Evidence map›Paper›PMID 40081891›Full record

Trial reportLupus science & medicine2025

Comparison of flares in 85 patients with SLE who maintained, discontinued or reduced dose of hydroxychloroquine during a prospective study of ophthalmological screening for retinopathy (PERFOCTAPS Study).

Joana Isabel Marques Dias, Kevin Chevalier, Vivien Vasseur, Elsa Laumonier, Sabine Derrien, Nathalie Morel, Véronique Le Guern, Alexis Mathian, Luc Mouthon, Martine Mauget Faÿsse and 2 more

Registry-linked trialAbstract readComparative StudyClinical Trial
In one paragraph

Trial report in Lupus science & medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02719002 (Studying the Performance of OCT C-scan in the Screening for Retinopathy Related to Synthetic Antimalarials), which is not on this 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.

NCT02719002 nacompletednot on this map

Studying the Performance of OCT C-scan in the Screening for Retinopathy Related to Synthetic Antimalarials

TypeinterventionalSponsorFondation Ophtalmologique Adolphe de RothschildRan2016 to 2021Enrolled109ConditionsToxicity, Drug, MaculopathyArmsspectral domain optical coherence tomography C-scan and multifocal electroretinogram
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

12 authors.

Joana Isabel Marques DiasInternal Medicine, Hospital Beatriz Angelo, Loures, Portugal.ORCID 0000-0003-1407-0790
Kevin ChevalierDepartment of Internal Medicine, Centre de Référence Maladies Auto-Immunes et Systémiques Rares d'Ile de France, AP-HP.Centre, Université Paris Cité, Hospital Cochin, Paris, France.
Vivien VasseurClinical Investigation Platform, Rothschild Foundation Hospital, Paris, France.
Elsa LaumonierElectrophysiology Department, Rothschild Foundation Hospital, Paris, France.
Sabine DerrienElectrophysiology Department, Rothschild Foundation Hospital, Paris, France.
Nathalie MorelDepartment of Internal Medicine, Centre de Référence Maladies Auto-Immunes et Systémiques Rares d'Ile de France, AP-HP.Centre, Université Paris Cité, Hospital Cochin, Paris, France.
Véronique Le GuernDepartment of Internal Medicine, Centre de Référence Maladies Auto-Immunes et Systémiques Rares d'Ile de France, AP-HP.Centre, Université Paris Cité, Hospital Cochin, Paris, France.
Alexis MathianService de Médecine Interne 2, Centre de Référence lupus et syndrome des antiphospholipides, Pitié-Salpêtrière University Hospital, Paris, France.
Luc MouthonDepartment of Internal Medicine, Centre de Référence Maladies Auto-Immunes et Systémiques Rares d'Ile de France, AP-HP.Centre, Université Paris Cité, Hospital Cochin, Paris, France.
Martine Mauget FaÿsseClinical Investigation Platform, Rothschild Foundation Hospital, Paris, France.
Yann NguyenDepartment of Internal Medicine, Centre de Référence Maladies Auto-Immunes et Systémiques Rares d'Ile de France, AP-HP.Centre, Université Paris Cité, Hospital Cochin, Paris, France.ORCID 0000-0002-0866-3824
Nathalie Costedoat-ChalumeauDepartment of Internal Medicine, Centre de Référence Maladies Auto-Immunes et Systémiques Rares d'Ile de France, AP-HP.Centre, Université Paris Cité, Hospital Cochin, Paris, France nathalie.costedoat@aphp.fr.ORCID 0000-0002-1555-9021

Funding

EPA EP-C-15-008
6 · The paper itself

Abstract

objectiveLittle is known about the risk of SLE flares associated with hydroxychloroquine (HCQ) reduction or cessation, especially after ophthalmological screening. We analysed the risk of SLE flares after HCQ reduction or discontinuation after detection of early ophthalmological toxicity.

methodsThis study includes all patients with SLE among the 109 included in the prospective PERFOCTAPS Study and treated with HCQ for at least 5 years. Patients were divided into 3 groups: HCQ maintenance, reduction and discontinuation after intensive ophthalmological screening. Flare occurrence (SELENA-SLEDAI Flare Index) was assessed for 2 years after HCQ reduction or discontinuation or after inclusion in the maintenance group.

resultsThis study included 85 patients (98% women, mean age 40.0 years, and mean durations of SLE and HCQ treatment 14.4±7.7 years and 12.9±7.2 years, respectively). The PERFOCTAPS Study identified ophthalmological abnormalities in 25 patients (29.4%); these led to dose reduction in 20 patients and discontinuation in 5. Flares occurred in 29 patients (34.1%): 17 (28.3%) in the maintenance group, 10 (50%) in the reduction group and 2 (40%) in the discontinuation group. After adjustment for potential confounders, HCQ reduction was independently associated with the risk of flare (adjusted HR 2.26; 95% CI 1.03 to 4.97). The same trend was observed in the discontinuation group, but was no longer statistically significant (adjusted HR 2.13; 95% CI 0.44 to 10.27).

conclusionIn this prospective study, HCQ reduction due to early suspicion of retinal toxicity was associated with a statistically significantly increased risk of disease flare. TRIAL REGISTRATION NUMBER: NCT02719002.

Indexed as

Antirheumatic AgentsHydroxychloroquineLupus Erythematosus, SystemicRetinal DiseasesAdultFemaleHumansMaleMiddle AgedProspective StudiesSymptom Flare UpAntirheumatic AgentsHydroxychloroquineAutoimmune DiseasesLupus Erythematosus, SystemicTherapeutics

Identifiers

PMID40081891
PMCPMC11907073

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Registered trials

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.