Description

An instrument was developed in the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) study for evaluating a flare of disease activity in lupus. This can be used to monitor a patient over time and to evaluate the response to therapeutic interventions.


 

Parameters:

(1) SLEDAI scores, current and previous

(2) symptoms (see below)

(3) prednisone dose

(4) additional medications

(5) physician global assessment (PGA), an 8 cm VAS scale anchored at 0 (none) and 3 (severe), with intermediate lines at 1 (mild) and 2 (moderate).

 

change in SLEDAI score =

= (current SLEDIA) – (previous SLEDIA)

Mild to Moderate Symptoms

Severe Symptoms

rash (discoid, photosensitive, profundus, cutaneous vasculitis, bullous lupus)

systemic vasculitis

nasopharyngeal ulcers

nephritis

pleuritis

myositis

pericarditis

thrombocytopenia (< 60,000 per µL)

arthritis

hemolytic anemia (hemoglobin < 7 g/dL or decrease by <= 3 g/dL)

fever due to SLE

 

 

Outcome classes:

(1) no change or better

(2) mild to moderate flare

(3) severe flare

 

No change or better:

(1) change in SLEDAI scores: decrease, no change, or increase <= 2 (not > 12 with increase)

(2) symptoms (improved or none)

(3) prednisone dose: decrease or unchanged

(4) additional medications: none

(5) PGA: decrease in PGA, or < 1.0

 

Mild to Moderate flare:

(1) change in SLEDAI scores: increase by >= 3 but not > 12

(2) symptoms: new or worsening of mild to moderate symptoms (see table above)

(3) prednisone dose: increase but not > 0.5 mg/kg/day

(4) additional medications: added NSAID or plaquenil for disease activity

(5) PGA: increase in PGA to >= 1.0 and <= 2.5

 

Severe flare:

(1) change in SLEDAI scores: increase to > 12

(2) symptoms: new or worsening severe symptoms (see table above), requiring hospitalization or increase in prednisone dose

(3) prednisone dose: > 0.5 mg/kg/day

(4) additional medications: new cytoxan, azathioprine, methotrexate

(5) PGA: increase to > 2.5

 


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