Table 2:
Baseline characteristics of patients used for patient profile development
| Variables | Patients for Step-3 (N=120) | Patients for Step-6 (N=66) | |
|---|---|---|---|
| Mean +/− SD or (N) % | Mean +/− SD or (N)% | ||
| Age at LN onset (year) | 13.47 ± 3.06 | 13.50 ± 2.89 | |
| Female | (96) 80% | (55) 83% | |
| Race | |||
| White | (59) 49% | (35) 53% | |
| Black or African American | (45) 37.5% | (25) 38% | |
| Other | (13) 11% | (5) 8% | |
| Unknown | (3) 2.5% | (1) 1% | |
| Ethnicity | |||
| Hispanic | (35) 29% | (19) 29% | |
| Non-Hispanic | (84) 70% | (47) 71% | |
| Unknown | (1) 1% | (0) 0% | |
| Laboratory testing | |||
| UPCR (mg/mg)¥ | 3.04 ± 3.85 | 2.77 ± 2.46 | |
| Serum Creatinine (mg/dL) | 0.90 ± 0.70 | 0.98 ± 0.89 | |
| SDI Total Score at LN onset ¶ | 0.19 ± 0.58 | 0.15 ± 0.47 | |
|
SLEDAI-2K†; % with feature present |
|||
| Seizure | (2) 2% | (1) 2% | |
| Organic Brain Syndrome | (3) 3% | (1) 2% | |
| Visual Disturbances | (2) 2% | (0) 0% | |
| Cranial Nerve Disorder | (1) 1% | (1) 2% | |
| Lupus Headache | (1) 1% | (1) 2% | |
| CVA# | (1) 1% | (0) 0% | |
| Vasculitis | (10) 10% | (8) 14% | |
| Arthritis | (45) 43% | (28) 49% | |
| Myositis | (7) 7% | (5) 9% | |
| Urinary Casts | (36) 35% | (17) 30% | |
| Hematuria | (80) 77% | (47) 82 % | |
| Proteinuria | (92) 88% | (53) 93% | |
| Pyuria | (60) 58% | (36) 63% | |
| Rash | (58) 56% | (34) 60% | |
| Alopecia | (7) 7% | (4) 7% | |
| Mucosal Ulcers | (13) 12.5% | (8) 14% | |
| Pleurisy | (7) 7% | (1) 2% | |
| Pericarditis | (12) 12% | (5) 9% | |
| Low Complement | (96) 92 % | (53) 93% | |
| Increased DNA Binding | (93) 89% | (53) 93% | |
| Fever | (21) 20% | (12) 21% | |
| Thrombocytopenia | (15) 14% | (9) 16% | |
| Leukopenia | (19) 18% | (12) 21% | |
| SLEDAI-2K Total Score | 19.88 ± 7.43 | 20.86 ± 6.78 | |
| Oral Prednisone (equivalent‡) (mg/day) | |||
| <7.5 | (11) 9% | (6) 9% | |
| 7.5, 16 | (7) 6% | (1) 2% | |
| 16, 45 | (51) 42.5% | (28) 42% | |
| >45 | (51) 42.5% | (31) 47% | |
| Other medications at Visit-1; % present | |||
| IV Methylprednisolone | (3) 2.5% | (1) 2% | |
| Mycophenolate mofetil | (3) 2.5% | (1) 2% | |
| Cyclophosphamide | (33) 27.5% | (26) 39% | |
| Angiotensin system inhibitors | (51) 42.5% | (24) 36% | |
Urine protein creatinine ratio (UPCR)
Systemic Lupus International Collaborating Clinics/ACR Damage Index. For item definitions please see: Gladman D, Ginzler E, Goldsmith C, Fortin P, Liang M, Urowitz M, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis and rheumatism. 1996;39(3):363–9.
SLE disease activity index, version 2K. For item definitions please see: Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002;29(2):288–91.
Cerebrovascular accident (CVA)
Other corticosteroid dosages were converted to prednisone equivalent doses