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TOPLINE:

Hydroxychloroquine did not slow progression from incomplete to full-blown systemic lupus erythematosus (SLE) in patients who had antinuclear antibody (ANA) positivity and met one or two SLE classification criteria.

METHODOLOGY:

• Researchers conducted a randomized, double-blind trial to evaluate whether hydroxychloroquine could slow the accumulation of features of SLE in patients with incomplete lupus erythematosus.
• They included 180 patients who had ANA positivity and met one or two classification criteria for SLE (mean age, 33 years; 91% women; 74.4% White individuals) and randomly assigned them 1:1 to receive hydroxychloroquine or placebo.
• Patients were evaluated at 3-month intervals over 24 months; those who met four or more classification criteria for SLE were required to exit the trial.
• The primary endpoint was the rate of accumulation of SLE International Collaborating Clinics (SLICC) criteria, and the secondary endpoints included the proportion of patients who transitioned to SLE.

TAKEAWAY:

• During the trial, 24 patients progressed to SLE and were required to exit the study.
• Rates of acquiring new SLICC criteria and progression to SLE were comparable between the hydroxychloroquine and placebo groups (P = .72 and P = .98, respectively).
• Malar rash, oral ulcers, joint tenderness, or pleurisy (P < .04) predicted progression to SLE in patients with incomplete lupus erythematosus.

IN PRACTICE:

“Targeting the [incomplete lupus erythematosus] population for early intervention has the potential to decrease or prevent severe SLE manifestations,” the authors wrote.

SOURCE:

The study was led by Nancy Olsen, MD, Penn State Health Milton S. Hershey Medical Center in Hershey, Pennsylvania. It was published online on September 16, 2025, in Arthritis & Rheumatology.

LIMITATIONS:

There was a predominance of White patients older than 30 years in the study population. Additionally, hydroxychloroquine levels were not measured during the study, making it impossible to determine if subtherapeutic dosing affected the results.

DISCLOSURES:

The study received support through awards from the National Institutes of Health, the National Center for Advancing Translational Sciences, National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors reported having no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.