Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease
Status:
Not yet recruiting
Trial end date:
2028-12-21
Target enrollment:
Participant gender:
Summary
Hydroxychloroquine (HCQ) is a systemic lupus erythematosus (SLE) medication that has been
very effective in reducing lupus disease activity and keeping patients stable with reduced
symptoms. Despite a track record of safety with regard to infection compared to traditional
immunosuppressive agents, the risk of HCQ retinal toxicity escalates with continued use.
Evaluation using sensitive standard of care approaches suggests nearly a third of patients
accrue retinal damage. Data are needed to accurately weigh the balance between accumulating
ocular exposure of HCQ versus the risk of disease flare in a population that may have more
inactive disease than younger patients. The purpose of this trial is to address the safety of
withdrawal of HCQ in SLE patients =60 years old. The central hypothesis is that HCQ can be
safely discontinued in stable/quiescent patients assessed by validated disease activity and
flare instruments in the context of serologic, cytokine and transcriptomic profiling.
Patients will be randomized to either the placebo or active arm and followed every 2 months
for one year to assess disease activity and flares.