Evidence map›Paper›PMID 40955637›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2026

A Randomized, Placebo-Controlled Trial of Hydroxychloroquine in Incomplete Lupus.

Nancy J Olsen, Duanping Liao, Judith A James, Joel M Guthridge, Cristina Arriens, Diane Kamen, Mariko Ishimori, Daniel J Wallace, Christopher Striebich, Sonali Narain and 5 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2026. 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. Rheumatology 2050: How our specialty is changing.Future healthcare journal · 2025
    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

15 authors.

Nancy J OlsenDepartment of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania.ORCID 0000-0002-6588-3364
Duanping LiaoDepartment of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
Judith A JamesDepartment of Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City.ORCID 0000-0002-9574-7355
Joel M GuthridgeDepartment of Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City.
Cristina ArriensDepartment of Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City.ORCID 0000-0002-9546-1664
Diane KamenDepartment of Medicine, Medical University of South Carolina, Charleston.
Mariko IshimoriKao Autoimmunity Institute, Cedars Sinai Medical Center, Los Angeles, California.
Daniel J WallaceKao Autoimmunity Institute, Cedars Sinai Medical Center, Los Angeles, California.
Christopher StriebichDepartment of Medicine, Anschutz Medical Center, University of Colorado, Aurora.
Sonali NarainDonald and Barbara Zucker School of Medicine at Hofstra/Northwell Health, Great Neck, New York.
Benjamin F ChongDepartment of Medicine, University of Texas Southwestern Medical Center, Dallas.ORCID 0000-0002-4092-7658
Fan HeDepartment of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
Eric W SchaeferDepartment of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
Vernon M ChinchilliDepartment of Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
David R KarpDepartment of Medicine, University of Texas Southwestern Medical Center, Dallas.ORCID 0000-0002-9005-1690

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
Tracking and Evaluation CoreU54GM104938 · NIGMS · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI TIMOTHY M VANWAGONER · 2013 to 2026
$68.2M
UT Southwestern Center for Translational MedicineUL1TR003163 · NCATS · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2021 to 2025
$39.3M
Oklahoma Rheumatic Disease Research Cores Center (Overall Application)P30AR073750 · NIAMS · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI JUDITH A JAMES · 2018 to 2026
$8.5M
Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE)U01AR071077 · NIAMS · PENNSYLVANIA STATE UNIV HERSHEY MED CTR · PI KARP, DAVID R, OLSEN, NANCY J · 2017 to 2022
$6.8M
Oklahoma ACE: Molecular Destruction of Autoimmune Disease to Aid Clinical Trail SuccessUM1AI144292 · NIAID · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI JUDITH A JAMES · 2019 to 2026
$3.3M
NCATS NIH HHS UL1 TR003163NIAMS NIH HHS U01 AR071077NIH HHS P30AR073750NIH HHS U01AI76244NIH HHS U01AR071077NIH HHS U54GM104938NIH HHS U54TR002014NIH HHS UL1TR001881NIH HHS UL1TR003163NIH HHS UM1AI144292
6 · The paper itself

Abstract

objectivePatients with features of systemic lupus erythematosus (SLE) who do not fulfill classification criteria can be designated as incomplete lupus erythematosus (ILE). This condition includes individuals with a high risk of progression to SLE. Treatment of ILE may reduce symptoms, severity, and incidence of SLE.

methodsHydroxychloroquine (HCQ) was chosen as an ILE intervention for a randomized, double-blind trial to determine whether the rate of accumulation of SLE features defined by the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria could be reduced. ILE was defined as antinuclear antibody positivity with one to two additional criteria. Patients 15 to 49 years old were eligible. Randomization was 1:1 HCQ to placebo. Evaluations were at 3-month intervals over 24 months. Meeting SLICC classification sooner required exit.

resultsParticipants (N = 187) were randomized at seven sites. After excluding 7 patients who met SLE classification at baseline when screening laboratory data were completed, 180 patients were analyzed: 92 receiving HCQ and 88 receiving placebo. Considering all these enrollees, 55 developed additional criteria. Of the 118 participants who exited early with SLE or who completed 24 months of evaluation, SLE classification developed in 24 (13.3%); another 24 developed additional criteria but did not meet classification. The rates of acquisition of SLICC criteria and progression to SLE were similar in the two groups (P = 0.72 and P = 0.98, respectively). Development of SLE was associated with new malar rash, oral ulcers, joint tenderness, or pleurisy (P < 0.04).

conclusionAlthough the Study of Antimalarials in Incomplete Lupus Erythematosus (SMILE) did not show effects of HCQ on ILE progression, the results offer insights into SLE risk in the ILE population.

Indexed as

Antirheumatic AgentsHydroxychloroquineLupus Erythematosus, SystemicAdolescentAdultAntibodies, AntinuclearDisease ProgressionDouble-Blind MethodFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeYoung AdultAntibodies, AntinuclearAntirheumatic AgentsHydroxychloroquine

Identifiers

PMID40955637
PMCPMC13054461

What OpenQuestion holds

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LicenceCC BY
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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.