Researchers conducted a randomized, double-blind trial to see if hydroxychloroquine could stop the progression of incomplete lupus erythematosus. The study included 187 patients aged 15 to 49 who had antinuclear antibody positivity and one or two other criteria for lupus. Participants were treated at seven different sites and followed for 24 months with check-ins every three months.
The main finding showed that the rate of acquiring new lupus features was the same in both groups. Specifically, 55 patients total developed additional criteria, and 24 patients total met the full classification for systemic lupus erythematosus. The drug did not reduce the risk of progressing to full disease compared to the placebo.
Safety was not a major concern in this report, as no adverse events or discontinuations were highlighted. The study did note that progression to lupus was associated with new symptoms like a malar rash or joint tenderness, regardless of treatment. Readers should understand that this trial offers insights into risk but does not show that hydroxychloroquine prevents disease progression in this specific population.