Pre-emptive Treatments in Lupus Nephritis Patients With Serological Reactivation

LN patients who presented with ASR [defined as 1) increase in anti-dsDNA >100 IU/mL , with or without drop in serum complement; or 2) increase in anti-dsDNA to higher than the normal range and >2 times of the preceding value, with or without drop in serum complement; and 3) Absence of renal or systemic manifestations of SLE) will be randomized to receive pre-emptive increase in immunosuppression or had their current immunosuppressive therapies unchanged.

Patients will be followed at 4-, 12-, 24-wk and then every 12 weeks up to 24 months to monitor for renal or extra-renal relapses. Bloods and urine will be collected for measurement of renal and serological parameters, and also B cell signatures.

Primary outcomes: Renal Flare (denoted as proteinuria >1g/D; presence of urinary RBC >30 hpf/RBC casts, or increase in SCr >15% and positive anti-dsDNA)

Secondary outcomes:

• Safety & tolerability of pre-emptive increase of immunosuppressive treatments
• Extra-renal flares
• Renal function at 24 months
• Changes in serological parameters

Inclusion criteria

• Patients with biopsy-proven lupus nephritis who experienced an episode of Asymptomatic Serological Flare (ASF) as defined by:

• Increase in anti-dsDNA to >100 IU/mL, with or without drop in serum complement levels OR
• Increase in anti-dsDNA to higher than the normal range and more than two times of the preceding value, with or without drop in serum complement levels

AND

• Absence of renal or systemic manifestation of SLE.

Exclusion criteria

• Patients who cannot provide informed consent.
• Patients whom the clinicians opined to have excessively high risk of infection or malignancy.
• Patients who are pregnant or lactating.