questionnaire. The following parameters were evaluated: Xerostomia Inventory, Ocular Surface Disease Index, EULAR (European League Against Rheumatism) Sjögren's Syndrome Disease Activity Index, EULAR Sjögren's Syndrome Patient Reported Index, Schirmer's I test and non-stimulated/stimulated salivary flow rates. HCQ blood levels were 775.3(25.0-2,568.6)ng/mL. Eleven patients (14.9%) had HCQ blood levels < 200ng/mL (non-adherent group); 11(14.9%), 200-499ng/mL (sub-therapeutic levels group); and 52(70.2%), ≥ 500ng/mL (adherent group). PR classified incorrectly all non-adherent/sub-therapeutic patients and 2/52(3.9%) adherent patients. Using MAT, the overall misclassification was 24/52(46.2%) in the adherent group, and were correctly identified 9/11(81.8%) patients in non-adherent and 7/11(63.6%) in sub-therapeutic groups. MAT sensitivity and specificity to identify non-adherent/sub-therapeutic patients were 72.7% and 53.9%, respectively. The three groups were comparable regarding glandular/extraglandular disease parameters (p > 0.05). The assessment of HCQ blood levels is a promising tool for evaluating drug adherence in SjD. This is particularly crucial as one-third of patients exhibited non-adherence/sub-therapeutic levels, and neither PR nor MAT reliably identified these patients.

Indexed as

Antirheumatic AgentsHydroxychloroquineMedication AdherenceSjogren's SyndromeAdultAgedCross-Sectional StudiesFemaleHumansMaleMiddle AgedSurveys and QuestionnairesAntirheumatic AgentsHydroxychloroquineAdherenceHydroxychloroquineLC-MS/MSSjogren diseaseSjogren syndromeTreatment

Identifiers

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.