Effects of Stopping Hydroxychloroquine in Elderly Lupus Disease

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for theduration of the study

• Age ≥ 60 years at time of enrollment

• Normal OCT and VF assessment within 6 months of screening visit

• Ability to take oral medication

• Have established SLE (≥ 4 ACR criteria or SLICC criteria or ≥ 10 points by EULARcriteria, SLE diagnosed at least seven years ago)

• Stable disease at screening visit by attaining DORIS remission (meeting allcriterion listed below) and not on any immunosuppressants.

• Criterion 1: Clinical SLEDAI= 0

• Criterion 2: SELENA-SLEDAI PGA ≤ 0.5 (on a scale from 0-3, where 0 is nodisease activity and 3 is maximum disease activity)

• Criterion 3: Current prednisolone (or equivalent corticosteroid) dose ≤ 5 mgdaily

• No moderate or severe flares one year prior to screening

• Taking ≥ 200 HCQ daily for ≥ 7 years

Exclusion Criteria:

• Any patient that does not attain stable disease status by DORIS

• Ophthalmologic evidence of retinopathy (these patients would be advised todiscontinue HCQ and therefore unethical to randomize for this study)

• Clinical SLEDAI > 0

• Taking > 5 mg/day prednisone

• Taking any immunosuppressive drugs or biological agents (including: methotrexate,azathioprine, mycophenolate mofetil, mycophenolic acid, leflunomide, cyclosporine,cyclophosphamide, tacrolimus, rituximab, and belimumab)

• Any reason the treating rheumatologist is concerned about ongoing activity notcaptured by SLEDAI

• HCQ level < 100 ng/ml as this would support noncompliance and less reliance on HCQto control activity

• Patient unwilling or unable to comply with study procedures for any reason

• Any indications of potentially diminished capacity, such as a diagnosis of dementiaor cognitive impairment (including, but not limited to stroke-related cognitiveimpairment)