1. Malar rash: Fixed erythema, flat or raised, over the malar eminences, tending to spare the nasolabial folds |
2. Discoid rash: Erythematous raised patches with adherent keratotic scaling and follicular plugging; atrophic scarring may occur in older lesions: |
3. Photosensitivity: Skin rash as a result of unusual reaction to sunlight, by patient history or physician observation |
4. Oral ulcers: Oral or nasopharyngeal ulceration, usually painless, observed by physician |
5. Arthritis: Nonerosive arthritis involving 2 or more peripheral joints, characterized by tenderness, swelling, or effusion |
6. Serositis: a) Pleuritis--convincing history of pleuritic pain or rubbing heard by a physician or evidence of pleural effusion OR b) Pericarditis--documented by ECG or rub or evidence of pericardial effusion |
7. Renal disorder: a) Persistent proteinuria greater than 0.5 grams per day or greater than 3+ if quantitation not performed OR b) Cellular casts--may be red cell, hemoglobin, granular, tubular, or mixed |
8. Neurologic disorder: a) Seizures--in the absence of offending drugs or known metabolic derangements; e.g., uremia, ketoacidosis, or electrolyte im-balance OR b) Psychosis--in the absence of offending drugs or known metabolic derangements, e.g., uremia, ketoacidosis, or electrolyte imbalance |
9. Hematologic disorder: a) Hemolytic anemia--with reticulocytosis OR b) Leukopenia--less than 4,000/mm3total on 2 or more occasions OR c) Lyphopenia--less than 1,500/mm3on 2 or more occasions OR d) Thrombocytopenia--less than 100,000/mm3in the absence of offending drugs |
10. Immunologic disorder: a) Positive LE cell preparation OR b) Anti-DNA: antibody to native DNA in abnormal titer OR c) Anti-Sm: presence of antibody to Sm nuclear antigen OR d) False positive serologic test for syphilis known to be positive for at least 6 months and confirmed by Treponema pallidum immobilization or fluorescent treponemal antibody absorption test |
11. Antinuclear antibody: An abnormal titer of antinuclear antibody by immunofluorescence or an equivalent assay at any point in time and in the absence of drugs known to be associated with "drug-induced lupus" syndrome |