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Objective  To examine correlations between blood levels of complement split product  iC 3b and serum component C3 with clinically meaningful changes in disease activity in patients with systemic lupus erythematosus ( SLE ).    Methods  A total of 159 consecutive patients with  SLE , diagnosed according to the American College of Rheumatology or Systemic Lupus International Collaborating Clinics classification criteria, were enrolled in  CASTLE  (Complement Activation Signatures in Systemic Lupus Erythematosus), a prospective observational study. Patients with 1–7 study visits were included in this longitudinal analysis. In addition, 48 healthy volunteers were enrolled to establish a normal reference value for the ratio of blood  iC 3b to serum C3 concentrations. Serum C3 and C4 levels were measured by nephelometry, and blood  iC 3b levels were measured by a lateral flow assay.  SLE  disease activity was monitored with the Responder Index 50 instrument of the  SLE  Disease Activity Index 2000.    Results  Relative changes in the  iC 3b:C3 ratio, levels of anti–double‐stranded  DNA  (anti‐ds DNA ) antibodies, and use of a supraphysiologic dose of prednisone (>7.5 mg/day) each independently correlated with  SLE  disease activity, as determined in multilevel multiple logistic regression analyses. Only the  iC 3b:C3 ratio was significantly associated with clinically meaningful improvements in disease activity among patients with  SLE  who were receiving a supraphysiologic dose of prednisone. The  iC 3b:C3 ratio outperformed C3 and C4 levels with regard to discriminating active  SLE  from inactive  SLE , and major flares from no disease activity. The  iC 3:C3 ratio, anti‐ds DNA  antibody levels, erythrocyte sedimentation rate, and use of a supraphysiologic prednisone dose were each independently associated with the presence of lupus nephritis, whereas none of these measures was associated with  SLE  rash. The association of the  iC 3b:C3 ratio with lupus nephritis was independent of other observed clinical manifestations.    Conclusion  The ratio of blood  iC 3b to serum C3 concentrations correlates with the extent of  SLE  disease activity and with clinically meaningful changes in disease activity in patients with  SLE . Furthermore, the  iC 3b:C3 ratio may discriminate between active and inactive  SLE , and between major flares and no active disease.

Association of Blood Concentrations of Complement Split Product iC 3b and Serum C3 With Systemic Lupus Erythematosus Disease Activity